多中心针刺临床研究实施过程中的质控方法体会  

Quality control in the implementation of multi-center acupuncture clinical trial

作　　者：李思琦 慕容志苗 王辉[1,2] 樊小农 LI Si-qi;MURONG Zhi-miao;WANG Hui;FAN Xiao-nong(Tianjin University of TCM,Tianjin 300193,China;First Teaching Hospital of Tianjin University of TCM,Tianjin 300193;National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300193;Tianjin Acupuncture and Moxibustion Institute,Tianjin 300193;Tianjin Key Laboratory of Acupuncture and Moxibustion,Tianjin 300193)

机构地区：[1]天津中医药大学,天津300193 [2]天津中医药大学第一附属医院,天津300193 [3]国家中医针灸临床医学研究中心,天津300193 [4]天津市针灸研究所,天津300193 [5]天津市针灸学重点实验室,天津300193

出　　处：《中国针灸》2022年第3期321-324,共4页Chinese Acupuncture & Moxibustion

基　　金：国家重点研发计划资助项目:2018YFC1705004;国家科技支撑计划课题项目:2013BAI13B03;天津市科技计划项目:18PTLCSY00040。

摘　　要：探讨多中心针刺临床研究实施过程中的质量管理工作体会及针刺操作人员培训的关键点,对研究者分工、方案学习、分中心联络交流等过程管理工作进行阐述,并对针刺研究特性环节——针刺操作培训的实施概况及刺激量控制、医患沟通等相关实施关键点进行探索和总结,以期为后续多中心针刺临床研究的质量把控和提升提供有益参考。The paper introduced the experiences of quality management in the implementation of multi-center acupuncture clinical trials and the keys in training acupuncture operators.The process management was explained in view of the division of labor for researchers,protocol learning and the communication among sub-centers.Besides,specificity links of acupuncture research were summarized,i.e.meaning implementation brief of acupuncture operation training,control for quantity of stimulus in acupuncture and doctor-patient communication.It is anticipated to provide a valuable reference for the quality control and improvement of multi-center acupuncture clinical trial in future.

关 键 词：针刺 多中心 临床研究 质量控制 

分 类 号：R245[医药卫生—针灸推拿学]