针刀治疗腰椎间盘突出症随机对照试验的结局指标现状分析

Analysis of the current status of outcome measures in randomized controlled trials of acupotomy for lumbar disc herniation

关键词:  腰椎间盘突出症  针刀  结局指标  核心指标集  随机对照试验

Key words:  lumbar disc herniation  acupotomy  outcome measures  core outcome set（COS）  randomized controlled trial

摘要:

[目的] 通过分析针刀治疗腰椎间盘突出症（LDH）的随机对照试验（RCT）结局指标使用现状，为构建该领域核心指标集提供循证医学依据。[方法] 全面检索2005年1月至2024年9月PubMed、Web of Science、Cochrane Library、EMbase、中国知网、维普网、万方数据知识服务平台、SinoMed、ClinicalTrials.gov、CHiCTR和ITMCTR中所有有关针刀治疗LDH的RCT，通过提取、归纳和分析相关结局指标，制定针刀治疗LDH的指标域。[结果] 最终纳入369篇RCT，样本总量40 430例，涉及107种不同的结局指标，累计出现1 092次。结局指标以症状/体征最多（75.46%），其次是理化检查（18.41%）、生活质量评价（2.56%）、安全性评价（2.56%）、远期疗效（1.37%）、中医证候（1.28%）、患者满意度（0.64%）和经济学评估（0.18%）。结果表明当前针刀治疗LDH的RCT结局指标应用普遍存在主/次结局指标未区分、缺乏客观性、过度关注短期疗效、经济学指标缺乏、生活质量未受重视和安全性评价关注度低的问题。[结论] 建议研究者构建针刀治疗LDH的核心指标集，以此增进针刀治疗LDH研究设计的规范性、结局指标选定的合理性以及研究结论的可靠性。

Abstract:

[Objective] To analyze the current use of outcome measures in randomized controlled trials（RCTs） of acupotomy for lumbar disc herniation（LDH），so as to provide evidence for developing a core outcome set（COS） in this field. [Methods] From January 2005 to September 2024，all RCTs related to the treatment of LDH by acupotomy in PubMed，Web of Science，the Cochrane Library，EMbase，CNKI，VIP，Wanfang Data，SinoMed，ClinicalTrials.gov，CHiCTR and ITMCTR were comprehensively searched. Relevant outcome measures were extracted，summarized，and analyzed to establish an outcome domain for acupotomy in treating LDH. [Results] A total of 369 RCTs were ultimately included，involving a sample size of 40 430 cases and 107 different outcome measures，which appeared 1 092 times in total. The most common outcome measures were symptoms/signs（75.46%），followed by physical and chemical tests（18.41%），quality of life（2.56%），safety evaluation（2.56%），long-term efficacy indicators（1.37%），traditional Chinese medicine syndrome（1.28%），patient satisfaction（0.64%）and economic indicators（0.18%）. The results indicated that the application of outcome measures in current RCTs on needle-knife treatment for LDH generally had problems such as no distinction between primary and secondary outcomes，lack of objectivity，excessive focus on short-term efficacy，lack of economic indicators，neglect of quality of life，and low attention to safety evaluation. [Conclusion] It is recommended to develop a COS for RCTs of acupotomy for LDH. This will help standardize trial design，improve the rationale for outcome selection，and enhance the reliability of research conclusions.