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中国临床药理学与治疗学 ›› 2007, Vol. 12 ›› Issue (5): 582-585.

• 临床药理学 • 上一篇    下一篇

WHO/TDR 操作指南:支持草药产品临床试验所必须的信息

汪秀琴1,2 翻译, 熊宁宁2, 卜擎燕2,居文正2 审校   

  1. 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,南京 210029,江苏
  • 收稿日期:2007-01-22 修回日期:2007-02-28 发布日期:2020-10-29
  • 通讯作者: 熊宁宁,男,教授,主任医师,博士生导师,主要从事临床药理研究。Tel:025-86506055 E-mail:jsszyyjd@jlonline.com
  • 作者简介:汪秀琴,女,博士研究生,从事临床试验伦理学研究。
  • 基金资助:
    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)

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

Translated by WANG Xiu-qin1,2, Revised by XIONG Ning-ning2, BO Qin-yan2, JU Wen-zheng2   

  1. 1University of Traditional Chinese Medicine, 2Department of Clinical Pharmacology, Affiliated Hospital of NanjingUniversity of Traditional Chinese Medicine, Nanjing 210029, Jiangsu, China
  • Received:2007-01-22 Revised:2007-02-28 Published:2020-10-29

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。

关键词: 世界卫生组织, 临床试验, 草药产品

Abstract: 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 clinical trials supported and conducted according to the principles of modern 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.

Key words: WHO, clinical trial, herbal products

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