摘要
目的分析中成药治疗优势病种临床应用指南中对低质量证据给予强推荐的现状并探讨其推荐意见的合理性。方法指南选择:纳入国家中医药管理局立项、中国中药协会承担的“中成药治疗优势病种临床应用指南”项目(项目标号SATCM-2015-BZ402)于2019年2月至2022年8月公开发表的29部指南。数据提取:由2名研究人员独立提取资料,提取内容包括:推荐意见类型(共识意见或循证意见)、制订推荐意见的分级系统、推荐强度和证据质量。结果本研究共纳入29部指南,所有的指南均采用GRADE方法进行证据质量评价及推荐强度评级。在纳入的262条推荐意见中,低/极低证据质量强推荐的条目共计27条(10.3%),仅6.8%(2/29)的指南低/极低质量强推荐条目超过总推荐意见条目的50%。无循证证据支持、依据专家共识法达成的推荐条目共计36条(13.7%)。结论中成药循证指南的制定应遵循证据质量与推荐强度的一致性和合理性的循证基本原则。基于古籍文献和专家经验的推荐意见应有令人信服的理由,以增强中成药循证指南的可信赖性。
Objective To analyze current status of strong recommendation based on low-quality evidence in Clinical Application Guidelines of Chinese Traditional Patent Medicine for Treatment of Common Diseases,and discuss the rationality of the recommendation.Methods Guideline selection:29 guidelines,published from Feb.2019 to Aug.2022,included into the project of Clinical Application Guidelines of Chinese Traditional Patent Medicine for Treatment of Common Diseases approved by State Administration of Traditional Chinese Medicine and China Association of Traditional Chinese Medicine(No.SATCM-2015-BZ402).Data extracted:2 independent researchers,and extract content including types of recommendations(recognition opinions or evidence-based opinions),hierarchical system,strength and evidence quality of recommendations.Results A total of 29 guidelines were included in this study,and all guidelines were given quality review and recommendation strength grading by using method of grades of recommendations assessment,development and evaluation(GRADE).Of 262 included recommendations,there were 27 items(10.3%)with strong recommendations based on low or very low evidences,and only 6.8%guidelines(2/29)had more than 50%of the total recommendations with strong recommendations based on low or very low evidences.There were 36 recommendation items(13.7%)without evidence support but with expert consensus.Conclusion The development of evidence-based guidelines for Chinese traditional patent medicine should follow the basic evidence-based principles with the consistency and rationality in evidence quality and recommendation strength.The recommendations based on ancient literature and expert experience should have convincing reasons to enhance the trustworthiness.
作者
王建新
孙瑞
高学敏
孙媛媛
高蕊
Wang Jianxin;Sun Rui;Gao Xuemin;Sun Yuanyuan;Gao Rui(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;不详)
出处
《中国循证心血管医学杂志》
2024年第6期657-660,680,共5页
Chinese Journal of Evidence-Based Cardiovascular Medicine
基金
国家中医药管理局《中成药治疗优势病种临床应用指南》标准化项目(SATCM-2015-BZ[402])
中国中医科学院科技创新工程重大攻关项目(CI2021A04701)。
关键词
中成药
指南
GRADE
推荐强度
Chinese traditional patent medicine
Guideline
Grades of recommendations assessment development and evaluation
Recommended strength
