我国中药临床试验开展现状及特征分析

Analysis of the current situation and characteristics of clinical trials of traditional Chinese medicine in China

摘要

目的: 分析2013—2024年我国中药临床试验的开展情况与特征,为中药新药研发与临床研究策略提供参考依据。方法: 检索国家药品监督管理局药物临床试验登记与信息公示平台建库起至2024年12月31日登记的所有中药临床试验。从试验数量、分期、设计类型、药物剂型、适应证(采用ICD-11编码分类)、牵头单位等多个维度进行描述性统计分析。结果: 共纳入1 125项中药临床试验,占同期全部登记试验的4.03%。2013—2024年间,中药临床试验年度登记数量未呈现显著增长趋势,其占全部临床试验的比例呈下降趋势。试验以国内多中心为主(99.73%),Ⅱ期临床试验占比最高(59.20%)。随机、双盲、平行对照设计占主导(86.31%)。数据安全监察委员会设置率(3.64%)与受试者保险购买率(32.09%)较低。剂型以口服(胶囊、颗粒、片剂等)为主(85.87%)。适应证集中于呼吸系统(21.69%)、消化系统(15.64%)和泌尿生殖系统疾病(13.51%)。牵头单位地域分布高度集中,北京、天津、上海三地合计占比55.64%。结论: 我国中药临床试验在规范化设计方面取得进步,但总体发展缓慢,面临国际参与度低、受试者保护措施不足、研究领域及地域分布不均衡等挑战。建议出台针对性激励政策,鼓励创新制剂和疑难疾病领域探索,加强受试者权益保障,以促进中医药高质量可持续发展。

Abstract

Objective: To analyze the characteristics and trends of traditional Chinese medicine (TCM) clinical trials registered in China from 2013 to 2024, and to provide a reference for the development of new TCM drugs and clinical research strategies. Methods: All TCM clinical trials registered on the National Medical Products Administration Drug Clinical Trial Registration and Information Disclosure Platform from its inception to December 31, 2024, were retrieved. A descriptive statistical analysis was conducted from multiple dimensions, including the number of trials, phases, design types, drug dosage forms, indications (classified using ICD-11 codes), and leading institutions. Results: A total of 1 125 TCM clinical trials were included, accounting for 4.03% of all registered trials during the same period. From 2013 to 2024, the annual number of registered TCM clinical trials did not show a significant growth trend, and their proportion relative to all clinical trials showed a declining trend. The trials were predominantly domestic multi-center studies (99.73%), with Phase II trials constituting the highest proportion (59.20%). A randomized, double-blind, parallel-controlled design was used in 86.31% of the trials. The rates of data safety monitoring committee establishment (3.64%) and subject insurance coverage (32.09%) were low. Oral dosage forms (capsules, granules, tablets, etc.) were the most common (85.87%). Indications were concentrated in respiratory system diseases (21.69%), digestive system diseases (15.64%), and urogenital system diseases (13.51%). The geographical distribution of leading institutions was highly concentrated, with Beijing, Tianjin, and Shanghai collectively accounting for 55.64% of the total. Conclusion: While progress has been made in the standardization of TCM clinical trial design in China, overall development remains slow, with challenges including low international participation, insufficient subject protection measures, and imbalanced distribution across research areas and regions. It is recommended to introduce targeted incentive policies, encourage exploration of innovative formulations and difficult-to-treat diseases, strengthen subject rights protection, and promote the high-quality and sustainable development of TCM.

关键词

中药 / 临床试验 / 登记与信息公示平台 / ICD-11 / 现状 / 特征

Key words

traditional Chinese medicine / clinical trials / registration and information disclosure platform / ICD-11 / status / characteristics

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基金资助

山东省中医药科技项目(M20241206);山东第二医科大学附属医院科研发展基金资助项目(2024FYM146)