预试验在针灸临床研究中的应用与思考

预试验是大型研究必不可少的先决条件。针灸属复杂干预措施,影响针灸临床疗效的因素和作用机制繁复,未经科学验证而冒然开展大规模临床研究易造成科研浪费。当前仍欠缺高质量针灸临床研究证据,影响了针灸疗效的推广与应用。开展针灸预试验可以评价研究实施的可行性和流程协调性,优化研究方案与流程,并为正式试验提供样本量计算依据,从而提高针灸研究的方法学质量、增加结果可靠性。本文从预试验的定义、设计和报告等层面进行论述,以期对针灸临床研究预试验的设计与实施提供思路与借鉴。

Application and reflection on pilot study in acupuncture clinical research

Pilot study is essential prerequisite for large-scale research.Acupuncture is a complex intervention measure.The factors of its clinical effect and effect mechanism are complicated.Hence,the resource waste is easily induced in research if the large-scale clinical research is rashly carried out before scientific verification.Currently,there is still a lack of high-quality evidence of clinical research,which affects the promotion and application of the curative effect of acupuncture.The pilot study of acupuncture can evaluate the feasibility and the process coordination of trial,optimize program and process and provide the basis of sample size calculation prior to launching a full-scale trial.Thereby,the methodological quality of acupuncture research and the reliability of trial results can be improved.In the paper,the arguments focus on the definition,design and report of pilot study so as to provide the approaches and references for the design and implementation of pilot study of clinical research of acupuncture.