非药物疗法安全性评价的方法学探讨

中国药物警戒 ›› 2010, Vol. 7 ›› Issue (10): 595-597.

非药物疗法安全性评价的方法学探讨

曹卉娟,李迅,刘建平

北京中医药大学循证医学中心,北京 100029

收稿日期:2010-05-30 修回日期:2016-03-12 出版日期:2010-10-08 发布日期:2016-03-09
通讯作者: 刘建平,男,教授,循证中医药临床研究。E-mail: liujp@bucm.edu.cn
作者简介:曹卉娟,女,在读博士研究生,中医临床疗效及安全性评价。
基金资助:
国家重点基础研究发展计划（973计划）课题（2006CB504602）；科技部国际合作项目（2009DFA31460）

Exploration of the Methodology in the Evaluation of Safety of Non-pharmaceutical Therapy

CAO Hui –juan, LI Xun ,LIU Jian –ping

Center for Evidence -Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China

Received:2010-05-30 Revised:2016-03-12 Online:2010-10-08 Published:2016-03-09

摘要/Abstract

摘要： 非药物疗法在传统医学中具有重要地位,然而,其安全性的报告受到重视的程度不够。本文针对非药物疗法安全性评价所涉及的方法,分别介绍了随机对照试验、队列研究、个案报道、问卷调查以及定性研究等方法,并针对上述研究进行资料的二次分析的系统综合方法加以阐述,以供中医非药物疗法临床研究参考使用。

关键词: 非药物疗法, 安全性, 不良事件, 评价方法

Abstract: Non -pharmaceutical therapies play a major role in traditional medicine. However, the reporting of their safety is not paid enough attention. This paper focused on safety issues of non-pharmaceutical therapies, introduced several Methods including randomized clinical trials, cohort study, case report, questionnaire, and qualitative method, respectively. Based on findings of above research methods, we introduced method of research synthesis so to provide references for clinical researches in non-pharmaceutical therapies.

Key words: non-pharmaceutical therapy, safety, adverse event, evaluation methods

中图分类号:

R954

曹卉娟,李迅,刘建平. 非药物疗法安全性评价的方法学探讨[J]. 中国药物警戒, 2010, 7(10): 595-597.

CAO Hui –juan, LI Xun ,LIU Jian –ping. Exploration of the Methodology in the Evaluation of Safety of Non-pharmaceutical Therapy [J]. Chinese Journal of Pharmacovigilance, 2010, 7(10): 595-597.

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