天津中医药2024，Vol.41Issue(6)：735-743,9.DOI:10.11656/j.issn.1672-1519.2024.06.11
中医药治疗类风湿关节炎临床研究结局指标文献研究
Literature study on outcome indicators of clinical trials of traditional Chinese medicine in the treatment of rheumatoid arthritis
摘要
Abstract
[Objective]To systematically analyze outcome measures in clinical trials of rheumatoid arthritis with intervention of traditional Chinese medicine(TCM),and to establish the basis for core outcome set(COS)of clinical trials of rheumatoid arthritis.[Methods]CNKI,WANFANG DATA,SinoMed,VIP,PubMed,Cochrane library and EMbase databases were searched by computer,and the clinical trials of TCM for the treatment of rheumatoid arthritis were comprehensively collected.The retrieval time was set in 2020.Literature screened and data extraction were conducted independently by 2 researchers according to inclusion and exclusion criteria.[Results]The 69 studies were included,involving 56 randomized controlled trials(RCT),3 non-RCTs,9 case-control studies and 1 before-after study,with a total of 4 077 patients and 37(class)outcome indicators.The number of outcome indicators in one of included RCTs varied from 3 to 29 with the average of 11.After frequency analysis,the top 10 rate of outcome indicators were erythrocyte sedimentation rate(ESR,73.91%),C-reactive protein(CRP,71.01%),effective rate(71.01%),rheumatoid factor(RF,66.67%),adverse effects(60.87%),Disease Activity Score 28(DAS28,46.38%),visual analogue scale(VAS,40.58%),tender joint count(TJC,40.58%),morning stiffness duration(MSD,40.58%),swollen joint count(SJC,39.13%).Classified by the functional properties of the indicators,the setting rate of the indicator domains of the included studies were,in descending order,physical and chemical tests evaluation(92.75%),overall disease evaluation(91.30%),symptoms/signs evaluation(73.91%),safety events evaluation(60.87%),TCM disease evidence evaluation(34.78%),quality of life evaluation(4.35%),and no economics and long-term prognostic evaluation were involved.[Conclusion]There were some common problems about outcome indicators of clinical trials,such as heterogeneity,non-standardization and lack of TCM characteristics,long-term prognosis and economic evaluation.Therefore,it is urgent to establish COS-TCM characteristic indicator of rheumatoid arthritis.关键词
中医药/类风湿关节炎/结局指标/核心指标集Key words
traditional Chinese medicine/rheumatoid arthritis/outcome measure/core outcome set分类
医药卫生引用本文复制引用
宋梦歌,姜泉,韩曼,姚传辉,张富渊,赵雪琦,巩勋,夏聪敏..中医药治疗类风湿关节炎临床研究结局指标文献研究[J].天津中医药,2024,41(6):735-743,9.基金项目
国家自然科学基金重点项目(82230121) （82230121）
中华中医药学会团体标准(20211246-BZ-CACM) （20211246-BZ-CACM）
中国中医科学院科技创新工程重大攻关项目(CI2021A01503). （CI2021A01503）
