药品说明书外用法中国专家共识中的证据和推荐意见评价方法研究  

Study of the evaluation methods for evidence and recommendation in Chinese expert consensus on off-label use of drugs

作　　者：张明月 陈楠 徐玲 拜争刚[3] 林丽开 ZHANG Mingyue;CHEN Nan;XU Ling;BAI Zhenggang;LIN Likai(School of Pharmacy,Henan University of Chinese Medicine,Zhengzhou 450046,China;Dept.of Pharmacy,People’s Hospital of Henan University of Chinese Medicine/People’s Hospital of Zhengzhou,Zhengzhou 450003,China;Evidence-based Research Center of Social Science&Health,Nanjing University of Science and Technology,Nanjing 210094,China;Hospital Management Institute,Wuhan University,Wuhan 430071,China)

机构地区：[1]河南中医药大学药学院,郑州450046 [2]河南中医药大学人民医院/郑州人民医院药学部,郑州450003 [3]南京理工大学循证社会科学与健康研究中心,南京210094 [4]武汉大学医院管理研究所,武汉430071

出　　处：《中国药房》2025年第6期641-647,共7页China Pharmacy

基　　金：河南省中青年卫生健康科技创新人才培养项目(No.LJRC2023017);郑州市卫生健康委医学科研项目(No.ZZYK2024042)。

摘　　要：目的为优化或制定统一的药品说明书外用法专家共识的证据和推荐意见评价方法提供参考。方法检索中国知网、万方数据、维普网、中国生物医学文献数据库、PubMed和Web of Science,纳入各数据库自建库起至2024年8月1日收录的包含证据和推荐意见评价方法的药品说明书外用法中国专家共识,筛选文献并提取资料后进行描述性统计分析。结果与结论最终纳入32篇文献,14篇(43.8%)采用Micromedex的Thomson分级系统,形成推荐意见时仅有7篇(21.9%)考虑了经济性,10篇(31.3%)报告了利益冲突情况,仅2篇(6.3%)有循证医学方法学专家的参与。不同专家共识评价方法中证据来源类型、形成推荐意见时考量的因素、证据和推荐意见分级标准有差异,同一用法在不同专家共识中的证据等级和推荐意见也有差异。建议未来制定共识时应提高对参与共识人员利益冲突的关注度,加强与方法学专家的合作,并尽快制定统一的证据和推荐意见评价方法标准。OBJECTIVE To provide reference for optimizing or formulating unified evaluation methods for evidence and recommendation in expert consensus on off-label use of drugs.METHODS Retrieved from CNKI,Wanfang data,VIP,CBM,PubMed and Web of Science,Chinese expert consensuses on off-label use of drugs involving evaluation methods for evidence and recommendations were collected from the inception to August 1,2024.After screening the literature and extracting relevant data,descriptive statistical analysis was conducted.RESULTS&CONCLUSIONS Among the 32 articles included,14 articles(43.8%)used Micromedex’s Thomson grading system,only 7 articles(21.9%)considered economic factors when forming recommendations,10 articles(31.3%)reported the conflicts of interest;only 2 articles(6.3%)involved experts in the field of evidence-based medicine methodology.There were differences in the sources of evidence,factors considered in forming recommendations,and the grading standards for evidence and recommendations among different expert consensus evidence evaluation methods.There were also differences in evidence levels and recommendation strength of the same drug off-label use in different expert consensus.It is recommended that in future consensus-building processes,greater attention should be paid to potential conflicts of interest among participants,collaboration with methodological experts should be enhanced,and efforts should be expedited to establish unified standards for evaluating evidence and recommendation methodologies.

关 键 词：药品说明书外用法 证据 推荐意见 专家共识 

分 类 号：R95[医药卫生—药学]