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中国临床药理学与治疗学 ›› 2005, Vol. 10 ›› Issue (5): 594-597.

• 设计·统计·方法 • 上一篇    下一篇

中药新药治疗慢性功能性便秘的临床试验设计特点

蒋萌, 熊宁宁, 周晓虹, 沈洪   

  1. 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:2005-03-17 修回日期:2005-05-14 出版日期:2005-05-26 发布日期:2020-11-19
  • 通讯作者: 蒋萌, 女,医学博士, 主任医师, 硕士研究生导师, 主要从事临床药理研究。Tel:025-86555033  Email:jmjsszyy@sina.com
  • 基金资助:
    科技部“临床试验关键技术及平台研究”课题资助(No2004AA2Z3766)

Design of clinical trials of TCM new drugs in treatment of patients with chronic idiopathic constipation

JIANG Meng, XIONG Ning-ning, ZHOU Xian-hong, SHEN Hong   

  1. Department of Clinical Pharmacology, the Affiliated Hospital, NanjingUniversity of Chinese Medicine, Nanjing 210029, Jiangsu, China
  • Received:2005-03-17 Revised:2005-05-14 Online:2005-05-26 Published:2020-11-19

摘要: 慢性功能性便秘的鉴别诊断方法临床操作比较复杂。本文提出了中药新药治疗慢性功能性便秘的临床试验应按照诊治分流原则纳入病例, 对试验中的无效病例进行二级诊治, 并根据反馈的诊治结果评价无效病例的疗效的试验流程, 以及根据试验药物的处方组分、效应特点设计的试验方案。达到保证试验结果的准确、保护受试者的权益、并使临床具有可操作性的目的。

关键词: 中药新药, 方案, 慢性功能性便秘, 诊治分流, 临床研究

Abstract: In treatment of patients with chronic func-tional constipation, the clinical trials of TCM new drugs should include cases in accordance with the principle of shunting diagnosis and treatment. If the cases do not ob-tain effect, they are converted to secondary diagnosis and treatment, and the results will be feedback to re-evaluate the curative effect of the new drug. The design of protocol will take into account the drug formulae and the charac-teristics of the effects.This design may guarantee the ac-curacy of the results of trials and safety of subject.

Key words: TCM new drug, protocol, chronic idio-pathic constipation, clinical trial

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