中国全科医学2026，Vol.29Issue(5)：656-667,12.DOI:10.12114/j.issn.1007-9572.2025.0107
中医药治疗消化性溃疡随机对照试验结局指标现状研究
Current Situation Analysis of Outcome Indexes of Randomized Controlled Trial on Treatment of Peptic Ulcer with Chinese Medicine
摘要
Abstract
Background Peptic ulcer(PUD)is a common disease of the digestive system.Traditional Chinese Medicine(TCM)treatment is an effective treatment for PUD.However,in the randomized controlled trials(RCTs)of TCM treatment of this disease,there are great limitations in the selection of methodological quality and outcome indicators,which brings some challenges to efficacy evaluation and data integration analysis.Objective To systematically review the application status and experimental design points of RCTs outcome indicators of TCM intervention in PUD in the past 15 years,aiming to provide reference for the construction of core indicator set of TCM treatment of PUD and the optimization of clinical trial design.Methods Computerized searches were conducted in Chinese databases:CNKI,Wanfang Data,VIP,and SinoMed,as well as international authoritative databases:PubMed,Embase,Cochrane Library,and Web of Science for RCTs on the treatment of PUD with TCM.The search time frame was from 2010 to 2024.Cochrane bias risk assessment was performed on the included literature,and relevant outcome indicators were counted,summarized and analyzed.Results A total of 323 RCTs with 34 933 patients were included.The maximum sample size of single study was 498 cases,the minimum was 40 cases,and the average sample size was 108 cases.Among the 171 reports of TCM syndromes,the highest frequency of use was spleen and stomach deficiency cold(31 articles,18.13%);47 articles were treated with pure TCM,and 276 articles were treated with integrated Traditional Chinese and Western Medicine.The course of treatment was mostly 4 weeks(119 times,36.84%);the outcome indicators were divided into 6 categories according to functional attributes.A total of 170 outcome indicators were reported,with a total frequency of 1 962 times.The outcome indicators with higher frequency of use were total clinical effective rate(233 times,11.88%),Helicobacter pylori eradication rate(165 times,8.41%),and adverse reactions(155 times,7.90%).The risk assessment of bias in the included literature was not clear.Conclusion The RCTs of PUD treated with TCM still exist in the following aspects:the dialectical classification and disease staging of TCM are not standardized,the methodological design(blind method,distribution concealment)needs to be improved,the primary and secondary outcome indicators are not clearly distinguished,the clinical efficacy standards are not unified,the measurement time gap of outcome indicators is large,the scoring criteria of TCM syndromes/symptoms is diversified,the ethical registration needs to be paid attention to,and the report of safety indicators is not standardized.It is suggested to actively carry out the research on the core index set of TCM treatment of PUD,optimize and improve the methodological quality,and provide high scientific,reliable and practical evidence for the clinical practice of TCM treatment of PUD.关键词
消化性溃疡/中医药/结局指标/核心指标集/随机对照试验Key words
Peptic ulcer/Traditional Chinese medicine/Outcome index/Core index set/Randomized controlled trial分类
医药卫生引用本文复制引用
田蓉,李开楊,杨梅,黄敬,张飞,赵琦..中医药治疗消化性溃疡随机对照试验结局指标现状研究[J].中国全科医学,2026,29(5):656-667,12.基金项目
国家自然科学基金资助项目(82160866) （82160866）
贵州省高等学校中西结合防治疾病转化医学重点实验室(黔教技[2023]017号) （黔教技[2023]017号）
2023年度中医药、民族医药重点学科建设[QZYYZDXK(JS)-2023-03] （JS）
贵州省中医药管理局中医药、民族医药科学技术研究课题(QZYY-2023-015) （QZYY-2023-015）
