Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-...Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-year data retrived from FDA adverse event reporting system(FAERS).Methods:This is a retrospective analysis on 15-year data of artemether-related adverse effects(AEs)retrieved from the FAERS.AEs were classified according to System Organ Class(SOC)and Preferred Terms(PT).Signal detection was performed using Reporting Odds Ratios(ROR),Proportional Reporting Ratios(PRR),and Empirical Bayes Geometric Mean(EBGM).Stratified analyses examined the impact of demographic factors such as sex,age,and time-to-onset.Temporal patterns and associated risk factors were also investigated.Results:Haemolytic anaemia and haemolysis emerged as the most frequently reported AEs,exhibiting significantly elevated RORs(males:ROR 381.36,95%CI 247.06-588.60;females:ROR 455.11,95%CI 286.43-723.12).Sex-specific differences were evident,with females showing a higher incidence of reproductive-related AEs,including spontaneous abortion and premature labour.Temporal trend analysis revealed that the majority of AEs occurred within the first 30 days after the initiation of artemether administration,indicating a rapid onset.The most affected SOCs were blood and lymphatic system disorders and hepatobiliary disorders.Conclusions:Artemether is associated with a notable frequency of early-onset AEs,particularly hematological and hepatobiliary disorders.The observed sex-specific vulnerability to reproductive AEs highlights the need for sex-conscious clinical approaches.Enhanced post-treatment monitoring and further investigations into the drug’s pharmacokinetics and mechanistic pathways are recommended.展开更多
BACKGROUND Minimally invasive esophagectomy(MIE)is a widely accepted treatment for esophageal cancer,yet it is associated with a significant risk of surgical adverse events(SAEs),which can compromise patient recovery ...BACKGROUND Minimally invasive esophagectomy(MIE)is a widely accepted treatment for esophageal cancer,yet it is associated with a significant risk of surgical adverse events(SAEs),which can compromise patient recovery and long-term survival.Accurate preoperative identification of high-risk patients is critical for improving outcomes.AIM To establish and validate a risk prediction and stratification model for the risk of SAEs in patients with MIE.METHODS This retrospective study included 747 patients who underwent MIE at two centers from January 2019 to February 2024.Patients were separated into a train set(n=549)and a validation set(n=198).After screening by least absolute shrinkage and selection operator regression,multivariate logistic regression analyzed clinical and intraoperative variables to identify independent risk factors for SAEs.A risk stratification model was constructed and validated to predict the probability of SAEs.RESULTS SAEs occurred in 10.2%of patients in train set and 13.6%in the validation set.Patients with SAE had significantly higher complication rate and a longer hospital stay after surgery.The key independent risk factors identified included chronic obstructive pulmonary disease,a history of alcohol consumption,low forced expiratory volume in the first second,and low albumin levels.The stratification model has excellent prediction accuracy,with an area under the curve of 0.889 for the training set and an area under the curve of 0.793 for the validation set.CONCLUSION The developed risk stratification model effectively predicts the risk of SAEs in patients undergoing MIE,facilitating targeted preoperative interventions and improving perioperative management.展开更多
Objective:Despite established associations between certain medications and urticaria,the risk profiles of most pharmaceutical agents remain poorly characterized.This investigation aimed to identify risk factors for me...Objective:Despite established associations between certain medications and urticaria,the risk profiles of most pharmaceutical agents remain poorly characterized.This investigation aimed to identify risk factors for medication-induced urticaria through comprehensive analysis of the FDA Adverse Event Reporting System(FAERS)database.Methods:We employed reporting odds ratios(ROR)to evaluate drug-urticaria associations using FAERS data spanning from Q12004 to Q32024.Analytical approaches included univariate screening,LASSO regression,and multivariate logistic regression to identify potential risk factors.Multiple comparison adjustments were implemented using the Bonferroni method.Results:The study identified 1807 pharmaceutical agents potentially associated with urticaria development.Univariate analysis categorized these agents into several therapeutic classes:antimicrobials(19/85),biologics(16/85),analgesics(8/85),dermatologicals(3/85),anti-rheumatic agents(4/85),hormonal preparations(3/85),antihypertensives(2/85),neuropsychiatric medications(2/85),uric acid-lowering drugs(2/85),multiple sclerosis therapies(2/85),and miscellaneous agents(17/85).Multivariate analysis identified three significant risk determinants:middle-aged individuals(36-53 years),female gender,and exposure to any of 82 specific medications.Conclusion:These evidence-based findings provide valuable insights for early clinical recognition of drug-induced urticaria and establish a foundation for subsequent mechanistic investigations into medication-related hypersensitivity reactions.展开更多
BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in ...BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.展开更多
This letter addressed the impactful study by Zhong et al,which introduced a risk prediction and stratification model for surgical adverse events following minimally invasive esophagectomy.By identifying key risk facto...This letter addressed the impactful study by Zhong et al,which introduced a risk prediction and stratification model for surgical adverse events following minimally invasive esophagectomy.By identifying key risk factors such as chronic obstructive pulmonary disease and hypoalbuminemia,the model demonstrated strong predictive accuracy and offered a pathway to personalized perioperative care.This correspondence highlighted the clinical significance,emphasizing its potential to optimize patient outcomes through tailored inter-ventions.Further prospective validation and application across diverse settings are essential to realize its full potential in advancing esophageal surgery practices.展开更多
BACKGROUND Intra-arterial chemotherapy(IAC)has become a first-line standard treatment for retinoblastoma(RB).However,studies describing its adverse events are sparse,especially from the developing world.Our study desc...BACKGROUND Intra-arterial chemotherapy(IAC)has become a first-line standard treatment for retinoblastoma(RB).However,studies describing its adverse events are sparse,especially from the developing world.Our study described the outcomes and adverse events from a single center in South India.AIM To describe the challenges,treatment outcomes,and complications of selective IAC for RB in Indian eyes.METHODS This study was a single center,retrospective study that included 17 patients with RB who underwent IAC using melphalan(5/7.5 mg)and topotecan(1/2 mg)(n=12)or melphalan(5 mg)alone(n=3)or triple therapy that included carboplatin(30 mg)along with these drugs(n=2)between January 2018 and December 2023.In all,17 IAC procedures were performed using selective ophthalmic artery cannulation.Treatment outcomes were evaluated in terms of tumor control,vitreous and subretinal seed control,complications,and globe salvage rates.RESULTS Out of the 17 patients,11 were diagnosed with unilateral RB and 6 were diag-nosed with bilateral RB.The mean age at the time of diagnosis was 19.8 months.The mean interval between the first symptom and presentation was 6.5 months.IAC was employed as the primary(n=9)or secondary(n=8)modality of treatment.Each eye received a mean of 1.5 IAC sessions(median:1 session;range:1-3 sessions).Eyes were classified according to the international classification of RB as group B(n=5),group C(n=1),group D(n=4),and group E(n=7).Following IAC,complete regression of the main tumor was seen in 15 eyes(88%)and partial regression in 2 eyes(12%).Globe salvage was achieved in 15 eyes(88%).Adverse effects included vitreous hemorrhage(n=3),rhegmatogenous retinal de-tachment(n=2),choroidal ischemia(n=1),isolated subretinal hemorrhage(n=2),retinal pigment epithelium degeneration(n=2),forehead pigmentation(n=1),third nerve palsy with complete ptosis(n=1),and 30-degree exotropia(n=1).The mean follow-up period was 28.6 months(median:24 months,range:1–72 months).CONCLUSION IAC is an effective way to control RB and globe preservation.In the Indian context we encountered many cha-llenges highlighting the importance of case selection.Further studies in India are required to thoroughly un-derstand IAC as a treatment for RB.展开更多
BACKGROUND Depression is a common psychological disorder often associated with genetic,neurobiological,and psychosocial factors.This condition is characterized by low mood and decreased conscious activity and can lead...BACKGROUND Depression is a common psychological disorder often associated with genetic,neurobiological,and psychosocial factors.This condition is characterized by low mood and decreased conscious activity and can lead to severe consequences such as suicidal thoughts.Respiratory failure,a disorder of pulmonary ventilation and gas exchange,is frequently complicated by depression,aggravating the condition and creating complications in treatment.Patients with both conditions tend to exhibit poor compliance with medical advice,resulting in adverse outcomes such as sleep disorders,arrhythmias,and electrolyte imbalances.Therefore,effective nursing interventions are crucial for improving patient outcomes.While routine nursing care can provide basic support,dedicated nursing,which involves specialized and personalized care by highly trained professionals,may offer additional benefits.AIM To examine the effect of dedicated nursing intervention on medical advice compliance and adverse event incidence in patients with depression complicated by respiratory failure.METHODS A total of 160 patients with depression complicated by respiratory failure admitted to the Second Affiliated Hospital of Soochow University from January to December 2024 were randomly categorized into a control group(n=80)receiving routine nursing care and observation group(n=80)receiving routine nursing combined with dedicated nursing care.The establishment of a specialized nursing team;the development of a personalized nursing plan;and the implementation of comprehensive care strategies targeting emotional support,sleep improvement,pulmonary function enhancement,and adherence to medical advice were included in the dedicated nursing intervention.Emotional state[evaluated using the Self-Rating Depression Scale(SDS)],sleep quality[assessed using the Pittsburgh Sleep Quality Index(PSQI)],hope level[measured using the Herth Hope Scale(HHS)],pulmonary function[comprising forced vital capacity(FVC)and forced expiratory volume in the first second(FEV1)],exercise endurance[6-minute walk distance test(6MWD)],compliance with medical advice,and incidence of adverse events were compared between the two groups.RESULTS No significant differences were observed in SDS,PSQI,HHS,FVC,FEV1,6MWD,or compliance with medical advice between the two groups(P>0.05)before the intervention.However,after the intervention,the control group exhibited significantly lower SDS and PSQI scores;higher HHS scores;greater improvements in FVC,FEV1,and 6MWD;and higher compliance with medical advice compared with the control group(P<0.05).In addition,the incidence of adverse events was significantly lower in the control group(P<0.05).CONCLUSION Dedicated nursing intervention significantly improves emotional state,sleep quality,hope level,pulmonary function,exercise endurance,and compliance with medical advice while reducing adverse events in patients with depression complicated by respiratory failure.Therefore,dedicated nursing appears to be an effective approach to enhance patient outcomes in this population.展开更多
Immune checkpoint inhibitors have markedly improved outcomes in patients with multiple advanced malignancies.However,their widespread use has markedly increased the incidence of immune-related adverse events(irAEs).ir...Immune checkpoint inhibitors have markedly improved outcomes in patients with multiple advanced malignancies.However,their widespread use has markedly increased the incidence of immune-related adverse events(irAEs).irAEs can affect a wide range of organ systems and are characterized by heterogeneous onset,broad toxicity spectra,and complex management requirements,thus ultimately impairing treatment continuation and patient quality of life.This review systematically summarizes the epidemiological features,clinical progression,and current management of irAEs.Existing guidelines largely focus on acute toxicities but have not provided structured strategies for chronic,delayed-onset,or multisystem irAEs.Moreover,clinical practice is hampered by incomplete multidisciplinary collaboration,insufficient training of oncologists,and fragmented treatment pathways,all of which limit the efficacy of irAE management.We propose incorporating irAE management into core oncology training and call for the establishment of comprehensive interdisciplinary frameworks to ensure the standardized long-term use of immunotherapy.展开更多
Minimally invasive esophagectomy(MIE)has transformed esophageal surgery by reducing morbidity,accelerating recovery,and improving postoperative out-comes compared to traditional open esophagectomy.By utilizing techniq...Minimally invasive esophagectomy(MIE)has transformed esophageal surgery by reducing morbidity,accelerating recovery,and improving postoperative out-comes compared to traditional open esophagectomy.By utilizing techniques such as laparoscopic,thoracoscopic,and robotic-assisted approaches,MIE mini-mizes surgical trauma while maintaining oncological thoroughness.However,it also presents unique challenges,including risks of complications such as ana-stomotic leakage,pulmonary complications,and atrial fibrillation.Zhong et al developed and validated a risk stratification model for predicting surgical adverse events after MIE,enhancing preoperative assessment and patient management.This editorial further examines the advantages of MIE,its comparable oncological and long-term outcomes,as well as the incidence and contributing factors of post-operative complications.Emerging technologies,including machine learning models,intraoperative nerve monitoring,and robotic-assisted surgery,are high-lighted as innovative solutions for risk prediction and prevention.Strategies such as enhanced recovery after surgery protocols and multidisciplinary collaboration are emphasized for their critical roles in minimizing complications and optimizing patient outcomes.By addressing these aspects,this editorial provides guidance to surgical teams in maximizing the benefits of MIE while effectively managing its associated risks.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 develop nursing adverse events’reporting content of hospital.Methods:The study included two phases.The first phase was to develop the category and definition of nursing adverse events that need to be rep...Objective:To develop nursing adverse events’reporting content of hospital.Methods:The study included two phases.The first phase was to develop the category and definition of nursing adverse events that need to be reported through an expert meeting.The second phase was to develop every nursing adverse event’s reporting content by using the Delphi method.In total,8 experts attended the meeting and 15 experts conducted two rounds of consultation letter.Results:Nursing adverse events that need to be reported of hospital include pressure sore,fall/falling from bed,unplanned extubation,medication error,and accident.Reporting content of these events in detail had also been obtained,which was helpful for cause analysis systematically.Conclusions:The reporting content of the nursing adverse event of hospital is established,and it is a basis for further study of the development of nursing adverse event reporting and feedback system.展开更多
Introduction: Sorafenib is an orally active multikinase inhibitor approved for the treatment of advanced hepatocellular carcinoma (HCC) and is the only systemic treatment associated with a survival benefit in advanced...Introduction: Sorafenib is an orally active multikinase inhibitor approved for the treatment of advanced hepatocellular carcinoma (HCC) and is the only systemic treatment associated with a survival benefit in advanced stage. The aims of this study were to evaluate the tolerance and survival of sorafenib-treated patients, and to identify potential prognostic factors of survival. Methods: A total of 88 HCC patients treated with sorafenib from June 2010 to January 2014 were retrospectively reviewed. Tumour stage, liver function and adverse events to sorafenib were analyzed. Univariate and multivariate analysis were carried out to identify predictors of survival in patients with advanced HCC treated with sorafenib. Results: There were 64 (73%) males included in this study, with a median age of 61.16 years. Eight (91%) patients had Child-Pugh class A cirrhosis. Most patients were classified as BCLC C (82%). Hepatitis C virus was the predominant cause of HCC (68%). Sorafenib was the initial treatment modality in 43%. Median time of sorafenib therapy was 8.23 months. Overall survival in 1 year was 57.3% and 36.7% in 2 years. The median survival was 16.3 months. In the univariate analysis of the OS based on Child-Pugh score did not demonstrate a significant difference in our study (p = 0.62). The presence of dermatologic adverse event predicted a better overall survival in the multivariate analysis. Better survival was also observed in patients with AFP level <100 ng/ml in the start of sorafenib therapy (p = 0.001). Patients that used Sorafenib for ≥6 months had shown better outcome. None of the patients discontinued sorafenib because of adverse effects. Conclusions: Advanced HCC patients treated with sorafenib who experienced dermatologic adverse event and low AFP level <100 ng/ml showed better overall survival. As expected, longer sorafenib therapy (≥6 months) was associated to better survival. Even in the presence of adverse events, the use of sorafenib should be continued because the longer usage time improves survival.展开更多
AIM： To assess the safety of bismuth used in Helicobacter pylori （H pylorl） eradication therapy regimens. METHODS： We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched （up to Octob...AIM： To assess the safety of bismuth used in Helicobacter pylori （H pylorl） eradication therapy regimens. METHODS： We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched （up to October 2007） to identify randomised controlled tri- als comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or, in combination, with acid suppresion. Total numbers of adverse events were recorded. Data were pooled and expressed as relative risks with 95% confidence intervals （CI）.RESULTS： We identified 35 randomised controlled trials containing 4763 patients. There were no serious adverse events occurring with bismuth therapy. There was no statistically significant difference detected in total adverse events with bismuth rrelative risk （RR） = 1.01; 95% CI： 0.87-1.16], specific individual adverse events, with the exception of dark stools （RR = 5.06; 95% CI： 1.59-16.12）, or adverse events leading to withdrawal of therapy （RR = 0.86; 95% CI： 0.54-1.37）. CONCLUSION： Bismuth for the treatment of H py/ori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools.展开更多
Biliary adverse events following orthotopic liver transplantation (OLT) are relatively common and continue to be serious causes of morbidity, mortality, and transplant dysfunction or failure. The development of these ...Biliary adverse events following orthotopic liver transplantation (OLT) are relatively common and continue to be serious causes of morbidity, mortality, and transplant dysfunction or failure. The development of these adverse events is heavily influenced by the type of anastomosis during surgery. The low specificity of clinical and biologic findings makes the diagnosis challenging. Moreover, direct cholangiographic procedures such as endoscopic retrograde cholangiopancreatography and percutaneous transhepatic cholangiography present an inadmissible rate of adverse events to be utilized in clinically low suspected patients. Magnetic resonance (MR) maging with MR cholangiopancreatography is crucial in assessing abnormalities in the biliary system after liver surgery, including liver transplant. MR cholangiopancreatography is a safe, rapid, non-invasive, and effective diagnostic procedure for the evaluation of biliary adverse events after liver transplantation, since it plays an increasingly important role in the diagnosis and management of these events. On the basis of a recent systematic review of the literature the summary estimates of sensitivity and specificity of MR cholangiopancreatography for diagnosis of biliary adverse events following OLT were 0.95 and 0.92, respectively. It can provide a non-invasive method of imaging surgical reconstruction of the biliary anastomoses as well as adverse events including anastomotic and non-anastomotic strictures, biliary lithiasis and sphincter of Oddi dysfunction in liver transplant recipients. Nevertheless, conventional T2-weighted MR cholangiography can be implemented with T1-weighted contrast-enhanced MR cholangiography using hepatobiliary contrast agents (in particular using Gd-EOB-DTPA) in order to improve the diagnostic accuracy in the adverse events’ detection such as bile leakage and strictures, especially in selected patients with biliary-enteric anastomosis.展开更多
Objective:We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events(irAEs)as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpo...Objective:We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events(irAEs)as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpoint inhibitors(ICIs)in patients with advanced pan-cancer in a real-world setting.Methods:We retrospectively analyzed data from 105 patients with advanced pan-cancer treated with multi-type ICIs at the First Hospital of Jilin University between January 1,2016 and August 1,2020.We used logistic regression analyses to investigate the associations of irAEs with clinical baseline characteristics,blood count parameters,and biochemical indicators during treatment.Receiver operating characteristic curves were used to determine cutoff values for parameters and area under the curve values.Kaplan–Meier and Cox multivariate regression analyses were performed to estimate the relationships of baseline characteristics and irAEs with progression-free survival(PFS)and overall survival(OS).Results:A lower relative lymphocyte count(cutoff=28.5%),higher albumin level(cutoff=39.05 g/L),and higher absolute eosinophil count(AEC)(cutoff=0.175×10^(9)/L)were significantly associated with the occurrence of irAEs,among which a higher AEC(cutoff=0.205×10^(9)/L)was strongly associated with skin-related irAEs[odds ratios(ORs)=0.163,P=0.004].Moreover,a higher lactate dehydrogenase level(cutoff=237.5 U/L)was an independent predictor of irAEs of grade≥3(OR=0.083,P=0.023).In immune cell subgroup analysis,a lower absolute count of CD8+CD28−suppressor T cells(OR=0.806;95%confidence interval:0.643–1.011;P=0.062),which are regulatory T lymphocytes,was associated with the occurrence of irAEs,although the difference was not statistically significant.Furthermore,a higher percentage of CD19+B cells was associated with the occurrence of irAEs of grade≥3(P=0.02)and grade≥2(P=0.051).In addition,patients with any grade of irAE had a significantly high PFS(8.37 vs.3.77 months,hazard ratios(HR)=2.02,P=0.0038)and OS(24.77 vs.13.83 months,HR=1.84;P=0.024).Conclusions:This retrospective study reports clinical profile data for irAEs in unselected patients in a real-world setting and explored some parameters that may be potential predictive markers of the occurrence,type,or grade of irAEs in clinical practice.Evidence of a correlation between safety and efficacy may facilitate a complete assessment of the risk-benefit ratio for patients treated with ICIs.展开更多
BACKGROUND Endoscopic retrograde cholangiopancreatography(ERCP)is a valuable therapeutic technique for pancreatobiliary diseases,and its application in the elderly is no longer limited.However,a higher incidence of pr...BACKGROUND Endoscopic retrograde cholangiopancreatography(ERCP)is a valuable therapeutic technique for pancreatobiliary diseases,and its application in the elderly is no longer limited.However,a higher incidence of procedure difficulty and periprocedural adverse events might be expected in elderly patients due to the presence of other medical disorders and the poor general condition of this population.AIM To evaluate the incidence,causes,and management of difficult biliary cannulation during ERCP in elderly patients and the role of difficult cannulation as a risk factor for adverse events.METHODS A total of 614 patients who underwent ERCP during the study period were prospectively studied and divided into two groups based on their age.One hundred and forty-six patients were aged 80 years or older and 468 patients were aged less than 80 years.The primary outcome measurements were cannulation difficulty,cannulation success rate,ERCP procedure time,and related adverse events.RESULTS There was no difference in the incidence of difficult cannulation among the two groups(32.9%vs 34.4%,P=0.765),as well as in the cannulation success rate(96.6%vs 96.8%,P=0.54).The cannulation techniques were shown to be safe and efficient in achieving successful cannulation.Logistic regression analysis showed that patients aged 80 years or older were not associated with increased adverse events;however,difficult cannulation cases[adjusted odds ratio(AOR)=3.478;95%confidence interval(CI):1.877-6.442;P<0.001]and patients with Charlson Comorbidity Index≥2(AOR=1.824;95%CI:0.993-3.349;P=0.045)were more likely to develop adverse events.In contrast,other factors including age≤65(AOR=3.460;95%CI:1.511-7.922;P=0.003),female gender(AOR=2.362;95%CI=1.089-5.124;P=0.030),difficult cannulation(AOR=4.527;95%CI:2.078-9.860;P<0.001),and patients with cholangitis(AOR=3.261;95%CI:1.204-8.832;P=0.020)were strongly associated with a higher rate of post-ERCP pancreatitis.CONCLUSION Advanced age has not been proved to be a risk factor for difficult cannulation,and secondary cannulation techniques can be safely and efficaciously utilized in this group.Patients with a Charlson Comorbidity Index≥2 and difficult cannulation are associated with an increased overall adverse events rate,while age≥80 years is not.展开更多
BACKGROUND Pancreatic adenoma can potentially transform into adenocarcinoma, so it is recommended to be resected surgically or endoscopically. Endoscopic papillectomy is one of the main treatments for papillary adenom...BACKGROUND Pancreatic adenoma can potentially transform into adenocarcinoma, so it is recommended to be resected surgically or endoscopically. Endoscopic papillectomy is one of the main treatments for papillary adenoma, and bleeding, perforation, and pancreatitis are the most frequent and critical adverse events that restrict its wider use. There is no standard procedure for endoscopic papillectomy yet. The procedure is relevant to postoperative adverse events.AIM To reduce the postoperative adverse event rates and improve patients' postoperative condition, we developed a standard novel procedure for endoscopic papillectomy.METHODS The novel endoscopic papillectomy had two main modifications based on the conventional method: The isolation of bile from pancreatic juice with a bile duct stent and wound surface protection with metal clips and fibrin glue. We performed a single-center retrospective comparison study on the novel and conventional methods to examine the feasibility of the novel method for reducing postoperative adverse events.RESULTS A total of 76 patients, of whom 23 underwent the novel procedure and 53 underwent the conventional procedure, were retrospectively evaluated in this study. The postoperative bleeding and pancreatitis rates of the novel method were significantly lower than those of the conventional method(0 vs 20.75%, P = 0.028, and 17.4% vs 41.5%, P = 0.042, respectively). After applying the novel method, the most critical adverse event, perforation, was entirely prevented, compared to a prevalence of 5.66% with the conventional method. Several postoperative symptoms, including fever, rapid pulse, and decrease in hemoglobin level, were significantly less frequent in the novel group(P = 0.042, 0.049, and 0.014, respectively). Overall, the total adverse event rate of the novel method was lower(0 vs 24.5%, P = 0.007) than that of the conventional method.CONCLUSION Patients who underwent the novel procedure had lower postoperative adverse event rates. This study demonstrates the potential efficacy and safety of the novel endoscopic papillectomy in reducing postoperative adverse events.展开更多
AIM To study the type and frequency of adverse events associated with anti-tumor necrosis factor(TNF)therapy and evaluate for any serologic and genetic associations.METHODS This study was a retrospective review of pat...AIM To study the type and frequency of adverse events associated with anti-tumor necrosis factor(TNF)therapy and evaluate for any serologic and genetic associations.METHODS This study was a retrospective review of patients attending the inflammatory bowel disease(IBD) centers at Cedars-Sinai IBD Center from 2005-2016. Adverse events were identified via chart review. IBD serologies were measured by ELISA. DNA samples were genotyped at Cedars-Sinai using Illumina Infinium Immunochipv1 array per manufacturer's protocol. SNPs underwent methodological review and were evaluated using several SNP statistic parameters to ensure optimal allele-calling. Standard and rigorous QC criteria were applied to the genetic data, which was generated using immunochip. Genetic association was assessed by logistic regression after correcting for population structure.RESULTS Altogether we identified 1258 IBD subjects exposed to anti-TNF agents in whom Immunochip data were available. 269/1258 patients(21%) were found to have adverse events to an anti-TNF-α agent that required the therapy to be discontinued. 25% of women compared to 17% of men experienced an adverse event. All adverse events resolved after discontinuing the antiTNF agent. In total: n = 66(5%) infusion reactions; n = 49(4%) allergic/serum sickness reactions; n = 19(1.5%) lupus-like reactions, n = 52(4%) rash, n = 18(1.4%) infections. In Crohn's disease, Ig A ASCA(P = 0.04) and Ig G-ASCA(P = 0.02) levels were also lower in patients with any adverse events, and anti-I2 level in ulcerative colitis was significantly associated with infusion reactions(P = 0.008). The logistic regression/human annotation and network analyses performed on the Immunochip data implicated the following five signaling pathways: JAK-STAT(Janus Kinase-signal transducer and activator of transcription), measles, IBD, cytokine-cytokine receptor interaction, and toxoplasmosis for any adverse event. CONCLUSION Our study shows 1 in 5 IBD patients experience an adverse event to anti-TNF therapy with novel serologic, genetic, and pathways associations.展开更多
AIM To evaluate the rate of adverse events(AEs)during consecutive gastric and duodenal polypectomies in several Spanish centers.METHODS Polypectomies of protruded gastric or duodenal polyps≥5 mm using hot snare were ...AIM To evaluate the rate of adverse events(AEs)during consecutive gastric and duodenal polypectomies in several Spanish centers.METHODS Polypectomies of protruded gastric or duodenal polyps≥5 mm using hot snare were prospectively included.Prophylactic measures of hemorrhage were allowed in predefined cases.AEs were defined and graded according to the lexicon recommended by the American Society for Gastrointestinal Endoscopy.Patients were followed for 48 h,one week and 1 mo after theprocedure.RESULTS308 patients were included and a single polypectomy was performed in 205.Only 36(11.7%)were on prior anticoagulant therapy.Mean polyp size was 15±8.9 mm(5-60)and in 294 cases(95.4%)were located in the stomach.Hemorrhage prophylaxis was performed in 219(71.1%)patients.Nine patients presented AEs(2.9%),and 6 of them were bleeding(n=6,1.9%)(in 5 out of 6 AE,different types of endoscopic treatment were performed).Other 24 hemorrhagic episodes could be managed without any change in the outcome of the endoscopy and,consequently,were considered incidents.We did not find any independent risk factor of bleeding.CONCLUSION Gastroduodenal polypectomy using prophylactic measures has a rate of AEs small enough to consider this procedure a safe and effective method for polyp resection independently of the polyp size and location.展开更多
The patient was an asymptomatic 43-year-old woman. Abdominal ultrasonography and enhanced computed tomography showed a tumor lesion accompanied by multiple cystic changes in the liver and the pancreatic tail. Endoscop...The patient was an asymptomatic 43-year-old woman. Abdominal ultrasonography and enhanced computed tomography showed a tumor lesion accompanied by multiple cystic changes in the liver and the pancreatic tail. Endoscopic ultrasound-fine needle aspiration was performed on the pancreatic tumor lesion and revealed pancreatic neuroendocrine tumor(PNET). As it was unresectable due to multiple liver metastases, the decision was made to initiate treatment with everolimus and transcatheter arterial chemoembolization. The patient ceased menstruating after the start of everolimus administration. When the administration was discontinued due to interstitial lung disease, menstruation resumed, but then again stopped with everolimus resumption. An association between everolimus and amenorrhea was highly suspected. Amenorrhea occurred as a rare adverse event of everolimus. As the younger women might be included in PNETs patients, we should put this adverse event into consideration.展开更多
文摘Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-year data retrived from FDA adverse event reporting system(FAERS).Methods:This is a retrospective analysis on 15-year data of artemether-related adverse effects(AEs)retrieved from the FAERS.AEs were classified according to System Organ Class(SOC)and Preferred Terms(PT).Signal detection was performed using Reporting Odds Ratios(ROR),Proportional Reporting Ratios(PRR),and Empirical Bayes Geometric Mean(EBGM).Stratified analyses examined the impact of demographic factors such as sex,age,and time-to-onset.Temporal patterns and associated risk factors were also investigated.Results:Haemolytic anaemia and haemolysis emerged as the most frequently reported AEs,exhibiting significantly elevated RORs(males:ROR 381.36,95%CI 247.06-588.60;females:ROR 455.11,95%CI 286.43-723.12).Sex-specific differences were evident,with females showing a higher incidence of reproductive-related AEs,including spontaneous abortion and premature labour.Temporal trend analysis revealed that the majority of AEs occurred within the first 30 days after the initiation of artemether administration,indicating a rapid onset.The most affected SOCs were blood and lymphatic system disorders and hepatobiliary disorders.Conclusions:Artemether is associated with a notable frequency of early-onset AEs,particularly hematological and hepatobiliary disorders.The observed sex-specific vulnerability to reproductive AEs highlights the need for sex-conscious clinical approaches.Enhanced post-treatment monitoring and further investigations into the drug’s pharmacokinetics and mechanistic pathways are recommended.
基金Supported by Joint Funds for the Innovation of Science and Technology,Fujian Province,No.2023Y9187 and No.2021Y9057.
文摘BACKGROUND Minimally invasive esophagectomy(MIE)is a widely accepted treatment for esophageal cancer,yet it is associated with a significant risk of surgical adverse events(SAEs),which can compromise patient recovery and long-term survival.Accurate preoperative identification of high-risk patients is critical for improving outcomes.AIM To establish and validate a risk prediction and stratification model for the risk of SAEs in patients with MIE.METHODS This retrospective study included 747 patients who underwent MIE at two centers from January 2019 to February 2024.Patients were separated into a train set(n=549)and a validation set(n=198).After screening by least absolute shrinkage and selection operator regression,multivariate logistic regression analyzed clinical and intraoperative variables to identify independent risk factors for SAEs.A risk stratification model was constructed and validated to predict the probability of SAEs.RESULTS SAEs occurred in 10.2%of patients in train set and 13.6%in the validation set.Patients with SAE had significantly higher complication rate and a longer hospital stay after surgery.The key independent risk factors identified included chronic obstructive pulmonary disease,a history of alcohol consumption,low forced expiratory volume in the first second,and low albumin levels.The stratification model has excellent prediction accuracy,with an area under the curve of 0.889 for the training set and an area under the curve of 0.793 for the validation set.CONCLUSION The developed risk stratification model effectively predicts the risk of SAEs in patients undergoing MIE,facilitating targeted preoperative interventions and improving perioperative management.
文摘Objective:Despite established associations between certain medications and urticaria,the risk profiles of most pharmaceutical agents remain poorly characterized.This investigation aimed to identify risk factors for medication-induced urticaria through comprehensive analysis of the FDA Adverse Event Reporting System(FAERS)database.Methods:We employed reporting odds ratios(ROR)to evaluate drug-urticaria associations using FAERS data spanning from Q12004 to Q32024.Analytical approaches included univariate screening,LASSO regression,and multivariate logistic regression to identify potential risk factors.Multiple comparison adjustments were implemented using the Bonferroni method.Results:The study identified 1807 pharmaceutical agents potentially associated with urticaria development.Univariate analysis categorized these agents into several therapeutic classes:antimicrobials(19/85),biologics(16/85),analgesics(8/85),dermatologicals(3/85),anti-rheumatic agents(4/85),hormonal preparations(3/85),antihypertensives(2/85),neuropsychiatric medications(2/85),uric acid-lowering drugs(2/85),multiple sclerosis therapies(2/85),and miscellaneous agents(17/85).Multivariate analysis identified three significant risk determinants:middle-aged individuals(36-53 years),female gender,and exposure to any of 82 specific medications.Conclusion:These evidence-based findings provide valuable insights for early clinical recognition of drug-induced urticaria and establish a foundation for subsequent mechanistic investigations into medication-related hypersensitivity reactions.
文摘BACKGROUND In randomized controlled trials(RCTs),the placebo arm has often been ignored as the attention tends to be focused on the treatment arm.We undertook a meta-analysis based on the data from the placebo arm in RCTs of hepatocellular carci-noma(HCC),the response rates and survival status,and adverse events(AEs)were summarized and evaluated.AIM To systematically evaluate the response rates,survival status and AEs in the placebo arms of RCTs for HCC.METHODS A systematic search was performed on PubMed,Ovid MEDLINE,Embase and Cochrane Library to identify relevant trials evaluating the efficacy of drugs for the treatment of HCC,published until December 31,2023.Statistical analysis was performed using R statistical software(version 4.3.2).RESULTS A total of 18 RCTs,involving 2390 patients,met the criteria for inclusion in the meta-analysis.The pooled overall disease control rate and objective response rate in the placebo group were 38%[95%confidence interval(CI):33%-42%]and 1%(95%CI:1%-2%),respectively.Overall survival and progression-free survival in the placebo group were 7.9 months(95%CI:7.6-8.31 months)and 1.9 months(95%CI:1.6-2.1 months),respectively.The incidence of grade 3 or 4 AEs was 37%(95%CI:30%-43%).Additionally,the incidence of interruptions or dose reductions due to AEs was 20%(95%CI:13%-27%),while the incidence of treatment discontinuation due to AEs was 9%(95%CI:6%-12%).CONCLUSION Over one-third of advanced HCC patients exhibit therapy-free disease control,with placebo-arm AEs observed.These findings guide single-arm trials design and enhance patient acceptance of anticancer therapies.
文摘This letter addressed the impactful study by Zhong et al,which introduced a risk prediction and stratification model for surgical adverse events following minimally invasive esophagectomy.By identifying key risk factors such as chronic obstructive pulmonary disease and hypoalbuminemia,the model demonstrated strong predictive accuracy and offered a pathway to personalized perioperative care.This correspondence highlighted the clinical significance,emphasizing its potential to optimize patient outcomes through tailored inter-ventions.Further prospective validation and application across diverse settings are essential to realize its full potential in advancing esophageal surgery practices.
文摘BACKGROUND Intra-arterial chemotherapy(IAC)has become a first-line standard treatment for retinoblastoma(RB).However,studies describing its adverse events are sparse,especially from the developing world.Our study described the outcomes and adverse events from a single center in South India.AIM To describe the challenges,treatment outcomes,and complications of selective IAC for RB in Indian eyes.METHODS This study was a single center,retrospective study that included 17 patients with RB who underwent IAC using melphalan(5/7.5 mg)and topotecan(1/2 mg)(n=12)or melphalan(5 mg)alone(n=3)or triple therapy that included carboplatin(30 mg)along with these drugs(n=2)between January 2018 and December 2023.In all,17 IAC procedures were performed using selective ophthalmic artery cannulation.Treatment outcomes were evaluated in terms of tumor control,vitreous and subretinal seed control,complications,and globe salvage rates.RESULTS Out of the 17 patients,11 were diagnosed with unilateral RB and 6 were diag-nosed with bilateral RB.The mean age at the time of diagnosis was 19.8 months.The mean interval between the first symptom and presentation was 6.5 months.IAC was employed as the primary(n=9)or secondary(n=8)modality of treatment.Each eye received a mean of 1.5 IAC sessions(median:1 session;range:1-3 sessions).Eyes were classified according to the international classification of RB as group B(n=5),group C(n=1),group D(n=4),and group E(n=7).Following IAC,complete regression of the main tumor was seen in 15 eyes(88%)and partial regression in 2 eyes(12%).Globe salvage was achieved in 15 eyes(88%).Adverse effects included vitreous hemorrhage(n=3),rhegmatogenous retinal de-tachment(n=2),choroidal ischemia(n=1),isolated subretinal hemorrhage(n=2),retinal pigment epithelium degeneration(n=2),forehead pigmentation(n=1),third nerve palsy with complete ptosis(n=1),and 30-degree exotropia(n=1).The mean follow-up period was 28.6 months(median:24 months,range:1–72 months).CONCLUSION IAC is an effective way to control RB and globe preservation.In the Indian context we encountered many cha-llenges highlighting the importance of case selection.Further studies in India are required to thoroughly un-derstand IAC as a treatment for RB.
基金Supported by the Second Nursing Research Project of the Humanities Nursing Professional Committee,No.RW2024PY03the Open Project of Suzhou Key Laboratory of Elderly Smart Nursing and Health Care in 2024.
文摘BACKGROUND Depression is a common psychological disorder often associated with genetic,neurobiological,and psychosocial factors.This condition is characterized by low mood and decreased conscious activity and can lead to severe consequences such as suicidal thoughts.Respiratory failure,a disorder of pulmonary ventilation and gas exchange,is frequently complicated by depression,aggravating the condition and creating complications in treatment.Patients with both conditions tend to exhibit poor compliance with medical advice,resulting in adverse outcomes such as sleep disorders,arrhythmias,and electrolyte imbalances.Therefore,effective nursing interventions are crucial for improving patient outcomes.While routine nursing care can provide basic support,dedicated nursing,which involves specialized and personalized care by highly trained professionals,may offer additional benefits.AIM To examine the effect of dedicated nursing intervention on medical advice compliance and adverse event incidence in patients with depression complicated by respiratory failure.METHODS A total of 160 patients with depression complicated by respiratory failure admitted to the Second Affiliated Hospital of Soochow University from January to December 2024 were randomly categorized into a control group(n=80)receiving routine nursing care and observation group(n=80)receiving routine nursing combined with dedicated nursing care.The establishment of a specialized nursing team;the development of a personalized nursing plan;and the implementation of comprehensive care strategies targeting emotional support,sleep improvement,pulmonary function enhancement,and adherence to medical advice were included in the dedicated nursing intervention.Emotional state[evaluated using the Self-Rating Depression Scale(SDS)],sleep quality[assessed using the Pittsburgh Sleep Quality Index(PSQI)],hope level[measured using the Herth Hope Scale(HHS)],pulmonary function[comprising forced vital capacity(FVC)and forced expiratory volume in the first second(FEV1)],exercise endurance[6-minute walk distance test(6MWD)],compliance with medical advice,and incidence of adverse events were compared between the two groups.RESULTS No significant differences were observed in SDS,PSQI,HHS,FVC,FEV1,6MWD,or compliance with medical advice between the two groups(P>0.05)before the intervention.However,after the intervention,the control group exhibited significantly lower SDS and PSQI scores;higher HHS scores;greater improvements in FVC,FEV1,and 6MWD;and higher compliance with medical advice compared with the control group(P<0.05).In addition,the incidence of adverse events was significantly lower in the control group(P<0.05).CONCLUSION Dedicated nursing intervention significantly improves emotional state,sleep quality,hope level,pulmonary function,exercise endurance,and compliance with medical advice while reducing adverse events in patients with depression complicated by respiratory failure.Therefore,dedicated nursing appears to be an effective approach to enhance patient outcomes in this population.
基金supported by grants from the Beijing Natural Science Foundation,Beijing Economic and Technological Development Zone Innovation Joint Fund(Grant no.L248072).
文摘Immune checkpoint inhibitors have markedly improved outcomes in patients with multiple advanced malignancies.However,their widespread use has markedly increased the incidence of immune-related adverse events(irAEs).irAEs can affect a wide range of organ systems and are characterized by heterogeneous onset,broad toxicity spectra,and complex management requirements,thus ultimately impairing treatment continuation and patient quality of life.This review systematically summarizes the epidemiological features,clinical progression,and current management of irAEs.Existing guidelines largely focus on acute toxicities but have not provided structured strategies for chronic,delayed-onset,or multisystem irAEs.Moreover,clinical practice is hampered by incomplete multidisciplinary collaboration,insufficient training of oncologists,and fragmented treatment pathways,all of which limit the efficacy of irAE management.We propose incorporating irAE management into core oncology training and call for the establishment of comprehensive interdisciplinary frameworks to ensure the standardized long-term use of immunotherapy.
文摘Minimally invasive esophagectomy(MIE)has transformed esophageal surgery by reducing morbidity,accelerating recovery,and improving postoperative out-comes compared to traditional open esophagectomy.By utilizing techniques such as laparoscopic,thoracoscopic,and robotic-assisted approaches,MIE mini-mizes surgical trauma while maintaining oncological thoroughness.However,it also presents unique challenges,including risks of complications such as ana-stomotic leakage,pulmonary complications,and atrial fibrillation.Zhong et al developed and validated a risk stratification model for predicting surgical adverse events after MIE,enhancing preoperative assessment and patient management.This editorial further examines the advantages of MIE,its comparable oncological and long-term outcomes,as well as the incidence and contributing factors of post-operative complications.Emerging technologies,including machine learning models,intraoperative nerve monitoring,and robotic-assisted surgery,are high-lighted as innovative solutions for risk prediction and prevention.Strategies such as enhanced recovery after surgery protocols and multidisciplinary collaboration are emphasized for their critical roles in minimizing complications and optimizing patient outcomes.By addressing these aspects,this editorial provides guidance to surgical teams in maximizing the benefits of MIE while effectively managing its associated risks.
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.
文摘Objective:To develop nursing adverse events’reporting content of hospital.Methods:The study included two phases.The first phase was to develop the category and definition of nursing adverse events that need to be reported through an expert meeting.The second phase was to develop every nursing adverse event’s reporting content by using the Delphi method.In total,8 experts attended the meeting and 15 experts conducted two rounds of consultation letter.Results:Nursing adverse events that need to be reported of hospital include pressure sore,fall/falling from bed,unplanned extubation,medication error,and accident.Reporting content of these events in detail had also been obtained,which was helpful for cause analysis systematically.Conclusions:The reporting content of the nursing adverse event of hospital is established,and it is a basis for further study of the development of nursing adverse event reporting and feedback system.
文摘Introduction: Sorafenib is an orally active multikinase inhibitor approved for the treatment of advanced hepatocellular carcinoma (HCC) and is the only systemic treatment associated with a survival benefit in advanced stage. The aims of this study were to evaluate the tolerance and survival of sorafenib-treated patients, and to identify potential prognostic factors of survival. Methods: A total of 88 HCC patients treated with sorafenib from June 2010 to January 2014 were retrospectively reviewed. Tumour stage, liver function and adverse events to sorafenib were analyzed. Univariate and multivariate analysis were carried out to identify predictors of survival in patients with advanced HCC treated with sorafenib. Results: There were 64 (73%) males included in this study, with a median age of 61.16 years. Eight (91%) patients had Child-Pugh class A cirrhosis. Most patients were classified as BCLC C (82%). Hepatitis C virus was the predominant cause of HCC (68%). Sorafenib was the initial treatment modality in 43%. Median time of sorafenib therapy was 8.23 months. Overall survival in 1 year was 57.3% and 36.7% in 2 years. The median survival was 16.3 months. In the univariate analysis of the OS based on Child-Pugh score did not demonstrate a significant difference in our study (p = 0.62). The presence of dermatologic adverse event predicted a better overall survival in the multivariate analysis. Better survival was also observed in patients with AFP level <100 ng/ml in the start of sorafenib therapy (p = 0.001). Patients that used Sorafenib for ≥6 months had shown better outcome. None of the patients discontinued sorafenib because of adverse effects. Conclusions: Advanced HCC patients treated with sorafenib who experienced dermatologic adverse event and low AFP level <100 ng/ml showed better overall survival. As expected, longer sorafenib therapy (≥6 months) was associated to better survival. Even in the presence of adverse events, the use of sorafenib should be continued because the longer usage time improves survival.
文摘AIM： To assess the safety of bismuth used in Helicobacter pylori （H pylorl） eradication therapy regimens. METHODS： We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched （up to October 2007） to identify randomised controlled tri- als comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or, in combination, with acid suppresion. Total numbers of adverse events were recorded. Data were pooled and expressed as relative risks with 95% confidence intervals （CI）.RESULTS： We identified 35 randomised controlled trials containing 4763 patients. There were no serious adverse events occurring with bismuth therapy. There was no statistically significant difference detected in total adverse events with bismuth rrelative risk （RR） = 1.01; 95% CI： 0.87-1.16], specific individual adverse events, with the exception of dark stools （RR = 5.06; 95% CI： 1.59-16.12）, or adverse events leading to withdrawal of therapy （RR = 0.86; 95% CI： 0.54-1.37）. CONCLUSION： Bismuth for the treatment of H py/ori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools.
文摘Biliary adverse events following orthotopic liver transplantation (OLT) are relatively common and continue to be serious causes of morbidity, mortality, and transplant dysfunction or failure. The development of these adverse events is heavily influenced by the type of anastomosis during surgery. The low specificity of clinical and biologic findings makes the diagnosis challenging. Moreover, direct cholangiographic procedures such as endoscopic retrograde cholangiopancreatography and percutaneous transhepatic cholangiography present an inadmissible rate of adverse events to be utilized in clinically low suspected patients. Magnetic resonance (MR) maging with MR cholangiopancreatography is crucial in assessing abnormalities in the biliary system after liver surgery, including liver transplant. MR cholangiopancreatography is a safe, rapid, non-invasive, and effective diagnostic procedure for the evaluation of biliary adverse events after liver transplantation, since it plays an increasingly important role in the diagnosis and management of these events. On the basis of a recent systematic review of the literature the summary estimates of sensitivity and specificity of MR cholangiopancreatography for diagnosis of biliary adverse events following OLT were 0.95 and 0.92, respectively. It can provide a non-invasive method of imaging surgical reconstruction of the biliary anastomoses as well as adverse events including anastomotic and non-anastomotic strictures, biliary lithiasis and sphincter of Oddi dysfunction in liver transplant recipients. Nevertheless, conventional T2-weighted MR cholangiography can be implemented with T1-weighted contrast-enhanced MR cholangiography using hepatobiliary contrast agents (in particular using Gd-EOB-DTPA) in order to improve the diagnostic accuracy in the adverse events’ detection such as bile leakage and strictures, especially in selected patients with biliary-enteric anastomosis.
基金This work was supported by grants from the National Key R&D Program of China(Grant No.2016YFC1303800)Jilin Provincial Key Laboratory of Biological Therapy(Grant No.20170622011JC)+1 种基金Jilin Provincial Science and Technology Department(Grant No.20190303146SF)Jilin Province Finance Department(Grant No.2018SCZWSZX-010).
文摘Objective:We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events(irAEs)as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpoint inhibitors(ICIs)in patients with advanced pan-cancer in a real-world setting.Methods:We retrospectively analyzed data from 105 patients with advanced pan-cancer treated with multi-type ICIs at the First Hospital of Jilin University between January 1,2016 and August 1,2020.We used logistic regression analyses to investigate the associations of irAEs with clinical baseline characteristics,blood count parameters,and biochemical indicators during treatment.Receiver operating characteristic curves were used to determine cutoff values for parameters and area under the curve values.Kaplan–Meier and Cox multivariate regression analyses were performed to estimate the relationships of baseline characteristics and irAEs with progression-free survival(PFS)and overall survival(OS).Results:A lower relative lymphocyte count(cutoff=28.5%),higher albumin level(cutoff=39.05 g/L),and higher absolute eosinophil count(AEC)(cutoff=0.175×10^(9)/L)were significantly associated with the occurrence of irAEs,among which a higher AEC(cutoff=0.205×10^(9)/L)was strongly associated with skin-related irAEs[odds ratios(ORs)=0.163,P=0.004].Moreover,a higher lactate dehydrogenase level(cutoff=237.5 U/L)was an independent predictor of irAEs of grade≥3(OR=0.083,P=0.023).In immune cell subgroup analysis,a lower absolute count of CD8+CD28−suppressor T cells(OR=0.806;95%confidence interval:0.643–1.011;P=0.062),which are regulatory T lymphocytes,was associated with the occurrence of irAEs,although the difference was not statistically significant.Furthermore,a higher percentage of CD19+B cells was associated with the occurrence of irAEs of grade≥3(P=0.02)and grade≥2(P=0.051).In addition,patients with any grade of irAE had a significantly high PFS(8.37 vs.3.77 months,hazard ratios(HR)=2.02,P=0.0038)and OS(24.77 vs.13.83 months,HR=1.84;P=0.024).Conclusions:This retrospective study reports clinical profile data for irAEs in unselected patients in a real-world setting and explored some parameters that may be potential predictive markers of the occurrence,type,or grade of irAEs in clinical practice.Evidence of a correlation between safety and efficacy may facilitate a complete assessment of the risk-benefit ratio for patients treated with ICIs.
文摘BACKGROUND Endoscopic retrograde cholangiopancreatography(ERCP)is a valuable therapeutic technique for pancreatobiliary diseases,and its application in the elderly is no longer limited.However,a higher incidence of procedure difficulty and periprocedural adverse events might be expected in elderly patients due to the presence of other medical disorders and the poor general condition of this population.AIM To evaluate the incidence,causes,and management of difficult biliary cannulation during ERCP in elderly patients and the role of difficult cannulation as a risk factor for adverse events.METHODS A total of 614 patients who underwent ERCP during the study period were prospectively studied and divided into two groups based on their age.One hundred and forty-six patients were aged 80 years or older and 468 patients were aged less than 80 years.The primary outcome measurements were cannulation difficulty,cannulation success rate,ERCP procedure time,and related adverse events.RESULTS There was no difference in the incidence of difficult cannulation among the two groups(32.9%vs 34.4%,P=0.765),as well as in the cannulation success rate(96.6%vs 96.8%,P=0.54).The cannulation techniques were shown to be safe and efficient in achieving successful cannulation.Logistic regression analysis showed that patients aged 80 years or older were not associated with increased adverse events;however,difficult cannulation cases[adjusted odds ratio(AOR)=3.478;95%confidence interval(CI):1.877-6.442;P<0.001]and patients with Charlson Comorbidity Index≥2(AOR=1.824;95%CI:0.993-3.349;P=0.045)were more likely to develop adverse events.In contrast,other factors including age≤65(AOR=3.460;95%CI:1.511-7.922;P=0.003),female gender(AOR=2.362;95%CI=1.089-5.124;P=0.030),difficult cannulation(AOR=4.527;95%CI:2.078-9.860;P<0.001),and patients with cholangitis(AOR=3.261;95%CI:1.204-8.832;P=0.020)were strongly associated with a higher rate of post-ERCP pancreatitis.CONCLUSION Advanced age has not been proved to be a risk factor for difficult cannulation,and secondary cannulation techniques can be safely and efficaciously utilized in this group.Patients with a Charlson Comorbidity Index≥2 and difficult cannulation are associated with an increased overall adverse events rate,while age≥80 years is not.
基金Supported by National Key R and D Program of China,No. 2016YFC1303601。
文摘BACKGROUND Pancreatic adenoma can potentially transform into adenocarcinoma, so it is recommended to be resected surgically or endoscopically. Endoscopic papillectomy is one of the main treatments for papillary adenoma, and bleeding, perforation, and pancreatitis are the most frequent and critical adverse events that restrict its wider use. There is no standard procedure for endoscopic papillectomy yet. The procedure is relevant to postoperative adverse events.AIM To reduce the postoperative adverse event rates and improve patients' postoperative condition, we developed a standard novel procedure for endoscopic papillectomy.METHODS The novel endoscopic papillectomy had two main modifications based on the conventional method: The isolation of bile from pancreatic juice with a bile duct stent and wound surface protection with metal clips and fibrin glue. We performed a single-center retrospective comparison study on the novel and conventional methods to examine the feasibility of the novel method for reducing postoperative adverse events.RESULTS A total of 76 patients, of whom 23 underwent the novel procedure and 53 underwent the conventional procedure, were retrospectively evaluated in this study. The postoperative bleeding and pancreatitis rates of the novel method were significantly lower than those of the conventional method(0 vs 20.75%, P = 0.028, and 17.4% vs 41.5%, P = 0.042, respectively). After applying the novel method, the most critical adverse event, perforation, was entirely prevented, compared to a prevalence of 5.66% with the conventional method. Several postoperative symptoms, including fever, rapid pulse, and decrease in hemoglobin level, were significantly less frequent in the novel group(P = 0.042, 0.049, and 0.014, respectively). Overall, the total adverse event rate of the novel method was lower(0 vs 24.5%, P = 0.007) than that of the conventional method.CONCLUSION Patients who underwent the novel procedure had lower postoperative adverse event rates. This study demonstrates the potential efficacy and safety of the novel endoscopic papillectomy in reducing postoperative adverse events.
文摘AIM To study the type and frequency of adverse events associated with anti-tumor necrosis factor(TNF)therapy and evaluate for any serologic and genetic associations.METHODS This study was a retrospective review of patients attending the inflammatory bowel disease(IBD) centers at Cedars-Sinai IBD Center from 2005-2016. Adverse events were identified via chart review. IBD serologies were measured by ELISA. DNA samples were genotyped at Cedars-Sinai using Illumina Infinium Immunochipv1 array per manufacturer's protocol. SNPs underwent methodological review and were evaluated using several SNP statistic parameters to ensure optimal allele-calling. Standard and rigorous QC criteria were applied to the genetic data, which was generated using immunochip. Genetic association was assessed by logistic regression after correcting for population structure.RESULTS Altogether we identified 1258 IBD subjects exposed to anti-TNF agents in whom Immunochip data were available. 269/1258 patients(21%) were found to have adverse events to an anti-TNF-α agent that required the therapy to be discontinued. 25% of women compared to 17% of men experienced an adverse event. All adverse events resolved after discontinuing the antiTNF agent. In total: n = 66(5%) infusion reactions; n = 49(4%) allergic/serum sickness reactions; n = 19(1.5%) lupus-like reactions, n = 52(4%) rash, n = 18(1.4%) infections. In Crohn's disease, Ig A ASCA(P = 0.04) and Ig G-ASCA(P = 0.02) levels were also lower in patients with any adverse events, and anti-I2 level in ulcerative colitis was significantly associated with infusion reactions(P = 0.008). The logistic regression/human annotation and network analyses performed on the Immunochip data implicated the following five signaling pathways: JAK-STAT(Janus Kinase-signal transducer and activator of transcription), measles, IBD, cytokine-cytokine receptor interaction, and toxoplasmosis for any adverse event. CONCLUSION Our study shows 1 in 5 IBD patients experience an adverse event to anti-TNF therapy with novel serologic, genetic, and pathways associations.
文摘AIM To evaluate the rate of adverse events(AEs)during consecutive gastric and duodenal polypectomies in several Spanish centers.METHODS Polypectomies of protruded gastric or duodenal polyps≥5 mm using hot snare were prospectively included.Prophylactic measures of hemorrhage were allowed in predefined cases.AEs were defined and graded according to the lexicon recommended by the American Society for Gastrointestinal Endoscopy.Patients were followed for 48 h,one week and 1 mo after theprocedure.RESULTS308 patients were included and a single polypectomy was performed in 205.Only 36(11.7%)were on prior anticoagulant therapy.Mean polyp size was 15±8.9 mm(5-60)and in 294 cases(95.4%)were located in the stomach.Hemorrhage prophylaxis was performed in 219(71.1%)patients.Nine patients presented AEs(2.9%),and 6 of them were bleeding(n=6,1.9%)(in 5 out of 6 AE,different types of endoscopic treatment were performed).Other 24 hemorrhagic episodes could be managed without any change in the outcome of the endoscopy and,consequently,were considered incidents.We did not find any independent risk factor of bleeding.CONCLUSION Gastroduodenal polypectomy using prophylactic measures has a rate of AEs small enough to consider this procedure a safe and effective method for polyp resection independently of the polyp size and location.
文摘The patient was an asymptomatic 43-year-old woman. Abdominal ultrasonography and enhanced computed tomography showed a tumor lesion accompanied by multiple cystic changes in the liver and the pancreatic tail. Endoscopic ultrasound-fine needle aspiration was performed on the pancreatic tumor lesion and revealed pancreatic neuroendocrine tumor(PNET). As it was unresectable due to multiple liver metastases, the decision was made to initiate treatment with everolimus and transcatheter arterial chemoembolization. The patient ceased menstruating after the start of everolimus administration. When the administration was discontinued due to interstitial lung disease, menstruation resumed, but then again stopped with everolimus resumption. An association between everolimus and amenorrhea was highly suspected. Amenorrhea occurred as a rare adverse event of everolimus. As the younger women might be included in PNETs patients, we should put this adverse event into consideration.
