Chen Wen-Jia, Li Tai-Xian, Wang Xiao-Yue, Xue Zhi-Peng, Lyu Cheng, Li Hui-Zhen, Li Yi-Qun, Fan Yuan-Fang, Tian Ya-Ge, Yang Jun, Guo Min-Qun, Wang Jing-Xia, Wu Hong-Yan, Zhang Yan-Qiong, Lin Na
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China.
Wangjing Hospital, China Academy of Chinese Medical Sciences Beijng 100102, China.
Zhongguo Zhong Yao Za Zhi. 2020 Feb;45(4):791-797. doi: 10.19540/j.cnki.cjcmm.20191115.503.
To evaluate the clinical efficacy of single administration of Tripterygium Glycosides Tablets(TGT) or combined administration with methotrexate(MTX) against rheumatoid arthritis(RA) based on American College of Rheumatology(ACR) efficacy standard. Six databases, namely CNKI, WanFang, VIP, PubMed, Embase and Cochrane Library, were retrieved for randomized controlled trials(RCT), and clinical trials were screened out according to the preset inclusion and exclusion criteria. Then, the study quality was evaluated by the risk assessment tools. Data extraction and analysis were performed by using RevMan 5.3 software for Meta-analysis. Sensitivity analysis and publication bias analysis were made to test the stability and reliability of results. Until December 2018, a total of 1 709 articles were obtained, and finally 10 clinical RCT studies with a total of 1 184 patients were included. As a result, the single administration of TGT showed a significantly better ACR efficiency(RR=1.31, 95%CI[1.15, 1.49], P<0.000 1) than methotrexate(MTX). The combined administration of TGT and MTX showed a significantly better ACR efficiency(RR=1.28, 95%CI[1.20, 1.38], P<0.000 01) than the single administration of MTX. In conclusion, the single administration of TGT and the combined administration of TGT and MTX were more effective in achieving ACR20, ACR50, ACR70 compliance than the single administration of MTX. Further validations based on more RCT studies with high-quality are required.
基于美国风湿病学会(ACR)疗效标准,评估单剂量服用雷公藤多苷片(TGT)或与甲氨蝶呤(MTX)联合用药治疗类风湿关节炎(RA)的临床疗效。检索中国知网、万方、维普、PubMed、Embase和Cochrane图书馆6个数据库中的随机对照试验(RCT),并根据预设的纳入和排除标准筛选临床试验。然后,使用风险评估工具评估研究质量。采用RevMan 5.3软件进行数据提取和Meta分析。进行敏感性分析和发表偏倚分析以检验结果的稳定性和可靠性。截至2018年12月,共获得1709篇文章,最终纳入10项临床RCT研究,共1184例患者。结果显示,单剂量服用TGT的ACR疗效(RR = 1.31,95%CI[1.15, 1.49],P<0.0001)显著优于甲氨蝶呤(MTX)。TGT与MTX联合用药的ACR疗效(RR = 1.28,95%CI[1.20, 1.38],P<0.00001)显著优于单剂量服用MTX。总之,单剂量服用TGT以及TGT与MTX联合用药在实现ACR20、ACR50、ACR70达标方面比单剂量服用MTX更有效。需要基于更多高质量RCT研究进行进一步验证。