艾拉莫德联合甲氨蝶呤对类风湿关节炎骨代谢影响的meta分析

Efficacy of iguratimod combined with methotrexate on bone metabolism in rheumatoid arthritis:a meta-analysis

目的系统评价艾拉莫德(iguratimod,IGU)联合甲氨蝶呤(methotrexate,MTX)对类风湿关节炎(rheumatoid arthritis,RA)骨代谢的影响。方法系统检索PubMed、Embase、Medline、Cochrane Library、中国知网、万方医学数据库、维普中文科技期刊数据库和中国生物医学文献数据库,收集IGU联合MTX干预RA患者骨代谢的临床随机对照试验。依据Cochrane Handbook6.2偏倚风险评估工具进行文献质量评价,并利用RevMan5.3软件进行meta分析。结果共检索到434篇文献,纳入9篇随机对照研究文献,涉及883例RA患者。Meta分析结果显示,与MTX单药治疗相比,IGU联合MTX显著改善患者骨代谢标志物血清浓度,包括N端中段骨钙素[均数差(mean difference,MD)=4.54,95%置信区间(confidence interval,CI)为(4.09,4.99),P<0.01]、总Ⅰ型前胶原氨基端前肽[MD=11.63,95%CI(10.04,13.21),P<0.01]、Ⅰ型胶原羧基端肽β特殊序列[MD=-0.22,95%CI(-0.27,-0.18),P<0.01]、以及25羟维生素D[MD=3.07,95%CI(2.22,3.92),P<0.01]。结论IGU联合MTX较MTX单药可显著改善RA患者的骨代谢。但因受纳入分析的文献数量和质量限制,有待更多、更高质量的文献进一步验证。

Objective To evaluate the efficacy of iguratimod(IGU) combined with methotrexate(MTX) on bone metabolism in rheumatoid arthritis(RA).Methods PubMed,Embase,Medline,Cochrane library,CNKI,WanFang Medical Online,VIP,and CBM were retrieved.The randomized controlled trial(RCT) was conducted.The literature quality was evaluated according to the Cochrane Handbook6.2 bias risk assessment tool,and the effect indicators were meta-analyzed using RevMan5.3 software.Results A total of 434 studies were retrieved,and 9 RCTs and 883 patients were included for meta-analysis.Compared with MTX monotherapy,IGU combined with MTX treatment could significantly improve the concentration of bone metabolism markers N-terminal midfragment of osteocalcin[mean difference(MD)=4.54,95% confidence interval(CI)(4.09,4.99),P<0.01],total N-terminal propeptide of type Ⅰ procollagen[MD=11.63,95% CI (10.04,13.21),P<0.01],β-C-terminal telopeptides of type Ⅰ collagen[MD=-0.22,95% CI(-0.27,-0.18),P<0.01],and 25-hydroxy-vitamin D[MD=3.07,95% CI(2.22,3.92),P<0.01].Conclusion The combination of IGU and MTX is more effective than MTX monotherapy in improving the bone metabolism in RA patients.Subject to the quantitative and qualitative limitations of the studies included,more high-quality studies would be needed to further validate the results.