基于CONSORT声明和STRICTA指南评估针灸治疗带状疱疹的随机对照研究的报告质量  

Quality Evaluation of the Report of RCTs on Acupuncture Therapy for Herpes Zoster Based on CONSORT Statements and STRICTA Guidelines

作　　者：罗镇科 曾婧纯[2] 佘雅琳 王澍欣[2] 许纪超 林国华[2] LUO Zhenke;ZENG Jingchun;SHE Yalin;WANG Shuxin;XU Jichao;LIN Guohua(The First Clinical Medical School,Guangzhou University of Chinese Medicine;Rehabilitation Center The First Affiliated Hospital of Guangzhou University of Chinese Medicine)

机构地区：[1]广州中医药大学第一临床医学院,广东广州510405 [2]广州中医药大学第一附属医院康复中心

出　　处：《西部中医药》2022年第10期74-79,共6页Western Journal of Traditional Chinese Medicine

基　　金：国家自然基金面上项目(81574061);广东省省级科技计划项目(2017A020213019);广东省科学技术厅项目(2017A020213019)。

摘　　要：目的:评价不同针灸疗法治疗带状疱疹随机对照研究(randomized controlled trial,RCTs)的报告质量及方法学现状,探讨提高该领域临床试验报告质量的方法。方法:计算机检索MEDLINE、Embase、Cochrane Library、中国知网(China national knowledge infrastructure,CNKI)、万方、维普等数据库(检索时限为建库至2019年12月31日)。由两名研究者独立进行文献筛选和资料提取,采用Cochrane偏倚风险评估工具及CONSORT 2010声明、STRICTA标准进行方法学及报告质量的评价。结果:共纳入RCTs49篇。参照CONSORT声明对RCTs进行质量报告,42个RCT(85.71%)详细描述了受试者符合纳入标准,全部研究描述了准确的干预措施。随机序列产生方法、分配隐藏、盲法、基线完整性、样本量估算及研究方案注册的报告率分别为40.82%、6.12%、2.04%、14.29%、0、0。根据STRICTA标准对针灸干预措施进行评价,针灸理论依据、针灸施加其他干预措施的细节、治疗师背景报告率分别为100%、87.75%、0%。结局指标的总疗效、皮疹消退时间、疼痛VAS评分、后遗神经痛发生率及安全性评价的报告率依次为89.80%、28.57%、28.57%、12.24%、6.12%。Cochrane偏倚风险评估发现全部RCTs在盲法及选择性报告方面有未知风险,另有18个RCT(36.73%)在随机方法、3个RCT(6.12%)在分配方案隐藏提示为低偏倚风险。结论:目前针灸治疗带状疱疹的临床研究质量普遍较低,但针灸细节的详细描述对临床医生在针灸干预的实施上具有参考意义。Objective:To assess the quality of the reports of RCTs on different acupuncture therapies for herpes zoster(HZ)and the current status of methodology,and explore the methods of improving the quality of clinical trial reporting in the field.Methods:Databases including MEDLINE,Embase,Cochrane Library,CNKI,Wanfang,VIP and others were searched by computer,and the retrieval limit was between database-building and December 31,2019.Two researchers independently conducted literarure screening and data extraction,Cochrane bias risk assessment tool,CONSORT 2010 statement,STRICTA guideline were used to evaluate the quality of methodology and the reporting.Results:Altogether 49 RCTs were included.RCTs were reported according to CONSORT statement,42 RCTs(85.71%)described in details that the subjects met the inclusion standard,all the studies showed the accurate intervention measures.The report rates of random sequences generation method,allocation concealment,blind method,baseline integrity,sample size estimation and study protocol registration were 40.82%,6.12%,2.04%,14.29%,0 and 0 respectively.Acupuncture intervention measures were assessed according to STRICTA standard,the reporting rates of theoretical basis of acupuncture,the details of acupuncture plus other intervention measures,the background of therapists were 100%,87.75%and 0%respectively.The report rates of overall clinical effects of outcome indicators,disappearing time of rash,VAS scores,the incidence of postherpetic neuralgia and safety evaluation were 89.80%,28.57%,28.57%,12.24%and 6.12%successively.Cochrane bias risk assessment found that all RCTs have unknown risks in blind and selective reporting,the other 18 RCTs(36.73%)showed low biased risk in randomized method,and other three RCTs(6.12%)in allocation concealment.Conclusion:Currently,clinical studies on acupuncture in the treatment of HZ are in low quality,while the detailed description of acupuncture could serve as the reference for the doctors'implementation of acupuncture intervention.

关 键 词：带状疱疹 针灸疗法 随机对照研究 方法学质量评价 报告质量 

分 类 号：R246.7[医药卫生—针灸推拿学]