目的 构建综合中药特点的中成药临床综合评价指标体系,探索中成药临床综合评价路径,为中成药治疗或干预疾病的临床综合价值判断提供科学、可操作、可量化的评价工具,提高中成药临床合理用药水平和药事服务质量。方法 采用文献研究法,梳理研究中开展药品临床综合评价的流程、维度和方法。构建体现中成药特点的中成药临床综合评价理论框架,初步形成指标池。通过德尔菲法对形成的指标池进行遴选和优化,形成中成药临床综合评价指标体系。采用多准则决策法探索构建中成药临床综合评价路径。结果 通过文献研究法和德尔菲法对指标体系进行确认、遴选和优化,最终形成包含7个一级指标和39个二级指标的中成药临床综合评价指标体系。参考国际药物经济学与结果研究学会(ISPOR)发布的多准则决策分析(MCDA)实践指南,探索构建中成药临床综合评价路径。结论 构建的中成药临床综合评价指标体系层次分明、系统性和可操作性强,在一级指标及二级指标中分别融入了中成药特色指标,可量化评价中成药的临床价值,多维度、多层次、全面综合的反映中成药的临床综合价值。构建的中成药临床综合价值评价路径能够为相关研究开展提供指导,具有一定的合理性和可行性。

Objective To construct a clinical comprehensive evaluation indicator system of Chinese patent medicine based on the characteristics of Chinese patent medicine and explore the evaluation path. To provide a scientific, operable and quantifiable evaluation tool for the clinical comprehensive value evaluation of Chinese patent medicine in disease treatment or intervention, and to improve the clinical rational drug use level and pharmaceutical service quality of Chinese patent medicine.Methods The literature research method was used to sort out the process, dimensions and methods of clinical comprehensive evaluation of drugs in the study. To construct a theoretical framework for clinical comprehensive evaluation of Chinese patent medicines that reflects the characteristics of Chinese patent medicines, and initially form an indicator pool. The index pool was selected and optimized by Delphi method to form a clinical comprehensive evaluation indicator system of Chinese patent medicine. The multi-criteria decisionmaking method was used to explore the construction of clinical comprehensive evaluation path of Chinese patent medicine.Results Through literature research and Delphi method, the indicator system was confirmed, selected and optimized, and finally a comprehensive clinical evaluation system of Chinese patent medicine containing seven first-level indicators and 39 second-level indicators was formed. Referring to the MCDA practice guide published by ISPOR, the clinical comprehensive evaluation path of Chinese patent medicine was explored.Conclusion The clinical comprehensive evaluation index system of Chinese patent medicine is clear, systematic and operable. The characteristic indexes of Chinese patent medicine are integrated into the first-level indexes and the second-level indexes respectively, which can quantitatively evaluate the clinical value of Chinese patent medicine and reflect the clinical comprehensive value of Chinese patent medicine in a multi-dimensional, multi-level and comprehensive way. The constructed clinical comprehensive value evaluation path of Chinese patent medicine can provide guidance for related research,which has certain rationality and feasibility.

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