| 唐宇亭,陈红霞.针刺治疗中风后痉挛性瘫痪随机对照试验的结局指标分析[J].安徽医药,2026,30(4):754-762. |
| 针刺治疗中风后痉挛性瘫痪随机对照试验的结局指标分析 |
| Outcome measures in the randomized controlled trials of acupuncture for treating post-stroke spastic paralysis |
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| DOI：10.3969/j.issn.1009-6469.2026.04.023 |
| 中文关键词: 针刺疗法 中风康复 痉挛性瘫痪 随机对照试验 结局指标 |
| 英文关键词: Acupuncture therapy Stroke rehabilitation Spastic paralysis Randomized controlled trial Outcome indicators |
| 基金项目:广东省卫生健康委项目( A2022239) |
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| 中文摘要: |
| 目的探讨中风后痉挛性瘫痪的针刺治疗随机对照试验中结局指标的使用情况及现存问题，为针刺治疗该病的核心指标集构建提供依据，提高后续研究的价值。方法检索中国生物医学文献数据库、中国知网、维普、万方、 Embase、PubMed、Co-chrane Library、Web of Science等 8个数据库中针刺治疗中风后痉挛性瘫痪的临床随机对照试验文献，检索时限为建库至 2024年 2月 22日。提取文献结局指标相关资料，按照功能属性将结局指标整理分类并进行描述性分析。结果最终纳入文献 58篇，共使用 55种( 227次)结局指标，按功能属性分类分为症状 /体征，理化检测，安全性事件，中医病证，生活质量，远期预后，经济学评估 7类。测量时点共 23个，跨度为治疗后 7～98 d，82.76%的文献使用基线、治疗后两个测量时点。报告有效率指标的有 32篇，包括阿什沃思量表( Ashworth scale，AS)或改良阿什沃思量表( Modified Ashworth scale，MAS)、肌张力、神经功能缺损程度、运动功能、中医病证，参考标准不一。 6篇文献进行了安全性评价， 2篇涉及中医结局指标， 1篇提及远期疗效评估，纳入文献均无经济学评估。结论针刺治疗中风后痉挛性瘫痪的 RCT结局指标使用存在测量时点繁多且跨度大，疗效评价测量工具参考标准多样，安全性指标报告少，缺乏卫生经济学、中医特色及远期预后指标报告等问题，不利于各研究结果的比较分析，造成资源浪费。目前，亟须构建核心结局指标集，形成必须报告、统一且标准化的最小指标，推动临床评价体系的发展。 |
| 英文摘要: |
| Objective To analyze the applications and current challenges of outcome measures in randomized controlled trials(RCTs) investigating acupuncture therapy of post-stroke spastic paralysis (PSSP), thereby providing the development of core outcomeset for this domain to enhance the value of future research.Methods We comprehensively searched eight databases (SinoMed, CNKI,VIP, Wanfang, PubMed, Embase, Cochrane Library, and Web of Science) from inception through February 22, 2024, and included liter-ature on RCTs evaluating acupuncture interventions for PSSP. Outcome measures were categorized by functional domains before de-scriptive statistical analysis was conducted.Results The analysis encompassed 58 eligible RCTs reporting 55 distinct outcome mea-sures (total occurrences=227), classified into seven domains: symptom/sign assessments, clinical evaluations,safety monitoring, tradi-tional Chinese medicine (TCM) syndrome differentiation, quality of life measures, long-term prognosis, and economic evaluations. There were 23 measurement time points in total, spanning 7d to 98 d post-treatment, with 82.76% of studies utilizing only baseline and end-point assessments. Thirty-two studies employed efficacy indices, including Ashworth Scale (AS) or Modified Ashworth Scale (MAS)scores, muscle tone grading, neurological deficit scales, motor function assessments, and TCM diagnostic criteria. The criteria usedwere inconsistent. Safety reporting remained limited to 6 studies. Two studies involved TCM outcome measures. Only 1 study incorpo-rated long-term follow-up. No economic evaluations were identified.Conclusions In the RCTs of acupuncture for PPSP, significant is-sues persist in the use of outcome measures. These include excessive number of measurement time points with wide intervals, diversereference standards for efficacy evaluation tools, insufficient reporting of safety indicators, and a lack of data on health economics, TCM-specific outcomes, and long-term prognostic indicators. These limitations hinder cross-study comparisons and lead to resource ineffi-ciencies. There is an urgent need to establish a core outcome set to standardize the minimum reporting requirements, ensuring consis- |
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