针刺辅助治疗难治性肠易激综合征临床试验方案关键点设计的思考

Reflections on the Design of Key Points in Clinical Trial Protocols for Acupuncture-Assisted Treatment of Refractory Irritable Bowel Syndrome

肠易激综合征(Irritable bowel syndrome,IBS)是临床常见病、多发病,其治疗方法丰富,但部分患者疗效欠佳,发展成难治性IBS。目前国内外关于针灸治疗难治性IBS的临床随机对照试验尚不多见。本文立足试验方案设计的"PICOS"原则,从研究对象及诊断标准、干预措施、对照措施、结局指标四个方面入手,重点探讨针刺辅助治疗难治性肠易激综合征临床试验设计的关键要点。从选择特色优势病种、明确诊断标准、制定符合临床实际的干预方案、运用符合目标的安慰针刺、结合研究设计和目的选定结局指标几个角度,阐述试验相关环节设计的原因和思考。

Irritable bowel syndrome(IBS)is a common and prevalent clinical disease,and there are many treatment approaches,but some patients experience poor outcomes and develop into refractory IBS.In this paper,we focus on the key points of clinical trial design of acupuncture-assisted treatment of refractory IBS based on the"PICOS"principle of trial protocol design,starting from the four aspects of study subjects and diagnostic criteria,interventions,control measures,and outcome indicators.The reasons and considerations for the design of the trial are presented from the perspectives of selecting the distinctive and advantageous disease,clarifying the diagnostic criteria,developing a clinically appropriate intervention plan,applying comfort needling that meets the objectives,and selecting the outcome indicators in the context of the study design and objectives.