基于CONSORT声明评价推拿治疗腰椎间盘突出症随机对照试验报告质量  

Evaluation of the Reporting Quality of Randomized Controlled Trials of Tuina Treating Lumbar Disc Herniation Based on CONSORT Statement

作　　者：诸豪 邓新源 郑伟康 吕子萌 张宇[3] 吴以诚 ZHU Hao;DENG Xinyuan;ZHENGWeikang;LYU Zimeng;ZHANG Yu;WU Yicheng(The First Clinical Medical College of Anhui University of Chinese Medicine,Hefei 230038,China;Anhui Integrated Hospital of Traditional Chinese and Western Medicine,Hefei 230063,China;The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230038,China)

机构地区：[1]安徽中医药大学第一临床医学院,安徽合肥230038 [2]安徽省中西医结合医院,安徽合肥230063 [3]安徽中医药大学第一附属医院,安徽合肥230038

出　　处：《中国中医药图书情报杂志》2023年第1期45-52,共8页Chinese Journal of Library and Information Science for Traditional Chinese Medicine

基　　金：安徽省卫生健康委科研项目(AHWJ2021b047);安徽省中医药传承创新项目(2020ccyb06);安徽中医药大学第一附属医院临床科研基金(2020yfyzc30);国家中医药管理局国医大师工作室建设项目(2018-474)。

摘　　要：目的 基于CONSORT声明对推拿治疗腰椎间盘突出症(LDH)临床随机对照试验(RCT)文献质量进行评估。方法 检索中国知识资源总库(CNKI)、中国生物医学文献数据库(CBM)、中文科技期刊数据库(VIP)、万方数据知识服务平台(WanFang Data)、PubMed、Cochrane Library、Embase数据库2001年1月1日-2021年10月31日推拿治疗LDH的RCTs,使用CONSORT声明、Cochrane偏倚风险评估工具评价报告质量。结果 共纳入24篇RCT文献。根据CONSORT声明,“背景和目的”“受试者”“干预措施”等条目报告良好,报告率>60%,“样本量”“结局指标”等条目报告质量差,报告率<5%。根据Cochrane偏倚风险评估工具,在选择偏倚的生成随机序列方面及报告偏倚方面,50%以上文献属于低风险偏倚;实施偏倚方面,95%以上文献为高风险偏倚。整体上有2篇文献属于高风险偏倚,有2篇文献属于低风险偏倚。结论 推拿治疗LDH RCTs报告质量不高,研究人员今后需按照CONSORT声明和Cochrane偏倚风险评估工具规范RCT报告。本研究为提升RCT质量提供一定参考。Objective To evaluate the literature quality of clinical randomized controlled trials(RCTs) of Tuina for the treatment of lumbar disc herniation(LDH) based on CONSORT statement. Methods RCTs about Tuina for the treatment of LDH were retrieved from CNKI, CBM, VIP, WanFang Data, PubMed, Cochrane Library, and Embase from 1st, Jan. 2001 to 31st, Oct. 2021. The Cochrane bias risk assessment tool and CONSORT statement were used to evaluate the reporting quality. Results A total of 24 RCT articles were included. According to CONSORT statement, items such as “background and purpose”“subjects”“intervention measures” were reported well, with the reporting rate of more than 60%. Some items such as “sample size” and “outcome indicators” were reported poorly,with the reporting rate of less than 5%. According to Cochrane’s risk assessment tool for bias, more than 50% of articles were considered with low risk of bias in generating random sequences and reporting bias in selection bias;as for implementation bias, more than 95% of articles were considered high-risk bias. Two articles were high-risk bias and two articles were low-risk bias. Conclusion The reporting quality of clinical RCTs of Tuina for the treatment of LDH is not high, and researchers should standardize the RCTs reports about Tuina in accordance with the CONSORT statement and Cochrane bias risk assessment tool. This study can provide certain reference for promoting quality of clinical RCTs.

关 键 词：推拿 腰椎间盘突出症 CONSORT声明 报告质量评价 

分 类 号：R2-05[医药卫生—中医学] R255.6