| 引用本文:尹聪,程静,李娟.雷公藤多苷联合来氟米特治疗类风湿关节炎的系统评价[J].世界中医药,2022,(03):. |
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| 雷公藤多苷联合来氟米特治疗类风湿关节炎的系统评价 |
| A Systematic Review of Tripterygium Glycosides Combined with Leflunomide in Treatment of Rheumatoid Arthritis |
| 投稿时间：2020-09-07 |
| DOI：10.3969/j.issn.1673-7202.2022.03.014 |
| 中文关键词: 雷公藤多苷 雷公藤多甙 免疫抑制剂 来氟米特 类风湿关节炎 免疫疾病 系统评价 Meta分析 |
| English Keywords:Tripterygium glycosides Polyglycosides from Tripterygii Wilfordii Radix et Rhizoma Immunosuppressor Leflunomide Rheumatoid arthritis Immunological diseases Systematic review Meta-analysis |
| 基金项目:重大新药创制国家科技重大专项（2014ZX09304307001）——中药新药安全性检测技术与标准研究；湖北省教育厅科学技术研究项目（Q20172009） |
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| 目的：系统评价雷公藤多苷联合来氟米特治疗类风湿关节炎的疗效和安全性。方法：计算机检索Cochrane library、Web of Science、Pubmed、国家知识基础设施数据库（CNKI）、中国生物医学文献数据库（CBM)、中国学术期刊数据库（CSPD）和中文科技期刊数据库（CCD），检索时限为建库起至2020年8月14日，收集雷公藤多苷联合来氟米特治疗类风湿关节炎的临床试验资料，采用Cochrane5.1.0系统评价手册进行质量评估，采用RevMan5.3软件进行数据分析。结果：共纳入随机对照试验13项，含类风湿关节炎患者1 004例，其中观察组503例，对照组501例。Meta分析结果显示，晨僵时间（SMD=-1.55，95%CI为-1.87～-1.23）、（SMD=-2.29，95%CI为-3.46～-1.12）、关节疼痛数（SMD=-0.94，95%CI为-1.40～-0.49）、关节肿胀数（SMD=-0.78，95%CI为-1.52～-0.04）、红细胞沉降率（SMD=-1.75，95%CI为-2.38～-1.13）、C反应蛋白（SMD=-2.23，95%CI为-2.96～-1.51）、类风湿因子（SMD=-2.97，95%CI为-4.22～-1.72）、免疫球蛋白G（SMD=-0.58，95%CI为-1.10～-0.06）、白细胞介素-1（SMD=-0.84，95%CI为-1.20～-0.49）、白细胞介素-6（SMD=-4.08，95%CI为-4.86～-3.30）、肿瘤坏死因子-α（SMD=-3.24，95%CI为-3.92～-2.56）、（SMD=-0.94，95%CI为-1.30～-0.57）和可溶性细胞间黏附分子-1（SMD=-0.53，95%CI为-0.96～-0.10），观察组均显著低于对照组；临床总有效率观察组明显优于对照组（OR=4.12，95%CI为2.74～6.18）；休息痛、免疫球蛋白A、免疫球蛋白M、白细胞介素-10和不良反应发生率观察组与对照组差异无统计学意义。结论：雷公藤多苷联合来氟米特治疗类风湿关节炎可提高患者的临床总有效率，改善类风湿关节炎患者相关的各项体征及症状，并且具有良好的安全性，值得临床推广应用；但由于受收录文献质量的限制和临床异质性的影响，研究结果尚需临床实践验证。 |
| English Summary: |
| To systematically evaluate the efficacy and safety of tripterygium glycosides combined with leflunomide in the treatment of rheumatoid arthritis.Methods:The Cochrane Library，Web of Science，PubMed，CNKI，CBM，WanFang Data，and VIP were searched from database inception to August 14，2020，for the clinical trial data of tripterygium glycosides combined with leflunomide in the treatment of rheumatoid arthritis.Cochrane Handbook for Systematic Reviews of Interventions (5.1.0) was used for quality evaluation and RevMan 5.3 for data analysis.Results:Thirteen randomized controlled trials (RCTs) were included，with 1 004 patients with rheumatoid arthritis involved，including 503 in the observation group and 501 in the control group.As revealed by Meta-analysis results，the observation group was lower than the control group in morning stiffness time [SMD=-1.55，95%CI (-1.87 to -1.23)，SMD=-2.29，95%CI (-3.46 to -1.12)]，number of joint pain [SMD=-0.94，95%CI (-1.40 to -0.49)]，number of joint swelling [SMD=-0.78，95%CI (-1.52 to -0.04)]，erythrocyte sedimentation rate [SMD=-1.75，95%CI (-2.38 to -1.13)]，C-reactive protein [SMD=-2.23，95%CI (-2.96 to -1.51)]，rheumatoid factor [SMD=-2.97，95%CI (-4.22 to -1.72)]，immunoglobulin G [SMD=-0.58，95%CI (-1.10 to -0.06)]，interleukin-1 [SMD=-0.84，95%CI (-1.20 to -0.49)]，interleukin-6 [SMD=-4.08，95%CI (-4.86 to -3.30)]，tumor necrosis factor-α [SMD=-3.24，95%CI (-3.92 to -2.56)，SMD=-0.94，95%CI (-1.30 to -0.57)]，and soluble intercellular adhesion molecule-1 [SMD=-0.53，95%CI (-0.96 to -0.10)].The total clinical effective rate of the observation group was better than that of the control group [OR=4.12，95%CI (2.74 to 6.18)].There was no significant difference between the observation group and the control group in rest pain，immunoglobulin A，immunoglobulin M，interleukin-10，and the incidence of adverse events.Conclusion:Tripterygium glycosides combined with leflunomide in the treatment of rheumatoid arthritis can increase the total clinical effective rate of patients and improve the signs and symptoms of rheumatoid arthritis patients with good safety，which is worthy of clinical promotion.However，due to the limitations of the quality of the included RCTs and the influence of clinical heterogeneity，the results still need to be verified by clinical practice. |
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