■高剂量类固醇被推荐用于诱发特发性肾病综合征。这项研究的目的是比较标准诱导治疗与霉酚酸酯(MMF)。我们假设MMF在维持类固醇诱导的缓解方面可能不劣于类固醇。第二个目标是减少类固醇引起的副作用。
■这是一项观察性研究。
■在标准类固醇治疗2周内进入缓解期的2-11年肾病综合征首发患者符合入选条件。实验组患者完成了12周的MMF诱导,而对照组继续标准的12周类固醇方案。
■MMF和泼尼松龙用于研究。
■主要研究结果是52周随访期间的复发率和无复发间隔。
■描述性统计用于分析。
■41名符合条件的患者中有10名同意参加MMF组,8名完成了研究。对照组包括31例患者,23例完成52周随访的患者。在诱导阶段,MMF组10例患者中有3例(30%),对照组31例中有1例(3%)复发(P=0.04)。在52周的随访期间,MMF组10例患者中有7例(70%),对照组31例中有19例(61%)复发(P=0.72)。MMF组和对照组的中位无复发间隔为11周和19周,分别为(P=0.60)。两组均无严重副作用。
■本研究的局限性是接受MMF和单中心设计的患者数量少。
■我们的一小组接受MMF治疗的患者报告在诱导阶段有较高的复发率。然而,随访12个月时,两组的复发率和无复发间期相似.所有患者均耐受MMF,无明显副作用,那些复发的人仍然对类固醇敏感。
尽管已知其副作用,类固醇仍然是儿童新发肾病综合征的标准诱导疗法。这项研究的目的是评估霉酚酸酯(MMF)在维持类固醇诱导的缓解方面是否可以像类固醇一样成功。在类固醇治疗2周内获得缓解的患者要么继续使用类固醇再治疗10周,要么改用MMF。研究结果表明,MMF组的复发率和感染率更高。到12个月,两组之间的复发率和无复发间隔没有差异。正在进行更大的多中心研究,以证明MMF在类固醇敏感性肾病综合征中对类固醇的非劣效性。
UNASSIGNED: High-dose steroids are recommended for the
induction of idiopathic nephrotic syndrome. The aim of this
study was to compare standard
induction therapy with Mycophenolate Mofetil (MMF). We hypothesized that MMF could be noninferior to steroids in maintaining steroid-induced remission. The second aim was to reduce steroid-induced side effects.
UNASSIGNED: This was an observational
study.
UNASSIGNED: Patients 2-11 years with first episode of nephrotic syndrome who entered remission within 2 weeks of standard steroid treatment were eligible for enrollment. Patients in the experimental group completed 12-week
induction with MMF, whereas the control group continued a standard 12-week steroid protocol.
UNASSIGNED: MMF and prednisolone were used in the
study.
UNASSIGNED: The primary study outcomes were relapse rate and relapse-free interval during a 52-week follow-up.
UNASSIGNED: Descriptive statistics were used for analysis.
UNASSIGNED: Ten of 41 eligible patients consented to participate in the MMF group and 8 completed the study. The control group included 31 patients, with 23 patients who completed 52 weeks follow-up. During the induction phase, 3 out of 10 patients (30%) in the MMF group and 1 out of 31 (3%) in the control group (P = 0.04) developed relapse. During the 52 weeks follow-up period, 7 out of 10 patients (70%) in the MMF group and 19 out of 31 (61%) in the control group developed relapse (P = 0.72). The median relapse-free interval was 11 and 19 weeks in MMF and control groups, respectively (P = 0.60). No serious side effects were recorded in either group.
UNASSIGNED: The limitations of the study were low patient numbers receiving MMF and single-center design.
UNASSIGNED: Our small cohort of patients treated with MMF reported a higher relapse rate during the induction phase. However, by 12 months of follow-up the relapse rate and relapse-free intervals were similar between both groups. All patients tolerated MMF without significant side effects, and those who relapsed remained steroid-sensitive.
Despite their known side effects steroids remain a standard induction therapy for new onset nephrotic syndrome in children. The aim of this study was to assess whether mycophenolate mofetil (MMF) can be as successful as steroids in maintaining steroid-induced remission. Patients who achieved remission within 2 weeks of steroid treatment had either continued steroids for an additional 10 weeks or switched to MMF. The results of the study showed a higher relapse and infection rate in the MMF group. By 12 months there were no differences in the relapse rate and relapse-free interval between the groups. Larger multicenter studies are underway to demonstrate noninferiority of MMF to steroids in steroid-sensitive nephrotic syndrome.