麦考酚吗乙酯联合来氟米特与麦考酚吗乙酯单药维持治疗狼疮肾炎的疗效对比

摘要

目的 比较麦考酚吗乙酯(MMF)联合来氟米特与MMF单药维持治疗狼疮肾炎的疗效和安全性.方法 收集经诱导治疗达到完全缓解或部分缓解后的44例Ⅲ～Ⅴ型狼疮肾炎患者临床资料,按其治疗方案分为多靶点组21例与单药组23例,2组在相同的综合治疗基础上,多靶点组予MMF 0.5 g每日2次联合来氟米特10 mg/d,单药组予MMF 0.5 g每日2次,总观察时间18个月,比较治疗前后疗效(主要观察终点为肾脏复发)及安全性.结果 2组治疗后均未出现死亡和终末期肾病患者.多靶点组维持治疗狼疮肾炎的无复发生存率高于单药组(95％vs.70％,P＜0.05).多靶点组完全缓解率高于单药组(81％ vs.44％,P＜0.05),且多靶点组患者维持治疗后完全缓解率高于治疗前(81％ vs.24％,P＜0.01),单药组治疗前后完全缓解率比较差异无统计学意义(35％ vs.44％,P＞0.05).2组患者的不良反应以感染及胃肠道症状最为常见,组间不良反应发生率比较差异无统计学意义(P＞0.05).结论 MMF联合来氟米特多靶点维持治疗狼疮肾炎预防肾脏复发和维持肾脏完全缓解均优于MMF单药治疗.%Objective To compare the clinical efficacy and safety between mycophenolate mofetil (MMF) in combination with leflunomide and MMF alone in the maintenance therapy of lupus nephritis.Methods Clinical data of 44 patients with type Ⅲ-Ⅴ lupus nephritis who obtained complete remission (CR) or partial remission (PR) after induction treatment were collected.All patients were assigned into the multi-target (n =21) and monotherapy groups (n =23).Besides the comprehensive treatment,MMF at a dose of 0.5 g twice a day in combination with leflunomide at a dose of 10 mg/d was administered in the multi-target group,and MMF at a dosage of 0.5 g was given twice daily in the monotherapy group.The duration of follow-up was 18 months.The clinical efficacy (renal flare as the end-point event) and safety before and after corresponding treatment were statistically compared.Results In both groups,no patient died or presented with end-stage renal disease after treatment.In the multi-target group,the lupus nephritis recurrence-free survival rate was 95％,significantly higher compared with 70％ in the monotherapy group (P ＜ 0.05).In the multi-target group,the CR rate was 81％,higher than 44％ in the monotherapy group (P ＜0.05).In the multi-target group,the CR rate after treatment was 81％,higher than 24％ before treatment (P ＜0.01),whereas no statistical significance was observed in the monotherapy group in terms of CR rate before and after treatment (35％vs.44％,P ＞0.05).In both groups,infection and gastrointestinal symptom were the most common adverse events.No statistical significance was noted regarding the incidence of adverse events between two groups (P ＞0.05).Conclusion Compared with the MMF monotherapy,MMF in combination with leflunomide maintenance therapy is more efficacious in preventing the incidence of renal flare and maintaining the CR of kidney.