赛妥珠单抗治疗类风湿性关节炎疗效及不良反应的荟萃分析

Efficacy and safety of Certolizumab pegol in treatment of rheumatoid arthritis:a meta-analysis

目的:探究赛妥珠单抗治疗类风湿性关节炎的有效性及安全性。方法:计算机检索Pubmed、Medline、Embase、The Cochrane Library、万方数据库(WANFANG)、中国期刊全文数据库(CNKI)、中国生物医学文献数据库中关于赛妥珠单抗与安慰剂治疗类风湿性关节炎的随机对照研究(Randomized controlled trials,RCTs),检索时限均为建库至2015年3月。采用Rev Man5.3软件进行统计分析。结果:共纳入10篇文献、8项研究,纳入文献质量均较高,本meta分析结果显示CZP在改善类风湿患者病情的疗效(ACR20、ACR50、ACR70),关节疾病活动性评分,患者对疾病活动性评价指标(HAQ-DI、关节疼痛、疲劳)方面优于安慰剂组。在轻度、中度、重度不良反应方面两组差异无统计学意义,CZP并未增加不良反应的发生率。结论:CZP能减缓患者关节炎症进展,改善患者关节功能,提高患者生活质量,短期安全性较高,CZP长期疗效及安全性有待于进一步研究证实。

Objective： To explore the efficacy and safety of Certolizumab pegol in patients with rheumatoid arthritis. Methods：Such databases as Pubmed,Medline,Embase,The Cochrane Library,WANFANG,CNKI,Science,CBM and VIP were searched from their establishment to March 2015 for collecting the randomized controlled trials comparing Certolizumab pegol and placebo in the treatment of RA. The meta-analysis was undertaken using Rev Man5. 3 for Windows. Results： Ten publications and eight researches met the inclusion criteria with high quality. The results revealed CZP significantly improved the ACR20,ACR50,ACR70 response rates,and physical function. CZP was associated with a statistically significant reduction in Disease Activity Score in 28 joints-Erythrocyte sedimentation rate,arthritis pain,and fatigue. There were no significant differences of incidence of treatment-related adverse events between CZP group and placebo group. Conclusion： CZP significantly reduced the RA signs and symptoms,improved physical function and life quality as compared with the placebo in the treatment of RA. More large-scale RCTs are needed to evaluate the long-term efficacy and safety of CZP in the treatment of RA.