小剂量霉酚酸酯与环磷酰胺诱导治疗严重狼疮肾炎疗效比较

Comparison of Efficacy of Low Dose Mycophenolate Mofetil and Cyclophosphamide in the Treatment of Proliferative Lupus Nephritis

目的:评估小剂量霉酚酸酯(MMF)和环磷酰胺(CYC)诱导治疗严重狼疮肾炎(LN)的有效性及安全性。方法:研究对象为84例Ⅲ-Ⅴ型LN患者,随机分为MMF组(n=42)和CYC组(n=42)。治疗6个月后,比较两组患者临床疗效和不良反应。结果:治疗6个月,CYC组血清肌酐由1.73降至0.92 mg/dL,MMF组由1.54降至0.83 mg/dL。eGFR(ml·min^-1·1.73 m^-2)CYC组从70.75增加至89.49,MMF组从68.08增加至88.52。24 h蛋白尿在CYC组从3.36下降到0.73,MMF组从3.31下降到0.53。MMF组患者部分缓解率高于CYC组(28.6%vs 19.0%),但差异无统计学意义。两组患者完全缓解率相同(66.7%)。CYC组治疗失败比例高于MMF组(14.3%vs 4.8%)。CYC不良事件发生率显著高于MMF组(112 vs 30事件)。结论:小剂量MMF和CYC在LN诱导治疗中,在减轻蛋白尿和改善肾功能方面具有同等疗效,但是MMF不良事件发生率低于CYC组。

Objective:Objective To evaluate and compare the effectiveness and safety of low dose mycophenolate mofetil(MMF)and cyclophosphamide(CYC)in induction therapy of proliferative lupus nephritis(LN).Methods:The subjects were 84 patients withⅢ-ⅤLN,who were randomly divided into MMF group(n=42)and CYC group(n=42).After 6 months of treatment,the clinical efficacy and adverse reactions of the two groups were compared.Results:At 6 months,serum creatinine decreased from 1.73 to 0.92 in CYC and from 1.54 to 0.83 in the MMF group with improvement in eGFR(ml/min/1.73 m^2)from 70.75 to 89.49 in CYC and from 68.08 to 88.52 in MMF group.Twenty-four-hour urinary protein reduced from 3.36 to 0.73 in CYC and from 3.31 to 0.53 in the MMF group.Partial remission achieved in higher percentage of patients with MMF than CYC(28.6%vs 19.0%)while equal proportion of patients(66.7%in each group)achieved complete remission in both groups.Number of non-responders was higher in CYC group than in the MMF group(14.3%vs 4.8%).The occurrence of adverse events was higher in the CYC than in MMF group(112 vs 30 events).Conclusion:Present study has concluded that MMF,used in relatively lower dose,is equally effective in inducing remission with reduction of proteinuria and improvement of kidney function with lesser adverse events than CYC in the induction therapy of proliferative lupus nephritis.