中医药治疗神经根型颈椎病随机对照试验结局指标的评价  

Evaluation of Outcome Indexes of Randomized Controlled Trials on Chinese Medicine for Cervical Spondylotic Radiculopathy

作　　者：张迪晖[1,2] 侯宇[1,2] 杨丽虹[2] 刘少南[2] 李永津[2] 陈博来[2] 林定坤[2] 郭新峰[2] ZHANG Dihui;HOU Yu;YANG Lihong;LIU Shaonan;LI Yongjin;CHEN Bolai;LIN Dingkun;GUO Xinfeng

机构地区：[1]广州中医药大学第二临床医学院,广东广州510405 [2]广东省中医院,广东广州510120

出　　处：《新中医》2022年第8期26-32,共7页New Chinese Medicine

基　　金：岭南骨伤科流派传承工作室项目(E43607);石仰山学术经验传承工作室项目(E43715)。

摘　　要：目的:分析评价中医药治疗神经根型颈椎病随机对照试验选用的结局指标,并针对目前存在的问题提出建议。方法:计算机检索中国生物医学文献数据库(CBM)、中国知网(CNKI)、维普数据库(CQVIP)、万方数据、PubMed、Embase、CINAHL、CENTRAL和AMED等中英文数据库,搜集有关中医药治疗神经根型颈椎病的随机对照试验,检索时间从各数据库建库至2021年5月1日,由2名研究者独立筛选文献、提取资料,采用定性分析的方法描述纳入研究的结局指标情况。同时,检索结局指标测量工具分析评价数据库(COSMIN)及国内外指南的结局指标,进行两者的比较分析。结果:共纳入120个随机对照试验(RCT),涉及17种结局指标,分为疗效评价指标和安全性评价指标2大类。120个RCT中,结局指标中使用最多的量表是视觉模拟评分法(VAS),有49个;神经根型颈椎病评分系统(SSCR),有15个;安全性评价指标有33个,占27.5%,只有VAS、McGill疼痛问卷(MPQ)、颈椎功能障碍指数(NDI)、健康状况调查问卷简表(SF-36)这4个结局指标是国际公认推荐使用的。而使用总有效率作为临床疗效评价指标,有82个,占68.3%,大部分使用了《中医病证诊断疗效标准》及《中药新药临床研究指导原则(试行)》为具体评价标准。结论:中医药治疗神经根型颈椎病RCT中采用的结局指标与国际公认的结局指标存在一定差距,建议今后开展相关临床研究时应当参照国际公认的结局指标及测量量表进行,提高相关研究质量。Objective:To analyze and evaluate the outcome indexes of randomized controlled trials on Chinese medicine for cervical spondylotic radiculopathy,and put forward suggestions for the existing problems.Methods:Computer retrieval were conducted on Chinese and English databases,including China Biology Medicine disc(CBM),China National Knowledge Infrastructure(CNKI),VIP database(CQVIP),Wanfang Database,PubMed,Embase,CINAHL,CENTRAL and AMED,to collect randomized controlled trials on Chinese medicine for cervical spondylotic radiculopathy,from the construction date of each database to May 1st,2015.Two researchers independently screened the literature and extracted data,and used the method of qualitative analysis to describe the outcome indexes included in the study.At the same time,the outcome indexes from Consensus-based Standards for the selection of health Measurement Instruments(COSMIN)and domestic and foreign guidelines were analyzed and evaluated by measuring instrument of outcome indexes,and the two indexes were compared and analyzed.Results:A total of 120 randomized controlled trials(RCTs)involving 17 outcome indexes were included,which were divided into two categories,namely efficacy evaluation and safety evaluation.Among the 120 RCTs,the most used scales in the outcome indexes were visual analogue scale(VAS)with 49 times,and cervical spondylotic scoring system(SSCR)with 15 times.There were 33 safety evaluation indexes,accounting for 27.5%.Only VAS,McGill Pain Questionnaire(MPQ),Neck Disability Index(NDI)and 36-Item Short Form Health Survey(SF-36)were internationally recognized and recommended.The total effective rate was used as the clinical efficacy evaluation index for 82 times,accounting for 68.3%,most of which applied Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine and Guiding principles for clinical research of new Chinese medicine(Trial)as the specific evaluation criteria.Conclusion:There is a certain gap between the outcome indexes used in the RCT of

关 键 词：神经根型颈椎病 中医药 随机对照试验 结局指标 测量工具 

分 类 号：R681.53[医药卫生—骨科学]