艾拉莫德与羟氯喹治疗原发性干燥综合征有效性和安全性比较的系统分析

Efficacy and safety of Iguratimod and hydroxychloroquine for primary Sjogren’s Syndrome:a meta-analysis

目的:系统评价艾拉莫德(T-614)与羟氯喹(HCQ)治疗原发性干燥综合征(pSS)的有效性及安全性。方法:计算机检索PubMed、The Cochrane Library、Embase、Web of Science、CBM、VIP、WanFang Data和CNKI数据库,从建库至2020年12月间有关T-614和HCQ治疗pSS有效性和安全性的随机对照试验(RCT)。由两名研究者采用方法学质量评价标准进行文献质量评估,采用RevMan 5.3软件进行Meta分析。结果:共纳入12个RCT,包括1004例患者。Meta分析结果显示:T-614组在提高治疗总有效率[RR=1.23,95%CI(1.16,1.31),P<0.00001],降低ESSDAI评分[MD=-1.94,95%CI(-2.25,-1.33),P<0.00001],降低ESSPRI评分[MD=-2.16,95%CI(-2.98,-1.34),P<0.00001],提高Schirmeri试验数值[MD=2.09,95%CI(1.62,2.56),P<0.00001],提高唾液流率[MD=0.39,95%CI(0.29,0.49),P<0.00001],降低IgG[MD=-2.96,95%CI(-3.55,-2.37),P<0.00001],降低ESR[MD=-5.67,95%CI(-8.02,-3.33),P<0.00001],降低RF[MD=-4.53,95%CI(-5.80,-3.25),P<0.00001],升高PLT[MD=11.29,95%CI(7.53,15.06),P<0.00001],降低CD19+CD27+B细胞百分率[MD=-0.04,95%CI(-0.06,-0.02),P<0.0001],降低ACL[MD=-0.33,95%CI(-0.50,-0.16),P<0.0001]方面均优于HCQ组。T-614组与HCQ组不良反应发生率差异无统计学意义[RR=0.69,95%CI(0.47,1.00),P=0.05]。结论:当前证据表明,T-614联合甲泼尼龙治疗pSS的疗效优于HCQ联合甲泼尼龙。二者安全性相当。由于本研究受到纳入文献的数量和质量影响,结论可能存在一定的局限性,仍需大量高质量的研究加以证实。

Objective:To systematically review the efficacy and safety of Iguratimod(T-614)and hydroxychloroquine(HCQ for primary Sjogren’s syndrome(pSS).Methods:PubMed,The Cochrane Library,Embase,Web of Science,CBM,VIP,CNKI and WanFang Data databases were electronically searched to gather randomized controlled trials(RCT)on the effectiveness and safety of T-614 and HCQ in the treatment of pSS from the establishment of the database to December 2020.Two researchers used methodological quality evaluation standards to evaluate the quality of the literature,and RevMan 5.3 software was used to perform Meta analysis.Results:A total of 12 RCT involving 1004 patients were enrolled.The Meta-analysis showed that:compared with HCQ,the T-614 group increased total treatment efficicency[RR=1.23,95%CI(1.16,1.31),P<0.00001],decreased ESSDAI score[MD=-1.94,95%CI(-2.25,-1.33),P<0.00001],decreased ESSPRI score[MD=-2.16,95%CI(-2.98,-1.34),P<0.00001],increased Schirmeri test value[MD=2.09,95%CI(1.62,2.56),P<0.00001],increased saliva flow rate[MD=0.39,95%CI(0.29,0.49),P<0.00001],provided more reduction in IgG[MD=-2.96,95%CI(-3.55,-2.37),P<0.00001],ESR[MD=-5.67,95%CI(-8.02,-3.33),P<0.00001]and RF[MD=-4.53,95%CI(-5.80,-3.25),P<0.00001],increased PLT[MD=11.29,95%CI(7.53,15.06),P<0.00001],decreased percentage of CD19+CD27+B cells[MD=-0.04,95%CI(-0.06,-0.02),P<0.0001]and ACL[MD=-0.33,95%CI(-0.50,-0.16),P<0.0001].There were no significant differences between two groups in the total incidence of adverse reactions[RR=0.69,95%CI(0.47,1.00),P=0.05].Conclusion:Current evidence shows that the efficacy of T-614 combined with Methylprednisolone for pSS were significantly superior to HCQ combined with Methylprednisolone.The safety of T-614 was similar to HCQ.Since this study was affected by the quantity and quality of the included studies,the conclusions may have certain limitations and still need to be confirmed by a large number of high-quality studies.