摘要
目的 分析中成药治疗优势病种临床应用指南的研制现状与质量.方法 检索2019年1月至2023年12月公开发表的中成药治疗优势病种临床应用指南,提取纳入指南的相关信息包括名称、参与人员、临床问题与结局指标、证据评级、推荐强度与推荐意见等,分析其研制现状,并运用临床实践指南科学性、透明性和适用性的评级工具(STAR)对其进行质量评价.结果 纳入指南34部,涉及中成药273种.29部指南分别构建临床问题1～10个(中位数5个);全部指南均使用GRADE分级系统将证据质量分为4个等级;28部指南将推荐强度分为5级,全部指南共提取推荐意见344条,其中强推荐86条,弱推荐191条(包含36条仅依据专家共识形成的弱推荐),无法明确整体推荐强度67条.所有指南在"临床问题"(94.20％)、"证据"(91.45％)、"推荐意见"(89.06％)3个领域的得分率较高,而在"注册"(22.06％)、"计划书"(19.00％)、"可及性"(31.51％)3个领域的得分率较低.8部指南的STAR推荐星级为5.0～4.0星(高星级),18部为3.5～2.5星(中星级),8部为2.0～1.0星(低星级).推荐星级最高的3部指南分别是抑郁障碍、社区获得性肺炎、成人流感.结论 已发表的中成药临床应用指南质量评分之间存在一定差距,整体在注册、计划书、资助、可及性领域均有待提高.
Abstract
Objective To analyze the development status and quality of clinical practice guidelines for the treat-ment of dominant diseases with Chinese patent medicines(CPMs).Methods Databases were searched from Jan.2019 to Dec.2023 to collect the published clinical practice guidelines of CPMs for the treatment of dominant diseases.The information about the title,the participants,clinical problems,outcomes,evidence grade,recommendations,and recommendation strength in the included clinical practice guidelines were collected,for which the development status was analyzed,and the quality was evaluated with the Scientific,Transparent and Applicable Rankings(STAR)tool for clinical practice guidelines.Results Totally,34 guidelines were included,involving 273 kinds of CPMs.One to ten(with the medium five)clinical problems were proposed from 29 clinical practice guidelines respectively.All the guidelines divided the evidence into four grades according to Grade of Recommendation Assessment,Deve-lopement an Evaluation.And 28 guidelines had five levels of recommendation strength.A total of 344 recommenda-tions were extracted,including 86 strong-recommendations,191 weak-recommendations(including 36 weak recommen-dations only based on expert consensus)and 67 recommendations with unclear recommendation strength.All guide-lines had high scores in the three areas of"clinical questions(94.20％)","evidence(91.45％)"and"recommenda-tions(89.06％)",while the scores in the three areas of"registry(22.06％)","protocol(19.00％)"and"accessibility(31.51％)"were low.The STAR recommended stars of 8 guidelines were 5.0～4.0 stars,while that of 18 guidelines were 3.5～2.5 stars,and 8 guidelines were 2.0～1.0 stars.The three guidelines with the highest recommended stars were depressive disorder,community-acquired pneumonia,and influenza in adult.Conclusion There is a certain gap in the quality of the published clinical practice guidelines of CPMs,and the quality of the guidelines could be fur-ther improved in registry,protocols,funds,and accessibility.
基金项目
国家中医药局中成药治疗优势病种标准化项目(SATCM-2015-BZ402-407)
国家中医药局青年岐黄学者支持项目(国中医药人教发[2020]7号)
中原英才计划领军人才项目(ZYYCYU202012124)
国家重点研发计划(2023YFC3502602)
国家科技期刊平台
NSTL
万方数据