世界科学技术-中医药现代化2025，Vol.27Issue(9)：2453-2460,8.DOI:10.11842/wst.20240915002
针灸多中心临床试验的精细化质量控制经验
Experience with Refined Quality Control in Multicenter Clinical Trials of Acupuncture
摘要
Abstract
As evidence-based medicine advances and the number of published acupuncture clinical trials in international journals increases,the quality of these trials has become a major focus.The inherent diversity,complexity,and individualization of acupuncture treatments pose unique challenges for quality control in multicenter clinical studies,particularly in Investigator-Initiated Trial(IIT).Refined quality control is essential for the successful conduct of multicenter clinical trials in acupuncture.This study uses the multicenter clinical trials of acupuncture led by our research group as a case study to summarize the quality control experiences throughout the entire process of multicenter IITs.It synthesizes quality control strategies across the trial lifecycle,examines the management of key elements such as participants,materials,data,and specimens,and discusses project design,process management,protocol adherence,and subject safety.These insights are intended to enhance the scientific rigor and reliability of the trials,providing a reference and point of view for researchers in future similar studies.关键词
针灸干预/多中心临床研究/质量控制/IIT/偏倚Key words
Acupuncture/Multicenter clinical studies/Quality control/IIT/Bias分类
医药卫生引用本文复制引用
孙粼希,魏绪强,王珂,周嘉..针灸多中心临床试验的精细化质量控制经验[J].世界科学技术-中医药现代化,2025,27(9):2453-2460,8.基金项目
上海市科学技术委员会"科技创新行动计划"医学创新研究专项(21Y31920100):针灸促进大肠癌根治术术后胃肠功能康复临床研究,负责人:周嘉 （21Y31920100）
国家中医药管理局中医药高水平重点学科建设项目(zyyzdxk-2023068):针灸学,负责人:周嘉 （zyyzdxk-2023068）
上海中医药大学校级项目(2023LCRC12):2022年度上海中医药大学附属医院"临床研究型骨干人才培养计划",负责人:魏绪强. （2023LCRC12）
