吗替麦考酚酯联合来氟米特或他克莫司诱导治疗狼疮肾炎的疗效及安全性比较

Comparison of the efficacy and safety of mycophenolate mofetil combined with leflunomide or tacrolimus induction in the treatment of lupus nephritis

目的评估吗替麦考酚酯(mycophenolate mofetil,MMF)联合来氟米特(leflunomide,LEF)或他克莫司(tacrolimus,TAC)诱导治疗狼疮肾炎(lupus nephritis,LN)的疗效和安全性。方法从单用MMF或环磷酰胺(cyclophosphamide,CYC)治疗无效的LN患者中筛选出改用MMF(1 g/d)联合LEF(20 mg/d)或TAC(2 mg/d)治疗的患者,分析两组间缓解达标率、实验室指标及不良反应差异。结果共纳入LN患者278例,从中筛选出38例并分为MMF+LEF组和MMF+TAC组,每组各19例,分析两组患者治疗情况结果显示:(1)治疗LN缓解达标中,治疗3个月时MMF+LEF组有7例(36.84%),MMF+TAC组有10例(52.63%);治疗6个月时MMF+LEF组有10例(52.63%),MMF+TAC组有14例(73.68%);治疗3个月、6个月两组间的达标率差异均无统计学意义(均P>0.05);(2)治疗6个月后,两组补体成分3(component 3,C3)、补体成分4(component 4,C4)、尿素氮、白蛋白、免疫球蛋白(immunoglobulin,Ig)A、IgM、尿总蛋白/尿液肌酐前后比较差异均有统计学意义(均P<0.05);治疗3个月、6个月时两组间差异均无统计学意义(均P>0.05);(3)两组不良反应差异无统计学意义(P>0.05)。结论MMF联合LEF和联合TAC均可改善LN病情,两者缓解达标率和安全性无明显差异。

Objective To evaluate the efficacy and safety of mycophenolate mofetil(MMF)in combination with either leflunomide(LEF)or tacrolimus(TAC)as induction therapy for lupus nephritis(LN).Methods Patients with refractory LN who did not respond to monotherapy with MMF or cyclophosphamide(CYC)were selected for switching to combination therapy with MMF(1 g/d)plus either LEF(20 mg/d)or TAC(2 mg/d).The remission rates,laboratory parameters,and adverse reactions were compared between the two groups.Results A total of 278 patients with LN were included,and 38 patients(19 in each group)were selected for analysis.The results showed that:(1)In terms of achieving remission in LN,at 3 months,there were 7 cases(36.84%)in the MMF+LEF group and 10 cases(52.63%)in the MMF+TAC group;at 6 months,there were 10 cases(52.63%)in the MMF+LEF group and 14 cases(73.68%)in the MMF+TAC group.However,the differences in remission rates between the two groups at 3 months and 6 months were not statistically significant(all P>0.05).(2)After 6 months of treatment,there were statistically significant differences in complement C3,C4,blood urea nitrogen,albumin,IgA,IgM,and urine total protein/creatinine ratio between the two groups(all P<0.05).However,there were no statistically significant differences between the two groups at 3 months and 6 months(all P>0.05).(3)There were no significant differences in adverse reactions between the two groups(P>0.05).Conclusions Both the combination of MMF and LEF,as well as the combination of MMF and TAC,significantly improved the condition of LN.There were no significant differences in remission rates and safety between the two combinations.