白芍总苷联合来氟米特治疗类风湿关节炎疗效与安全性的Meta分析

Meta-analysis on efficacy and safety of total glucosides of paeony combined with leflunomide for treatment of rheumatoid arthritis

目的系统评价白芍总苷联合来氟米特治疗类风湿关节炎的临床疗效与安全性。方法计算机检索2006年至2018年万方数据库、维普中文科技期刊数据库(VIP)、中国知网全文数据库(CNKI)、江苏省工程技术文献信息中心、Pubmed、Medline和Sciencedirect中的文献,并对最终数据库采用Revman5.3进行Meta分析。结果共纳入21项研究(包含1 662例患者)。Meta分析结果显示,白芍总苷与来氟米特联用(治疗组)与使用来氟米特(对照组)治疗类风湿关节炎的疗效有效率(RR=1.18,95%CI 1.13～1.24)P<0.000 01,实验室检查指标C反应蛋白(CRP)改善率(SMD=0.40,95%CI 0.26～0.54,P<0.000 01),血沉(ESR)改善率(SMD=0.25,95%CI 0.13～0.36,P<0.000 1)总体不良反应发生率(RR=0.48,95%CI 0.38～0.60,P<0.000 01)的差异均具有统计学意义。针对相对较严重的不良反应进行亚组分析,2组间肝功能异常发生率(RR=0.29,95%CI 0.17～0.51,P<0.000 1)白细胞减少的发生率差异均具有统计学意义(RR=0.31,95%CI 0.12～0.76,P=0.01)。进行敏感分析后,所有结局指标均与基础分析结果一致。结论白芍总苷与来氟米特联用治疗类风湿关节炎比用来氟米特能够有效改善患者症状和实验室检查指标,显著减少总体不良反应发生率、肝功能异常和白细胞减少的发生率。亚组分析样本量较少,尚待扩大样本量后进一步分析。

AIM To evaluate the clinical efficacy and safety of total glucosides of paeony combined with leflunomide for treatment of rheumatoid arthritis.METHODS We searched Wanfang Database,VIP,CNKI,Jiangsu Engineering Technology Literature information Center,Pubmed,Medline and Sciencedirect from 2006 to 2018.Meta-analysis was performed using Rev Man 5.3 software.RESULTS The 21 trials were involved,including 1 662 cases.The results showed that there was significant difference in the clinical effectiveness of total glucosides of paeony combined with leflunomide and leflunomide alone in treatment of rheumatoid arthritis(RR=1.18,95%CI 1.13-1.24,P<0.000 01),as with the improvement rate of laboratory examination with C reactive protein(CRP)(SMD=0.40,95%CI 0.26-0.54,P<0.000 01)and erythrocyte sedimentation rate(ESR)(SMD=0.25,95%CI 0.13-0.3 6,P<0.000 01),and the incidence of total adverse drug reactions(RR=0.48,95%CI 0.38-0.60,P<0.000 01).A subgroup analysis was done in the view of the severe adverse drug reactions.The results showed that there were significant differences in the incidence of abnormal liver-function(RR=0.29,95%CI 0.17-0.51,P<0.000 1)and in the incidence of leukocyte depletion(RR=0.31,95%CI 0.12-0.76,P=0.01)between the 2 groups.The result of sensitivity analysis of final indicators was consistent with the funda-mental analysis.CONCLUSION Comparing with leflunomide alone,total glucosides of paeony combined with le-flunomide for treatment of rheumatoid arthritis can effectively improve the clinical effectiveness,the laboratory examination index,and significantly reduce the incidence of total adverse drug reactions,abnormal liver function and the incidence of leukocyte depletion.Subgroup analysis between the 2 groups may need further study after more samples be tested.