CAJ | 학술논문

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 Clinical Practice,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.
목적:통과대중초약림상수궤대조시험중유관중초약질량공제적방법진행분석평개,탐토여하실시중초약림상시험적약물질량공제.방법:문헌검색2005년7월전발표우Cochrane도서관적중초약계통평개공11편,포함167개중초약림상수궤대조시험,실증분석중초약림상시험중유관중초약질량공제적방법.결과:재납입분석적167개중초약림상수궤대조시험중,소채용적중초약제제류형공유11충,기중지유1개림상수궤대조시험제급중약적질량공제방법.결론:재중초약림상수궤대조시험과정중,중초약적질량공제시일개비상박약적배절.건의:재중초약림상수궤대조시험과정중,필수제고중초약적질량공제의식급건립중초약질량공제적기술평태,정합포괄중약재생산질량관리규범(Good Agricultural Practice,GAP)、약물생산질량관리규범(Good Manufacturing Practice,GMP)、약물림상시험질량관리규범(Good Clinical Practice,GCP)이급중약지문도보등기술,건립계통공제림상시험약물적질량공제체계.
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 Chinesecrude 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.