国际草药CONSORT声明及中药临床试验报告规范化问题思考  

Herbal CONSORT statement and standardization of reporting traditional Chinese drug trials

作　　者：费宇彤[1] 刘建平[1] 

机构地区：[1]北京中医药大学循证医学中心,北京100029

出　　处：《中国中药杂志》2008年第1期89-94,共6页China Journal of Chinese Materia Medica

基　　金：国家重点基础研究发展计划项目(2006CB504602)

摘　　要：通过对国际草药CONSORT声明内容的详细说明,结合中药临床试验特点,分析中药临床试验报告规范化问题。中药临床试验报告规范化问题已经引起广泛注意,但是至今尚无统一标准。与此最为相关的是2006年CONSORT小组出台的《草药随机对照临床试验的报告:CONSORT声明细则》。该声明包括5部分,共22项条目,重点对试验报告中受试者标准、干预措施、对照设置、结局指标设置等内容的报告制定了详细的说明。虽然,鉴于中药具备的中医理论背景和其中包括的动物、矿物药材,所以中药临床试验的报告不宜完全按照《国际草药CONSORT声明》来进行规范,但是《草药CONSORT声明》的出台为下一步制定专门的中药临床试验报告规范提供了有益参考。中药的临床试验设计和报告应该根据不同的中药类型和试验目的制定不同标准。以中医药理论指导临床应用的中药,其临床试验的报告应体现辨证论治内容;从中药中经过提纯而成的类似于现代化学药品的药物,其临床试验可以在很大程度上参照《国际草药CONSORT声明》来报告。Based on detailed explanation of the herbal CONSORT statement, and the consideration of the character of traditional Chinese drugs, to discuss the standardization of reporting traditional Chinese drug trials. The standards of reporting traditional Chinese drug trials are not consolidated yet. In the year 2006, Reporting Randomized, Controlled Trials of Herbal Interventions ： An Elaborated CONSORT Statement was developed by the CONSORT group and published. This herbal CONSORT statement includes 5 parts, and totally 22 items, in which the items of participant criteria, intervention, control setting and outcomes, et al. are elaborated to be adaptable to herbal intervention trials. This herbal CONSORT statement has provided valuable basis for the development of standards of reporting traditional Chinese drug trials, though it is not completely adaptive to be the reporting standards in consideration of the background theory and the animal drugs and mineral drugs that traditional Chinese drugs contain. The proper reporting standards of traditional Chinese drug trials should take the different types of drugs and the different purposes of trials into consideration. The trial reports of drugs that must be applied under the instruction of traditional Chinese medicine （TCM） theory should report participant criteria that include TCM syndrome differentiation and other important characters of TCM interventions.

关 键 词：草药 CONSORT 中药 随机对照临床试验 报告标准 

分 类 号：R288[医药卫生—中药学]