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目的:通过对中草药临床随机对照试验中有关中草药质量控制的方法进行分析评价,探讨如何实施中草药临床试验的药物质量控制。方法:文献检索2005年7月前发表于Cochrane图书馆的中草药系统评价共11篇,包含167个中草药临床随机对照试验,实证分析中草药临床试验中有关中草药质量控制的方法。结果:在纳入分析的167个中草药临床随机对照试验中,所采用的中草药制剂类型共有11种,其中只有1个临床随机对照试验提及中药的质量控制方法。结论:在中草药临床随机对照试验过程中,中草药的质量控制是一个非常薄弱的环节。建议:在中草药临床随机对照试验过程中,必须提高中草药的质量控制意识及建立中草药质量控制的技术平台,整合包括中药材生产质量管理规范(Good Agricultural Practice,GAP)、药物生产质量管理规范(Good Manufacturing Practice,GMP)、药物临床试验质量管理规范(Good ClinicalPractice,GCP)以及中药指纹图谱等技术,建立系统控制临床试验药物的质量控制体系。
Objective: To analyze and evaluate the methods of quality control of Chinese herbal medicine in clinical randomized controlled trials of Chinese herbal medicine, and to explore how to implement quality control of Chinese herbal medicine in clinical trials. METHODS: Literature search A total of 11 reviews of Chinese herbal medicines published in the Cochrane Library before July 2005 consisted of 167 randomized controlled clinical trials of Chinese herbal medicines and an empirical analysis of the quality control methods of Chinese herbal medicines in clinical trials. Results: Of the 167 Chinese herbal medicine randomized controlled trials included in the analysis, there were 11 kinds of Chinese herbal preparations used, of which only one clinical randomized controlled trial mentioned the quality control methods of traditional Chinese medicine. Conclusion: The quality control of Chinese herbal medicine is a very weak link in the clinical randomized controlled trials of Chinese herbal medicine. Suggestion: During the process of clinical randomized controlled trials of Chinese herbal medicine, it is necessary to improve the quality control awareness of Chinese herbal medicine and establish a technical platform for the quality control of Chinese herbal medicine. The integration includes Good Agricultural Practice (GAP) and Good Manufacturing Practice (Good Manufacturing Practice). Manufacturing Practice, GMP), Good Clinical Practice (GCP), TCM Fingerprinting, and other technologies establish a system for controlling the quality of clinical trials.