文献类型：期刊文献

中文题名：中医药干预溃疡性结肠炎随机对照试验的结局指标现状分析

英文题名：Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis

作者：邓亚胜[1,2];毛兰芳[3];林江[1];范燕萍[1];李汶玥[1];刘永辉[1];倪召兵[1];余金钟[4]

第一作者：邓亚胜

机构：[1]广西中医药大学基础医学院,南宁530200;[2]防城港市中医医院,广西防城港538000;[3]甘肃中医药大学附属医院,兰州730000;[4]上海中医药大学附属曙光医院消化医学部,上海200000

第一机构：广西中医药大学基础医学院,南宁530200

年份：2025

卷号：31

期号：7

起止页码：245

中文期刊名：中国实验方剂学杂志

外文期刊名：Chinese Journal of Experimental Traditional Medical Formulae

收录：;北大核心:【北大核心2023】；

基金：国家自然科学基金项目(82460908);国家中医脾胃病优势专科2023年专项经费开放基金项目(2023PW-03);2023年甘肃省教育科技创新项目(2023B-108);中医学广西一流学科项目(桂教科研[2022]1号);广西中医药多学科交叉创新团队项目(GZKJ2302);广西名中医林江传承工作室项目(桂中医药科教发[2021]6号)。

语种：中文

中文关键词：溃疡性结肠炎;中医药;随机对照试验;结局指标;核心指标;研究现状

外文关键词：ulcerative colitis;traditional Chinese medicine;randomized controlled trials;outcome indicators;core indicators;research status

摘要：系统梳理中医药干预溃疡性结肠炎(UC)的随机对照试验(RCT),分析中医药临床试验的研究特征和结局指标,以期为后续开展中医药干预UC的RCT设计提供参考,为中医药在UC中的临床应用提供证据支持。计算机检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane Library、EMbase、Web of Science数据库2021年1月至2024年8月中医药治疗UC的RCT,评估偏倚风险,定性分析结局指标。最终纳入555篇RCT,样本量44853例,样本量最大为218例,最小为28例,多集中在60~100例;386篇RCT明确报告了中医证型,排序前3的分别是大肠湿热证(31.05%)、脾肾阳虚证(12.47%)及脾虚湿蕴证(9.17%);干预措施使用频数由高到低包括内服中药复方/制剂(64.5%)、中药复方/制剂保留灌肠(18.2%)、内服中药复方/制剂+中医外治(5.95%)、中医外治(4.86%)等;治疗疗程多集中在4~8周(64.86%),61篇(10.99%)研究报告了随访时间;共使用了157种结局指标,使用频数3460次,分属6个指标域:中医证候/症状(346次,10%)、症状/体征(541次,15.64%)、理化检查(2119次,61.24%)、生活质量(107次,3.09%)、远期预后(61次,1.76%)、安全性事件(284次,8.21%)。结果表明,中医药治疗UC的结局指标面临样本量计算缺乏依据、中医辨证分型欠规范、试验方案的设计与注册缺失、盲法与分配隐藏不足、干预措施的依从性、替代指标与终点指标选择不平衡、结局指标测量时点不统一以及设计待规范、伦理与安全性问题的局限性。建议未来应积极构建一套涵盖中医证型的标准化分类、明确的疗效评价指标、关键的终点指标及合理的测量时点,同时强调对远期预后影响的追踪、患者生活质量的全面评估及经济学效益考量的UC核心指标集,为中医药治疗UC的临床实践提供依据。
To systematically review randomized controlled trials(RCTs)of traditional Chinese medicine(TCM)intervention in ulcerative colitis(UC),and analyze the characteristics of these studies and their outcome indicators,thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC.A computerized search was conducted in the China National Knowledge Infrastructure(CNKI),Wanfang Data,VIP,SinoMed,PubMed,Cochrane Library,EMbase,and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024.The risk of bias was assessed,and outcome indicators were qualitatively analyzed.A total of 555 RCTs were included,with a sample size of 44853 participants.The largest sample size was 218 cases,and the smallest was 28 cases,with most studies focusing on 60-100 participants.Of the 386 RCTs that explicitly reported TCM syndrome types,the top three were large intestine dampness-heat syndrome(31.05%),spleen and kidney yang deficiency syndrome(12.47%),and spleen deficiency with dampness syndrome(9.17%).The interventions,ranked by frequency of use,included internal Chinese medicine compounds/preparations(64.5%),Chinese medicine compounds/preparations with retained enema(18.2%),internal Chinese medicine compounds/preparations+external TCM treatment(5.95%),and external TCM treatment alone(4.86%).The treatment duration was mainly 4-8 weeks(64.86%),with 61 studies(10.99%)reporting follow-up time.A total of 157 outcome indicators were used,with a frequency of 3460 occurrences,classified into six domains:TCM syndromes and symptoms(346 occurrences,10%),symptoms/signs(541 occurrences,15.64%),physical and chemical examinations(2119 occurrences,61.24%),quality of life(107 occurrences,3.09%),long-term prognosis(61 occurrences,1.76%),and safety events(284 occurrences,8.21%).The analysis reveals several limitations in the outcome indicators of TCM intervention in UC,including the lack of a basis for sample size calculation,non-standardized TCM syndrome classification,absence of trial design and registration,inadequate blinding and allocation concealment,adherence issues with interventions,imbalanced selection of surrogate and endpoint indicators,inconsistency in the timing of outcome measurements,design issues that require standardization,and ethical and safety concerns.It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification,clear efficacy evaluation indicators,key endpoint indicators,and reasonable measurement time points.Long-term prognostic impacts,comprehensive assessments of patients'quality of life,and consideration of economic benefits should be emphasized,providing a basis for the clinical practice of TCM in the treatment of UC.