针刺治疗动眼神经麻痹随机对照试验结局指标现状分析

Analysis of the current status of outcome measures in randomized controlled trials on acupuncture treatment for oculomotor nerve palsy

关键词:  动眼神经麻痹  针刺  随机对照试验  结局指标  核心指标

Key words:  oculomotor nerve palsy  acupuncture  randomized controlled trial  outcome indicator  core outcome set

摘要:

[目的] 基于近20年文献数据，分析针刺治疗动眼神经麻痹（ONP）/随机对照试验（RCT）的结局指标特征及现存优势与不足，为核心指标集构建提供依据。[方法] 检索PubMed、Cochrane Library、Embase、Web of Science、Clinical Trials.gov、中国知网（CNKI）、万方数据知识服务平台（Wanfang Data）、维普资讯中文期刊服务平台（VIP）、中国生物医学文献服务系统（SinoMed）、中国临床试验注册中心（ChiCTR）中有关针刺治疗ONP RCT相关文献，检索时间为2005年1月1日—2025年10月1日，检索方式为主题词与自由词相结合。使用Cochrane偏倚风险评估工具评价纳入文献的质量后梳理结局指标。由2名研究者筛查文献，提取文献特征，并分析针刺治疗ONP RCT结局指标。[结果] 初步检索获得1 379篇相关文献，经多重筛选后最终纳入46篇文献，样本量2 785例，共使用32种结局指标，具体分为中医病证指标、临床症状指标、临床疗效指标、血液流变学指标、生活质量指标、安全性指标6类。[结论] 研究首次对针刺治疗ONP RCT的结局指标进行总结分析，发现现有研究已聚焦ONP核心症状，探索了多种针刺干预方案，以眼裂大小、复视角度等为核心的疗效评估指标具备一定临床合理性，但仍然存在文献方法学规范不足、结局指标主次不明确、表达欠规范、适用范围及优缺点阐释不清、联用模式集中、中医特色与针刺特异性不足、生活质量与远期疗效及经济学指标关注欠缺、安全性评价不充分等问题，且不同病因ONP的疗效评价差异尚未得到充分体现。建议研究者在开展RCT研究时，充分借鉴现有研究基础，对ONP的结局指标进行全面了解，选用科学合理的结局指标来评价疗效，建立规范公认的针刺治疗ONP的核心指标集，推动研究结果向高质量临床证据转化。

Abstract:

[Objective] Based on literature from the past 20 years，the study analyzes the characteristics of outcome indicators in RCTs evaluating acupuncture for ONP，as well as the existing advantages and limitations，thereby providing a basis for the development of a core outcome set. [Methods] A search was conducted for RCTs related to acupuncture for ONP in databases including PubMed，Cochrane Library，Embase，Web of Science，ClinicalTrials.gov，CNKI，Wanfang Data，VIP，SinoMed，and ChiCTR. The search period was from January 1，2005，to October 1，2025，using a combination of MeSH terms and free-text words. The quality of included studies was assessed using the Cochrane Risk of Bias Tool，and outcome indicators were systematically organized. Two researchers independently screened the literature，extracted study characteristics，and analyzed the outcome indicators of RCTs on acupuncture for ONP. [Results] The initial search yielded 1 379 relevant articles. After multiple rounds of screening，46 articles were finally included，covering a total sample size of 2 785 cases. A total of 32 outcome indicators were used，which were categorized into six types：traditional Chinese medicine syndrome indicators，clinical symptom indicators，clinical efficacy indicators，hemorheological indicators，quality of life indicators，and safety indicators. [Conclusion] The study is the first to comprehensively analyze the outcome indicators of RCTs on acupuncture for ONP. It was found that existing studies have focused on the core symptoms of ONP and explored various acupuncture intervention protocols. Outcome indicators such as palpebral fissure size and diplopia angle have certain clinical rationality. However，several issues remain：insufficient methodological standardization in the literature，unclear prioritization of outcome indicators，non-standardized expression of indicators，lack of clarity regarding their scope of application，advantages and disadvantages，concentrated combined treatment models，insufficient emphasis on the unique characteristics of traditional Chinese medicine and the specific effects of acupuncture，inadequate attention to quality of life，long-term efficacy and economic indicators，and insufficient safety evaluation. Moreover，the differences in therapeutic efficacy for ONP caused by different etiologies have not been fully addressed. It is recommended that researchers，when conducting RCTs，fully draw on existing research，comprehensively understand the outcome indicators for ONP，select scientific and reasonable indicators to evaluate efficacy，establish a standardized and widely recognized core outcome set for acupuncture treatment of ONP，and promote the translation of research findings into high-quality clinical evidence.