不同剂量赛妥珠单抗治疗类风湿性关节炎有效性和安全性的系统评价

摘要

Objective:To explore the efficacy and safety about two dosing regimens 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 different dosing regimens of Certolizumab pegol in the treatment of RA.The meta-analysis was undertaken using RevMan5.3 for Windows.Results: Six publications and four researches met the inclusion criteria with high quality.The ACR20,ACR50,ACR70 response rates,and physical function were no significant difference among two dosing regimens of Certolizumab pegol.The difference were not statistically significant associated with 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 two groups.Conclusion: 200 mg CZP and 400 mg CZP were comparable for maintaining clinical response in the treatment of RA.More large-scale RCTs are needed to evaluate the long-term efficacy and safety about different dosing regimens of CZP in the treatment of RA.%目的:探究不同剂量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不同剂量赛妥珠单抗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RevMan5.3软件进行统计分析.结果:共纳入6篇文献、4项研究,纳入文献质量均较高,本meta分析结果显示不同剂量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),轻度、中度、重度不良反应方面差异无统计学意义.结论:不同剂量CZP治疗RA具有相同的治疗效果,短期安全性相似,不同剂量CZP长期疗效及安全性有待于进一步研究证实.