基于混合方法探讨中药注射剂临床疗效评价指标的筛选

Screening of Clinical Efficacy Evaluation Indicators for Traditional Chinese Medicine Injections based on Mixed Method Research

目前中药注射剂疗效与风险证据严重不足,现有中药注射剂临床疗效评价指标难以全面、真实、客观地评价中药注射剂,急需构建能有效反映中药注射剂疗效的评价指标体系。核心指标集(COS)研究在中医药疗效评价指标筛选中发挥了重要作用,但尚存在疗效指标差异大、不规范、缺乏中医药特色疗效指标等问题。混合方法研究(MMR)具有从定量、定性两种研究视角综合性分析问题的优势。据此提出,在借鉴COS研究模式的基础上,采用MMR模式,从中医药干预角度出发,探索建立既充分考虑中药注射剂自身干预特色、又突出中药注射剂干预治疗的疗效和优势的临床疗效评价指标体系,并形成以MMR优化COS研究模式的指标筛选方法,以期为中药注射剂的临床疗效指标研究提供思路。

Currently,evidence on the efficacy and risk of traditional Chinese medicine(TCM)injections is seri⁃ously insufficient,and it is difficult to evaluate TCM injections comprehensively,truly and objectively using available efficacy evaluation indicators.Therefore,establishing a clinical efficacy evaluation system that can effectively reflect TCM injections is imperative.Core outcome set(COS)has played an important role in screening TCM efficacy evaluation indicators,however,there are still certain problems,such as large differences in efficacy indicators,nonstandardization,and lack of featured and specific TCM indicators.Mixed method research(MMR)has the advantages of looking at problems from both quantitative and qualitative perspectives.It is thereby proposed to use COS and MMR integrated model to establish a clinical efficacy evaluation indicator system that not only fully considers the characteristics of TCM injections,but also highlights the efficacy and advantages of TCM injections from the perspective of TCM intervention.Simultaneously,an indicator screening method using MMR to optimize COS research model is formulated,which can provide ideas for the research on efficacy evaluation indicators of TCM injections.