基于混合方法的中药注射剂上市后临床安全性综合评价模型构建研究思路探讨  

Discussion on the construction of comprehensive evaluation model of post-marketing clinical safety of traditional Chinese medicine injection based on mixed methods research

作　　者：李春晓[1,2,3] 杨玉晴 凌霄 程子豪 宋学坤 郭静[1,4] 李学林[1,2,3] LI Chunxiao;YANG Yuqing;LING Xiao;CHENG Zihao;SONG Xuekun;GUO Jing;LI Xuelin(The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,P.R.China;Henan Province Engineering Research Center for Clinical Application,Evaluation and Transformation of Traditional Chinese Medicine/Henan Provincial Key Laboratory for Clinical Pharmacy of Traditional Chinese Medicine,Zhengzhou 450000,P.R.China;Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province&Education Ministry of P.R.China,Henan University of Chinese Medicine,Zhengzhou 450046,P.R.China;Henan University of Chinese Medicine,Zhengzhou 450046,P.R.China)

机构地区：[1]河南中医药大学第一附属医院,郑州450000 [2]河南省中药临床应用、评价与转化工程研究中心/河南省中药临床药学中医药重点实验室,郑州450000 [3]河南中医药大学/呼吸疾病中医药防治省部共建协同创新中心,郑州450006 [4]河南中医药大学,郑州450046

出　　处：《中国循证医学杂志》2024年第4期484-489,共6页Chinese Journal of Evidence-based Medicine

基　　金：国家重点研发计划项目(编号:2017YFC1703400);河南省科技攻关项目(编号:232102310476);河南省科技攻关项目(编号:202102310182);河南省中医药拔尖人才培养项目(编号:2022ZYBJ05);河南省中医药科学研究专项课题(编号:2022ZY1049)。

摘　　要：中药注射剂上市后临床安全性再评价研究分别获取了主动监测、被动监测及文献研究等多种研究类型的安全性证据。但缺乏可有效整合上述研究类型数据的综合评价方法,至今无法进一步产出更全面、更客观的高级别循证医学研究证据,严重影响了中药注射剂的监督管理和临床合理使用。而建立综合评价方法的关键是先建立综合评价核心指标的优选方法,形成可赋权量化评分的模型应用于综合评价方法中。混合方法研究通过对数据反复进行定量与定性研究,可实现有效、深入整合不同研究类型数据并科学、规范地完成评价模型中指标的筛选;其次,对于模型构建研究中最关键的指标赋权与权重调节,笔者创新性地将层次分析法与不变权重次约束法相结合,引入混合方法研究设计的定量研究部分,保证模型构建过程中指标的准确赋权。故本文在参考针对有效性试验核心结局指标提出的核心指标集的研究基础上,提出运用混合方法开展基于多源复杂数据的指标筛选与权重调节研究,构建融合不同研究类型数据的中药注射剂上市后临床安全性综合评价模型,为中药注射剂上市后临床安全性综合评价提供测量工具和新方法。The post-marketing clinical safety re-evaluation studies of traditional Chinese medicine injections have obtained safety evidence of various research types such as active monitoring,passive monitoring and literature review.However,there is a lack of comprehensive evaluation methods that can effectively integrate the data of the above research types.So far,it is impossible to further produce more comprehensive and objective high-level evidence-based evidence,which seriously affects the supervision and management of traditional Chinese medicine injections and clinical rational use.The key to establishment of a comprehensive evaluation method is to first establish a comprehensive evaluation of the core indicators of the preferred method,the formation of weighted quantitative scoring model applied to the comprehensive evaluation method.Mixed methods research(MMR)can effectively and deeply integrate different types of research data and scientifically and normatively complete the screening of indicators in the evaluation model through repeated quantitative and qualitative research on data.Secondly,for the most critical index weighting and weight adjustment research in the model construction research,the author innovatively combines the analytic hierarchy process with the invariant weight sub-constraint method,and introduces the quantitative research part of the MMR design.It ensures the accurate weighting of indicators in the process of model construction.Therefore,based on the research on the core outcome set proposed for the core outcome outcomes of the effectiveness test,this paper proposes the use of MMR to carry out index screening and weight adjustment research based on multi-source complex data,and to construct a comprehensive evaluation model of post-marketing clinical safety of traditional Chinese medicine injections that integrates different research types of data.It provides measurement tools and new methods for the comprehensive evaluation of post-marketing clinical safety of traditional Chinese medicine in

关 键 词：混合方法研究 临床安全性评价指标 综合评价 中药注射剂 核心指标集 

分 类 号：R288[医药卫生—中药学]