中成药临床实践指南和专家共识中安全性推荐意见的现况分析

Analysis of safety recommendations in clinical practice guidelines and expert consensuses for Chinese patent medicine

目的探讨我国中成药临床实践指南及专家共识(指南/共识)中安全性推荐意见的现状及存在的问题。方法检索万方医学网、中国知网、维普网、中国生物医学数据库、中华医学期刊全文数据库,以及医脉通、中华中医药学会网站,收集中成药相关的指南/共识,提取其基本信息、类型、学科领域、证据评级方法、报告安全性条目、安全性推荐级别及证据来源等信息,进行描述性统计分析。结果共138篇指南/共识纳入分析,包括指南19篇,共识119篇。首篇中成药指南/共识于2004年发布,2016―2023年分别发布5、3、9、15、29、32、29及11篇指南/共识,2020―2023年发布101篇,是以往16年发布总数的2.73倍(101/37)。138篇指南/共识中“以病为纲”59篇(42.75%),“以药为纲”79篇(57.25%)。发布数量排名前5位的机构为国家中医药管理局、中华中医药学会、中国中医科学院中医临床基础医学研究所、中国中西医结合学会和中国医师协会。其中19篇指南的发布机构均为国家中医药管理局,发布单位为医学院校/医疗机构者26篇,未报告发布或牵头单位者8篇。138篇指南/共识中有18篇(13.04%)未对药物的安全性进行报告,120篇(86.96%)报告了治疗的安全性,但均未按照循证医学证据分级的评估、制订与评价(GRADE)标准对安全性推荐意见做出分级,仅32.50%(39/120)的证据来源中包含随机对照试验。138篇指南/共识中50.72%(70篇)未报告资助情况,37.68%(52篇)未做利益冲突披露。结论近年来我国中成药相关指南/共识发布数量明显增多,但部分指南/共识发布机构的权威性差,“以药为纲”者居多,安全性报道不足,证据等级较低,可能存在一定偏倚。

Objective To explore the status and problems of safety recommendations in clinical practice guidelines and expert consensuses(guidelines/consensuses)on Chinese patent medicine(CPM)in China.Methods Wanfang Med Online,CNKI,VIP,China Biology Medicine Database,Chinese Medical Journal Full Text Database,and the websites of Medlive,and China Association of Chinese Medicine were searched,and the guidelines/consensuses related to CPM were collected.The basic information,types,subject areas,evidence rating methods,safety reporting items,safety recommendation levels,and evidence sources of these guidelines/consensuses were extracted and analyzed by descriptive statistics.Results A total of 138 guidelines/consensuses were included in the analysis,including 19 guidelines and 119 consen-suses.The first guideline/consensus on CPM was published in 2004.Five,3,9,15,29,32,29,and 11 guide-lines/consensuses were published respectively from 2016 to 2023.From 2020 to 2023,101 guidelines/consensuses were published,which was 2.73 times the total number of those published in the past 16 years.(101/37).Among the 138 guidelines/consensuses,59(42.75%)were"disease-based"and 79(57.25%)were"drug-based".The top 5 institutions in terms of the number of publications were National Administra-tion of Traditional Chinese Medicine,China Association of Chinese Medicine,Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences,Chinese Association of Integrative Medicine,and Chinese Medical Association,of which National Administration of Traditional Chinese Medicine issued 19 guidelines.However,the issuing units of 26 guidelines/consensuses were medical colleges/medical institutions and the issuing units of 8 guildlines/consensuses were not clearly stated.Among the 138 guidelines/consensuses,18(13.04%)didnotdescribethesafety of drugs and 120(86.96%)described.Among the 120 guidelines/consensuses,none of the safety recommendations were graded according to The Grading of Recommendations Assessment,Development and Evaluation,and only 32.50%(39/120)of the evidence sources contained randomized controlled trials.A proportion of 50.72%(70/138)in 138 guide-lines/consensuses did not report the funding situation,and 37.68%(52/138)did not disclose the conflict of interest.Conclusions In recent years,the number of guidelines/consensuses on CPM has increased significantly in China,but the issuing agencies of some of them had poor authority.Most of the guidelines/consensuses are"drug-based",the descriptions of safety are insufficient,the evidence level is low,and there may be some bias.