rhTNFR-Fc治疗强直性脊柱炎的临床疗效及安全性的Meta分析

发布时间：2019-06-18 08:31

【摘要】：目的:评价rhTNFR-Fc治疗强直性脊柱炎(AS)的临床疗效及安全性。方法:计算机检索PubMed、Cochrane Library、ISI、CNKI、VIP、CBM和万方数据库,检索时限均从建库至2017年2月,按照纳入和排除标准纳入rhTNFR-Fc与传统药物治疗AS的随机对照研究。两名研究者独立提取数据,参照Cochrane协作网偏倚风险评价标准进行方法学质量评价,采用RevMan 5.3软件进行Meta分析。结果:共纳入17个随机对照研究,包含1410例AS患者。Meta分析结果示在有效率[RR=1.38,95%CI(1.17,1.62)]、BASDAI[MD=-1.42,95%CI(-1.76,-1.08)]、BASFI[MD=-1.51,95%CI(-1.80,-1.21)]、ASAS20[RR=2.12,95%CI(1.53,2.94)]、脊柱疼痛[SMD=-0.74,95%CI(-0.99,-0.50)]、晨僵[SMD=-1.19,95%CI(-1.53,-0.85)]、枕壁距[MD=-0.68,95%CI(-1.33,-0.03)]、扩胸度[MD=0.24,95%CI(0.01,0.48)]、脊柱侧弯[MD=2.68,95%CI(1.04,4.32)]、Schober试验[MD=0.68,95%CI(0.44,0.91)]、ESR[MD=-7.02,95%CI(-9.13,-4.92)]、CRP[SMD=-0.62,95%CI(-0.79,-0.46)]及TNF-α[SMD=-0.79,95%CI(-1.17,-0.41)]方面,rhTNFR-Fc组与传统药物组间的差异有统计学意义。在注射局部皮肤不良反应[RR=5.39,95%CI(2.50,11.65)]、上呼吸道感染[RR=3.97,95%CI(1.02,15.4 2)]、白细胞减少[RR=0.23,95%CI(0.08,0.67)]、胃肠道不良反应[RR=0.10,95%CI(0.04,0.28)]及肝功能异常[RR=0.32,95%CI(0.15,0.66)]方面,Meta分析结果显示两组间的差异有统计学意义。结论:rhTNFR-Fc能显著提高临床疗效,增加治疗有效率、达到ASAS20的例数,改善BASDAI、BASFI、脊柱疼痛、晨僵、枕壁距、扩胸度、脊柱侧弯、Schober试验,降低ESR、CRP及TNF-α水平。在不良反应方面,白细胞减少、胃肠道不良反应及肝功能异常发生的频数减少,但注射局部皮肤不良反应、上呼吸道感染发生的频数增加。由于纳入研究的局限性,仍需大样本、高质量、长时间的临床观察进一步评估rhTNFR-Fc治疗AS的真实临床疗效及安全性,探索最佳用药周期及剂量调定方案。
[Abstract]:Objective: to evaluate the clinical efficacy and safety of rhTNFR-Fc in the treatment of ankylosing spondylitis (AS). Methods: PubMed,Cochrane Library,ISI,CNKI,VIP,CBM and Wanfang database were searched by computer, and the retrieval time was from database establishment to February 2017. A randomized controlled study of rhTNFR-Fc and traditional drug therapy AS was included according to the criteria of inclusion and exclusion. The data were extracted independently by the two researchers, and the methodological quality was evaluated according to the bias risk evaluation standard of Cochrane collaborative network. Meta analysis was carried out by RevMan 5.3 software. Results: a total of 17 randomized controlled studies were included, including 1410 patients with AS. Meta-analysis showed that the effective rate [RR=1.38,95%CI (1.17, 1.62)], BASDAI [MD =-1.42, 95% CI (- 1.76, 鈮，

本文编号：2501330