多中心针灸临床研究课题的设计实施监查和报道

作者	单位
李瑛	成都中医药大学针灸推拿学院
梁繁荣	成都中医药大学针灸推拿学院
赵凌	成都中医药大学针灸推拿学院
吴曦	成都中医药大学针灸推拿学院
田小平	成都中医药大学针灸推拿学院
杨旭光	成都中医药大学针灸推拿学院
陈晓琴	成都中医药大学针灸推拿学院

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中文摘要:

为了保证和提高针灸临床研究的水平和质量,本研究以目前正在进行的国家重点基础研究("973"计划)和国家科技支撑课题为例,介绍多中心针灸临床研究课题从设计、实施到监查和报道的具体方法及其重要意义。多中心临床研究课题的设计除了重视随机、对照和盲法以外,检验效能和样本量计算以及伦理学同样重要;实施过程中,临床试验的注册、标准操作规程的制定和研究培训是关键;监查重在监查制度的建立和监查制度的执行,是保证研究质量的重要环节,此外,针灸临床试验的报道应遵从CONSORT声明和STRICTA推荐的规范。

英文摘要:

In order to ensure and enhance the level and quality of acupunctural clinical trial,the design,implementation,supervision and reporting of multi-centered acupunctural clinical trial,its concrete methods and main significance,were introduced in this paper by taking the Major State Basic Research Development Program of China("973 Program")and "11th Five-Year Plan Period " National Key Technology Research and Development Program of China supported items for illustration.Besides that attention should be paid to randomization,controlling and blinded methods,the power and the sample size calculation as well as the medical ethics are also important in design.The registration of clinical trials,formulation of the standard operation procedures and training of researchers are the key points in the implementing process.And the emphases in supervision are the establishment and execution of a supervising system,which are the important links for ensuring the quality of research.In addition,the reporting of acupunctural clinical trials should follow the CONSORT(Consolidated Standards for Reporting Trials)statement and the STRICTA(Standards for Reporting Interventions in Controlled Trials of Acupuncture)recommendations.

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