Introduction.Well-designed,strictly implemented,and fully standardized randomized controlled trials(RCTs)are a prerequisite for developing reliable scientific evidence,which can improve clinical practice,health outcom...Introduction.Well-designed,strictly implemented,and fully standardized randomized controlled trials(RCTs)are a prerequisite for developing reliable scientific evidence,which can improve clinical practice,health outcomes,and ultimately benefit patients.Suboptimal reporting is pervasive in medical research,resulting in biased research records and persistent uncertainty about the quality of available evidence.1,2,3,4 The standardization of research reports has attracted considerable attention.In 1996,the Consolidated Standards of Reporting Trials(CONSORT)was first published to improve the quality of RCTs and enhance the reproducibility of trial methods,results,and inferences.展开更多
The important work of Yu,et al.[1]who presented one of the first randomized controlled trials(RCTs)to directly compare robot-assisted and manual percutaneous coronary intervention(PCI),is commendable;offering importan...The important work of Yu,et al.[1]who presented one of the first randomized controlled trials(RCTs)to directly compare robot-assisted and manual percutaneous coronary intervention(PCI),is commendable;offering important insights into the feasibility and outcomes of this emerging technology.While the analysis is timely,several issues warrant further consideration.展开更多
Both large-scale prospective randomized controlled trials(RCTs)and smaller investigator-initiated trials are essential for evaluating the efficacy and safety of medical interventions.Robust protocols and statistical d...Both large-scale prospective randomized controlled trials(RCTs)and smaller investigator-initiated trials are essential for evaluating the efficacy and safety of medical interventions.Robust protocols and statistical designs ensure the reliability of trial outcomes and improve the credibility of research findings.By reviewing the statistical approaches used in the TORCHLIGHT,NCC2167,and NeoTENNIS trials,this article illustrates the principles underlying large-sample confirmatory RCTs,small-sample exploratory adaptive designs,and single-arm two-stage designs.This discussion is aimed at helping researchers apply these design methods more effectively,to increase the likelihood of success in clinical studies.展开更多
Iron deficiency anemia affects approximately 1.62 billion people worldwide,yet traditional iron supplements present bioavailability limitations and gastrointestinal side effects.This randomized,double-blind clinical t...Iron deficiency anemia affects approximately 1.62 billion people worldwide,yet traditional iron supplements present bioavailability limitations and gastrointestinal side effects.This randomized,double-blind clinical trial investigated a novel Auricularia auricula polysaccharide-iron complex(AAPIC)compared with heme iron and ferrous glycinate in 180 iron-deficient adults receiving 30 mg elemental iron daily for 12 weeks.AAPIC achieved comparable hemoglobin improvements(from 98.3±8.7 to 126.5±9.2 g/L)to heme iron(from 97.8±9.1 to 128.3±8.6 g/L)and was significantly superior to ferrous glycinate(from 98.6±8.9 to 119.7±10.3 g/L;p<0.001).Iron absorption efficiency showed AAPIC at 23.7±4.2%,heme iron at 25.1±3.8%,and ferrous glycinate at 18.4±5.1%.Toxicological assessments revealed no hepatotoxicity,nephrotoxicity,or mutagenicity.Gastrointestinal adverse events occurred in 8.3%of AAPIC recipients versus 15.0%with ferrous glycinate and 10.0%with heme iron.The polysaccharide component facilitates iron transport through enhanced intestinal uptake mechanisms.AAPIC represents a promising,well-tolerated alternative with clinical efficacy comparable to established iron formulations.展开更多
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized byclinical symptoms of diarrhea and mucopurulent bloody stools, and its incidenceis increasing globally. The etiology and pathogenesis of U...Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized byclinical symptoms of diarrhea and mucopurulent bloody stools, and its incidenceis increasing globally. The etiology and pathogenesis of UC remain elusive. Currenttherapeutic approaches, including anti-inflammatory, immunosuppressiveand immunomodulating agents, are often limited in efficacy and frequently associatedwith adverse drug reactions. Therefore, there is an urgent need to developsafer and more effective treatment strategies to address the limitations of existingtherapies. Scutellaria baicalensis Georgi (HQ), a traditional Chinese medicinal herb,has been employed in the treatment of UC for over 2000 years. Recent studieshave demonstrated that HQ contains multiple active components capable oftreating UC through anti-inflammation, immune modulation, intestinal barrierprotection, antioxidant activity, and regulation of the gut microbiota. This paperreviews recent studies on the mechanism of action and clinical trials of HQ intreating UC based on relevant literature, with the aim of providing valuable insightsinto future treatment approaches.展开更多
OBJECTIVE:To assess the efficacy of point application therapy(PAT)in alleviating the exacerbation of chronic respiratory diseases represented by bronchial asthma.METHODS:In this multicenter randomized placebocontrolle...OBJECTIVE:To assess the efficacy of point application therapy(PAT)in alleviating the exacerbation of chronic respiratory diseases represented by bronchial asthma.METHODS:In this multicenter randomized placebocontrolled trial,eligible bronchial asthma patients received placebo PAT on the dog days of the first summer to establish a baseline,and then patients who continued to participate in the trial and repassed the eligibility review were randomized to receive regular or placebo PAT in the next two consecutive summers.The primary outcome was the change from baseline in the number of asthma exacerbations at 24 months.Secondary outcomes included severity of asthma exacerbation,asthma control test(ACT)score,percentage of forced expiratory volume in 1 s(FEV1)to the predicated value(FEV1%pred),peak expiratory flow(PEF),ratio of FEV1 to forced vital capacity(FEV1/FVC),and use of palliative drugs during bronchial asthma exacerbations at 12 and 24 months.The adverse events(AEs)were also assessed.RESULTS:A total of 835 patients with bronchial asthma were randomized in this trial.Compared with the placebo control,the PAT significantly decreased the mean number of asthma exacerbations(1.42;95%confidence interval,0.69 to 2.14;P<0.001),and increased the FEV1%pred at 24 months(P=0.039)and FEV1/FVC at 12 months(P=0.01)and 24 months(P=0.01).There were no significant differences between the groups in PEF or ACT score at 12 and 24 months,or in FEV1%pred at 12 months.Treatment-related AEs were mild and more common in the PAT group than in the placebo PAT group.No serious AEs were reported.CONCLUSION:PAT conducted on dog days could reduce asthma exacerbations in patients with bronchial asthma.展开更多
OBJECTIVE:To investigate Acupuncture-herb therapy modulates gut microbiota in abdominal obesity.METHODS:A randomized controlled trial was designed in accordance with standard protocols.Abdominally obese subjects were ...OBJECTIVE:To investigate Acupuncture-herb therapy modulates gut microbiota in abdominal obesity.METHODS:A randomized controlled trial was designed in accordance with standard protocols.Abdominally obese subjects were randomized into four groups:A2(Control):double placebo,A1(Needle):press needle+placebo herb,A3(herb):herbal medicine(Huatan Lishi Fang化痰利湿方)+placebo needle,A4(Combination):press needle+herbal medicine.After 12 weeks of treatment,groups were relabeled B1-B4.Weight,waist circumference,and body mass index were measured monthly.Gut microbiota was analyzed via 16S rRNA sequencing for diversity and abundance.RESULTS:Combined needle-herb therapy significantly reduced waist circumference(P<0.05).All treatments altered gut microbiota composition.The combination group showed significant changes in diversity(Chao1,Shannon,Simpson;P<0.05).Needle therapy increased Bacteroidia;herbs reduced Lachnospiraceae and Megamonas.All results were significant(P<0.05).CONCLUSION:Combined needle-herb treatment modulated 25 key gut flora across multiple taxonomic levels in abdominal obesity.It reduced Firmicutes and Bacteroidota.Bacteroidota,Actinobacteriota,and Prevotellaceae may suppress obesity,whereas Proteobacteria,Lachnospiraceae,and Megamonas may promote it.The combination specifically altered Bacteroidaceae,Lachnospiraceae,Bacteroidia,and Megamonas.展开更多
Objectives This study aimed to design and evaluate a detection system for the accidental dislodgement of head-and-neck medical supplies through hand position recognition and tracking in Intensive Care Unit(ICU)patient...Objectives This study aimed to design and evaluate a detection system for the accidental dislodgement of head-and-neck medical supplies through hand position recognition and tracking in Intensive Care Unit(ICU)patients.Methods We conducted a single-center,prospective,parallel-group feasibility randomized controlled trial.We recruited 80 participants using convenience sampling from the ICU of a hospital in Ningbo City,Zhejiang Province,between March 2025 and June 2025,and they were randomly assigned to either the control group(routine care)or the intervention group(routine care plus image recognition-based detection system).The system continuously tracked patients’hand positions via bedside cameras and generated real-time alarms when hands entered predefined risk zones,notifying on-duty nurses to enable early intervention.System stability was assessed by continuous system uptime;system performance and clinical feasibility were evaluated by the frequencies of risk actions and accidental dislodgement of medical supplies(ADMS).Results All 80 participants completed the intervention,with 40 patients in each group.The baseline characteristics and median observation time of the two groups were balanced(intervention group:48 h/patient vs.control group:49 h/patient).Compared with the control group,the intervention group showed fewer ADMS(2/40 vs.9/40)and detected more risk actions per 100 h(36 vs.25);all system-detected events had corroborating images with complete concordance on manual review,and all nurse-recorded hand-contact events were accurately captured.Conclusions The study demonstrated that the image recognition-based detection system can function stably in clinical settings,providing accurate and continuous surveillance while supporting the early detection of risk actions.By reducing the observation burden and offering real-time cognitive support,the system complements routine nursing care and serves as an additional safety measure in ICU practice.With further optimization and larger multicenter validation,this approach could have the potential to make a significant contribution to the development of smart ICUs and the broader digital transformation of nursing care.展开更多
Background:Most sepsis patients develop sepsis-associated acute kidney injury(SA-AKI),which poses a significant threat to survival and lacks specific treatment.To date,there are no published randomized controlled tria...Background:Most sepsis patients develop sepsis-associated acute kidney injury(SA-AKI),which poses a significant threat to survival and lacks specific treatment.To date,there are no published randomized controlled trials that have established a link between albumin use and SA-AKI development in sepsis.Therefore,it is unclear whether albumin use may influence the risk of SA-AKI.Methods:The present study employed a target trial emulation using observational data to track adult sepsis patients initially admitted to the intensive care unit at Beth Israel Deaconess Medical Center,Boston,Massachusetts,for a period of 7 d from 2008 to 2022.Immortal time bias was controlled using the clone-censor-weight(CCW)method,along with a new-user design to address current user bias.The exposure variable was the early administration of albumin following the onset of sepsis.Based on albumin use,patients were classified into two groups:the albumin group(n=27,088)and the no albumin group(n=27,088).The primary outcome was the development of SA-AKI,and the secondary outcome was 7-day all-cause mortality.The primary outcome was analyzed using competing risk analyses.Furthermore,sensitivity and subgroup analyses were also performed.Results:Among the 27,088 patients analyzed,albumin administration was associated with a significantly higher SA-AKI risk(relative difference=3.47%,95%CI 1.76-5.23)compared to non-administration.There was no clinically meaningful difference in 7-day survival(relative difference=0.05%,95%CI-2.30 to 2.45).Sensitivity analyses consistently supported these results.All these analyses were conducted on data that were collected after CCW.Conclusions:Early albumin administration may increase the risk of SA-AKI in sepsis patients without conferring a short-term survival benefit.These results underscore the need for a rigorous risk-benefit assessment when incorporating albumin into sepsis resuscitation protocols and highlight the need for further clinical validation.However,it is important to exercise caution when interpreting the conclusions of this study,given its exploratory and preliminary nature.展开更多
Unresectable hepatocellular carcinoma(HCC)remains a global challenge,with limited effective treatment options for advanced-stage disease.The HIMALAYA trial(phase III randomized study that evaluated the STRIDE regimen)...Unresectable hepatocellular carcinoma(HCC)remains a global challenge,with limited effective treatment options for advanced-stage disease.The HIMALAYA trial(phase III randomized study that evaluated the STRIDE regimen)introduced the Single Tremelimumab Regular Interval Durvalumab(STRIDE)regimen,an immunotherapy-based approach that achieved a median overall survival(OS)of 16.43 months compared to 13.77 months with sorafenib.While statistically significant,this~2.7 months OS gain warrants scrutiny in light of STRIDE’s increased immune-related toxicity and cost.This commentary evaluates STRIDE’s impact within the broader landscape of first-line systemic therapy for unresectable HCC,alongside other regimens such as atezolizumab plus bevacizumab and nivolumab plus ipilimumab.We explore STRIDE’s mechanism of action,safety profile,modest progression-free survival(PFS)improvement,and implementation challenges,incorporating insights from 2023-2025 research.In addition,we discussed its limitations in non-viral HCC and Child-Pugh B patients,the role of emerging biomarkers,and the potential of radiation to enhance immunotherapy efficacy.As a dual immune checkpoint inhibitor(ICI)strategy,STRIDE offers an important advance that may not only extend survival but also open the door to future curative approaches.However,optimizing its use will require refined patient selection and further investigation of synergistic combination therapies.展开更多
Since 2016,the number of clinical trials registered in the World Health Organization-International Clinical Trials Registry Platform has been steadily increasing.The number of clinical trials registered between 2018 a...Since 2016,the number of clinical trials registered in the World Health Organization-International Clinical Trials Registry Platform has been steadily increasing.The number of clinical trials registered between 2018 and 2022 is 39765 for BRICS countries.Though India’s contribution increased from 33%to 40%in the interim,the number of infectious disease trials registered in India is low(325)compared to the number of oncology clinical trials(1936)[1].The number of phase 3 registrational antibacterial clinical trials conducted in India is also low(Table 1).This poses a serious public health challenge given the infectious disease burden in India[2].展开更多
Background:Since the launch of drug regulatory reform in 2015,China has substantially increased the availability of new cancer therapies.However,the efficacy evidence criteria for modified new anticancer drugs have no...Background:Since the launch of drug regulatory reform in 2015,China has substantially increased the availability of new cancer therapies.However,the efficacy evidence criteria for modified new anticancer drugs have not been evaluated.This cross-sectional study aimed to assess the pivotal trials supporting the indication approvals of innovative and modified new chemical anticancer drugs in China.Methods:The characteristics of indications,regulatory aspects,and pivotal trial designs were extracted and described.The primary efficacy endpoints of the pivotal clinical trials,including overall survival(OS)and progression-free survival(PFS),were quantitatively assessed by meta-analysis.Results:Between 2016 and 2022,77 cancer therapeutics for 107 indications were approved in China based on 128 pivotal trials.Among the 107 indications,64(59.8%)were classified as innovative anticancer drugs,and 43(40.2%)as modified new anticancer drugs.The study found that pivotal trials for innovative approvals tended to be single-arm trials,while modified approvals were more likely to employ randomized clinical trials with larger sample sizes and rigorous designs.Despite innovative drugs often receiving more expedited regulatory designations,there were no statistically significant differences in clinical benefit of OS or PFS outcomes between innovative and modified approvals.Conclusions:These results suggest that the current regulatory framework may prioritize the speed of approval for innovative drugs over the strength of supporting evidence.These findings align with the strategic trends of pharmaceutical companies and regulatory inclinations that aim to expedite the approval of innovative anticancer drugs with a high unmet need,thereby accelerating patients’accessibility to treatment.展开更多
Enrolling in clinical trials could be time-sensitive and time-demanding tasks for the research site, especially if it is a private research organization compared to the research conducted at an academic or medical cen...Enrolling in clinical trials could be time-sensitive and time-demanding tasks for the research site, especially if it is a private research organization compared to the research conducted at an academic or medical center. Every study differs in various aspects, such as phases, study indication, eligibility criteria, etc. In terms of meeting the enrollment deadline, typically, the study indication and availability of the patient’s population at the geographical area of the research site would decide if the trial could be time-consuming. Patient recruitment and retention are critical for the success of every clinical trial;however, worldwide, this area is facing tremendous pressure and challenges. Globally 55% of clinical trials terminated due to low recruitment, with an average enrollment success rate of 40% for Phase III and IV trials. Over 80% of clinical trial attempts fail to enroll, extending the study and adding new study sites. In the United States, more than 80% of clinical trials fail to achieve targeted patient enrollment, and 30% of study participants discontinue participation. This article reviewed various factors hindering clinical trial recruitment and retention and suggested strategies to make the research site successful.展开更多
OBJECTIVE To investigate the intervention effects of tissue-bone homeostasis manipulation(TBHM)on peripatellar biomechanical parameters and knee joint function in knee osteoarthritis(KOA)patients.METHODS Sixty patient...OBJECTIVE To investigate the intervention effects of tissue-bone homeostasis manipulation(TBHM)on peripatellar biomechanical parameters and knee joint function in knee osteoarthritis(KOA)patients.METHODS Sixty patients with KOA(Kellgren-Lawrence gradeⅡ-Ⅲ)were recruited from the Acupuncture-Moxibustion Rehabilitation Department,Anhui University of Chinese Medicine between October 2024 and May 2025.Participants were randomized into a TBHM group(n=30)or a transcutaneous electrical neuromuscular stimulation(TENS)group(n=30).Using two-way repeated measures ANOVA,biomechanical indicators,including rectus femoris tension,vastus medialis tension,vastus lateralis tension,patellar ligament tension,lateral patellar displacement(LPD),medial patellar displacement(MPD),normalized patellar mobility(LPD/patellar width[PW],MPD/PW),knee flexion range of motion,and functional indicators,including KOOS subscales,time up and go test(TUGT),were compared between groups at baseline and after 6 weeks of intervention.RESULTS After intervention,all biomechanical and knee joint function indicators in the TBHM group were significantly improved(P<0.05,P<0.01),while only the vastus medialis tension,TUGT and KOOS Pain,ADL and QoL scores in the control group were significantly improved(P<0.01).The improvement amplitudes of biomechanical indicators in the TBHM group,including rectus femoris tension,vastus lateralis tension,patellar ligament tension,MPD/PW,LPD/PW and knee flexion range of motion were better than those in the control group(P<0.05,P<0.01).In the functional evaluation,the interaction effects of the TBHM group in all dimensions of the KOOS score and TUGT were statistically significant(P<0.05,P<0.01).Post-hoc simple effect analysis confirmed that there were significant differences in the above indicators between the two groups after intervention(P<0.05),and all indicators showed a significant main effect of time(P<0.01),suggesting that the intervention measures had continuous and cumulative curative effects.CONCLUSION TBHM effectively improves joint function and quality of life in KOA patients by restoring dynamic equilibrium in soft tissue tension and patellar mobility,ultimately achieving the therapeutic goal of concurrent tissue-bone management.展开更多
Objectives:To explore the efficacy and safety of virtual reality(VR)in relieving negative emotions in patients with breast cancer with different personalities.Methods:A randomized controlled trial was conducted.Betwee...Objectives:To explore the efficacy and safety of virtual reality(VR)in relieving negative emotions in patients with breast cancer with different personalities.Methods:A randomized controlled trial was conducted.Between April 2023 and October 2023,we enrolled patients with breast cancer treated in the Department of Breast Cancer and Oncology at Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangdong Province.The patients were randomly divided into an intervention group(n=118)and a control group(n=119)using block randomization.The intervention group received the VR intervention 3-5 times over 5±2 weeks using natural landscapes with music or relaxation guidance,and the duration of each VR intervention was 15±3 min.The control group received routine nursing care,including disease education and psychological counseling.Patients were assessed using the Type D Scale,Positive and Negative Affect Scale,and Distress Thermometer,and adverse events during the intervention were recorded.Results:Overall,85 patients completed the study(44 in the intervention group and 41 in the control group).Patients with Type D personalities showed more negative emotions[25.0(21.5,27.5)vs.19.0(16.0,24.0),P=0.001]and distressed attitudes[4.0(2.0,5.0)vs.3.0(1.0,4.0),P=0.020]with fewer positive emotions(27.2±5.6 vs.31.0±5.9,P=0.014)than those with non-Type D personalities.Total population analysis revealed no significant differences between the groups.However,in the subgroup analysis,patients with Type D personalities in the intervention group showed greater relief from negative emotions than those in the control group[median difference,-5.0(-9.0,-2.5)vs.-2.0(-4.0,2.0),P=0.046].No significant differences were found between groups of patients with non-Type D personality traits.The proportion of adverse events was not significantly different between groups(P=0.110).Conclusions:Breast cancer patients with Type D personalities suffer more severe negative emotions and distress,and more attention should be paid to them.VR intervention significantly and safely reduced negative emotions in patients with Type D personalities.展开更多
Objective:This study aimed to assess the feasibility and safety of the SHURUI single-port robotic surgical system for a range of major urological surgeries.Methods:In this prospective,multicenter clinical trial,we exa...Objective:This study aimed to assess the feasibility and safety of the SHURUI single-port robotic surgical system for a range of major urological surgeries.Methods:In this prospective,multicenter clinical trial,we examined the effectiveness of the SHURUI single-port robotic surgical system in urological interventions.The first 50 patients from four centers in China underwent single-port surgeries including partial nephrectomy,radical prostatectomy,partial adrenalectomy,and pyeloureteroplasty,exclusively by the SHURUI single-port robotic surgical system.The study's primary endpoints focused on the success of surgeries,defined as no deviations from planned procedures,no need for more than one port,and no re-operations within 24 h after surgery.Secondary endpoints encompassed a range of surgical metrics,functional outcomes,and patient demographic data.Clinical assessments were conducted before surgery,before discharge,and 1 month after discharge.Results:The surgical procedures were executed successfully without requiring intraoperative conversions or transfusions.Both estimated blood loss and operation durations were maintained within satisfactory limits.For each type of surgery,the mean console times and estimated blood loss were 179.8(standard deviation[SD]39.4)min and 125.6(SD 126.0)mL for radical prostatectomy,126.7(SD 47.8)min and 39.2(SD 54.4)mL for partial nephrectomy,112.6(SD 37.4)min and 20.0(SD 13.2)mL for partial adrenalectomy,and 148.0(SD 18.2)min and 18.0(SD 17.9)mL for pyeloureteroplasty,respectively.Across the cohort,17 patients experienced a total of 25 adverse events,while 10 postoperative complications,all rated as Clavien-Dindo grade I,were encountered by eight patients.All patients had shown recovery or improvement from these events before the end of this trial.Conclusion:The SHURUI single-port robotic surgical system demonstrated feasibility and safety in the performance of major urological surgeries.These initial findings highlight the system's potential,though further research and longer follow-up are required to assess long-term outcomes.展开更多
OBJECTIVE:To evaluate the efficacy of electroacupuncture(EA)at scalp motor area for treating post-stroke wrist dyskinesia and its influence on the function of wrist movement-related agonistic muscles.METHODS:A randomi...OBJECTIVE:To evaluate the efficacy of electroacupuncture(EA)at scalp motor area for treating post-stroke wrist dyskinesia and its influence on the function of wrist movement-related agonistic muscles.METHODS:A randomized,single-blind,controlled clinical trial was conducted.Sixty-six patients undergoing post-stroke wrist dyskinesia were enrolled and randomized 1:1 to EA or control group.Patients in the control group received manual acupuncture in the scalp motor area(MS 6)on the lesion side.The same acupoint was selected to accept EA stimulation in the EA group.All patients were treated six times a week for three weeks.The primary outcome was the Chinese Stroke Scale(CSS)score.The secondary outcomes included upper limb-related Barthel Index(BI)score,active range of motion(AROM)of the wrist joint,and root mean square(RMS)of the four agonistic muscles associated with wrist motion on the hemiplegic side of patients,i.e.,the extensor carpi radialis longus(ECRL),extensor digitorum(ED),flexor carpi radialis(FCR)and flexor carpi ulnaris(FCU).The above indicators were measured before and after three weeks of treatment.RESULTS:After 3-week treatment,the CSS score and AROM of wrist dorsiflexion of the EA group were better than those in the control group(P=0.038,P=0.047).The differences between the two groups of BI scores and AROM of wrist flexion were not significant(P>0.05).All RMS of the EA group were higher than those in the control group(ECRL:P=0.047,ED:P=0.048,FCR:P=0.049,FCU:P=0.047).The total effective rate in the EA group was 87.50%(28/32),which was higher than that in the control group(77.42%,24/31,P=0.048).CONCLUSION:EA stimulation of the scalp motor area can promote the recovery of the strength and function of the agonistic muscles related to wrist movement and effectively improve post-stroke wrist dyskinesia.展开更多
基金supported by the Talent Development Plan for High-level Public Health Technical Personnel Project in Beijing,Beijing Municipal Health Commission[No.XKGG-02-03].
文摘Introduction.Well-designed,strictly implemented,and fully standardized randomized controlled trials(RCTs)are a prerequisite for developing reliable scientific evidence,which can improve clinical practice,health outcomes,and ultimately benefit patients.Suboptimal reporting is pervasive in medical research,resulting in biased research records and persistent uncertainty about the quality of available evidence.1,2,3,4 The standardization of research reports has attracted considerable attention.In 1996,the Consolidated Standards of Reporting Trials(CONSORT)was first published to improve the quality of RCTs and enhance the reproducibility of trial methods,results,and inferences.
文摘The important work of Yu,et al.[1]who presented one of the first randomized controlled trials(RCTs)to directly compare robot-assisted and manual percutaneous coronary intervention(PCI),is commendable;offering important insights into the feasibility and outcomes of this emerging technology.While the analysis is timely,several issues warrant further consideration.
基金supported by a grant from the National Science and Technology Major Project(Grant No.2024ZD0519800).
文摘Both large-scale prospective randomized controlled trials(RCTs)and smaller investigator-initiated trials are essential for evaluating the efficacy and safety of medical interventions.Robust protocols and statistical designs ensure the reliability of trial outcomes and improve the credibility of research findings.By reviewing the statistical approaches used in the TORCHLIGHT,NCC2167,and NeoTENNIS trials,this article illustrates the principles underlying large-sample confirmatory RCTs,small-sample exploratory adaptive designs,and single-arm two-stage designs.This discussion is aimed at helping researchers apply these design methods more effectively,to increase the likelihood of success in clinical studies.
文摘Iron deficiency anemia affects approximately 1.62 billion people worldwide,yet traditional iron supplements present bioavailability limitations and gastrointestinal side effects.This randomized,double-blind clinical trial investigated a novel Auricularia auricula polysaccharide-iron complex(AAPIC)compared with heme iron and ferrous glycinate in 180 iron-deficient adults receiving 30 mg elemental iron daily for 12 weeks.AAPIC achieved comparable hemoglobin improvements(from 98.3±8.7 to 126.5±9.2 g/L)to heme iron(from 97.8±9.1 to 128.3±8.6 g/L)and was significantly superior to ferrous glycinate(from 98.6±8.9 to 119.7±10.3 g/L;p<0.001).Iron absorption efficiency showed AAPIC at 23.7±4.2%,heme iron at 25.1±3.8%,and ferrous glycinate at 18.4±5.1%.Toxicological assessments revealed no hepatotoxicity,nephrotoxicity,or mutagenicity.Gastrointestinal adverse events occurred in 8.3%of AAPIC recipients versus 15.0%with ferrous glycinate and 10.0%with heme iron.The polysaccharide component facilitates iron transport through enhanced intestinal uptake mechanisms.AAPIC represents a promising,well-tolerated alternative with clinical efficacy comparable to established iron formulations.
基金Supported by National Natural Science Foundation of China,No.82374200Construction of Traditional Chinese Medicine Inheritance and Innovation Development Demonstration Pilot Projects in Pudong New Area-High-Level Research-Oriented Traditional Chinese Medicine Hospital Construction,No.YC-2023-0901.
文摘Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized byclinical symptoms of diarrhea and mucopurulent bloody stools, and its incidenceis increasing globally. The etiology and pathogenesis of UC remain elusive. Currenttherapeutic approaches, including anti-inflammatory, immunosuppressiveand immunomodulating agents, are often limited in efficacy and frequently associatedwith adverse drug reactions. Therefore, there is an urgent need to developsafer and more effective treatment strategies to address the limitations of existingtherapies. Scutellaria baicalensis Georgi (HQ), a traditional Chinese medicinal herb,has been employed in the treatment of UC for over 2000 years. Recent studieshave demonstrated that HQ contains multiple active components capable oftreating UC through anti-inflammation, immune modulation, intestinal barrierprotection, antioxidant activity, and regulation of the gut microbiota. This paperreviews recent studies on the mechanism of action and clinical trials of HQ intreating UC based on relevant literature, with the aim of providing valuable insightsinto future treatment approaches.
基金Supported by“12th Five-year” National Science and Technology Pillar Program by the Ministry of Science and Technology of the People’s Republic of China:Clinical Evaluation and Technical Operation Specification Research on Preventing Bronchial Asthma Attacks by Acupoint Application in Winter Disease Summer Treatment(No. 2015BAI04B11)。
文摘OBJECTIVE:To assess the efficacy of point application therapy(PAT)in alleviating the exacerbation of chronic respiratory diseases represented by bronchial asthma.METHODS:In this multicenter randomized placebocontrolled trial,eligible bronchial asthma patients received placebo PAT on the dog days of the first summer to establish a baseline,and then patients who continued to participate in the trial and repassed the eligibility review were randomized to receive regular or placebo PAT in the next two consecutive summers.The primary outcome was the change from baseline in the number of asthma exacerbations at 24 months.Secondary outcomes included severity of asthma exacerbation,asthma control test(ACT)score,percentage of forced expiratory volume in 1 s(FEV1)to the predicated value(FEV1%pred),peak expiratory flow(PEF),ratio of FEV1 to forced vital capacity(FEV1/FVC),and use of palliative drugs during bronchial asthma exacerbations at 12 and 24 months.The adverse events(AEs)were also assessed.RESULTS:A total of 835 patients with bronchial asthma were randomized in this trial.Compared with the placebo control,the PAT significantly decreased the mean number of asthma exacerbations(1.42;95%confidence interval,0.69 to 2.14;P<0.001),and increased the FEV1%pred at 24 months(P=0.039)and FEV1/FVC at 12 months(P=0.01)and 24 months(P=0.01).There were no significant differences between the groups in PEF or ACT score at 12 and 24 months,or in FEV1%pred at 12 months.Treatment-related AEs were mild and more common in the PAT group than in the placebo PAT group.No serious AEs were reported.CONCLUSION:PAT conducted on dog days could reduce asthma exacerbations in patients with bronchial asthma.
基金Supported by National Key R&D Program of China:Clinical Evaluation Research on Intervention Technologies for Abdominal Obesitythe Role of Gut Microbiota in the Effects of Combined Acupuncture and Medication on Abdominal Obesity:an Exploration with 16S rRNA Technology(Project Code:2019YFC1710102)。
文摘OBJECTIVE:To investigate Acupuncture-herb therapy modulates gut microbiota in abdominal obesity.METHODS:A randomized controlled trial was designed in accordance with standard protocols.Abdominally obese subjects were randomized into four groups:A2(Control):double placebo,A1(Needle):press needle+placebo herb,A3(herb):herbal medicine(Huatan Lishi Fang化痰利湿方)+placebo needle,A4(Combination):press needle+herbal medicine.After 12 weeks of treatment,groups were relabeled B1-B4.Weight,waist circumference,and body mass index were measured monthly.Gut microbiota was analyzed via 16S rRNA sequencing for diversity and abundance.RESULTS:Combined needle-herb therapy significantly reduced waist circumference(P<0.05).All treatments altered gut microbiota composition.The combination group showed significant changes in diversity(Chao1,Shannon,Simpson;P<0.05).Needle therapy increased Bacteroidia;herbs reduced Lachnospiraceae and Megamonas.All results were significant(P<0.05).CONCLUSION:Combined needle-herb treatment modulated 25 key gut flora across multiple taxonomic levels in abdominal obesity.It reduced Firmicutes and Bacteroidota.Bacteroidota,Actinobacteriota,and Prevotellaceae may suppress obesity,whereas Proteobacteria,Lachnospiraceae,and Megamonas may promote it.The combination specifically altered Bacteroidaceae,Lachnospiraceae,Bacteroidia,and Megamonas.
文摘Objectives This study aimed to design and evaluate a detection system for the accidental dislodgement of head-and-neck medical supplies through hand position recognition and tracking in Intensive Care Unit(ICU)patients.Methods We conducted a single-center,prospective,parallel-group feasibility randomized controlled trial.We recruited 80 participants using convenience sampling from the ICU of a hospital in Ningbo City,Zhejiang Province,between March 2025 and June 2025,and they were randomly assigned to either the control group(routine care)or the intervention group(routine care plus image recognition-based detection system).The system continuously tracked patients’hand positions via bedside cameras and generated real-time alarms when hands entered predefined risk zones,notifying on-duty nurses to enable early intervention.System stability was assessed by continuous system uptime;system performance and clinical feasibility were evaluated by the frequencies of risk actions and accidental dislodgement of medical supplies(ADMS).Results All 80 participants completed the intervention,with 40 patients in each group.The baseline characteristics and median observation time of the two groups were balanced(intervention group:48 h/patient vs.control group:49 h/patient).Compared with the control group,the intervention group showed fewer ADMS(2/40 vs.9/40)and detected more risk actions per 100 h(36 vs.25);all system-detected events had corroborating images with complete concordance on manual review,and all nurse-recorded hand-contact events were accurately captured.Conclusions The study demonstrated that the image recognition-based detection system can function stably in clinical settings,providing accurate and continuous surveillance while supporting the early detection of risk actions.By reducing the observation burden and offering real-time cognitive support,the system complements routine nursing care and serves as an additional safety measure in ICU practice.With further optimization and larger multicenter validation,this approach could have the potential to make a significant contribution to the development of smart ICUs and the broader digital transformation of nursing care.
基金supported by grants from the National Institute of Biomedical Imaging and Bioengineering(NIBIB)of the National Institutes of Health(NIH)under award numbers R01-EB001659(2003-2013)and R01-EB017205(2014-2018)approved by the Institutional Review Boards of Beth Israel Deaconess Medical Center(Boston,MA)and the Massachusetts Institute of Technology(Cambridge,MA).
文摘Background:Most sepsis patients develop sepsis-associated acute kidney injury(SA-AKI),which poses a significant threat to survival and lacks specific treatment.To date,there are no published randomized controlled trials that have established a link between albumin use and SA-AKI development in sepsis.Therefore,it is unclear whether albumin use may influence the risk of SA-AKI.Methods:The present study employed a target trial emulation using observational data to track adult sepsis patients initially admitted to the intensive care unit at Beth Israel Deaconess Medical Center,Boston,Massachusetts,for a period of 7 d from 2008 to 2022.Immortal time bias was controlled using the clone-censor-weight(CCW)method,along with a new-user design to address current user bias.The exposure variable was the early administration of albumin following the onset of sepsis.Based on albumin use,patients were classified into two groups:the albumin group(n=27,088)and the no albumin group(n=27,088).The primary outcome was the development of SA-AKI,and the secondary outcome was 7-day all-cause mortality.The primary outcome was analyzed using competing risk analyses.Furthermore,sensitivity and subgroup analyses were also performed.Results:Among the 27,088 patients analyzed,albumin administration was associated with a significantly higher SA-AKI risk(relative difference=3.47%,95%CI 1.76-5.23)compared to non-administration.There was no clinically meaningful difference in 7-day survival(relative difference=0.05%,95%CI-2.30 to 2.45).Sensitivity analyses consistently supported these results.All these analyses were conducted on data that were collected after CCW.Conclusions:Early albumin administration may increase the risk of SA-AKI in sepsis patients without conferring a short-term survival benefit.These results underscore the need for a rigorous risk-benefit assessment when incorporating albumin into sepsis resuscitation protocols and highlight the need for further clinical validation.However,it is important to exercise caution when interpreting the conclusions of this study,given its exploratory and preliminary nature.
文摘Unresectable hepatocellular carcinoma(HCC)remains a global challenge,with limited effective treatment options for advanced-stage disease.The HIMALAYA trial(phase III randomized study that evaluated the STRIDE regimen)introduced the Single Tremelimumab Regular Interval Durvalumab(STRIDE)regimen,an immunotherapy-based approach that achieved a median overall survival(OS)of 16.43 months compared to 13.77 months with sorafenib.While statistically significant,this~2.7 months OS gain warrants scrutiny in light of STRIDE’s increased immune-related toxicity and cost.This commentary evaluates STRIDE’s impact within the broader landscape of first-line systemic therapy for unresectable HCC,alongside other regimens such as atezolizumab plus bevacizumab and nivolumab plus ipilimumab.We explore STRIDE’s mechanism of action,safety profile,modest progression-free survival(PFS)improvement,and implementation challenges,incorporating insights from 2023-2025 research.In addition,we discussed its limitations in non-viral HCC and Child-Pugh B patients,the role of emerging biomarkers,and the potential of radiation to enhance immunotherapy efficacy.As a dual immune checkpoint inhibitor(ICI)strategy,STRIDE offers an important advance that may not only extend survival but also open the door to future curative approaches.However,optimizing its use will require refined patient selection and further investigation of synergistic combination therapies.
文摘Since 2016,the number of clinical trials registered in the World Health Organization-International Clinical Trials Registry Platform has been steadily increasing.The number of clinical trials registered between 2018 and 2022 is 39765 for BRICS countries.Though India’s contribution increased from 33%to 40%in the interim,the number of infectious disease trials registered in India is low(325)compared to the number of oncology clinical trials(1936)[1].The number of phase 3 registrational antibacterial clinical trials conducted in India is also low(Table 1).This poses a serious public health challenge given the infectious disease burden in India[2].
基金supported by the Beijing Natural Science Foundation(L234038)the National Natural Science Foundation of China(no.82274015).
文摘Background:Since the launch of drug regulatory reform in 2015,China has substantially increased the availability of new cancer therapies.However,the efficacy evidence criteria for modified new anticancer drugs have not been evaluated.This cross-sectional study aimed to assess the pivotal trials supporting the indication approvals of innovative and modified new chemical anticancer drugs in China.Methods:The characteristics of indications,regulatory aspects,and pivotal trial designs were extracted and described.The primary efficacy endpoints of the pivotal clinical trials,including overall survival(OS)and progression-free survival(PFS),were quantitatively assessed by meta-analysis.Results:Between 2016 and 2022,77 cancer therapeutics for 107 indications were approved in China based on 128 pivotal trials.Among the 107 indications,64(59.8%)were classified as innovative anticancer drugs,and 43(40.2%)as modified new anticancer drugs.The study found that pivotal trials for innovative approvals tended to be single-arm trials,while modified approvals were more likely to employ randomized clinical trials with larger sample sizes and rigorous designs.Despite innovative drugs often receiving more expedited regulatory designations,there were no statistically significant differences in clinical benefit of OS or PFS outcomes between innovative and modified approvals.Conclusions:These results suggest that the current regulatory framework may prioritize the speed of approval for innovative drugs over the strength of supporting evidence.These findings align with the strategic trends of pharmaceutical companies and regulatory inclinations that aim to expedite the approval of innovative anticancer drugs with a high unmet need,thereby accelerating patients’accessibility to treatment.
文摘Enrolling in clinical trials could be time-sensitive and time-demanding tasks for the research site, especially if it is a private research organization compared to the research conducted at an academic or medical center. Every study differs in various aspects, such as phases, study indication, eligibility criteria, etc. In terms of meeting the enrollment deadline, typically, the study indication and availability of the patient’s population at the geographical area of the research site would decide if the trial could be time-consuming. Patient recruitment and retention are critical for the success of every clinical trial;however, worldwide, this area is facing tremendous pressure and challenges. Globally 55% of clinical trials terminated due to low recruitment, with an average enrollment success rate of 40% for Phase III and IV trials. Over 80% of clinical trial attempts fail to enroll, extending the study and adding new study sites. In the United States, more than 80% of clinical trials fail to achieve targeted patient enrollment, and 30% of study participants discontinue participation. This article reviewed various factors hindering clinical trial recruitment and retention and suggested strategies to make the research site successful.
文摘OBJECTIVE To investigate the intervention effects of tissue-bone homeostasis manipulation(TBHM)on peripatellar biomechanical parameters and knee joint function in knee osteoarthritis(KOA)patients.METHODS Sixty patients with KOA(Kellgren-Lawrence gradeⅡ-Ⅲ)were recruited from the Acupuncture-Moxibustion Rehabilitation Department,Anhui University of Chinese Medicine between October 2024 and May 2025.Participants were randomized into a TBHM group(n=30)or a transcutaneous electrical neuromuscular stimulation(TENS)group(n=30).Using two-way repeated measures ANOVA,biomechanical indicators,including rectus femoris tension,vastus medialis tension,vastus lateralis tension,patellar ligament tension,lateral patellar displacement(LPD),medial patellar displacement(MPD),normalized patellar mobility(LPD/patellar width[PW],MPD/PW),knee flexion range of motion,and functional indicators,including KOOS subscales,time up and go test(TUGT),were compared between groups at baseline and after 6 weeks of intervention.RESULTS After intervention,all biomechanical and knee joint function indicators in the TBHM group were significantly improved(P<0.05,P<0.01),while only the vastus medialis tension,TUGT and KOOS Pain,ADL and QoL scores in the control group were significantly improved(P<0.01).The improvement amplitudes of biomechanical indicators in the TBHM group,including rectus femoris tension,vastus lateralis tension,patellar ligament tension,MPD/PW,LPD/PW and knee flexion range of motion were better than those in the control group(P<0.05,P<0.01).In the functional evaluation,the interaction effects of the TBHM group in all dimensions of the KOOS score and TUGT were statistically significant(P<0.05,P<0.01).Post-hoc simple effect analysis confirmed that there were significant differences in the above indicators between the two groups after intervention(P<0.05),and all indicators showed a significant main effect of time(P<0.01),suggesting that the intervention measures had continuous and cumulative curative effects.CONCLUSION TBHM effectively improves joint function and quality of life in KOA patients by restoring dynamic equilibrium in soft tissue tension and patellar mobility,ultimately achieving the therapeutic goal of concurrent tissue-bone management.
基金supported by a project of the National Natural Science Foundation of China:Research on the integration of artificial intelligence and virtual reality technology to promote psychological rehabilitation of breast cancer patients with different personalities(project approval no.82073408).
文摘Objectives:To explore the efficacy and safety of virtual reality(VR)in relieving negative emotions in patients with breast cancer with different personalities.Methods:A randomized controlled trial was conducted.Between April 2023 and October 2023,we enrolled patients with breast cancer treated in the Department of Breast Cancer and Oncology at Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangdong Province.The patients were randomly divided into an intervention group(n=118)and a control group(n=119)using block randomization.The intervention group received the VR intervention 3-5 times over 5±2 weeks using natural landscapes with music or relaxation guidance,and the duration of each VR intervention was 15±3 min.The control group received routine nursing care,including disease education and psychological counseling.Patients were assessed using the Type D Scale,Positive and Negative Affect Scale,and Distress Thermometer,and adverse events during the intervention were recorded.Results:Overall,85 patients completed the study(44 in the intervention group and 41 in the control group).Patients with Type D personalities showed more negative emotions[25.0(21.5,27.5)vs.19.0(16.0,24.0),P=0.001]and distressed attitudes[4.0(2.0,5.0)vs.3.0(1.0,4.0),P=0.020]with fewer positive emotions(27.2±5.6 vs.31.0±5.9,P=0.014)than those with non-Type D personalities.Total population analysis revealed no significant differences between the groups.However,in the subgroup analysis,patients with Type D personalities in the intervention group showed greater relief from negative emotions than those in the control group[median difference,-5.0(-9.0,-2.5)vs.-2.0(-4.0,2.0),P=0.046].No significant differences were found between groups of patients with non-Type D personality traits.The proportion of adverse events was not significantly different between groups(P=0.110).Conclusions:Breast cancer patients with Type D personalities suffer more severe negative emotions and distress,and more attention should be paid to them.VR intervention significantly and safely reduced negative emotions in patients with Type D personalities.
基金funded by the National Key Research and Development Program of China(Grant No.2022YFB4700904 to Wang L)the Shanghai Shenkang Hospital Development Center's project for the Promotion of Clinical Skills and Clinical Innovation Three-Year Action Plan(Project No.SHDC2022CRT006 to Wang L and SHDC2022CRS010B to Tang S).
文摘Objective:This study aimed to assess the feasibility and safety of the SHURUI single-port robotic surgical system for a range of major urological surgeries.Methods:In this prospective,multicenter clinical trial,we examined the effectiveness of the SHURUI single-port robotic surgical system in urological interventions.The first 50 patients from four centers in China underwent single-port surgeries including partial nephrectomy,radical prostatectomy,partial adrenalectomy,and pyeloureteroplasty,exclusively by the SHURUI single-port robotic surgical system.The study's primary endpoints focused on the success of surgeries,defined as no deviations from planned procedures,no need for more than one port,and no re-operations within 24 h after surgery.Secondary endpoints encompassed a range of surgical metrics,functional outcomes,and patient demographic data.Clinical assessments were conducted before surgery,before discharge,and 1 month after discharge.Results:The surgical procedures were executed successfully without requiring intraoperative conversions or transfusions.Both estimated blood loss and operation durations were maintained within satisfactory limits.For each type of surgery,the mean console times and estimated blood loss were 179.8(standard deviation[SD]39.4)min and 125.6(SD 126.0)mL for radical prostatectomy,126.7(SD 47.8)min and 39.2(SD 54.4)mL for partial nephrectomy,112.6(SD 37.4)min and 20.0(SD 13.2)mL for partial adrenalectomy,and 148.0(SD 18.2)min and 18.0(SD 17.9)mL for pyeloureteroplasty,respectively.Across the cohort,17 patients experienced a total of 25 adverse events,while 10 postoperative complications,all rated as Clavien-Dindo grade I,were encountered by eight patients.All patients had shown recovery or improvement from these events before the end of this trial.Conclusion:The SHURUI single-port robotic surgical system demonstrated feasibility and safety in the performance of major urological surgeries.These initial findings highlight the system's potential,though further research and longer follow-up are required to assess long-term outcomes.
基金Supported by the National Natural Science Foundation of China:Exploration of Key Factors and Mechanisms of Modulating Motor Function Reconstruction After Cerebral Infarction Through Multimodal Brain Functional Connectivity Perspective in Procedural Acupoint Electrical Stimulation Research(No.82374601)the Jointly Guided Program of Natural Science Foundation of Heilongjiang Province:Quantitative Study on the Role of Scalp Acupuncture in the Motor Area in Promoting Motor Function Reconstruction after Stroke(No.LH2019H113)+1 种基金the Innovation Team Construction Project of Heilongjiang University of Chinese Medicine:Construction of a Doctoral Research and Innovation Team in Acupuncture Science(No.2017sit01)the Traditional Chinese Medicine Research Project of Heilongjiang Province:Clinical Study on the Promotion of Upper Limb Motor Function Reconstruction in Post-Stroke Patients Using Optimal Limb Positioning with Electroacupuncture(No.ZHY2022-171)。
文摘OBJECTIVE:To evaluate the efficacy of electroacupuncture(EA)at scalp motor area for treating post-stroke wrist dyskinesia and its influence on the function of wrist movement-related agonistic muscles.METHODS:A randomized,single-blind,controlled clinical trial was conducted.Sixty-six patients undergoing post-stroke wrist dyskinesia were enrolled and randomized 1:1 to EA or control group.Patients in the control group received manual acupuncture in the scalp motor area(MS 6)on the lesion side.The same acupoint was selected to accept EA stimulation in the EA group.All patients were treated six times a week for three weeks.The primary outcome was the Chinese Stroke Scale(CSS)score.The secondary outcomes included upper limb-related Barthel Index(BI)score,active range of motion(AROM)of the wrist joint,and root mean square(RMS)of the four agonistic muscles associated with wrist motion on the hemiplegic side of patients,i.e.,the extensor carpi radialis longus(ECRL),extensor digitorum(ED),flexor carpi radialis(FCR)and flexor carpi ulnaris(FCU).The above indicators were measured before and after three weeks of treatment.RESULTS:After 3-week treatment,the CSS score and AROM of wrist dorsiflexion of the EA group were better than those in the control group(P=0.038,P=0.047).The differences between the two groups of BI scores and AROM of wrist flexion were not significant(P>0.05).All RMS of the EA group were higher than those in the control group(ECRL:P=0.047,ED:P=0.048,FCR:P=0.049,FCU:P=0.047).The total effective rate in the EA group was 87.50%(28/32),which was higher than that in the control group(77.42%,24/31,P=0.048).CONCLUSION:EA stimulation of the scalp motor area can promote the recovery of the strength and function of the agonistic muscles related to wrist movement and effectively improve post-stroke wrist dyskinesia.
