摘要
针对中医药临床试验中存在的问题,包括随机方法、随机隐藏、组间均衡性、盲法、疗效评价指标、不良反应观察、统计方法及发表偏倚等的现状与对策进行探讨。建议采用国际推荐的CONSORT声明以提高中医药临床随机对照试验的设计与报告质量,并对以人作为受试对象,应根据伦理学的基本原则,在临床研究中进行伦理审查和签署知情同意书,以保证受试者的权益。
To explore the problems and the strategies in clinical trials of traditional Chinese medicine （TCM）, including the method and concealment of randomizing, equipoise of baseline, blindness and outcome measures, adverse reaction observation, statistical method and publication bias. The consolidated standard of reporting trials （CONSORT） is recommended to be applied in order to improve the quality of design and report of randomized controlled trials （RCTs） of TCM, and in case of human is taken as the subject of trial, according to the fundamental ethical principle, the clinical trial design should be censored by institutional review board （IRB）, and the informed consent should be signed to protect the rights and interests of the trial participator.
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2006年第4期298-302,共5页
Chinese Journal of Integrated Traditional and Western Medicine
关键词
中医药
临床试验
伦理学
问题
对策
traditional Chinese medicine
clinical trials
ethics
problems
strategy
