中西医结合治疗IgA肾病的随机对照试验结局指标的选择  

Selection of Outcome Indicators in Randomized Controlled Trials of Integrated Traditional Chinese and Western Medicine for IgA Nephropathy

作　　者：杨珂 李靖[1] 何俊伯 张正媚 王梅杰 周妍 赵鑫雨 周梦远 岳书颉 YANG Ke;LI Jing;HE Junbo;ZHANG Zhengmei;WANG Meijie;ZHOU Yan;ZHAO Xinyu;ZHOU Mengyuan;YUE Shuxie(Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]北京中医药大学东直门医院,北京100700

出　　处：《世界中医药》2023年第14期2045-2051,共7页World Chinese Medicine

基　　金：北京市卫生健康委员会2018年首都卫生发展科研专项项目(首发2018-1-4192)。

摘　　要：目的:结局指标是临床试验及研究中不可或缺的组成部分,尤其对于中医药治疗疾病相关的临床研究,建立具有中医药特色的核心结局指标集已经被很多中医药学者所呼吁。通过本研究为建立中医、中西医结合治疗IgA肾病的核心结局指标集提供佐助。方法:在计算机网络选择7个中英文数据库,检索中医药或中西医结合治疗肾功能正常的IgA肾病的临床随机对照试验相关文献。果:共纳入25篇文献,涉及到36个结局指标,使用率接近及超过一半的结局指标仅有5个,同时,未有1篇文章将终点事件作为结局指标。结论:目前已发表的随机对照试验结局指标的选择繁多,虽大都以实验室相关检查结果作为结局指标,但差异性较大,测量时点跨度较大,未能体现中医药特色,安全性指标涉及较少且较为模糊。关于IgA肾病的中医药核心结局指标的数据库建立或可从目前明显的不足入手。Objective:Outcome indicators are an integral part of clinical trials and studies,especially for those of traditional Chinese medicine(TCM)treatment of diseases.TCM researchers have called for the establishment of a core set of outcome indicators with TCM characteristics.This study aims to lay a foundation for the establishment of a core outcome indicator set for treating IgA nephropathy with integrated traditional Chinese and western medicine.Methods:The randomized controlled trials(RCTs)of the treatment of IgA nephropathy(renal function being normal)with TCM or integrated traditional Chinese and western medicine were retrieved from 7 databases.Results:A total of 25 articles were included,involving 36 outcome indicators,among which only 5 outcome indicators were used with the frequency close to or more than 50%.None of the articles used endpoint events as an outcome indicator.Conclusion:The published RCTs use diverse outcome indicators.Although most of RCTs take the results of laboratory tests as outcome indicators,there are problems such as great differences,large time span,ignorance of the indicators with TCM characteristics,and insufficient and confused safety indicators.The database of the core TCM outcome indicators of IgA nephropathy can be established in view of the problems above.

关 键 词：核心结局指标集 IGA肾病 中医药 中西医 随机对照试验 肾功能正常 中医证候评分 中医特色 

分 类 号：R242[医药卫生—中医临床基础]