阿普斯特用于治疗银屑病关节炎的疗效和安全性的Meta分析

A Meta-analysis of clinical efficacy and safety of apremilast in psoriatic arthritis patients

目的:评价阿普斯特(apremilast,APR)治疗银屑病关节炎(psoriatic arthritis,PsA)的有效性和安全性。方法:检索"PubMed"、"Cochrane Library"、"OVID"公开发表的相关研究,并查询"clinictrials.gov"。进行文献质量评价和资料提取,用Rev Man5.3.5软件进行Meta分析。结果:共纳入随机对照试验(randomized controlled trial,RCT)文献6篇,共计1 645例PsA患者。Meta分析结果显示,在治疗PsA的有效性方面,治疗12周或16周后,APR各剂量组合并后ACR20缓解率高于安慰剂对照组,RR=1.67[95%CI(1.36,2.05),P<0.000 01];HAQ-DI(Health assessment questionnaire-disability index)也优于安慰剂对照组,WMD=-0.14[95%CI(-0.17,-0.11),P<0.000 01]。在安全性方面,APR各剂量组合并后不良事件(adverse event,AEs)发生率高于安慰剂对照组,RR=1.91[95%CI(1.41,2.59),P<0.000 1]。结论:APR治疗可有效延缓或改善PsA病情,虽然导致不良反应,但患者耐受性良好。

OBJECTIVE To assess the clinical efficacy and safety of apremilast（APR）against psoriatic arthritis（PsA）.METHODS Studies were searched in PubMed,Cochrane Library,OVID,‘clinicaltrails.gov＇.After information collection and methodology quality evaluation,Meta-analysis was performed using Rev Man 5.3 software.RESULTS A total of 6 randomized controlled trials（RCTs）and 1 645 patients were included.The results of Meta-analysis indicated that,compared with controlled studies,APR combined ACR20 had higher remission and superior Health Assessment Questionnaire-Disability Index（HAQ-DI）compared to placebo（PBO）（RR=1.67,95% CI（1.36,2.05）,P0.000 01;WMD=-0.14,95% CI（-0.17,-0.11）,P0.000 01,respectively）,and the incidence rates of adverse events（AEs）were higher than those of PBO（RR=1.91,95% CI（1.41,2.59）,P0.000 1）.CONCLUSION APR is effective and safe in PsA patients.