中国药物警戒 ›› 2026, Vol. 23 ›› Issue (2): 219-223.
DOI: 10.19803/j.1672-8629.20250751

• 综述 • 上一篇    下一篇

基于临床需求的中成药遴选评价“6+1”框架研究进展

刘文静, 顾媛媛, 何婷, 曹俊岭, 赵薇, 巴娜, 岳晓妮, 王静莉, 陈鸿楠, 马丽娜*   

  1. 北京中医药大学东方医院药学部，北京 100078
  • 收稿日期:2025-10-31 出版日期:2026-02-15 发布日期:2026-02-13
  • 通讯作者: *马丽娜，女，副主任药师，博士，中药临床综合评价与合理用药研究。E-mail: malina8512@163.com
  • 作者简介:刘文静，女，药师，硕士，中药临床合理用药研究。
  • 基金资助:
    中央高水平中医医院临床科研业务费资助项目; 2025年度中医药监测统计研究课题（2025JCTJC53）

Research Progress in the “6+1” Framework for Evaluation & Selection of Proprietary Chinese Medicines Based on Clinical Needs

LIU Wenjing, GU Yuanyuan, HE Ting, CAO Junling, ZHAO Wei, BA Na, YUE Xiaoni, WANG Jingli, CHEN Hongnan, MA Lina*   

  1. Department of Pharmacy, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China
  • Received:2025-10-31 Online:2026-02-15 Published:2026-02-13

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摘要： 中成药作为中医药体系的重要组成部分，其科学遴选是保障临床合理用药的关键环节。在常规的安全性、有效性、经济性、创新性、适宜性与可及性评价基础上，纳入体现中医药特色的“传承性”维度，形成的“6+1”遴选框架，已成为系统评估中成药临床价值的共识。本文梳理“6+1”遴选框架下各维度的核心内涵，分析其在实践应用中的具体挑战，并从中视角提出实施建议，引入基于疾病特征、治疗阶段和医保政策等因素灵活调整权重的动态赋分机制，推动建立以真实世界证据与临床需求为基础的科学决策路径，提升评价体系的适应性与实用性，为优化医疗机构药品目录、提高中医药服务水平及相关政策制定提供参考。

关键词: 中成药, 综合评价, 临床需求, 动态赋分

Abstract: As a vital component of traditional Chinese medicine, proprietary Chinese medicines have to be properly selected to ensure rational clinical use. Based on the conventional evaluation of safety, effectiveness, economy, innovation, suitability, and accessibility, the incorporation of the “heritability” dimension, which shows the distinct features of traditional Chinese medicine, has resulted in a “6+1” selection framework that has become a widely-used approach to evaluating the clinical value of proprietary Chinese medicines. This paper is intended to interpret the core connotations of each dimension within the “6+1” selection framework, analyze the challenges to its practical applications, and recommend ways of implementation from a unique perspective. A dynamic weighting mechanism is proposed that can flexibly adjust weights based on such factors as disease profiles, stages of treatment, and health care policies so that a gateway to decision-making is grounded on real-world evidence and clinical needs, thereby improving the adaptability and applicability of the evaluation framework. This study is expected to offer a reference for optimizing drug directories in medical institutions, improving the quality of TCM services, and for formulating better guidelines.

Key words: Proprietary Chinese Medicines, Comprehensive Evaluation, Clinical Needs, Dynamic Weighting

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