【摘要】：目的:評價rhTNFR-Fc治療強(qiáng)直性脊柱炎(AS)的臨床療效及安全性。方法:計算機(jī)檢索PubMed、Cochrane Library、ISI、CNKI、VIP、CBM和萬方數(shù)據(jù)庫,檢索時限均從建庫至2017年2月,按照納入和排除標(biāo)準(zhǔn)納入rhTNFR-Fc與傳統(tǒng)藥物治療AS的隨機(jī)對照研究。兩名研究者獨立提取數(shù)據(jù),參照Cochrane協(xié)作網(wǎng)偏倚風(fēng)險評價標(biāo)準(zhǔn)進(jìn)行方法學(xué)質(zhì)量評價,采用RevMan 5.3軟件進(jìn)行Meta分析。結(jié)果:共納入17個隨機(jī)對照研究,包含1410例AS患者。Meta分析結(jié)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)]、擴(kuò)胸度[MD=0.24,95%CI(0.01,0.48)]、脊柱側(cè)彎[MD=2.68,95%CI(1.04,4.32)]、Schober試驗[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組與傳統(tǒng)藥物組間的差異有統(tǒng)計學(xué)意義。在注射局部皮膚不良反應(yīng)[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)]、白細(xì)胞減少[RR=0.23,95%CI(0.08,0.67)]、胃腸道不良反應(yīng)[RR=0.10,95%CI(0.04,0.28)]及肝功能異常[RR=0.32,95%CI(0.15,0.66)]方面,Meta分析結(jié)果顯示兩組間的差異有統(tǒng)計學(xué)意義。結(jié)論:rhTNFR-Fc能顯著提高臨床療效,增加治療有效率、達(dá)到ASAS20的例數(shù),改善BASDAI、BASFI、脊柱疼痛、晨僵、枕壁距、擴(kuò)胸度、脊柱側(cè)彎、Schober試驗,降低ESR、CRP及TNF-α水平。在不良反應(yīng)方面,白細(xì)胞減少、胃腸道不良反應(yīng)及肝功能異常發(fā)生的頻數(shù)減少,但注射局部皮膚不良反應(yīng)、上呼吸道感染發(fā)生的頻數(shù)增加。由于納入研究的局限性,仍需大樣本、高質(zhì)量、長時間的臨床觀察進(jìn)一步評估rhTNFR-Fc治療AS的真實臨床療效及安全性,探索最佳用藥周期及劑量調(diào)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，

本文編號：2501330