WHO/TDR操作指南:支持草药产品临床试验所必须的信息  

Operational guidance: information needed to support clinical trials of herbal products

作　　者：汪秀琴[1] 熊宁宁[2] 卜擎燕[2] 居文正[2] 

机构地区：[1]南京中医药大学 [2]南京中医药大学附属医院临床药理科

出　　处：《中国临床药理学与治疗学》2007年第5期582-585,共4页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家科学技术部"临床试验关键技术及平台研究"课题资助(2004AA2Z3766)

摘　　要：草药和其他传统药物治疗在全球范围内广泛使用。这种广泛使用提示传统药物具有良好的风险受益比,但并不确定,实际的风险与受益需要通过由现代临床科学原则支持并据此实施的临床试验来加以评价。一些国际组织和国家当局已发表声明,支持草药产品的临床试验,但是这些声明往往范围宽泛,且只使用本国语言。因此,WHO/TDR对评价草药产品诊断或治疗疾病的临床试验所必须的数据发布了简洁明确的建议。Herbal and other traditional pharmacologic therapies are in widespread use throughout the world. Such widespread use suggests, but does not assure, that traditional medicines have a favourable risk-benefit ratio. The actual benefits and risks remain to be evaluated by chnical trials supported and conducted according to the principles of modem clinical science. International organizations and national authorities have published statements for supporting clinical trials of herbal products, while these statements tend to be broad in their coverage, in addition, national statements focus on the regulatory requirements and languages of individual countries. Therefore, WHO-TDR released clear and concise recommendations for the data needed to support clinical trials in which herbal products are evaluated for diagnosis or treatment of diseases.

关 键 词：世界卫生组织 临床试验 草药产品 

分 类 号：R969[医药卫生—药理学]