Boston Children's Hospital, Boston, MA 02115, USA.
Lupus. 2012 Nov;21(13):1433-43. doi: 10.1177/0961203312458466. Epub 2012 Aug 24.
The safety and efficacy of mycophenolate mofetil (MMF) were evaluated in adolescent patients with systemic lupus erythematosus and active or active/chronic class III-V lupus nephritis. During the 24-week induction phase, patients were randomized to oral MMF (target dose 3.0 g/day) or intravenous cyclophosphamide (IVC) (0.5-1.0 g/m(2)/month), plus prednisone. Response was defined as a decrease in 24-hour urine protein:creatinine ratio (P:Cr) to < 3 in patients with baseline nephrotic range proteinuria, or by ≥ 50% if subnephrotic baseline proteinuria, and stabilization (± 25%) or improvement in serum creatinine. In the 36-month maintenance phase, induction therapy responders were randomized 1:1 to MMF (1.0 g twice daily) or oral azathioprine (AZA) (2 mg/kg/day), plus prednisone. In the induction phase, 10 patients received MMF and 14 received IVC; 15 (62.5%) achieved treatment response (MMF, 7 (70%); IVC, 8/15 (57.1%); p = 0.53, odds ratio (95% confidence interval) 2.0 (0.2, 15.5)). There was a non-statistically significant difference in maintenance of response to MMF (7/8; 87.5%) versus AZA (3/8; 37.5%). Seven patients withdrew (MMF, 2; AZA, 5). During both phases, rates of serious adverse events were similar in both arms. During both phases treatment response with MMF was as effective as the comparator.
霉酚酸酯（MMF）在患有系统性红斑狼疮和活动或活动/慢性 III-V 级狼疮性肾炎的青少年患者中的安全性和疗效进行了评估。在 24 周的诱导期，患者被随机分配接受口服 MMF（目标剂量 3.0 g/天）或静脉注射环磷酰胺（IVC）（0.5-1.0 g/m2/月）加泼尼松。反应定义为基线肾病范围蛋白尿患者的 24 小时尿蛋白：肌酐比（P:Cr）下降至<3，或亚肾病基线蛋白尿下降≥50%，以及血清肌酐稳定（±25%）或改善。在 36 个月的维持期，诱导治疗应答者以 1:1 的比例随机分配接受 MMF（1.0 g 每日两次）或口服硫唑嘌呤（AZA）（2 mg/kg/天）加泼尼松。在诱导期，10 名患者接受 MMF，14 名患者接受 IVC；15 名（62.5%）患者达到治疗反应（MMF 7 名[70%]；IVC 8/15 [57.1%]；p=0.53，优势比（95%置信区间）2.0（0.2，15.5））。MMF（7/8；87.5%）与 AZA（3/8；37.5%）的维持反应率存在无统计学意义的差异。7 名患者退出（MMF，2 名；AZA，5 名）。在两个阶段，严重不良事件的发生率在两个治疗组中相似。在两个阶段，MMF 的治疗反应与对照组一样有效。
