2025 年第 5 期 第 20 卷

医疗机构中成药短缺药评价专家共识

Expert consensus on the evaluation of Chinese patent medicine shortage in medical institutionsCenter of Drug Use Monitoring and Clinical Comprehensive

作者：

英文作者：

单位：北京市药品使用监测和临床综合评价中心,首都医科大学宣武医院药学部.

英文单位：Evaluation of Beijing Department of Pharmacy Xuanwu Hospital Capital Medical University

关键词：医疗机构；中成药；短缺药

英文关键词：Medicalinstitutions;Chinesepatentmedicine;Drugshortage

• 摘要：

• 中成药是我国临床治疗药物的重要组成部分，科学开展中成药短缺药评价与替换可为医疗机构内临床诊疗和药品规范供应提供良好保障。本文采用文献研究法，系统梳理中成药临床评价的流程、维度和方法，构建体现中成药特点的短缺品种评价流程及指标体系，初步形成指标池。通过德尔菲法对评价指标进行遴选和优化，采用层次分析法对各维度及各层级的指标赋权重。最终形成了“中成药短缺药临床使用迫切性评价-同类可替代品种确定评价-同类可替代品种综合评价”的评价流程，分别从临床应用、有效性、安全性、经济性、创新性、适宜性、可及性等不同维度，构建了包含15个一级指标、30个二级指标、65个三级指标的评价体系。为医疗机构开展中成药短缺药替换或评价提供科学、可操作的工具，推动医疗机构不断优化用药目录和用药结构，提高中成药临床合理用药水平和药事服务质量。

• Chinese patent medicine is an important part of clinical treatment drugs in China. Scientific evaluation and replacement of Chinese patent medicine shortage can provide a good guarantee for clinical diagnosis and treatment and standardized supply of drugs in medical institutions. In this paper, literature review was used to systematically review the process, dimensions and methods of clinical evaluation of Chinese patent medicine, to construct the evaluation process and index system of shortage varieties reflecting the characteristics of Chinese patent medicine, and to initially form an index pool. Delphi method was used to select and optimize the evaluation indicators, and the analytic hierarchy process was used to assign weights to the indicators of each dimension and level. Finally, the evaluation process of "Urgency evaluation of clinical use of CPM shortage-Evaluation of determining equivalent substitutable varieties-Comprehensive evaluation of equivalent substitutable varieties" was formed. From the different dimensions of clinical application, effectiveness, safety, economy, innovation, suitability and accessibility, the evaluation system was constructed, including 15 first-level indicators, 30 second-level indicators and 65 third-level indicators. It provides a scientific and operational tool for medical institutions to replace or evaluate the shortage of Chinese patent medicine, and promotes medical institutions to continuously optimize the drug use list and drug use structure, and improves the level of clinical rational use of Chinese patent medicine and the quality of pharmaceutical services.