提高中草药随机对照试验的质量Ⅲ:中草药的质量控制

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。

Improving the quality of randomized controlled trials in Chinese herbal medicine, part Ⅲ: quality control of Chinese herbal medicine used in randomized controlled trials

Objective: To discuss quality control of Chinese herbal medicine(CHM) in randomized controlled trials(RCTs),and to provide suggestions for improving this aspect in future clinical study in this therapeutic area.Methods: A search of the Cochrane Library was conducted to identify RCTs of CHM.Quality control information reported in those RCTs was then assessed independently.Results: The search yielded a total of 167 RCTs of CHM for a variety of conditions.A total of 11 CHM preparations were used in those RCTs. Only one trial discussed quality control of the CHM interventions used.Issues affecting the safety and efficacy of CHM products used in RCTs were discussed including standardization of raw herbal materials,processing methods,screening for product contamination,and effects of combination products.Conclusion: The overall quality of reporting of RCTs of CHM was poor,reflecting the need for improvements in reporting future clinical trials in this area.Recommendations: To improve quality control of CHM used in RCTs in future,we recommend developing and implementing guidelines such as Good Agricultural Practice(GAP) for Chinese crude drugs,and current Good Manufacturing Practice(GMP) specific to CHM products.Chemical analyses of individual herbs of CHM and combination products are also recommended to provide reference standards for quality control.