阿达木单抗治疗对缓解抗风湿性药物无效的类风湿性关节炎的系统评价

Adalimumab for Rheumatoid Arthritis Failing to Respond to Disease-Modifying Anti-Rheumatic Drugs:A Systematic Review

目的系统评价阿达木单抗对缓解抗风湿性药物无效的类风湿性关节炎的疗效和安全性。方法计算机检索Cochrane Library、PubMed、EMbase、中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊全文数据库和万方数据库,检索时间从各数据库建库至2010年6月;同时手检相关领域杂志,全面查找符合纳入标准的随机对照试验(RCT),用RevMan 5.0软件进行统计分析。结果共纳入4个RCT,研究地点均在国外,研究质量均较高,各试验间具有基线可比性。Meta分析结果显示:阿达木单抗和安慰剂在ACR20、ACR50和ACR70、触痛关节数、肿胀关节数、患者对疼痛的评估、患者对疾病活动性的综合评价、医生对疾病活动性的综合评价和患者对活动能力的评价方面的差异有统计学意义,而在严重不良反应、难治的不良反应和严重感染方面的差异无统计学意义。结论阿达木单抗可以作为治疗对缓解抗风湿性药物无效的类风湿性关节炎的药物,但在临床使用时,一定要权衡其效益和危险。

Objective To evaluate the efficacy and safety of adalimumab for rheumatoid arthritis failing to respond to disease-modifying anti-rheumatic drugs（DMARDs）.Methods The Cochrane Library,PubMed,EMbase,CBM,CNKI,VIP and Wanfang（from the date of their establishments to June 2010） were searched,and journals of relevant fields were retrieved to identify randomized controlled trials（RCTs）.The data were analyzed by using RevMan 5.0 software.Results Four RCTs were included,all of which were from abroad and with good methodological quality.The baseline data of each trial were comparable.Meta-analyses showed that there was a significant difference between the adalimumab and the placebo in terms of ACR20,ACR50,ACR70,tender joint count,swollen joint count,patient assessment of pain,patient global assessment of disease activity,doctor global assessment of disease activity,and disability index of the HAQ.There was no difference between the adalimumab and the placebo in terms of serious adverse events,intractable adverse events and serious infection.Conclusion Adalimumab can treat rheumatoid arthritis failing to respond to DMARDs,but clinically the doctor should balance the benefit and the risk of the adalimumab.