Efficacy and safety of high-dose of mycophenolate mofetil compared with cyclophosphamide pulse therapy as induction therapy in Japanese patients with proliferative lupus nephritis
Efficacy and safety of high-dose of mycophenolate mofetil compared with cyclophosphamide pulse therapy as induction therapy in Japanese patients with proliferative lupus nephritis
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DOI：
10.1093/mr/roab113
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发表时间：
2021-12-16
影响因子：
2.2
通讯作者：
Tanaka，Yoshiya
中科院分区：
文献类型：
--
作者：
Ohkubo，Naoaki;Iwata，Shigeru;Tanaka，Yoshiya
目的 明确吗替麦考酚酯（MMF）诱导治疗狼疮性肾炎（LN）患者的有效性和安全性。方法纳入2015年7月至2020年6月期间接受MMF（n= 35）或静脉环磷酰胺冲击疗法（IVCY）（n= 25）加大剂量皮质类固醇治疗的LN患者。 MMF 从 2 克/天增加到 3 克/天，没有出现不良事件 (AE)。主要终点是 6 个月肾缓解率。次要终点为保留率和AE。结果两组患者的年龄、性别、病程、肾脏组织学类型、SLE疾病活动指数、尿蛋白肌酐比值无显着差异。 26 名患者 (74%) 继续接受 MMF 治疗，而 12 名患者 (48%) 完成了 6 个 IVCY 疗程。 MMF 组的保留率显着高于 IVCY 组 (p= 0.048)。 MMF 组和 IVCY 组分别有 24 名和 14 名患者实现肾病缓解，但差异不显着。 MMF组和IVCY组分别有8例和14例患者观察到3级或以上AE（p= 0.014）。 结论 对于日本增殖性LN患者，高剂量MMF的疗效与IVCY相当，AE较少，保留率高于IVCY，表明MMF具有较高的耐受性。
ObjectivesTo clarify the effectiveness and safety of induction therapy with mycophenolate mofetil (MMF) in patients with lupus nephritis (LN).MethodsPatients with LN administered MMF (n= 35) or intravenous cyclophosphamide pulse therapy (IVCY) (n= 25) plus high-dose corticosteroids between July 2015 and June 2020 were included. MMF was increased from 2 to 3 g/day, with no adverse events (AEs). The primary endpoint was the 6 month renal remission rate. Secondary endpoints were retention rate and AEs.ResultsThere were no significant differences in age, sex, disease duration, renal histological type, SLE disease activity index, and urine protein creatinine ratio between the two groups. Twenty-six patients (74%) continued with MMF therapy, whereas 12 (48%) completed six IVCY courses. The retention rate was significantly higher in the MMF than in the IVCY group (p= 0.048). Twenty-four and 14 patients in MMF and IVCY groups, respectively, achieved renal remission with insignificant differences. Grade 3 or higher AEs were observed in 8 and 14 patients in the MMF and IVCY groups, respectively (p= 0.014).ConclusionsThe efficacy of high-dose MMF was comparable to that of IVCY in Japanese patients with proliferative LN, with fewer AEs and a higher retention rate than IVCY, suggesting the high tolerability of MMF.