中医康复2025，Vol.2Issue(2)：1-9,9.DOI:10.19787/j.issn.2097-3128.2025.02.001
针刺治疗帕金森病运动症状随机对照试验结局指标分析
Outcome Measure Analysis of Randomized Controlled Trials on Acupuncture Treatment for Motor Symptoms of Parkinson's Disease
摘要
Abstract
Objective:To analyze the outcome measures in randomized controlled trials(RCTs)of acupuncture for treating motor symptoms of Parkinson's disease(PD),providing a foundation for developing a core outcome set in clinical trials of acupuncture for PD motor symptoms.Methods:Six databases(PubMed,Embase,Web of Science,CNKI,Wanfang Data,and VIP Database)were searched for RCTs of acupuncture in treating PD motor symptoms,from their inception to July 31,2024.Outcome measures were extracted,categorized,and analyzed based on their functional attributes,with descriptive statistics on frequency,classifications,com-bined usage,and assessment timings.Results:A total of 53 studies were included,encompassing 37 types of outcome measures(164 instances in total).Symptom/sign measures appeared most frequently(109 instances,66.46%),followed by safety events(19 in-stances,11.59%),quality of life(17 instances,10.37%),physiological/chemical tests(8 instances,4.88%),TCM syndromes(6 in-stances,3.66%),and long-term prognosis(5 instances,3.05%).None of the studies included economic evaluation indicators.Among the studies,20 used only one category of indicators(37.74%),19 used two categories,11 used three categories,2 used four catego-ries,and 1 study used five categories.Only 2 studies clearly specified primary and secondary outcome measures.Thirty-eight studies reported clinical efficacy indicators,of which 15 explicitly referenced efficacy assessment criteria.Treatment duration across studies ranged from 10 to 90 sessions,with an average of 40 sessions;only 5 studies reported follow-up periods,with a follow-up reporting rate of 9.43%.Conclusion:The outcome measures in RCTs of acupuncture for PD motor symptoms are diverse,covering TCM syn-dromes,symptoms/signs,physiological/chemical tests,and quality of life.However,several issues remain,including lack of stan-dardized diagnostic criteria,unclear primary and secondary outcome measures,inconsistent evaluation methods for the same symp-toms/signs,inadequate standardization of clinical efficacy criteria,arbitrary use of combined indicators,insufficient emphasis on TCM-specific and objective evaluation indicators,and limited attention to long-term prognosis and economic measures.Future stud-ies should aim to improve methodological quality and establish a standardized core outcome set for acupuncture in treating PD mo-tor symptoms,promoting the further development of high-quality clinical research.关键词
帕金森病/针刺/结局指标/随机对照试验Key words
Parkinson's disease/acupuncture/outcome measures/randomized controlled trial分类
医药卫生引用本文复制引用
王拓然,杜世豪,彭浩轩,周宇..针刺治疗帕金森病运动症状随机对照试验结局指标分析[J].中医康复,2025,2(2):1-9,9.基金项目
国家自然科学基金项目(82104652) （82104652）
中国中医科学院针灸研究所自主选题项目(ZZ-2023014) （ZZ-2023014）
