韩盈盈　张潇文　张春鹏

摘要：目的 對近10年腕踝针治疗腰痛随机对照临床试验文献质量进行评价，分析存在的问题，并提出改进建议。方法 计算机检索中国知识资源总库（CNKI）、中国学术期刊数据库（万方数据）、中国生物医学文献数据库（CBM）、中文科技期刊数据库（重庆维普）、PubMed、Cochrane Library收录的腕踝针治疗腰痛随机对照临床试验文献，检索范围为2007年1月1日-2016年12月31日。参照临床试验报告统一标准（CONSORT）声明的25项条目和针刺临床试验干预措施报告标准（STRICTA）的6项条目对所纳入文献进行逐篇统计分析。结果 共纳入18篇文献。纳入的腕踝针治疗腰痛随机对照试验报告存在的问题主要有试验设计类型不明确、结局指标报告不完整、随机方法报告不具体、未选用公认的诊断标准和疗效标准、未完整报告干预措施等。结论 目前，腕踝针治疗腰痛随机对照临床试验报告质量偏低，建议参照CONSORT声明和STRICTA的要求实施和报告腕踝针治疗腰痛随机对照试验研究，提高该领域临床研究报告质量。

关键词：腕踝针；腰痛；随机对照试验；质量评价

DOI：10.3969/j.issn.1005-5304.2018.06.025

中图分类号：R245.31；R274.34 文献标识码：A 文章编号：1005-5304（2018）06-0104-06

Evaluation of Literature Quality of Randomized Controlled Trials on

Wrist-ankle Acupuncture for Low-back Pain

HAN Ying-ying， ZHANG Xiao-wen， ZHANG Chun-peng， MA Li-sha， CHEN Hong-yun， ZHOU Qing-hui

Changhai Hospital Affiliated to Second Military Medical University， Shanghai 200433， China

Abstract： Objective To evaluate the literature quality of randomized controlled trials （RCTs） on wrist-ankle acupuncture （WAA） for low-back pain in recent ten years； To analyze the existing problems in the clinical research； To provide corresponding improvement suggestions. Methods A computer-based retrieval was performed to search out the reports of RCTs on WAA for low-back pain from CNKI， Wanfang Data， CBM， Chongqing VIP， PubMed， and Cochrane Library was retrieved by computers. The search scope was January 1， 2007 - December 31， 2016. The 25 items in the Consolidated Standards of Reporting Trials （CONSORT） Statement and 6 items of the Standards for Reporting Interventions in Clinical Trials of Acupuncture （STRICTA） were consulted for assessing the literature quality of RCTs on WAA for low-back pain. Results 18 articles were included. There were many problems about literature of RCTs on WAA for low-back pain， mainly including that the type of test design was not clear， outcome indicators were incomplete， random method reports were not specific， accepted diagnostic criteria and efficacy criteria were not used， reporting interventions were incomplete. Conclusion Recently， literature quality of RCTs on WAA for low-back pain is low. It is suggested that CONSORT Statement and STRICTA should be taken into consideration in the conducting and reporting of RCTs on WAA for low-back pain， and the report quality of clinical research in this field should be improved.

Keywords： wrist-ankle acupuncture； low-back pain； randomized controlled trial； quality evaluation

腰痛是一种临床常见症状，女性发病率高于男性，常见于40～69岁年龄段的人群，给患者个人、家庭和社会造成了巨大的经济负担[1]。目前，腰痛的常见治疗方法有药物治疗、手术、针灸、推拿等。腕踝针作为一种新兴针刺疗法，对于疼痛类疾病有较好的止痛作用[2]。大量研究表明，腕踝针治疗腰痛具有见效快、安全简便等优势[3]，但目前相关临床研究文献能否为其临床干预提供最佳证据，并用来指导临床实践，需经过客观、全面的临床试验文献质量评价。……