单剂量与分剂量泼尼松龙治疗儿童肾病综合征初发：一项开放标签 RCT。

Single- versus Divided-Dose Prednisolone for the First Episode of Nephrotic Syndrome in Children: An Open-Label RCT.

机构信息

Division of Pediatric Nephrology, Institute of Child Health, Kolkata, India.

Department of Pediatrics, Mission Hospital, Durgapur, India.

出版信息

Clin J Am Soc Nephrol. 2023 Oct 1;18(10):1294-1299. doi: 10.2215/CJN.0000000000000216. Epub 2023 Jun 19.

DOI:10.2215/CJN.0000000000000216

PMID:37335578

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10578634/

Abstract

BACKGROUND

Early morning single-dose prednisolone has a hypothetical advantage of less hypothalamic-pituitary-adrenal (HPA) axis suppression, but lack of robust evidence has resulted in variation in practice, with divided-dose prednisolone still commonly used. We conducted this open-label randomized control trial to compare HPA axis suppression between single-dose or divided-dose prednisolone among children with first episode of nephrotic syndrome.

METHODS

Sixty children with first episode of nephrotic syndrome were randomized (1:1) to receive prednisolone (2 mg/kg per day), either as single or two divided doses for 6 weeks, followed by single alternative daily dose of 1.5 mg/kg for 6 weeks. The Short Synacthen Test was conducted at 6 weeks, with HPA suppression defined as postadrenocorticotropic hormone cortisol <18 µ mg/dl.

RESULTS

Four children (single=1 and divided dose=3) did not attend the Short Synacthen Test and were hence excluded from analysis. Remission was induced in all, and no relapse postremission was noted during the 6+6 weeks of steroid therapy. After 6 weeks of daily steroids, HPA suppression was greater in divided (100%) versus single dose (83%) ( P = 0.02). Time to remission and final relapse rates were similar, but for those children who relapsed within 6 months of follow-up period, time to first relapse was shorter for divided dose (median 28 versus 131 days) P = 0.002.

CONCLUSIONS

Among children with first episode of nephrotic syndrome, single-dose and/or divided-dose prednisolone were equally effective in inducing remission with similar relapse rates, but single dose had less HPA suppression and longer time to first relapse.

CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER

CTRI/2021/11/037940.

PODCAST

This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/CJASN/2023_10_09_CJN0000000000000216.mp3.

摘要

背景

清晨单次剂量的泼尼松具有假设的下丘脑-垂体-肾上腺（HPA）轴抑制作用较小的优势，但缺乏有力的证据导致实践中的差异，仍常使用分剂量泼尼松。我们进行了这项开放标签随机对照试验，比较了首次肾病综合征发作的儿童中单剂量或分剂量泼尼松之间的 HPA 轴抑制作用。

方法

60 名首次肾病综合征发作的儿童被随机（1:1）接受泼尼松（2 mg/kg/天），分别单剂量或分两次剂量治疗 6 周，随后再用 1.5 mg/kg 单剂量隔日治疗 6 周。在第 6 周进行短 Synacthen 试验，HPA 抑制定义为促肾上腺皮质激素后皮质醇<18 µg/dl。

结果

4 名儿童（单剂量=1 名，分剂量=3 名）未参加短 Synacthen 试验，因此被排除在分析之外。所有儿童均诱导缓解，在 6+6 周的类固醇治疗期间无缓解后复发。在每天使用类固醇 6 周后，分剂量组（100%）的 HPA 抑制作用大于单剂量组（83%）（P=0.02）。缓解时间和最终复发率相似，但对于在随访期内 6 个月内复发的儿童，分剂量组的首次复发时间更短（中位数 28 天与 131 天），P=0.002。