摘要
目的采用国际公认的研究方法,构建针刺治疗特发性面神经麻痹(Idiopathic facial palsy,IFP)临床研究核心结局指标集,建立与临床密切相关的核心指标,为IFP针刺临床研究提供疗效评价体系。方法通过全面检索中英文数据库,对近两年国内外发表的IFP相关临床研究进行系统评价,与患者半结构化访谈结果相结合构建结局指标池;以此清单为基础进行两轮德尔菲问卷调查,获得不同利益群体对IFP结局指标的Liker评分,在评分基础上采用层次分析法确定各层指标的权重;最后通过共识会议的方式确定最终纳入的指标,最终形成针刺治疗IFP临床研究核心结局指标集。结果针刺治疗特发性面神经麻痹核心结局指标集最终纳入结局指标包括面神经功能分级、面神经功能评分、面部肌力比较以及肌电图面神经传导速度和复合肌肉动作电位、耳后/周疼痛程度、耳后/周疼痛时长、心理状态、日常功能活动、治疗满意度、成本-效益、不良反应/事件发生率、实验室指标、生命体征以及痊愈率共15个指标。结论通过构建针刺治疗IFP的临床研究核心结局指标集,建立与针刺临床紧密相关的评价体系,此举对后期循证医学证据的产生提供了范式。
Objective To construct the core outcome sets for clinical studies of acupuncture treatment of idiopathic facial palsy(IFP)and to establish the core outcome system closely related to the clinic practice by using internationally recognized research methods,so as to provide a therapeutic effect evaluation system of acupuncture clinical study in treatment of IFP.Methods Through comprehensive search of Chinese and English databases,systematic evaluation was conducted on IFP-related clinical studies published at home and abroad in the past two years,combining the results of semi-structured interviews with patients,a list of outcome was constructed.Based on this list,two rounds of Delphi questionnaires were conducted and then,obtain Liker scores of IFP outcomes from different interest groups.On the basis of scoring,the weight of each index is determined by analytic hierarchy process(AHP).Finally,the included indicators were determined by consensus meeting,so as to form the core outcome sets for IFP clinical study of acupuncture.Results In the end,the outcomes including the facial nerve function classifications,facial nerve function scores,facial muscle strength comparison as well as physical and chemical examination in electromyography detection of facial nerve conduction velocity and complex muscle action potential,degree of pain behind/around the ear,duration of pain behind/around the ear,psychological state,daily functional activities,treatment satisfaction,cost-benefit,adverse reaction/event rate,laboratory indicators,vital signs,and recovery rate,a total of fifteen outcomes.Conclusion By constructing the core outcome sets of clinical research on acupuncture treatment of IFP,and establishing an evaluation system closely related to acupuncture clinical practice,this provides a paradigm for the generation of evidence-based medicine in the later stage.
作者
秦懿囡
徐天宇
李泽鑫
谢玥
白杨
杜元灏
Qin Yi'nan;Xu Tianyu;Li Zexin;Xie Yue;Bai Yang;Du Yuanhao(College of Acupuncture and Moxibustion,Shaanxi University of Chinese Medicine,Xianyang 712046,China;First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;Beijing Jishuitan Hospital,Beijing 100035,China;Linhai Hospital of Traditional Chinese Medicine,Linhai 317000,China;Qingyang Hospital of Traditional Chinese Medicine,Qingyang 745000,China)
出处
《世界科学技术-中医药现代化》
CSCD
北大核心
2023年第3期1069-1077,共9页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
陕西省自然科学基础研究计划一般项目-青年项目(2023-JC-QN-1002):分期构建符合针刺临床特点的特发性面神经麻痹核心结局指标集,负责人:秦懿囡
关键词
特发性面神经麻痹
针刺疗效评价
临床结局指标
核心结局指标集
Idiopathic facial palsy
Clinical evaluation of acupuncture
Clinical outcome indicators
Core outcome sets
作者简介
通讯作者:杜元灏,博士生导师,主任医师,主要研究方向:针灸病谱、循证针灸学及方法学、针刺治疗中风后血管神经发生机制。
