Objective To provide references for improving the authenticity and reliability of the retrospective study results,thus improving the quality of evidence in the real world and strengthening drug supervision and decisio...Objective To provide references for improving the authenticity and reliability of the retrospective study results,thus improving the quality of evidence in the real world and strengthening drug supervision and decision-making.Methods Literature review was used to study the data sources,the characteristics of retrospective research,the sources and the corrections of selective bias in the real world.Results and Conclusion The biases in retrospective study mainly come from admission rate bias,patient rate bias,survivors bias,health user bias and symptom bias.展开更多
Objective To introduce the design of observational trials under real-world study(RWS),and to provide guidance for clinical development of new research trials and reference for real-world researchers.Methods Relevant l...Objective To introduce the design of observational trials under real-world study(RWS),and to provide guidance for clinical development of new research trials and reference for real-world researchers.Methods Relevant literature of RWS and observational experiments at home and abroad were reviewed and analyzed,and then the design of observational studies was summarized under RWS.Results and Conclusion The data and information provided in observational studies not only help to further verify the clinical study results obtained by randomized controlled trial(RCT)in clinical practice,but also objectively reflect the real situation in the process of clinical research and application.展开更多
BACKGROUND Lenvatinib has become an indispensable part of treatment regimens for patients with advanced hepatocellular carcinoma(aHCC).Several recent real-world studies appear to have confirmed this;however,there are ...BACKGROUND Lenvatinib has become an indispensable part of treatment regimens for patients with advanced hepatocellular carcinoma(aHCC).Several recent real-world studies appear to have confirmed this;however,there are etiological differences.This necessitates further real-world studies of lenvatinib across diverse populations,such as in China.AIM To investigate the efficacy and safety of lenvatinib in a Chinese HCC patient population under real-world conditions.METHODS This is a retrospective and multiregional study involving patients with aHCC receiving lenvatinib monotherapy.Efficacy was assessed using the Response Evaluation Criteria in Solid Tumors version 1.1.Baseline characteristics and adverse events(AEs)were recorded throughout the entire study.RESULTS In total,54 HCC patients treated with lenvatinib monotherapy were included for final analysis.The objective response rate was 22%(n=12)with a progressionfree survival(PFS)of 168 d;however,AEs occurred in 92.8%of patients.Multivariate analysis showed that the Barcelona Clinic Liver Cancer stage[hazard ratio(HR)0.465;95%CI:0.23-0.93;P=0.031],portal vein tumor thrombus(HR 0.38;95%CI:0.15-0.94;P=0.037)and Child-Pugh classifications(HR 0.468;95%CI:and specificity(83.3%)of decreasing serum biomarkers including alphafetoprotein were calculated in order to predict tumor size reduction.Gene sequencing also provided insights into potential gene mutation signatures related to the effect of lenvatinib.CONCLUSION Our findings confirm previous evidence from the phase III REFLECT study.The majority of patients in this Chinese sample were suffering from concomitant hepatitis B virus-related HCC.However,further analysis suggested that baseline characteristics,changes in serum biomarkers and gene sequencing may hold the key for predicting lenvatinib responses.Further large-scale prospective studies that incorporate more basic medical science measures should be conducted.展开更多
Objective:Several studies have demonstrated different benefits for patients whose disease progressed despite previous trastuzumab treatment.Due to limited real-world data,we evaluate the effectiveness of anti-human ep...Objective:Several studies have demonstrated different benefits for patients whose disease progressed despite previous trastuzumab treatment.Due to limited real-world data,we evaluate the effectiveness of anti-human epidermal growth factor receptor 2(HER2)therapy(lapatinib or trastuzumab)plus chemotherapy or chemotherapy alone in patients who were previously treated with trastuzumab-containing regimens and investigate factors associated with effectiveness.And we further show the effectiveness of the two anti-HER2 therapy groups.Methods:A total of 342 HER2-positive metastatic breast cancer(MBC)patients whose disease progressed during prior anti-HER2(trastuzumab)and standard chemotherapy therapy from Department of Breast Oncology,the Fifth Medical Center of Chinese PLA General Hospital,from August 2010 to December 2016 were included.Seventy-eight patients received standard chemotherapy only,148 patients continued to receive trastuzumab and switched to other chemotherapy drugs,and 116 patients received tyrosine-kinase inhibitors(TKIs;lapatinib)and chemotherapy.The main outcome measures were progression-free survival(PFS),overall response rate(ORR),and clinical benefit rate(CBR).Subgroup analyses were conducted to identify patient characteristics associated with the greatest clinical benefit.Results:After a median follow-up of 26.2(range,2.0-56.0)months,PFS significantly improved with anti-HER2 therapy compared with chemotherapy alone:median 6.0 months with lapatinib[95%confidence interval(95%CI),4.53-7.47],4.5 months with trastuzumab(95%CI,3.99-5.01)vs.3.0 months with chemotherapy alone(95%CI,2.42-3.58);stratified hazard ratio(HR)=0.70,95%CI,0.60-0.81;P<0.0001.The ORR values were 33.6%,25.0%and 12.8%,respectively,the CBR values were 60.3%,48.6%and 26.9%,respectively.The effectiveness of lapatinib group and trastuzumab group were further analyzed.In multivariate analysis,lapatinib group was associated with a longer PFS,after controlling other potential confounders(HR=0.68,95%CI,0.52-0.90;P=0.006).Conclusions:The combination of TKIs and chemotherapy was effective in this cohort previously treated with trastuzumab treatment.Therefore,TKIs combined with chemotherapy is an option for Chinese HER2-positive MBC patients previously treated with trastuzumab treatment.展开更多
BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastroint...BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care.The primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product reported.Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.展开更多
Objective Our objective was to analyze the traditional Chinese medicine(TCM)syndrome and treatment laws of diabetic kidney disease(DKD)and the action mechanism of high-frequency Chinese herbs in the treatment of DKD b...Objective Our objective was to analyze the traditional Chinese medicine(TCM)syndrome and treatment laws of diabetic kidney disease(DKD)and the action mechanism of high-frequency Chinese herbs in the treatment of DKD based on realworldstudy.MethodsThe data of patients with DKD who had been treated in the First Hospital Affiliated to Henan Universityof ChineseMedicine from January1,2014to December 31,2021 were retrospectively analyzed through the hospital information management system.The contents of the cases were statistically analyzed using IBM SPsS Statistics 25 software,and the laws of DKDtreatment were summarized.Network pharmacology and molecular docking were used to analyze the action mechanism of high-frequency Chinese herbs in the treatment of DKD.ResultsThe data of a total of 1,201 patients with DKD were included,involving 72 kinds of TCM syndromes.Nine disease nature elements and six disease location elements were extracted,involving 405 Chinese herbs.The top five high-frequency Chinese herbs were Baizhu(Atractylodis Macrocephalae Rhizoma),Fuling(Poria),Huangqi(Astragali Radix),Chuanxiong(Chuanxiong Rhizoma),and Danshen(Salviae Miltiorrhizae Radix et Rhizoma).Thirty kinds of Chinese herbs with the frequency of≥100 were mainly deficiency-tonifying herbs and blood-activating and stasis-eliminating herbs.The medicinal properties were mainly warm and mild,and the medicinal flavors were sweet and bitter mostly.For the meridian tropism,the main meridian tropism of these herbs is spleen meridian and lung meridian.The clustering method.展开更多
Objective:Little progress has been made in recent years using first-line chemotherapy,including gemcitabine combined with nab-paclitaxel,FOLFIRINOX,and NALIRIFOX,for advanced pancreatic adenocarcinoma(APC).In addition...Objective:Little progress has been made in recent years using first-line chemotherapy,including gemcitabine combined with nab-paclitaxel,FOLFIRINOX,and NALIRIFOX,for advanced pancreatic adenocarcinoma(APC).In addition,the optimal second-line chemotherapy regimen has not been determined.This study aimed to compare the effectiveness of different types of second-line chemotherapy for APC.Methods:Patients with APC who received first-line treatment from January 2008 to January 2021 were considered eligible for this retrospective analysis.The primary and secondary endpoints were overall survival(OS)and progression-free survival(PFS),respectively.Results:Four hundred and thirty-seven and 617 patients were treated with 5-fluorouracil-and gemcitabine-based chemotherapy as first-line treatment,respectively.Demographic and clinical features,except age and liver metastasis,were comparable between the two groups(P<0.05).The median OS was 8.8 and 7.8 months in patients who received a 5-fluorouracil-and gemcitabine-based combined regimen for first-line therapy,respectively(HR=1.244,95%CI=1.090–1.419;P<0.001).The median OS was 5.6 and 1.9 months in patients who received second-line chemotherapy and supportive care,respectively(HR=0.766,95%CI=0.677–0.867;P<0.001).The median PFS was not significantly differently between gemcitabine or 5-fluorouracil monotherapy and combination therapy.Conclusions:A 5-fluorouracil-or gemcitabine-based combined regimen was shown to be as effective as a single 5-fluorouracil or gemcitabine regimen as second-line therapy for patients with APC.展开更多
Object:The aim is to evaluate how effective Traditional Chinese Medicine(TCM)is in treating patients who have central retinal vein occlusion with macular edema(CRVO-ME)in a real-world study.Furthermore,the objective o...Object:The aim is to evaluate how effective Traditional Chinese Medicine(TCM)is in treating patients who have central retinal vein occlusion with macular edema(CRVO-ME)in a real-world study.Furthermore,the objective of the research was to examine the TCM prescription trends in the management of CRVO-ME.Method:A single-center real-world study(RWS)was carried out over a span of 19 years,following the established design.The study encompassed 113 patients diagnosed with CRVO-ME.Out of these,74 patients received TCM treatment,while the remaining individuals underwent a combined therapy involving TCM and anti-VEGF drugs through intravitreal injection.The patients were matched using propensity score matching(PSM).The result measured in the RWS was BCVA.The oral prescriptions for CRVO-ME that led to observable and effective outcomes were collected.Excel and the TCM Inheritance Auxiliary Platform V2.5 were utilized to optimize mutual information,hierarchical clustering based on entropy,and other techniques to extract medication regulations and features.Result:After applying PSM,each group comprised 29 cases.Both groups exhibited improved BCVA following treatment;however,there was no statistically significant distinction in BCVA or effectiveness between the two groups(all P>0.05).Apart from the analysis of oral prescriptions for CRVO-ME,the investigation pinpointed the most frequently used TCMs,namely Flos Carthami,Semen Persicae,Radix Angelica sinensis,Radix Rehmanniae,and Radix et Rhizoma Notoginseng.Frequently utilized medications tended to possess cold,warm,or mild attributes and exhibited a taste profile that was either bitter or sweet.The primary meridians associated with the medicines employed in treating CRVO-ME were liver,spleen,stomach,heart,and lung.Through the application of association rule analysis,it was discerned that there were 195 commonly employed combinations of medicines.Additionally,a complex system entropy cluster analysis unveiled 13 key combinations of medicines.By employing an unsupervised entropy hierarchical clustering analysis,a novel prescription was formulated.Conclusion:Within a real-world population of CRVO-ME patients,TCM exhibited its effectiveness.The treatment approach for CRVO-ME predominantly involved the regulation of qi(Qi is an exceedingly subtle substance within the human body,brimming with vitality and ceaseless motion.It constitutes the fundamental element that shapes and sustains the various processes of human life.)and blood as well as the resolution of dampness.The oral prescriptions frequently targeted the meridians of liver,spleen,stomach,heart,and lungs.展开更多
Human epidermal growth factor receptor 2(HER2)amplification or activating mutations are found in 1.6%–4%of non-small cell lung cancer(NSCLC).Pyrotinib has been reported to have better potency in NSCLC patients with H...Human epidermal growth factor receptor 2(HER2)amplification or activating mutations are found in 1.6%–4%of non-small cell lung cancer(NSCLC).Pyrotinib has been reported to have better potency in NSCLC patients with HER2 exon 20 insertion(ex20ins)mutations;however,more clinical evidence is urgently needed to guide pyrotinib-based therapy in NSCLC with HER2 amplification or heterogeneous mutations.We retrospectively analyzed advanced NSCLC patients with HER2 amplification or mutations who were treated with pyrotinib-based therapy between September 25,2018 and October 30,2020 in our hospital.Molecular dynamics simulation was used to explore the bioactive conformation and binding mechanisms of pan-ErbB tyrosine kinase inhibitors(TKIs)including pyrotinib for different HER2 ex20ins variants.In this study,79 eligible patients were included with 70 ex20ins variants,6 missense mutations and 3 primary HER2 amplifications identified.A775_G776insYVMA insertion was the most common observed subtype.The median progression-free survival(mPFS)was 5.8(95%CI:4.1–7.4)months.Use of pyrotinib-based therapy in first-/second-line settings showed a significantly better prognosis than that observed in third-line settings or above(mPFS:9.1 vs.4.4 months;P=0.0003).Compared with HER2 amplification and exon 20 non-YVMA insertion variants,patients with HER2 missense mutations had a visible mPFS benefit(12.2 vs.6.8 vs.5.2 months).Computational docking simulations revealed that pyrotinib failed to interact with the specific insertion variant P780_Y781insGSP.These results indicated that pyrotinib-based therapy exhibited good anti-tumor activity and acceptable safety profile in HER2-altered advanced NSCLC.展开更多
Objective To study the research on real-world data and to provide new ideas and methods for the inheritance and development of empirical prescriptions of traditional Chinese medicine(TCM).Methods The disadvantages of ...Objective To study the research on real-world data and to provide new ideas and methods for the inheritance and development of empirical prescriptions of traditional Chinese medicine(TCM).Methods The disadvantages of using randomized controlled trials for empirical prescriptions of TCM and the advantages of using real-world study(RWS)were analyzed by summarizing the previous RWS and the empirical prescriptions.Meanwhile,the methods for marketing of new TCMs derived from empirical prescriptions of TCM,the data source and trial design of the RWS were discussed.Results and Conclusion RWS can provide new ideas for the listing of new TCMs.With the improvement of relevant laws and regulations,RWS will promote the development of TCM greatly.To promote the application of RWS in the inheritance and development of empirical prescriptions of TCM,the government should improve laws and regulations as soon as possible,and enterprises and research institutions should strengthen patient privacy protection and clarify the responsible parties.展开更多
BACKGROUND Although chronic erosive gastritis(CEG)is common,its clinical characteristics have not been fully elucidated.The lack of consensus regarding its treatment has resulted in varied treatment regimens.AIM To ex...BACKGROUND Although chronic erosive gastritis(CEG)is common,its clinical characteristics have not been fully elucidated.The lack of consensus regarding its treatment has resulted in varied treatment regimens.AIM To explore the clinical characteristics,treatment patterns,and short-term outcomes in CEG patients in China.METHODS We recruited patients with chronic non-atrophic or mild-to-moderate atrophic gastritis with erosion based on endoscopy and pathology.Patients and treating physicians completed a questionnaire regarding history,endoscopic findings,and treatment plans as well as a follow-up questionnaire to investigate changes in symptoms after 4 wk of treatment.RESULTS Three thousand five hundred sixty-three patients from 42 centers across 24 cities in China were included.Epigastric pain(68.0%),abdominal distension(62.6%),and postprandial fullness(47.5%)were the most common presenting symptoms.Gastritis was classified as chronic non-atrophic in 69.9%of patients.Among those with erosive lesions,72.1%of patients had lesions in the antrum,51.0%had multiple lesions,and 67.3%had superficial flat lesions.In patients with epigastric pain,the combination of a mucosal protective agent(MPA)and proton pump inhibitor was more effective.For those with postprandial fullness,acid regurgitation,early satiety,or nausea,a MPA appeared more promising.CONCLUSION CEG is a multifactorial disease which is common in Asian patients and has non-specific symptoms.Gastroscopy may play a major role in its detection and diagnosis.Treatment should be individualized based on symptom profile.展开更多
BACKGROUND Colon cancer is one the most common forms of cancer in both sexes.Due to important progress in the field of early detection and effective treatment,colon and rectal cancer survivors currently account for 10...BACKGROUND Colon cancer is one the most common forms of cancer in both sexes.Due to important progress in the field of early detection and effective treatment,colon and rectal cancer survivors currently account for 10%of cancer survivors worldwide.However,the effects of anti-cancer treatments,especially oxaliplatinbased chemotherapy,on the quality of life(QoL)have been less evaluated.Although the incidence of severe chemotherapy-induced neuropathy(CIPN)in clinical studies is below 20%,data from real-world studies is scarce,and CIPN is probably under-reported due to patient selection and the patients’fear that reporting side-effects might lead to treatment cessation.AIM To determine the impact of CIPN on QoL in colorectal cancer patients with a recent history of oxaliplatin-based chemotherapy.METHODS We performed a prospective cross-sectional study in two major Romanian oncology tertiary hospitals—the Regional Institute of Oncology Ia?i(Iasi,Romania)and the Fundeni Clinical Oncology Institute(Bucharest,Romania).All consecutive patients with colon or rectal cancer,undergoing Oxaliplatin-based chemotherapy that consented to enroll in the study,were assessed by means of two questionnaires—the EORTC QQ-CR29(quality of life in colon and rectal cancer patients)and the QLQ-CIPN20(assessment of neuropathy).Several demographical,social,clinical and treatment data were also collected.Statistical analysis was performed by means of SPSS v20.The student t test was used to assess the relationship between the QLQ-CIPN20 and QLQ-CR29 results.Kaplan Meyer-curves were used to report 3-year progression-free survival(PFS)in patients that discontinued chemotherapy vs those that completed the recommended course.RESULTS Of the 267 patients that fulfilled the inclusion criteria in the pre-specified time frame,101(37.8%)agreed to participate in the clinical study.At the time of the enrolment in the study,over 50%of the patients had recently interrupted their oxaliplatin-based chemotherapy,most often due to neuropathy.Almost 85%of the responders reported having tingling or numbness in their fingers or hands,symptoms that were associated with pain in over 20%of the cases.When comparing the scores in the two questionnaires,a statistically significant relationship(P<0.001)was found between the presence of neuropathic symptoms and a decreased quality of life.This correlation was consistent when the patients were stratified by sex,disease stage,comorbidities and the presence of stoma or treatment type,suggesting that neuropathy in itself may be a reason for a decreased quality of life.At the 3 year final assessment,median recurrence-free survival in stageⅢpatients was 26.88 mo.When stratified by completion of chemotherapy,median recurrence freesurvival of stageⅢpatients that completed chemotherapy was 28.27 mo vs 24.33 mo in patients that discontinued chemotherapy due to toxicity,a difference that did not reach statistical significance.CONCLUSION CIPN significantly impacts QoL in colorectal cancer patients.CIPN is also the most frequent reason for treatment discontinuation.Physicians should actively assess for CIPN in order to prevent chronic neuropathy.展开更多
OBJECTIVE:To explore the differences in Traditional Chinese Medicine(TCM)diagnosis and treatment rules for coronavirus disease 2019(COVID-19)between Northern and Southern China based on the real-world data from 982 CO...OBJECTIVE:To explore the differences in Traditional Chinese Medicine(TCM)diagnosis and treatment rules for coronavirus disease 2019(COVID-19)between Northern and Southern China based on the real-world data from 982 COVID-19 patients.METHODS:All consecutive cases of COVID-19 admitted to the TCM department of designated COVID-19 hospitals in eight provinces and cities were retrospectively analyzed.Patients were divided into a Northern and a Southern group according to the location of the admitting hospital.The symptoms,syndrome elements,syndrome distribution and herbal treatments were analyzed.The core prescriptions were extracted using the multiscale backbone-based network comparison algorithm(msbNC).RESULTS:The distribution of syndrome elements showed that dampness was common in Northern and Southern China,wind and heat were more often present in the South,while fire toxin and spleen deficiency were more often encountered in the North.The distribution of syndromes showed that the South was dominated by heat dampness accumulating in the lung(55.69%),while the North was dominated by dampness-toxin stagnating in the lung(44.90%).The results of core prescription mining showed that dispelling dampness,dispersing wind,clearing heat and strengthening spleen were the common treatment methods in Northern and Southern China.For mild cases,Jinyinhua(Flos Lonicerae)and Lianqiao(Fructus Forsythiae Suspensae)were often used in the South to clear heat and relieve exterior symptoms,while Chaihu(Radix Bupleuri Chinensis)and Huangqin(Radix Scutellariae Baicalensis)were often used in the North to relieve muscles by expelling heat.For moderate cases,Chaihu(Radix Bupleuri Chinensis),Qinghao(Herba Artemisiae Annuae),and Shigao(Gypsum Fibrosum)were often used to clear heat of Tri-jiao Channel and stomach in the South,while Fuling(Poria),Chenpi(Pericarpium Citri Reticulatae),and Dangshen(Radix Codonopsis)were often used to invigorate spleen and remove dampness in the North.For severe cases,spleen invigoration and dampness removal as well as relaxing the bowels and discharging heat were often used in the North.CONCLUSION:There were certain North-South differences in terms of symptoms,syndrome elements and syndrome distribution of COVID-19,as well as differences in core prescriptions during different periods of the disease.The regional differences in the rules of TCM diagnosis and treatment for COVID-19 should be further considered in the process of optimization and revision of relevant treatment guidance.展开更多
Objective:This study aimed to systematically evaluate the effect of idebenone tablets in the treatment of post-stroke depression(Post-Stroke Depression,PSD).Methods:This study was a single-arm,prospective,observationa...Objective:This study aimed to systematically evaluate the effect of idebenone tablets in the treatment of post-stroke depression(Post-Stroke Depression,PSD).Methods:This study was a single-arm,prospective,observational study that recruited PSD patients who met the inclusion criteria after being assessed by the investigator between January 2022 and June 2023.The demographic characteristics,disease status,treatment status,and medication status of the patients were collected through questionnaires,and the Hamilton depression score of the patients was collected through the Case Report Form(CRF)to evaluate the effectiveness and safety of idebenone tablet treatment.Results:A total of 4902 PSD patients were included in this study,of which 2496 were males,accounting for 50.9%,and 2406 were females,accounting for 49.1%.According to the Hamilton Depression Rating Scale(HAMD),13.9%were no depression at the first visit,53.0%were mildly depressed,24.3%were moderately depressed,and 8.8%were severely depressed.After treatment,the proportion of no depression was 26.1%,mild depression accounted for 53.3%,moderate depression accounted for 16.8%,and severe depression accounted for 3.8%,and the difference in the proportion of depression before and after treatment was statistically significant(P<0.05).Conclusion:Idebenone tablets can significantly reduce Hamilton’s depression score,suggesting that it has a significant therapeutic effect in improving PSD symptoms.展开更多
BACKGROUND Tofacitinib is an oral,selective Janus kinase inhibitor that is approved for the treatment of ulcerative colitis(UC).The 8-week induction protocol involves the administration of 10 mg twice daily(bid)with t...BACKGROUND Tofacitinib is an oral,selective Janus kinase inhibitor that is approved for the treatment of ulcerative colitis(UC).The 8-week induction protocol involves the administration of 10 mg twice daily(bid)with the possibility of extending the induction period to 16 weeks.The maintenance dose of tofacitinib is either 5 mg or 10 mg bid.AIM To assess predictors for clinical remission and drug persistence in patients with UC receiving the extended induction tofacitinib protocol.METHODS This was a real-world multicenter retrospective study in patients with moderateto-severe UC.Patients received physician-directed extended induction tofacitinib treatment.We collected clinical and demographic data at baseline and data regarding clinical,laboratory,and endoscopic evaluations,therapeutic modifications,and adverse events at the 52-week follow-up.Possible predictors for clinical remission at week 52 was the primary endpoint.Differences between patients receiving 5 mg bid vs 10 mg bid at week 52 and identification of predictors for treatment persistence were secondary endpoints.RESULTS Thirty-seven consecutive patients from 11 medical centers were included[51.4%males with median age 39(17-64)years].Twenty-eight patients continued treatment until week 52(75.7%)with 67.9%receiving 10 mg tofacitinib;all had prior history of biologic use.We observed that 57.1%of patients achieved clinical remission(66.7%in the 5 mg tofacitinib group and 52.6%in the 10 mg tofacitinib group,P=0.483).De-escalation to 5 mg tofacitinib was attempted in 17 patients with a success rate of 52.9%.Prior biologic use was significantly more frequent in patients treated with 10 mg tofacitinib.Active smoking was significantly associated with treatment discontinuation at week 52.We identified eight adverse events,and only one led to treatment discontinuation.CONCLUSION Our results supported the extended induction strategy with tofacitinib in selected patients with UC.Patients with prior failure of advanced therapies particularly benefitted,highlighting the importance of personalized maintenance regimens.展开更多
Background:This study aimed to evaluate the clinical efficacy and safety of combining a programmed cell death protein 1(PD-1)in-hibitor with a poly(ADP-ribose)polymerase inhibitor(PARPi)in patients with metastatic cas...Background:This study aimed to evaluate the clinical efficacy and safety of combining a programmed cell death protein 1(PD-1)in-hibitor with a poly(ADP-ribose)polymerase inhibitor(PARPi)in patients with metastatic castration-resistant prostate cancer(mCRPC)who progressed after multiple lines of treatment,from a real-world perspective.Materials and methods:This open-label,single-arm,prospective study enrolled patients with mCRPC who had experienced disease progression after docetaxel and at least 2 lines of next-generation hormonal agents to receive camrelizumab(PD-1 inhibitor)and fluzoparib(PARPi).The primary endpoints were radiographic progression-free survival and overall survival(OS),and the secondary end-points were prostate-specific antigen progression-free survival and safety.Results:Eight patients with mCRPC who met the inclusion criteria were enrolled.The results showed that the median radiographic progression-free survival was 5.1 months,the median OS was 8.1 months,and the median prostate-specific antigen progression-free survival was 3.1 months.Safety analysis revealed that 87.5%of the patients experienced one or more treatment-related adverse events(AEs),with 37.5%reporting grade 3 or higher treatment-related AEs.None of the patients discontinued treatment because of treatment-related AEs.Conclusions:This real-world study demonstrated that the combination of a PD-1 inhibitor and PARPi exhibited sustained antitumor activity with an acceptable safety profile in the fourth-line treatment of patients with mCRPC.展开更多
Background:Lenvatinib is primarily utilized for the treatment of inoperable or advanced hepatocellular carcinoma,radioiodine-refractory differentiated thyroid cancer,and advanced renal cell carcinoma.Primary informati...Background:Lenvatinib is primarily utilized for the treatment of inoperable or advanced hepatocellular carcinoma,radioiodine-refractory differentiated thyroid cancer,and advanced renal cell carcinoma.Primary information about adverse reactions is principally derived from clinical trials;however,there is a notable dearth of substantial real-world studies.Methods:In this research,an examination of the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database was performed to evaluate the potential side effects of lenvatinib.The FAERS database revealed a total of 20,290 reported adverse events associated with lenvatinib.Different algorithms for repeated measure analysis were employed to ascertain the significance of these adverse reactions.Results:The study identified 170 instances of adverse events(AEs)induced by lenvatinib,incorporating several significant adverse reactions that the product label does not mention.The investigation also evaluated the onset periods of the adverse reactions,pinpointing a median time of 43 days.The majority of adverse reactions manifested within the initial month of lenvatinib use.Sex-specific analysis revealed disparities in high risk adverse reactions between females(vascular and lymphatic diseases,and neuronal organ diseases)and males(death and infectious diseases).Our data mining has unveiled adverse reactions beyond those mentioned within the instructions,such as osteonecrosis of the jaw,cholecystitis,cholangitis,dehydration,tumor lysis syndrome,type 1 diabetes,hyperammonemia,liver abscess,interstitial lung disease,pneumothorax,sudden death,and aortic dissection.Conclusion:The insights derived from these findings contribute significant nuances for optimizing lenvatinib use,enhancing its efficacy,and substantially mitigating potential side effects.These data elements will substantially enhance the implementation of the drug in a clinical environment.展开更多
OBJECTIVE:To illustrate the effect of add-on therapy of Traditional Chinese Medicine(TCM)on the long-term survival of anemic lower-risk myelodysplastic syndromes(LR-MDS)patients.METHODS:In this study,we conducted a re...OBJECTIVE:To illustrate the effect of add-on therapy of Traditional Chinese Medicine(TCM)on the long-term survival of anemic lower-risk myelodysplastic syndromes(LR-MDS)patients.METHODS:In this study,we conducted a retrospective analysis of the data of patients with LR-MDS who were identified from Shuguang Hospital between January 2006 and June 2020.The Kaplan-Meier method was used to calculate overall survival(OS),while the Cox model was employed to analyze prognostic factors of long-term survival.A total of 162 patients who met the inclusion criteria were divided into two groups:the TCM group(n=78)or the non-TCM group(n=84).RESULTS:There were no significant differences in baseline characteristics.The cumulative survival rate of the TCM group was significantly higher than that of the non-TCM group[log-rank P=0.029,hazard ratio(HR)=0.484,95%confidence interval(CI)(0.249,0.942),P<0.05].Patients with longer TCM treatment appeared to have better OS(≥12 months vs<12 months);[HR,0.16695%CI(0.055,0.508),P<0.001].According to the Cox model analysis,the combination of TCM and conventional Western Medicine may be a protective factor affecting the long-term survival of LR-MDS patients[HR=0.509,95%CI,(0.261,0.993),P=0.048].The hematologic improvement erythroid response(HI-E)rate of the TCM group was significantly higher than that of the non-TCM group(69.23%vs 52.38%;P=0.028).However,the duration of HI-E and cases of disease progression after HI-E did not significantly differ from the non-TCM group(P>0.05).CONCLUSIONS:The integration of TCM and Western Medicine has the potential to extend the OS of LR-MDS patients when compared to the use of Western Medicine alone.展开更多
Objective Observational studies have found associations between inflammatory bowel disease(IBD)and the risk of dementia,including Alzheimer’s dementia(AD)and vascular dementia(VD);however,these findings are inconsist...Objective Observational studies have found associations between inflammatory bowel disease(IBD)and the risk of dementia,including Alzheimer’s dementia(AD)and vascular dementia(VD);however,these findings are inconsistent.It remains unclear whether these associations are causal.Methods We conducted a meta-analysis by systematically searching for observational studies on the association between IBD and dementia.Mendelian randomization(MR)analysis based on summary genome-wide association studies(GWASs)was performed.Genetic correlation and Bayesian colocalization analyses were used to provide robust genetic evidence.Results Ten observational studies involving 80,565,688 participants were included in this metaanalysis.IBD was significantly associated with dementia(risk ratio[RR]=1.36,95%CI=1.04-1.78;I2=84.8%)and VD(RR=2.60,95%CI=1.18-5.70;only one study),but not with AD(RR=2.00,95%CI=0.96-4.13;I^(2)=99.8%).MR analyses did not supported significant causal associations of IBD with dementia(dementia:odds ratio[OR]=1.01,95%CI=0.98-1.03;AD:OR=0.98,95%CI=0.95-1.01;VD:OR=1.02,95%CI=0.97-1.07).In addition,genetic correlation and co-localization analyses did not reveal any genetic associations between IBD and dementia.Conclusion Our study did not provide genetic evidence for a causal association between IBD and dementia risk.The increased risk of dementia observed in observational studies may be attributed to unobserved confounding factors or detection bias.展开更多
This paper proposes an interdisciplinary talent training model that combines foreign language education with area studies.The model aims to cultivate international ocean affairs professionals with cross-cultural commu...This paper proposes an interdisciplinary talent training model that combines foreign language education with area studies.The model aims to cultivate international ocean affairs professionals with cross-cultural communication skills,in-depth regional and country knowledge,and practical expertise in ocean affairs.Additionally,the paper presents specific training pathways and policy recommendations for implementing this model.展开更多
基金Special Fund of the National Medical Products Administration’s Drug Regulatory Science Research Base-Research Institute of Drug Regulatory Science of Shenyang Pharmaceutical University(No.2020jgkx005).
文摘Objective To provide references for improving the authenticity and reliability of the retrospective study results,thus improving the quality of evidence in the real world and strengthening drug supervision and decision-making.Methods Literature review was used to study the data sources,the characteristics of retrospective research,the sources and the corrections of selective bias in the real world.Results and Conclusion The biases in retrospective study mainly come from admission rate bias,patient rate bias,survivors bias,health user bias and symptom bias.
文摘Objective To introduce the design of observational trials under real-world study(RWS),and to provide guidance for clinical development of new research trials and reference for real-world researchers.Methods Relevant literature of RWS and observational experiments at home and abroad were reviewed and analyzed,and then the design of observational studies was summarized under RWS.Results and Conclusion The data and information provided in observational studies not only help to further verify the clinical study results obtained by randomized controlled trial(RCT)in clinical practice,but also objectively reflect the real situation in the process of clinical research and application.
基金Supported by the International Science and Technology Cooperation Projects,No.2016YFE0107100the Capital Special Research Project for Health Development,No.2014-2-4012+2 种基金the Beijing Natural Science Foundation,No.L172055 and No.7192158the National Tenthousand Talent Program,the Fundamental Research Funds for the Central Universities,No.3332018032and the CAMS Innovation Fund for Medical Science(CIFMS),No.2017-I2M-4-003 and No.2018-I2M-3-001.
文摘BACKGROUND Lenvatinib has become an indispensable part of treatment regimens for patients with advanced hepatocellular carcinoma(aHCC).Several recent real-world studies appear to have confirmed this;however,there are etiological differences.This necessitates further real-world studies of lenvatinib across diverse populations,such as in China.AIM To investigate the efficacy and safety of lenvatinib in a Chinese HCC patient population under real-world conditions.METHODS This is a retrospective and multiregional study involving patients with aHCC receiving lenvatinib monotherapy.Efficacy was assessed using the Response Evaluation Criteria in Solid Tumors version 1.1.Baseline characteristics and adverse events(AEs)were recorded throughout the entire study.RESULTS In total,54 HCC patients treated with lenvatinib monotherapy were included for final analysis.The objective response rate was 22%(n=12)with a progressionfree survival(PFS)of 168 d;however,AEs occurred in 92.8%of patients.Multivariate analysis showed that the Barcelona Clinic Liver Cancer stage[hazard ratio(HR)0.465;95%CI:0.23-0.93;P=0.031],portal vein tumor thrombus(HR 0.38;95%CI:0.15-0.94;P=0.037)and Child-Pugh classifications(HR 0.468;95%CI:and specificity(83.3%)of decreasing serum biomarkers including alphafetoprotein were calculated in order to predict tumor size reduction.Gene sequencing also provided insights into potential gene mutation signatures related to the effect of lenvatinib.CONCLUSION Our findings confirm previous evidence from the phase III REFLECT study.The majority of patients in this Chinese sample were suffering from concomitant hepatitis B virus-related HCC.However,further analysis suggested that baseline characteristics,changes in serum biomarkers and gene sequencing may hold the key for predicting lenvatinib responses.Further large-scale prospective studies that incorporate more basic medical science measures should be conducted.
基金Capital Clinical Medicine Special Project(No.Z181100001718215)National Natural Science Foundation of China(No.81602314).Research number:CSCO-BC RWS 16002。
文摘Objective:Several studies have demonstrated different benefits for patients whose disease progressed despite previous trastuzumab treatment.Due to limited real-world data,we evaluate the effectiveness of anti-human epidermal growth factor receptor 2(HER2)therapy(lapatinib or trastuzumab)plus chemotherapy or chemotherapy alone in patients who were previously treated with trastuzumab-containing regimens and investigate factors associated with effectiveness.And we further show the effectiveness of the two anti-HER2 therapy groups.Methods:A total of 342 HER2-positive metastatic breast cancer(MBC)patients whose disease progressed during prior anti-HER2(trastuzumab)and standard chemotherapy therapy from Department of Breast Oncology,the Fifth Medical Center of Chinese PLA General Hospital,from August 2010 to December 2016 were included.Seventy-eight patients received standard chemotherapy only,148 patients continued to receive trastuzumab and switched to other chemotherapy drugs,and 116 patients received tyrosine-kinase inhibitors(TKIs;lapatinib)and chemotherapy.The main outcome measures were progression-free survival(PFS),overall response rate(ORR),and clinical benefit rate(CBR).Subgroup analyses were conducted to identify patient characteristics associated with the greatest clinical benefit.Results:After a median follow-up of 26.2(range,2.0-56.0)months,PFS significantly improved with anti-HER2 therapy compared with chemotherapy alone:median 6.0 months with lapatinib[95%confidence interval(95%CI),4.53-7.47],4.5 months with trastuzumab(95%CI,3.99-5.01)vs.3.0 months with chemotherapy alone(95%CI,2.42-3.58);stratified hazard ratio(HR)=0.70,95%CI,0.60-0.81;P<0.0001.The ORR values were 33.6%,25.0%and 12.8%,respectively,the CBR values were 60.3%,48.6%and 26.9%,respectively.The effectiveness of lapatinib group and trastuzumab group were further analyzed.In multivariate analysis,lapatinib group was associated with a longer PFS,after controlling other potential confounders(HR=0.68,95%CI,0.52-0.90;P=0.006).Conclusions:The combination of TKIs and chemotherapy was effective in this cohort previously treated with trastuzumab treatment.Therefore,TKIs combined with chemotherapy is an option for Chinese HER2-positive MBC patients previously treated with trastuzumab treatment.
文摘BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care.The primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product reported.Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.
基金supported by the National Key Research Project(2020YFE0201800)Henan Province Science and Technology Program for Tackling Key Problems(21210230347)2021 Postgraduate Scientifc Re-search Innovation Progrpm of Henan Universityof Chinese Medicine(2021KYCX008).
文摘Objective Our objective was to analyze the traditional Chinese medicine(TCM)syndrome and treatment laws of diabetic kidney disease(DKD)and the action mechanism of high-frequency Chinese herbs in the treatment of DKD based on realworldstudy.MethodsThe data of patients with DKD who had been treated in the First Hospital Affiliated to Henan Universityof ChineseMedicine from January1,2014to December 31,2021 were retrospectively analyzed through the hospital information management system.The contents of the cases were statistically analyzed using IBM SPsS Statistics 25 software,and the laws of DKDtreatment were summarized.Network pharmacology and molecular docking were used to analyze the action mechanism of high-frequency Chinese herbs in the treatment of DKD.ResultsThe data of a total of 1,201 patients with DKD were included,involving 72 kinds of TCM syndromes.Nine disease nature elements and six disease location elements were extracted,involving 405 Chinese herbs.The top five high-frequency Chinese herbs were Baizhu(Atractylodis Macrocephalae Rhizoma),Fuling(Poria),Huangqi(Astragali Radix),Chuanxiong(Chuanxiong Rhizoma),and Danshen(Salviae Miltiorrhizae Radix et Rhizoma).Thirty kinds of Chinese herbs with the frequency of≥100 were mainly deficiency-tonifying herbs and blood-activating and stasis-eliminating herbs.The medicinal properties were mainly warm and mild,and the medicinal flavors were sweet and bitter mostly.For the meridian tropism,the main meridian tropism of these herbs is spleen meridian and lung meridian.The clustering method.
基金This work was supported by the National Key Research and Development Program of China(Grant No.2021YFA1201100)the National Natural Science Foundation of China(Grant No.82072657).
文摘Objective:Little progress has been made in recent years using first-line chemotherapy,including gemcitabine combined with nab-paclitaxel,FOLFIRINOX,and NALIRIFOX,for advanced pancreatic adenocarcinoma(APC).In addition,the optimal second-line chemotherapy regimen has not been determined.This study aimed to compare the effectiveness of different types of second-line chemotherapy for APC.Methods:Patients with APC who received first-line treatment from January 2008 to January 2021 were considered eligible for this retrospective analysis.The primary and secondary endpoints were overall survival(OS)and progression-free survival(PFS),respectively.Results:Four hundred and thirty-seven and 617 patients were treated with 5-fluorouracil-and gemcitabine-based chemotherapy as first-line treatment,respectively.Demographic and clinical features,except age and liver metastasis,were comparable between the two groups(P<0.05).The median OS was 8.8 and 7.8 months in patients who received a 5-fluorouracil-and gemcitabine-based combined regimen for first-line therapy,respectively(HR=1.244,95%CI=1.090–1.419;P<0.001).The median OS was 5.6 and 1.9 months in patients who received second-line chemotherapy and supportive care,respectively(HR=0.766,95%CI=0.677–0.867;P<0.001).The median PFS was not significantly differently between gemcitabine or 5-fluorouracil monotherapy and combination therapy.Conclusions:A 5-fluorouracil-or gemcitabine-based combined regimen was shown to be as effective as a single 5-fluorouracil or gemcitabine regimen as second-line therapy for patients with APC.
基金the support of the foundation projects:CACMS Innovation Fund(No.CI2021A02606).
文摘Object:The aim is to evaluate how effective Traditional Chinese Medicine(TCM)is in treating patients who have central retinal vein occlusion with macular edema(CRVO-ME)in a real-world study.Furthermore,the objective of the research was to examine the TCM prescription trends in the management of CRVO-ME.Method:A single-center real-world study(RWS)was carried out over a span of 19 years,following the established design.The study encompassed 113 patients diagnosed with CRVO-ME.Out of these,74 patients received TCM treatment,while the remaining individuals underwent a combined therapy involving TCM and anti-VEGF drugs through intravitreal injection.The patients were matched using propensity score matching(PSM).The result measured in the RWS was BCVA.The oral prescriptions for CRVO-ME that led to observable and effective outcomes were collected.Excel and the TCM Inheritance Auxiliary Platform V2.5 were utilized to optimize mutual information,hierarchical clustering based on entropy,and other techniques to extract medication regulations and features.Result:After applying PSM,each group comprised 29 cases.Both groups exhibited improved BCVA following treatment;however,there was no statistically significant distinction in BCVA or effectiveness between the two groups(all P>0.05).Apart from the analysis of oral prescriptions for CRVO-ME,the investigation pinpointed the most frequently used TCMs,namely Flos Carthami,Semen Persicae,Radix Angelica sinensis,Radix Rehmanniae,and Radix et Rhizoma Notoginseng.Frequently utilized medications tended to possess cold,warm,or mild attributes and exhibited a taste profile that was either bitter or sweet.The primary meridians associated with the medicines employed in treating CRVO-ME were liver,spleen,stomach,heart,and lung.Through the application of association rule analysis,it was discerned that there were 195 commonly employed combinations of medicines.Additionally,a complex system entropy cluster analysis unveiled 13 key combinations of medicines.By employing an unsupervised entropy hierarchical clustering analysis,a novel prescription was formulated.Conclusion:Within a real-world population of CRVO-ME patients,TCM exhibited its effectiveness.The treatment approach for CRVO-ME predominantly involved the regulation of qi(Qi is an exceedingly subtle substance within the human body,brimming with vitality and ceaseless motion.It constitutes the fundamental element that shapes and sustains the various processes of human life.)and blood as well as the resolution of dampness.The oral prescriptions frequently targeted the meridians of liver,spleen,stomach,heart,and lungs.
基金supported by the China Society of Clinical Oncology(CSCO)-Hengrui foundation(Grant No.Y-HR2018-239).
文摘Human epidermal growth factor receptor 2(HER2)amplification or activating mutations are found in 1.6%–4%of non-small cell lung cancer(NSCLC).Pyrotinib has been reported to have better potency in NSCLC patients with HER2 exon 20 insertion(ex20ins)mutations;however,more clinical evidence is urgently needed to guide pyrotinib-based therapy in NSCLC with HER2 amplification or heterogeneous mutations.We retrospectively analyzed advanced NSCLC patients with HER2 amplification or mutations who were treated with pyrotinib-based therapy between September 25,2018 and October 30,2020 in our hospital.Molecular dynamics simulation was used to explore the bioactive conformation and binding mechanisms of pan-ErbB tyrosine kinase inhibitors(TKIs)including pyrotinib for different HER2 ex20ins variants.In this study,79 eligible patients were included with 70 ex20ins variants,6 missense mutations and 3 primary HER2 amplifications identified.A775_G776insYVMA insertion was the most common observed subtype.The median progression-free survival(mPFS)was 5.8(95%CI:4.1–7.4)months.Use of pyrotinib-based therapy in first-/second-line settings showed a significantly better prognosis than that observed in third-line settings or above(mPFS:9.1 vs.4.4 months;P=0.0003).Compared with HER2 amplification and exon 20 non-YVMA insertion variants,patients with HER2 missense mutations had a visible mPFS benefit(12.2 vs.6.8 vs.5.2 months).Computational docking simulations revealed that pyrotinib failed to interact with the specific insertion variant P780_Y781insGSP.These results indicated that pyrotinib-based therapy exhibited good anti-tumor activity and acceptable safety profile in HER2-altered advanced NSCLC.
基金Special Fund of the National Medical Products Administration’s Drug Regulatory Science Research Base-Research Institute of Drug Regulatory Science of Shenyang Pharmaceutical University(No.2020jgkx005).
文摘Objective To study the research on real-world data and to provide new ideas and methods for the inheritance and development of empirical prescriptions of traditional Chinese medicine(TCM).Methods The disadvantages of using randomized controlled trials for empirical prescriptions of TCM and the advantages of using real-world study(RWS)were analyzed by summarizing the previous RWS and the empirical prescriptions.Meanwhile,the methods for marketing of new TCMs derived from empirical prescriptions of TCM,the data source and trial design of the RWS were discussed.Results and Conclusion RWS can provide new ideas for the listing of new TCMs.With the improvement of relevant laws and regulations,RWS will promote the development of TCM greatly.To promote the application of RWS in the inheritance and development of empirical prescriptions of TCM,the government should improve laws and regulations as soon as possible,and enterprises and research institutions should strengthen patient privacy protection and clarify the responsible parties.
基金the National Key Clinical Specialty Construction Project,No.ZK108000CAMS Innovation Fund for Medical Sciences,No.2021-I2M-C&T-A-001 and No.2022-I2M-C&T-B-012.
文摘BACKGROUND Although chronic erosive gastritis(CEG)is common,its clinical characteristics have not been fully elucidated.The lack of consensus regarding its treatment has resulted in varied treatment regimens.AIM To explore the clinical characteristics,treatment patterns,and short-term outcomes in CEG patients in China.METHODS We recruited patients with chronic non-atrophic or mild-to-moderate atrophic gastritis with erosion based on endoscopy and pathology.Patients and treating physicians completed a questionnaire regarding history,endoscopic findings,and treatment plans as well as a follow-up questionnaire to investigate changes in symptoms after 4 wk of treatment.RESULTS Three thousand five hundred sixty-three patients from 42 centers across 24 cities in China were included.Epigastric pain(68.0%),abdominal distension(62.6%),and postprandial fullness(47.5%)were the most common presenting symptoms.Gastritis was classified as chronic non-atrophic in 69.9%of patients.Among those with erosive lesions,72.1%of patients had lesions in the antrum,51.0%had multiple lesions,and 67.3%had superficial flat lesions.In patients with epigastric pain,the combination of a mucosal protective agent(MPA)and proton pump inhibitor was more effective.For those with postprandial fullness,acid regurgitation,early satiety,or nausea,a MPA appeared more promising.CONCLUSION CEG is a multifactorial disease which is common in Asian patients and has non-specific symptoms.Gastroscopy may play a major role in its detection and diagnosis.Treatment should be individualized based on symptom profile.
文摘BACKGROUND Colon cancer is one the most common forms of cancer in both sexes.Due to important progress in the field of early detection and effective treatment,colon and rectal cancer survivors currently account for 10%of cancer survivors worldwide.However,the effects of anti-cancer treatments,especially oxaliplatinbased chemotherapy,on the quality of life(QoL)have been less evaluated.Although the incidence of severe chemotherapy-induced neuropathy(CIPN)in clinical studies is below 20%,data from real-world studies is scarce,and CIPN is probably under-reported due to patient selection and the patients’fear that reporting side-effects might lead to treatment cessation.AIM To determine the impact of CIPN on QoL in colorectal cancer patients with a recent history of oxaliplatin-based chemotherapy.METHODS We performed a prospective cross-sectional study in two major Romanian oncology tertiary hospitals—the Regional Institute of Oncology Ia?i(Iasi,Romania)and the Fundeni Clinical Oncology Institute(Bucharest,Romania).All consecutive patients with colon or rectal cancer,undergoing Oxaliplatin-based chemotherapy that consented to enroll in the study,were assessed by means of two questionnaires—the EORTC QQ-CR29(quality of life in colon and rectal cancer patients)and the QLQ-CIPN20(assessment of neuropathy).Several demographical,social,clinical and treatment data were also collected.Statistical analysis was performed by means of SPSS v20.The student t test was used to assess the relationship between the QLQ-CIPN20 and QLQ-CR29 results.Kaplan Meyer-curves were used to report 3-year progression-free survival(PFS)in patients that discontinued chemotherapy vs those that completed the recommended course.RESULTS Of the 267 patients that fulfilled the inclusion criteria in the pre-specified time frame,101(37.8%)agreed to participate in the clinical study.At the time of the enrolment in the study,over 50%of the patients had recently interrupted their oxaliplatin-based chemotherapy,most often due to neuropathy.Almost 85%of the responders reported having tingling or numbness in their fingers or hands,symptoms that were associated with pain in over 20%of the cases.When comparing the scores in the two questionnaires,a statistically significant relationship(P<0.001)was found between the presence of neuropathic symptoms and a decreased quality of life.This correlation was consistent when the patients were stratified by sex,disease stage,comorbidities and the presence of stoma or treatment type,suggesting that neuropathy in itself may be a reason for a decreased quality of life.At the 3 year final assessment,median recurrence-free survival in stageⅢpatients was 26.88 mo.When stratified by completion of chemotherapy,median recurrence freesurvival of stageⅢpatients that completed chemotherapy was 28.27 mo vs 24.33 mo in patients that discontinued chemotherapy due to toxicity,a difference that did not reach statistical significance.CONCLUSION CIPN significantly impacts QoL in colorectal cancer patients.CIPN is also the most frequent reason for treatment discontinuation.Physicians should actively assess for CIPN in order to prevent chronic neuropathy.
基金National Key Research and Development Plan:Study on TCM Syndrome Regularity and Optimization of Coronavirus Disease 2019 Diagnosis and Treatment Plan(No.2021YFC1712901)。
文摘OBJECTIVE:To explore the differences in Traditional Chinese Medicine(TCM)diagnosis and treatment rules for coronavirus disease 2019(COVID-19)between Northern and Southern China based on the real-world data from 982 COVID-19 patients.METHODS:All consecutive cases of COVID-19 admitted to the TCM department of designated COVID-19 hospitals in eight provinces and cities were retrospectively analyzed.Patients were divided into a Northern and a Southern group according to the location of the admitting hospital.The symptoms,syndrome elements,syndrome distribution and herbal treatments were analyzed.The core prescriptions were extracted using the multiscale backbone-based network comparison algorithm(msbNC).RESULTS:The distribution of syndrome elements showed that dampness was common in Northern and Southern China,wind and heat were more often present in the South,while fire toxin and spleen deficiency were more often encountered in the North.The distribution of syndromes showed that the South was dominated by heat dampness accumulating in the lung(55.69%),while the North was dominated by dampness-toxin stagnating in the lung(44.90%).The results of core prescription mining showed that dispelling dampness,dispersing wind,clearing heat and strengthening spleen were the common treatment methods in Northern and Southern China.For mild cases,Jinyinhua(Flos Lonicerae)and Lianqiao(Fructus Forsythiae Suspensae)were often used in the South to clear heat and relieve exterior symptoms,while Chaihu(Radix Bupleuri Chinensis)and Huangqin(Radix Scutellariae Baicalensis)were often used in the North to relieve muscles by expelling heat.For moderate cases,Chaihu(Radix Bupleuri Chinensis),Qinghao(Herba Artemisiae Annuae),and Shigao(Gypsum Fibrosum)were often used to clear heat of Tri-jiao Channel and stomach in the South,while Fuling(Poria),Chenpi(Pericarpium Citri Reticulatae),and Dangshen(Radix Codonopsis)were often used to invigorate spleen and remove dampness in the North.For severe cases,spleen invigoration and dampness removal as well as relaxing the bowels and discharging heat were often used in the North.CONCLUSION:There were certain North-South differences in terms of symptoms,syndrome elements and syndrome distribution of COVID-19,as well as differences in core prescriptions during different periods of the disease.The regional differences in the rules of TCM diagnosis and treatment for COVID-19 should be further considered in the process of optimization and revision of relevant treatment guidance.
文摘Objective:This study aimed to systematically evaluate the effect of idebenone tablets in the treatment of post-stroke depression(Post-Stroke Depression,PSD).Methods:This study was a single-arm,prospective,observational study that recruited PSD patients who met the inclusion criteria after being assessed by the investigator between January 2022 and June 2023.The demographic characteristics,disease status,treatment status,and medication status of the patients were collected through questionnaires,and the Hamilton depression score of the patients was collected through the Case Report Form(CRF)to evaluate the effectiveness and safety of idebenone tablet treatment.Results:A total of 4902 PSD patients were included in this study,of which 2496 were males,accounting for 50.9%,and 2406 were females,accounting for 49.1%.According to the Hamilton Depression Rating Scale(HAMD),13.9%were no depression at the first visit,53.0%were mildly depressed,24.3%were moderately depressed,and 8.8%were severely depressed.After treatment,the proportion of no depression was 26.1%,mild depression accounted for 53.3%,moderate depression accounted for 16.8%,and severe depression accounted for 3.8%,and the difference in the proportion of depression before and after treatment was statistically significant(P<0.05).Conclusion:Idebenone tablets can significantly reduce Hamilton’s depression score,suggesting that it has a significant therapeutic effect in improving PSD symptoms.
文摘BACKGROUND Tofacitinib is an oral,selective Janus kinase inhibitor that is approved for the treatment of ulcerative colitis(UC).The 8-week induction protocol involves the administration of 10 mg twice daily(bid)with the possibility of extending the induction period to 16 weeks.The maintenance dose of tofacitinib is either 5 mg or 10 mg bid.AIM To assess predictors for clinical remission and drug persistence in patients with UC receiving the extended induction tofacitinib protocol.METHODS This was a real-world multicenter retrospective study in patients with moderateto-severe UC.Patients received physician-directed extended induction tofacitinib treatment.We collected clinical and demographic data at baseline and data regarding clinical,laboratory,and endoscopic evaluations,therapeutic modifications,and adverse events at the 52-week follow-up.Possible predictors for clinical remission at week 52 was the primary endpoint.Differences between patients receiving 5 mg bid vs 10 mg bid at week 52 and identification of predictors for treatment persistence were secondary endpoints.RESULTS Thirty-seven consecutive patients from 11 medical centers were included[51.4%males with median age 39(17-64)years].Twenty-eight patients continued treatment until week 52(75.7%)with 67.9%receiving 10 mg tofacitinib;all had prior history of biologic use.We observed that 57.1%of patients achieved clinical remission(66.7%in the 5 mg tofacitinib group and 52.6%in the 10 mg tofacitinib group,P=0.483).De-escalation to 5 mg tofacitinib was attempted in 17 patients with a success rate of 52.9%.Prior biologic use was significantly more frequent in patients treated with 10 mg tofacitinib.Active smoking was significantly associated with treatment discontinuation at week 52.We identified eight adverse events,and only one led to treatment discontinuation.CONCLUSION Our results supported the extended induction strategy with tofacitinib in selected patients with UC.Patients with prior failure of advanced therapies particularly benefitted,highlighting the importance of personalized maintenance regimens.
基金supported by the National Natural Science Foundation of China(grant numbers 82273262 and 81872078)the Tianjin Health Science and Technology Project(grant number TJWJ2024XK007)+5 种基金the Natural Science Foundation of Tianjin(grant number 21JCYBJC01430)Key Program of Tianjin Municipal Education Commission(grant number 2022ZD071)Tianjin Health Research Project(grant number TJWJ2023MS006)Tianjin Institute of Urology Funding Program(grant number MYSRC202315)Tianjin Health Research Project(grant number TJWJ2023XK008)Scientific Research Program of Tianjin Municipal Education Commission(grant number 2023KJ022).
文摘Background:This study aimed to evaluate the clinical efficacy and safety of combining a programmed cell death protein 1(PD-1)in-hibitor with a poly(ADP-ribose)polymerase inhibitor(PARPi)in patients with metastatic castration-resistant prostate cancer(mCRPC)who progressed after multiple lines of treatment,from a real-world perspective.Materials and methods:This open-label,single-arm,prospective study enrolled patients with mCRPC who had experienced disease progression after docetaxel and at least 2 lines of next-generation hormonal agents to receive camrelizumab(PD-1 inhibitor)and fluzoparib(PARPi).The primary endpoints were radiographic progression-free survival and overall survival(OS),and the secondary end-points were prostate-specific antigen progression-free survival and safety.Results:Eight patients with mCRPC who met the inclusion criteria were enrolled.The results showed that the median radiographic progression-free survival was 5.1 months,the median OS was 8.1 months,and the median prostate-specific antigen progression-free survival was 3.1 months.Safety analysis revealed that 87.5%of the patients experienced one or more treatment-related adverse events(AEs),with 37.5%reporting grade 3 or higher treatment-related AEs.None of the patients discontinued treatment because of treatment-related AEs.Conclusions:This real-world study demonstrated that the combination of a PD-1 inhibitor and PARPi exhibited sustained antitumor activity with an acceptable safety profile in the fourth-line treatment of patients with mCRPC.
基金The 2022 Educational Teaching Reform and Research Project of Guangxi University of Traditional Chinese Medicine(2022C032).
文摘Background:Lenvatinib is primarily utilized for the treatment of inoperable or advanced hepatocellular carcinoma,radioiodine-refractory differentiated thyroid cancer,and advanced renal cell carcinoma.Primary information about adverse reactions is principally derived from clinical trials;however,there is a notable dearth of substantial real-world studies.Methods:In this research,an examination of the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database was performed to evaluate the potential side effects of lenvatinib.The FAERS database revealed a total of 20,290 reported adverse events associated with lenvatinib.Different algorithms for repeated measure analysis were employed to ascertain the significance of these adverse reactions.Results:The study identified 170 instances of adverse events(AEs)induced by lenvatinib,incorporating several significant adverse reactions that the product label does not mention.The investigation also evaluated the onset periods of the adverse reactions,pinpointing a median time of 43 days.The majority of adverse reactions manifested within the initial month of lenvatinib use.Sex-specific analysis revealed disparities in high risk adverse reactions between females(vascular and lymphatic diseases,and neuronal organ diseases)and males(death and infectious diseases).Our data mining has unveiled adverse reactions beyond those mentioned within the instructions,such as osteonecrosis of the jaw,cholecystitis,cholangitis,dehydration,tumor lysis syndrome,type 1 diabetes,hyperammonemia,liver abscess,interstitial lung disease,pneumothorax,sudden death,and aortic dissection.Conclusion:The insights derived from these findings contribute significant nuances for optimizing lenvatinib use,enhancing its efficacy,and substantially mitigating potential side effects.These data elements will substantially enhance the implementation of the drug in a clinical environment.
基金China Academy of Chinese Medical Sciences Innovation Fund:Precise Positioning Decision-making Platform for Clinical Trials of Traditional Chinese Medicine Based on Predicition Model(CI2021A04707)The Fundamental Research Funds for the Central Public Welfare Research Institutes:Research on Traditional Chinese Medicine Syndrome Differentiation-based a Bayesian Decision Model of Basket Trial(ZZ13-YQ-076)+1 种基金The Fifth Batch of National TCM Clinical Outstanding Talent Training ProgramThe Fund of National Natural Science Foundation of China(Youth Science):Effect of Compound Shenlu Granule on Apoptosis of CD34+Cells in Lower-risk Myelodysplastic Syndromes Bone Marrow based on p38 Mitogen-activated Protein Kinase Pathway(81403233)。
文摘OBJECTIVE:To illustrate the effect of add-on therapy of Traditional Chinese Medicine(TCM)on the long-term survival of anemic lower-risk myelodysplastic syndromes(LR-MDS)patients.METHODS:In this study,we conducted a retrospective analysis of the data of patients with LR-MDS who were identified from Shuguang Hospital between January 2006 and June 2020.The Kaplan-Meier method was used to calculate overall survival(OS),while the Cox model was employed to analyze prognostic factors of long-term survival.A total of 162 patients who met the inclusion criteria were divided into two groups:the TCM group(n=78)or the non-TCM group(n=84).RESULTS:There were no significant differences in baseline characteristics.The cumulative survival rate of the TCM group was significantly higher than that of the non-TCM group[log-rank P=0.029,hazard ratio(HR)=0.484,95%confidence interval(CI)(0.249,0.942),P<0.05].Patients with longer TCM treatment appeared to have better OS(≥12 months vs<12 months);[HR,0.16695%CI(0.055,0.508),P<0.001].According to the Cox model analysis,the combination of TCM and conventional Western Medicine may be a protective factor affecting the long-term survival of LR-MDS patients[HR=0.509,95%CI,(0.261,0.993),P=0.048].The hematologic improvement erythroid response(HI-E)rate of the TCM group was significantly higher than that of the non-TCM group(69.23%vs 52.38%;P=0.028).However,the duration of HI-E and cases of disease progression after HI-E did not significantly differ from the non-TCM group(P>0.05).CONCLUSIONS:The integration of TCM and Western Medicine has the potential to extend the OS of LR-MDS patients when compared to the use of Western Medicine alone.
基金supported by the China Postdoctoral Science Foundation(Grant No.2021M703366)Shenzhen Science and Technology Program(Grant No.KQTD20190929172835662).
文摘Objective Observational studies have found associations between inflammatory bowel disease(IBD)and the risk of dementia,including Alzheimer’s dementia(AD)and vascular dementia(VD);however,these findings are inconsistent.It remains unclear whether these associations are causal.Methods We conducted a meta-analysis by systematically searching for observational studies on the association between IBD and dementia.Mendelian randomization(MR)analysis based on summary genome-wide association studies(GWASs)was performed.Genetic correlation and Bayesian colocalization analyses were used to provide robust genetic evidence.Results Ten observational studies involving 80,565,688 participants were included in this metaanalysis.IBD was significantly associated with dementia(risk ratio[RR]=1.36,95%CI=1.04-1.78;I2=84.8%)and VD(RR=2.60,95%CI=1.18-5.70;only one study),but not with AD(RR=2.00,95%CI=0.96-4.13;I^(2)=99.8%).MR analyses did not supported significant causal associations of IBD with dementia(dementia:odds ratio[OR]=1.01,95%CI=0.98-1.03;AD:OR=0.98,95%CI=0.95-1.01;VD:OR=1.02,95%CI=0.97-1.07).In addition,genetic correlation and co-localization analyses did not reveal any genetic associations between IBD and dementia.Conclusion Our study did not provide genetic evidence for a causal association between IBD and dementia risk.The increased risk of dementia observed in observational studies may be attributed to unobserved confounding factors or detection bias.
基金supported by“Dalian Maritime University Teaching Reform Research Fund 2022 Annual Project”(Fund No.XJG2022-96).
文摘This paper proposes an interdisciplinary talent training model that combines foreign language education with area studies.The model aims to cultivate international ocean affairs professionals with cross-cultural communication skills,in-depth regional and country knowledge,and practical expertise in ocean affairs.Additionally,the paper presents specific training pathways and policy recommendations for implementing this model.
