Efficacy And Safety Of Iguratimod Versus Hydroxychloroquine For Primary Sjogren’s Syndrome:a Meta-analysis

Background and objective:Primary Sjogren’s syndrome（p SS）is a chronic inflammatory autoimmune disease characterized by lymphocyte infiltration and inflammation of the exocrine glands.Hydroxychloroquine,methotrexate,and Iguratimod are commonly used to prevent disease progression in Patients.There is a lack of data on the efficacy and safety of direct comparison of p SS between different immunosuppressants.Therefore,this study systematically evaluated the efficacy and safety of Iguratimod and hydroxychloroquine in the treatment of p SS in order to provide a theoretical basis for the choice of clinical treatment options.Methods:Pub Med,The Cochrane Library,Embase,Web of Science,CBM,VIP,CNKI and Wan Fang Data databases were electronically searched to gather randomized controlled trials（RCTs）on the effectiveness and safety of Iguratimod and hydroxy-chloroquine in the treatment of p SS from the establishment of the database to December 2021.According to the included and exclusion criteria,two researchers screened literatures that meet the criteria,used methodological quality evaluation standards to evaluate the quality of the literature,and extracted information from the included studies.Rev Man 5.4 software was used to perform Meta analysis.Results:A total of 12 RCTs involving 1004 patients were enrolled.This study evaluated the clinical efficacy,laboratory indicators and safety of Iguratimod in the treatment of p SS.1.Clinical efficacy:Meta-analysis results showed that:Iguratimod combined with methylprednisolone increased total treaement efficicency[RR=1.23,95%CI（1.16,1.31）,P<0.001],decreased ESSDAI score[MD=-1.94,95%CI（-2.55,-1.33）,P<0.001],decreased ESSPRI score[MD=-2.16,95%CI（-2.98,-1.34）,P<0.001],increased Schirmeri test value[MD=2.09,95%CI（1.62,2.56）,P<0.001],increased saliva flow rate[MD=0.39,95%CI（0.29,0.49）,P<0.001]better than hydroxy-chloroquine combined with methylprednisolone in the treatment of p SS.2.laboratory indicators:Meta-analysis results showed that:Compared with the hydroxychloroquine group,the treatment of p SS in the Iguratimod group was more effective in reducing Ig G[MD=-2.96,95%CI（-3.55,-2.37）,P<0.001],ESR[MD=-5.67,95%CI（-8.02,-3.33）,P<0.001]and RF[MD=-4.53,95%CI（-5.80,-3.25）,P<0.001],increasing PLT[MD=11.29,95%CI（7.53,15.06）,P<0.001],decreasing the percentage of CD19⁺CD27⁺B cells[MD=-0.04,95%CI（-0.06,-0.02）,P<0.001),and ACL[MD=-0.33,95%CI（-0.50,-0.16）,P<0.001].3.Safety evaluation:There were no significant differences in the total incidence of adverse reactions in the treatment of p SS between the Iguratimod group and the hydroxychloroquine group[RR=0.69,95%CI（0.47,1.00）,P=0.05].The safety of two groups was similar.Conclusion:1.The Iguratimod combined with methylprednisolone was superior to hydroxy-chloroquine combined with methylprednisolone in alleviating clinical symptoms of p SS.2.Compared with hydroxychloroquine group,Iguratimod group can improve laboratory indicators of p SS patients more effectively,such as reducing Ig G,RF,ESR levels and increasing PLT levels.3.There were no serious adverse reactions in the treatment of p SS with Iguratimod combined with methylprednisolone,and the safety was similar to hydroxychloroquine combined with methylprednisolone.