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一项关于泼尼松治疗早期过敏性紫癜的随机、安慰剂对照试验[国际标准随机对照试验编号:ISRCTN85109383]

A randomized, placebo-controlled trial of prednisone in early Henoch Schönlein Purpura [ISRCTN85109383].

作者信息

Huber Adam M, King Jim, McLaine Peter, Klassen Terry, Pothos Mary

机构信息

IWK Health Centre and Dalhousie University, Halifax, Nova Scotia, Canada.

出版信息

BMC Med. 2004 Apr 2;2:7. doi: 10.1186/1741-7015-2-7.

Abstract

BACKGROUND

Henoch Schönlein Purpura (HSP) is the most common systemic vasculitis of childhood. There is considerable controversy over whether children with HSP should be treated with corticosteroids. The goal of this study was to investigate whether early corticosteroid administration could reduce the rate of renal or gastrointestinal complications in children with HSP.

METHODS

Forty children with HSP, seen in the emergency room of a tertiary-care, paediatric centre, entered a randomized, double-blind, placebo controlled study. The treatment group (n = 21) received oral prednisone, 2 mg/kg/day for one week, with weaning over a second week, while the placebo group (n = 19) received an identical appearing placebo. Co-primary outcomes were the rate of renal involvement at one year and the rate of acute gastrointestinal complications. Co-primary outcomes were analysed using Fisher's Exact test.

RESULTS

At one year, there was no difference in the rate of renal involvement (3/21 prednisone group vs. 2/19 placebo group, P = 1.0). There was also no statistically significant difference in the rate of acute gastrointestinal complications (2/21 prednisone group vs. 3/19 placebo group, P = 0.7). Two children in the placebo group did experience intussusceptions compared with none in the prednisone group (P = 0.2).

CONCLUSIONS

Early prednisone therapy in HSP does not appear to reduce the risk of renal involvement at one year, or the risk of acute gastrointestinal complications. There may be a reduced risk of intussusception. The routine, early use of prednisone in uncomplicated HSP cannot be recommended at this time.

摘要

背景

过敏性紫癜(HSP)是儿童期最常见的系统性血管炎。对于患有HSP的儿童是否应使用皮质类固醇进行治疗存在相当大的争议。本研究的目的是调查早期给予皮质类固醇是否可以降低HSP患儿发生肾脏或胃肠道并发症的几率。

方法

在一家三级儿科中心的急诊室就诊的40名HSP患儿进入了一项随机、双盲、安慰剂对照研究。治疗组组(n = 21)接受口服泼尼松,2mg/kg/天,共一周,第二周逐渐减量,而安慰剂组(n = 19)接受外观相同的安慰剂。共同主要结局是一年时的肾脏受累率和急性胃肠道并发症发生率。使用Fisher精确检验分析共同主要结局。

结果

一年时,肾脏受累率无差异(泼尼松组3/21 vs. 安慰剂组2/19,P = 1.0)。急性胃肠道并发症发生率也无统计学显著差异(泼尼松组2/21 vs. 安慰剂组3/19,P = 0.7)。安慰剂组有2名儿童发生肠套叠,而泼尼松组无(P = 0.2)。

结论

HSP早期泼尼松治疗似乎不会降低一年时肾脏受累的风险或急性胃肠道并发症的风险。肠套叠风险可能降低。目前不建议在无并发症的HSP中常规早期使用泼尼松。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d477/400510/442f00e71cd6/1741-7015-2-7-1.jpg

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