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A Randomized Controlled Trial of Intravenous versus Oral Cyclophosphamide in Steroid-resistant Nephrotic Syndrome in Children

机译:静脉与口服环磷酰胺治疗儿童类固醇耐药性肾病综合征的随机对照试验

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This is a randomized, parallel group, active-controlled trial to compare the efficacy of intravenous cyclophosphamide (IVCP) with oral cyclophosphamide (OCP) in patients with steroid-resistant nephrotic syndrome (SRNS) in children. Fifty consecutive children with idiopathic SRNS were biopsied and then randomized to receive either OCP at a dose of 2 mg/kg/day for 12 weeks or IVCP at a dose of 500 mg/m2/month for 6 months. Both groups received tapering doses of oral steroids. The response was evaluated in terms of induction of complete remission (CR) or partial remission (PR), time to remit, and side effects. The groups were followed up to determine the duration of remission, percentage of patients who remain in sustained remission for more than 1 year after completion of therapy, change in steroid response status, progression to chronic kidney disease stage 3 or more. Of the fifty patients, OCP was given to 25 children and IVCP to 25 children. The demographic data, histopathology, biochemical profile, and duration of follow-up in the two groups were comparable. The rates of induction of CR were 52% versus 44% and of PR were 8% versus 8% in the intravenous (IV) and oral group, respectively. Time to remit was shorter with OCP than IVCP (53 days vs. 84.4 days). Incidence of side effects (both major and minor) was 36% in IVCP versus 20% in OCP group. The actuarial cumulative sustained remission in our study was 12% in IVCP compared with 16% in OCP at 1 year after completion of therapy. Twelve percent children in both the groups exhibited restoration of steroid sensitivity. Thus, in our study, overall, more than half of SRNS patients showed initial response to cyclophosphamide, but only one-fourth patients had sustained remission on follow-up. OCP and IVCP were equally efficacious and safe in idiopathic SRNS in children.
机译:这是一项随机,平行分组的主动对照试验,比较静脉内环磷酰胺(IVCP)和口服环磷酰胺(OCP)在儿童类固醇抵抗性肾病综合征(SRNS)患者中的疗效。连续对50例特发性SRNS儿童进行活检,然后随机分组,以2 mg / kg /天的剂量接受OCP治疗12周,或以500 mg / m 2 /月的剂量接受IVCP接受6周几个月。两组均接受逐渐减少剂量的口服类固醇激素。根据完全缓解(CR)或部分缓解(PR)的诱导,缓解时间和副作用评估反应。对各组进行随访,以确定缓解的持续时间,完成治疗后保持持续缓解1年以上的患者百分比,类固醇反应状态的改变,进展为慢性肾病3期或以上。在这50名患者中,OCP给予25名儿童,IVCP给予25名儿童。两组的人口统计学数据,组织病理学,生化特征和随访时间具有可比性。在静脉内(IV)组和口服组中,CR的诱导率分别为52%和44%,PR的诱导率分别为8%和8%。 OCP的汇款时间比IVCP短(53天比84.4天)。 IVCP的副作用(主要和轻微)发生率为36%,而OCP组为20%。在我们的研究中,IVCP的精算累积持续缓解在完成治疗后1年为12%,而OCP为16%。两组中有12%的儿童表现出对类固醇敏感性的恢复。因此,在我们的研究中,总体上,超过一半的SRNS患者显示出对环磷酰胺的初始反应,但只有四分之一的患者在随访中持续缓解。 OCP和IVCP在儿童特发性SRNS中既有效又安全。

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