Zeng Cheng, Shuai Yun-Fei, Li Xin
School of Chinese Medicine, Hunan University of Chinese Medicine Changsha 410208, China.
the First Hospital of Hunan University of Chinese Medicine Changsha 410007, China.
Zhongguo Zhong Yao Za Zhi. 2021 Jan;46(1):214-224. doi: 10.19540/j.cnki.cjcmm.20200322.501.
To systemically evaluate the efficacy and safety of sinomenine combined with methotrexate(SIN+MTX) in the treatment of rheumatoid arthritis(RA). Literature databases of Wanfang, CNKI, VIP, SinoMed, PubMed, Cochrane Library and Web of Science were retrieved comprehensively for relevant clinical trials. The literature retrieval time was from database establishment to February 4, 2020. The quality of literatures was assessed by the Cochrane Evaluation Handbook 5.1.0, and qualified literature was reviewed and analyzed by using the RevMan 5.3 statistical software. Twenty randomized controlled trials met the inclusion criteria, and were enrolled in the Meta-analysis. The results showed that SIN+MTX remarkably reduced DAS28(MD=-0.85, 95%CI[-1.03,-0.67], P<0.000 01), and improved total efficiency(P<0.000 01). SIN+MTX could inhibit swollen joint count(MD=-1.19, 95%CI[-1.75,-0.63], P<0.000 1), tender joint count(MD=-1.58, 95%CI[-2.89,-0.28], P=0.02) and reduce morning stiffness time(MD=-8.44, 95%CI[-11.82,-5.07], P<0.000 01) compared with control group. The results showed that SIN+MTX was equal to control group in grip strength(SMD=0.20,95%CI[-1.11,1.51],P=0.77). SIN+MTX remarkably alleviated the erythrocyte sedimentation rate(MD=-9.87, 95%CI[-14.52,-5.22], P<0.000 1), C-reactive protein(SMD=-0.30, 95%CI[-0.51,-0.09], P=0.005), and rheumatoid factor(MD=-11.23,95%CI[-13.81,-8.65],P<0.000 01). The frequency of adverse reactions were reduced compared with that in the control group(P<0.000 01). Current clinical studies demonstrate that the efficacy and safety of SIN+MTX in the treatment of RA were superior to control group. However, due to the low quality and quantity of the included studies, high-quality randomized controlled trials are necessary to support the clinical evidences.
系统评价青藤碱联合甲氨蝶呤（SIN+MTX）治疗类风湿关节炎（RA）的有效性和安全性。全面检索万方、中国知网、维普、中国生物医学文献数据库、PubMed、Cochrane图书馆和Web of Science等文献数据库中的相关临床试验。文献检索时间为各数据库建库至2020年2月4日。采用Cochrane评价手册5.1.0评估文献质量，并用RevMan 5.3统计软件对符合标准的文献进行回顾分析。20项随机对照试验符合纳入标准，纳入Meta分析。结果显示，SIN+MTX能显著降低DAS28（MD=-0.85，95%CI[-1.03，-0.67]，P<0.000 01），提高总有效率（P<0.000 01）。与对照组相比，SIN+MTX能抑制关节肿胀数（MD=-1.19，95%CI[-1.75，-0.63]，P<0.000 1）、压痛关节数（MD=-1.58，95%CI[-2.89，-0.28]，P=0.02），并缩短晨僵时间（MD=-8.44，95%CI[-11.82，-5.07]，P<0.000 01）。结果显示，SIN+MTX与对照组在握力方面相当（SMD=0.20，95%CI[-1.11，1.51]，P=0.77）。SIN+MTX能显著降低红细胞沉降率（MD=-9.87，95%CI[-14.52，-5.22]，P<0.000 1）、C反应蛋白（SMD=-0.30，95%CI[-0.51，-0.09]，P=0.005）和类风湿因子（MD=-11.23，95%CI[-13.81，-8.65]，P<0.000 01）。与对照组相比，不良反应发生率降低（P<0.000 01）。目前的临床研究表明，SIN+MTX治疗RA的有效性和安全性优于对照组。然而，由于纳入研究的质量和数量较低，需要高质量的随机对照试验来支持临床证据。
