中国实验方剂学杂志2026，Vol.32Issue(8)：220-228,9.DOI:10.13422/j.cnki.syfjx.20260894
EtD框架要点解读及在《中成药药物警戒指南》编制中的应用
Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
摘要
Abstract
To interpret the evidence-to-decision(EtD)framework and to illustrate its application in traditional Chinese medicine(TCM)guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine,thereby providing methodological references for TCM guideline standardization.Based on the core three stages of the EtD framework(formulating the question,making an assessment of the evidence,and drawing conclusions),critical decision points and evaluation evidence within the evidence-translation process were systematically addressed,aligning with the purpose,scope,and key questions of the guideline.Qualitative research methods,such as the nominal group technique,were employed to formulate recommendations.The analysis was conducted based on the EtD framework.During question formulation,the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified,focusing on the core objective of safety assurance throughout the product lifecycle.In the evidence assessment,multi-source evidence was integrated,including policy documents,literature research,and expert consensus,completing the evidence evaluation.Finally,in recommendation-forming,dispersed research evidence and expert experience were synthesized into consensus,culminating in the guideline's completion through solicitation of opinions and peer review.The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development,effectively enhancing the transparency and scientific rigor of the process.Therefore,it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.关键词
证据到决策(EtD)框架/药物警戒/指南/证据/决策Key words
evidence-to-decision framework/pharmacovigilance/guideline/evidence/decision分类
医药卫生引用本文复制引用
张宏艳,马睿,谢雁鸣,王连心,崔鑫,黎元元,王志飞,王萌萌,杨硕,赵晓晓,刘福梅,王雅星..EtD框架要点解读及在《中成药药物警戒指南》编制中的应用[J].中国实验方剂学杂志,2026,32(8):220-228,9.基金项目
国家重点研发计划"中医药现代化研究"项目(2022YFC3502004) （2022YFC3502004）
2024年度中国中医科学院中药监管科学研究项目"中西药联合用药风险预警信号检测方法研究"(中央级公益性科研院所基本科研业务费专项)(ZYJGKX202407) （中央级公益性科研院所基本科研业务费专项）
国家药品监督管理局"中药临床用药风险评估处置方法与应用研究"项目(RS2024Z008) （RS2024Z008）
国家自然科学基金面上项目(81973982) （81973982）
