| Objective: To systematically evaluate the efficacy and safety of leflunomide(LEF)in the induction remission and maintenance of treatment for lupus nephritis(LN).Methods: Databases including Cochrane Library Central,Pub Med,Embase,Chinese Biomedical literature database(CBM),China national knowledge infrastructure(CNKI),Wanfang Data(Wan Fang)and China science and technology journal database(VIP),etc.The retrieval time from January 1998 to December 2019.Literature screening according to inclusion and exclusion criteria,data extraction and quality evaluation of inclusion documents.Meta-analysis using Review Manager software(Rev Man 5.3).Results : A total of 1108 literatures were retrieved and finally included in 38 randomized controlled trials(RCTs)for Meta analysis,of which 33 were induced remission(n=2147)and 5 were maintained therapy(n=477).The results of Meta analysis showed that:(1)In induction therapy,comparison with cyclophosphamide(CTX),LEF can significantly improve the total remission rate(OR=2.70,95%CI 2.03-3.59,P<0.00001),the complete remission rate(OR=1.81,95%CI 1.52-2.17,P<0.00001),reduction of 24-hour urinary protein(MD=-0.56,95%CI-0.77--0.36,P<0.00001)and serum creatinine levels(MD=-10.60,95%CI-15.95--5.25,P=0.0001),raised serum albumin(MD=2.58,95%CI 1.32-3.85,P<0.0001),complement C3 levels(MD=0.12,95%CI 0.06-0.18,P=0.002),there was no significant difference between the two groups in increasing partial remission rate(OR=1.05,95%CI 0.88-1.25,P=0.58)and decreasing SLEDAI score(MD=-0.11,95%CI-0.57-0.35,P=0.65).In terms of security,LEF can significantly reduce the incidence of digestive tract reactions(OR=0.42,95%CI0.30-0.60,P<0.00001),liver dysfunction(OR=0.63,95%CI 0.43-0.93,P=0.02),leukopenia(OR=0.23,95%CI 0.14-0.38,P<0.00001),infection(OR=0.44,95%CI 0.29-0.68,P=0.002),alopecia(OR=0.41,95%CI 0.22-0.77,P=0.005),menstrual disorders(OR=0.34,95%CI 0.16-0.72,P=0.005),there was no significant difference in the incidence of rash between the two groups(OR=0.69,95%CI 0.42-1.13,P=0.14).(2)In maintenance therapy,LEF can reduce the incidence of total adverse reactions(OR=0.57,95%CI 0.33-0.97,P=0.04)and menelipsis(OR=0.1,95%CI 0.03-0.31,P<0.0001)in four cases compared with compared with CTX,with no statistically significant difference in relapse rates between the two groups(OR=0.92,95%CI 0.43-1.94,P=0.82).Two articles were Compared with azathioprine(AZA),there was no significant difference between the two groups in relapse rate and total adverse reaction rate(OR=0.68,95%CI0.31-1.46,P=0.32 and OR=1.09,95%CI 0.66-1.81,P=0.74,respectively).In addition,the results of two LEF and AZA studies and one LEF and MMF comparative study show that: There was no significant difference between LEF and MMF,LEF and AZA in induction therapy,while the incidence of adverse reactions of LEF was higher than that of MMF.Conclusion : The existing research evidence suggests that : in the treatment of LN induced remission,the overall efficacy of LEF was significantly less than CTX;It is similar to AZA and Mycophenolate mofetil(MMF).In maintenance therapy,the LEF and CTX effects were comparable and the adverse reactions were significantly less than CTX;The recurrence rate and adverse reaction rate of LN were not increased compared with AZA.More high-quality,multicenter,long-term clinical studies are needed to confirm the efficacy and safety of LEF treatment LN. |
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