中西医治疗腰背痛临床试验结局指标及测量工具的比较研究  

A Comparative Study of Outcomes and Measurements Used in Randomized Controlled Trials for Low Back Pain Treated by Western Medicine and Traditional Chinese Medicine

作　　者：吴忆宁 万颖 胡超越 孙亚男[3] 于长禾[4] WU Yining;WAN Ying;HU Chaoyue;SUN Yanan;YU Changhe(Beijing University of Chinese Medicine,Beijing 100029,China;First School of Clinical Medicine,Beijing University of Chinese Medicine,Beijing 100029,China;TCM Department,Xuanwu Hospital,Capital Medical University,Beijing 100069,China;Tuina and Pain Management Department,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100007,China)

机构地区：[1]北京中医药大学,北京市100029 [2]北京中医药大学第一临床医学院,北京市100029 [3]首都医科大学宣武医院中医科,北京市100069 [4]北京中医药大学东直门医院推拿疼痛科,北京市100007

出　　处：《中国全科医学》2022年第35期4433-4442,共10页Chinese General Practice

基　　金：国家自然科学基金青年科学基金项目(81803956);北京市首发青年优才项目(2020-4-4195);首都临床特色应用研究(Z181100001718165)。

摘　　要：背景腰背痛是目前全球范围内造成运动功能减退的主要原因。而腰背痛临床试验的结局指标报告缺乏一致性、实用性、规范性,同领域研究结果无法进行合并比较,亟须同质性和实用性的结局指标。目的评价腰背痛临床随机对照试验(RCT)及其结局指标报告的质量,分析、比较不同干预措施在腰背痛RCT中结局指标及测量工具的差异,探索腰背痛同质性和实用性的结局指标。方法检索Complementary Medicine Field Trials Register(CRSO)、Back and Neck Review Group Trials Register(CRS)、ClinicalTrials.gov、WHO ICTRP 4个临床研究注册平台及Cochrane Library、PubMed、Web of Science、中国知网(CNKI)、万方数据知识服务平台(Wanfang Data)、中国生物医学文献服务系统(SinoMed)、维普网(VIP)数据库,获得2017—2021年中医、西医及中西医结合治疗腰背痛的RCT,筛选文献后提取文献信息并进行描述性分析。结果共纳入西医RCT 1014项,中医RCT 624项,中西医结合RCT 392项。腰背痛RCT Jadad评分总分西医2(2,4)分、中医2(2,3)分、中西医结合2(2,2)分,超过50%的研究Jadad评分总分为2分,超过10%的研究Jadad评分为3分,整体研究质量偏低。纳入研究中超过80%结局指标评分为1分,不同干预措施的结局指标报告均不完整。西医治疗腰背痛RCT报告的指标数量为1~8个(中位数M=2个),报告频率前5位的结局域为疼痛程度(28.2%)、身体功能(28.0%)、医院相关结局(8.0%)、经济学指标(8.0%)、不良事件/影响(8.0%),评价研究结局使用频率前3位的量表为视觉模拟评分量表(VAS)/口述分级量表(VRS)、Oswestry功能障碍指数问卷表(ODI)、日本骨科协会评估治疗分数(JOA);中医治疗腰背痛RCT报告的指标数量为1~6个(中位数M=2个),报告频率前5位的结局域为疼痛程度(45%)、身体功能(27%)、其他(14%)、整体生活质量(5%)、肌肉骨骼和及结缔组织结局(2%),主要使用的量表包含VAS/VRS、ODI、�Background Low back pain(LBP)is the leading cause of hypokinesia globally.Currently,the reporting of outcomes in clinical trials for LBP lacks consistency,utility,and standardization,and the results of studies in the same field cannot be combined for comparison.Thus,the homogeneity and utility of outcomes need to be enhanced.Objective To assess the quality of randomized controlled trials(RCTs)for LBP and their outcome reports,then to analyze the variations of reported outcomes and measurements among different interventions for LBP,and to explore homogeneous and practical outcome indices for LBP.Methods Four clinical trials registry platforms(Complementary Medicine Field Trials Register,Back and Neck Review Group Trials Register,ClinicalTrials.gov,WHO ICTRP)and seven databases(Cochrane Library,PubMed,Web of Science,CNKI,Wanfang Data,SinoMed,VIP)were searched for RCTs about LBP treated by traditional Chinese medicine(TCM),western medicine(WM)and integrated traditional Chinese and western medicine(TCM-WM)published during 2017 to 2021.Information was extracted and analyzed descriptively.Results In total,1014 RCTs of LBP with WM treatment,624 RCTs of LBP with TCM treatment,and 392 RCTs of LBP with integrated TCM-WM treatment were included.Overall,the quality of RCTs was low and the reporting of outcome in different interventions was deficient.Through our assessment,the total Jadad score was 2(2,4)for RCTs of LBP with WM treatment,2(2,3)for RCTs of LBP with TCM treatment,and 2(2,2)for those of LBP with integrated TCM-WM treatment,with more than 50%of the RCTs having a total Jadad score of 2,and more than 10%having a Jadad score of 3.More than 80%of the RCTs had an outcome score of 1.The number of indices reported in RCTs about WM for LBP ranged from 1 to 8(with a median value of 2),and the top five outcome domains reported with frequency were pain level(28.2%),physical function(28.0%),hospital-related outcomes(8.0%),economic indices(8.0%),and adverse events/effects(8.0%),and the top three scales used to evaluate outcom

关 键 词：腰背痛 结局指标 临床结局评价 比较研究 中西医结合 

分 类 号：R681.55[医药卫生—骨科学]