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

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

摘要:

[目的] 分析中医药治疗类风湿关节炎临床试验的结局指标，为构建类风湿关节炎临床试验的核心指标集奠定基础。[方法] 计算机检索中国期刊全文数据库（CNKI）、万方数据知识服务平台（WANFANG DATA）、中国生物医学文献数据库（SinoMed）、维普数据库（VIP）、PubMed、The Cochrane Library和EMbase数据库，收集中医药治疗类风湿关节炎的临床研究，检索时限设定为2020年。由两名研究者按照纳入与排除标准独立进行文献筛选和资料提取。[结果] 纳入69项研究（随机对照试验56项，非随机同期对照研究3项，病例对照研究9项，自身前后对照研究1项），共计4 077例患者，37个（类）结局指标。单篇文章使用指标数量差异大，为3~29个，平均为11个。使用频数排前10位的指标依次为：红细胞沉降率（73.91%）、C-反应蛋白（71.01%）、有效率（71.01%）、类风湿因子（66.67%）、不良反应（60.87%）、28个关节疾病活动度（DAS28）评分（46.38%）、视觉模拟评分法（VAS）评分（40.58%）、关节压痛数（40.58%）、晨僵持续时间（40.58%）、肿胀关节数（39.13%）。以指标功能属性为依据进行分类，所纳入研究指标域的设置比例由高到低依次为理化检测（92.75%）、疾病整体评价（91.30%）、症状/体征（73.91%）、安全性事件（60.87%）、中医病证（34.78%）、生活质量（4.35%），未涉及经济学评估及远期预后。[结论] 类风湿关节炎临床试验的结局指标存在差异大、不规范、缺乏中医特色指标、缺乏远期预后与经济学评价等共性问题，亟需建立类风湿关节炎核心指标和中医药特色指标。

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.