目的:分析针刺治疗帕金森病(PD)运动症状随机对照试验的结局指标，为构建针刺治疗PD运动症状临床试验的核心结局指标集提供基础。方法:检索中PubMed、Embase、Web of Science(WOS)、中国期刊全文数据库(CNKI)、万方数据知识服务平台(Wanfang)和维普(VIP)6个数据库建库起至2024年7月31日收录的针刺治疗PD运动症状的随机对照试验(RCT)，提取、归纳和分析相关结局指标，整理指标域，将其按照功能属性分类后进行频次的描述性分析，并对结局指标的分类、组合使用情况、评价时点等进行分析。结果:共纳入53篇文献，涉及结局指标37种(164次)。结局指标以症状/体征出现频次最高(109次，66。46%)，其次是安全性事件(19次，11。59%)、生活质量(17次，10。37%)、理化检测(8次，4。88%)、中医病证(6次，3。66%)和远期预后(5次，3。05%)，所有文献均未纳入经济学评估指标。20篇文献使用了1类指标(37。74%);19篇文献使用了2类指标，11篇文献使用了3类指标，2篇文献使用了4类指标及1篇文献使用了5类指标。仅有2篇文献明确了主要结局指标和次要结局指标;38篇文献报告了临床疗效评价指标，其中15篇文献明确报告疗效评定标准参考来源;纳入文献的针刺治疗疗程10～90次，平均40次，仅有5篇文献报告随访时间，随访报告率9。43%。结论:针刺治疗PD运动症状RCT结局指标的选择较丰富，在中医病证、症状/体征、理化检测、生活质量等方面均有涉及，但仍存在诊断标准欠统一、主次结局指标亟待厘清、相同症状/体征对应结局指标评价方法缺乏一致性、临床疗效评价标准的规范性不足、指标组合使用随意性大、忽视中医治疗特色及客观评价指标、缺少远期预后和经济学指标关注不足等问题。建议未来研究提升方法学质量，构建规范化的以针刺为主的帕金森病运动症状核心指标集，推动高质量临床研究的进一步发展。
Outcome Measure Analysis of Randomized Controlled Trials on Acupuncture Treatment for Motor Symptoms of Parkinson's Disease
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.
国家科技期刊平台
NSTL
万方数据
