针刺治疗原发性痛经随机对照试验结局指标现状分析

Analysis of the current status of outcome indicators in a randomised controlled trial of acupuncture for primary dysmenorrhea

关键词:  针刺  原发性痛经  随机对照试验  结局指标  核心指标集  RoB2.0

Key words:  acupuncture  primary dysmenorrhoea  randomised controlled trial  outcome indicator  core outcome set  RoB2.0

摘要:

[目的] 分析针刺治疗原发性痛经（PD）随机对照试验（RCT）的结局指标使用现状，为日后开展针刺治疗PD的临床研究和构建核心指标集提供依据。[方法] 检索中国知网（CNKI）、万方数据知识服务平台（Wangfang）、维普中文期刊数据库（VIP）、中国生物医学文献服务系统（SinoMed）、PubMed、EMbase、Cochrane Library、Web of Science数据库中自2014年1月1日—2024年3月19日，关于针刺治疗PD的RCT，对其结局指标进行提取、分类和分析，形成针刺治疗PD的指标域。[结果] 共纳入56项研究，共计49项结局指标，使用频次172次。按结局指标的频次排序，其所属的指标域依次为症状/体征（64.53%）、理化检查（18.60%）、远期预后（11.63%）、安全性事件（2.91%）、生活质量（2.33%）、满意度指标（1.16%）、中医病症（0.58%），纳入的研究均未报告经济学指标。[结论] 结局指标使用现状存在偏倚风险较大，方法学质量待提升、主/次要结局指标区分不明、过度依赖主观结局指标，客观结局指标欠缺、忽视中医病症指标，未体现中医特色、忽视生活质量评价、经济学评估指标欠缺等问题，未来应加快构建针刺治疗PD的核心指标集，提高针刺治疗PD的RCT质量与公认度，最大限度地发挥单个RCT的价值。

Abstract:

[Objective] To analyse the current status of the use of outcome indicators in randomized controlled trials（RCTs） of acupuncture for primary dysmenorrhea（PD），in order to provide a basis for future clinical studies on acupuncture for PD and for the construction of a core set of indicators. [Methods] China Knowledge Network（CNKI），Wanfang Data Knowledge Service Platform（Wangfang），Wipro Chinese Journal Database（VIP），China Biomedical Literature Service System（SinoMed），PubMed，EMbase，Cochrane Library，and Web of Science databases were searched for articles published from 1 January 2014 to 19 March 2024，RCTs on acupuncture for PD，were extracted，classified and analysed for their outcome indicators to form an indicator domain for acupuncture for PD. [Results] A total of 56 studies were included，with a total of 49 outcome indicators and a frequency of 172 uses. In the order of frequency of the outcome indicators，the indicator domains they belonged to were symptoms/signs（64.53%），physical and chemical examination（18.60%），long-term prognosis（11.63%），safety events（2.91%），quality of life（2.33%），satisfaction indicators（1.16%），and traditional Chinese medicine（TCM） illnesses（0.58%），and no economic indicators were reported in any of the included studies. [Conclusion] The current status of the use of outcome indicators exists a high risk of bias，methodological quality to be improved，unclear distinction between primary/secondary outcome indicators，over-reliance on subjective outcome indicators，lack of objective outcome indicators，neglect of indicators of Chinese medical conditions，failure to reflect the characteristics of TCM，neglect of the evaluation of the quality of life，and the lack of indicators of the evaluation of economics，in the future，we should accelerate the construction of the core set of indicators of PD treated by acupuncture to improve the RCT quality and recognition，and maximise the value of individual RCTs.