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中国临床药理学与治疗学 ›› 2004, Vol. 9 ›› Issue (2): 238-240.

• 设计与统计 • 上一篇    

复方蛇床子制剂临床试验不良反应的伦理审查

刘沈林, 熊宁宁, 刘芳, 汪秀琴, 高维敏   

  1. 南京中医药大学附属医院国家药品临床研究基地, 南京 210029, 江苏
  • 收稿日期:2003-10-23 修回日期:2003-11-05 出版日期:2004-02-26 发布日期:2020-11-16
  • 通讯作者: 熊宁宁,男, 教授, 主任医师, 博士生导师, 主要从事临床药理学研究。Tel:025-6506055  Fax:025-6555033 E-mail: jsszyyjd@jlonline.com; xiongnin@public1.ptt.js.cn
  • 作者简介:刘沈林, 男, 教授, 主任医师, 博士生导师, 伦理委员会主任。
  • 基金资助:
    科技部“ 临床试验关键技术及平台研究” 课题资助(NO.2002AA341i)

Ethic review on adverse reaction of compound prescription of cnidium fruit in clinical trail

LIU Shen-Lin, XIONG Ning-Ning, LIU Fang, WANG Xiu-Qin, GAO Wei-Min   

  1. National Base for Drug Clinical Trial, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, Jiangsu, China
  • Received:2003-10-23 Revised:2003-11-05 Online:2004-02-26 Published:2020-11-16

摘要: 复方蛇床子制剂(含蛇床子挥发油)Ⅱ期临床试验出现头晕, 心悸, 出汗, 胸闷, 口舌发麻, 恶心等不良反应, 发生率11 20 例。伦理委员会在分析不良反应与试验药物的关系后, 进一步对不良反应报告的可信度, 不良反应人群的特征, 不良反应的影响因素, 降低试验药物剂量是否可以继续进行临床试验进行了分析。伦理审查认为, 相对于治疗功能性阳痿的受益和已上市治疗阳痿的中药的安全性, 以及临床接受程度和不良反应难以预测与预防, 试验药的风险均过大, 决定暂停该药物的临床试验。

关键词: 蛇床子, 不良反应, 伦理审查, 临床试验

Abstract: In the clinical trail phase II of compound prescription of cnidium fruit (containing volatile oil extracted form cnidium fruit), 11 cases out of 20 exhibited adverse reactions, such as dizziness, palpitation, sweating, choking sensation in chest, numbness in lips and tongue.After analyzing the relationship between the adverse reactions and the drug, the ethical review committees further examined the credibility of the ADR reports, the common features of the group from which adverse reactions arose, the influencing factors of adverse reactions, as well as the continuation of the trial with decreased dosage. Comparing with the expected benefits of functional impotence, other marked Chinese patent medicines, and the clinical acceptance, ADR unforeknowable and unpreventable, the risks of the trial drug were much greater. Consequently, ethical review committees made the decision of cessation of the trial.

Key words: cnidium fruit, adverse reaction, ethical review, clinical trials

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