对比较效益研究GRACE准则的解析.pdfVIP

.1121. 中国中西医结合杂志 2012 年 8 月第 32 卷第 8 期 CJITWM ， August 2012 ，￥ 0 1. 32 , No‘ 8 对比较效益研究 GRACE 准则的解析 谢雁呜廖星 摘要 比较效益研究 (comparative effectiveness research , CER) 是目前国际上医疗卫生改革领域里非常 流行的一个新概念。虽然其所含内容并非有质的更新，但是其所倡导的是一种新医疗研究的理念，一种针对 国家医疗体系层面的政策导向。欧美国家正寄希望 CER 开启新一轮创历史的里程碑建设。虽然已有国际 权威组织对 CER 的设计和报告制定了相关标准，但是对于其坪价准则尚未涉及，故在国际药物流行病学会 的组织下，签署了好的比较效益研究( Good Research for Comparative Effectiveness , GRACE) 准则即 GRACE 准 则，该准则通过对观察性研究就如何进行评价制定了一系列的规范条例。本文通过对 GRACE 准则进行解 析，旨在为将来中医临床研究引入提供有关观察性研究实施的参考标准。 关键词 比较效益研究;观察性研究;中臣临床研究 jGRACE 准则 Anatysis of GRACE Principle for Comparative E胃副刻veness Res锦rch XIE Yan-ming and Ll AO Xing Insti? tute 0/ Bαsic Research in Clinical Medici肘 ， China Academy 0/ Chinese Medical Sciences , Beijing (100700) ABSTRACT Comparative effectiveness research (CER) now is a very popular concept in the field of inter? national heath care reformation. Although its contents are not essentially changed , it advocates a new medical i? dea, a policy orientation at the national medical system level. The European countries and America hope CER could initiate the construction of a new historical milestone. Although there are already some guidelines for the de? sign and report of CER by authorized international organizations , its assessment standards have not been in? volved. Therefore , Good Research for Comparative Effectiveness (GRACE) was signed by International Society Pharmacoepidemiology. A series of standard rules were formulated on how to assess the observational studies. In this article by analyzing the GRACE , we hope to provide the referential standards for enforcing observational studies by introducing CER in the clinical studies of Chinese medicine. KEYWORDS compar