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肾盂肾炎患儿口服与序贯静脉注射/口服头孢菌素的随机试验。

Randomised trial of oral versus sequential intravenous/oral cephalosporins in children with pyelonephritis.

作者信息

Neuhaus Thomas J, Berger Christoph, Buechner Katja, Parvex Paloma, Bischoff Gian, Goetschel Philippe, Husarik Daniela, Willi Ulrich, Molinari Luciano, Rudin Christoph, Gervaix Alain, Hunziker Urs, Stocker Sergio, Girardin Eric, Nadal David

机构信息

Department of Nephrology, University Children's Hospital Zurich, Steinwiesstrasse 75, 8032, Zurich, Switzerland.

出版信息

Eur J Pediatr. 2008 Sep;167(9):1037-47. doi: 10.1007/s00431-007-0638-1. Epub 2007 Dec 12.

DOI:10.1007/s00431-007-0638-1
PMID:18074149
Abstract

The hypothesis was tested that oral antibiotic treatment in children with acute pyelonephritis and scintigraphy-documented lesions is equally as efficacious as sequential intravenous/oral therapy with respect to the incidence of renal scarring. A randomised multi-centre trial was conducted in 365 children aged 6 months to 16 years with bacterial growth in cultures from urine collected by catheter. The children were assigned to receive either oral ceftibuten (9 mg/kg once daily) for 14 days or intravenous ceftriaxone (50 mg/kg once daily) for 3 days followed by oral ceftibuten for 11 days. Only patients with lesions detected on acute-phase dimercaptosuccinic acid (DMSA) scintigraphy underwent follow-up scintigraphy. Efficacy was evaluated by the rate of renal scarring after 6 months on follow-up scintigraphy. Of 219 children with lesions on acute-phase scintigraphy, 152 completed the study; 80 (72 females, median age 2.2 years) were given ceftibuten and 72 (62 females, median age 1.6 years) were given ceftriaxone/ceftibuten. Patients in the intravenous/oral group had significantly higher C-reactive protein (CRP) concentrations at baseline and larger lesion(s) on acute-phase scintigraphy. Follow-up scintigraphy showed renal scarring in 21/80 children treated with ceftibuten and 33/72 with ceftriaxone/ceftibuten (p = 0.01). However, after adjustment for the confounding variables (CRP and size of acute-phase lesion), no significant difference was observed for renal scarring between the two groups (p = 0.2). Renal scarring correlated with the extent of the acute-phase lesion (r = 0.60, p < 0.0001) and the grade of vesico-ureteric reflux (r = 0.31, p = 0.03), and was more frequent in refluxing renal units (p = 0.04). The majority of patients, i.e. 44 in the oral group and 47 in the intravenous/oral group, were managed as out-patients. Side effects were not observed. From this study, we can conclude that once-daily oral ceftibuten for 14 days yielded comparable results to sequential ceftriaxone/ceftibuten treatment in children aged 6 months to 16 years with DMSA-documented acute pyelonephritis and it allowed out-patient management in the majority of these children.

摘要

针对急性肾盂肾炎且经闪烁扫描证实有病灶的儿童,口服抗生素治疗与序贯静脉/口服治疗在肾瘢痕形成发生率方面疗效相当这一假设进行了检验。对365名年龄在6个月至16岁、经导尿收集的尿液培养有细菌生长的儿童进行了一项随机多中心试验。这些儿童被分配接受以下两种治疗之一:口服头孢布烯(9毫克/千克,每日一次),共14天;或静脉注射头孢曲松(50毫克/千克,每日一次),共3天,随后口服头孢布烯11天。仅对急性期二巯基丁二酸(DMSA)闪烁扫描检测到有病灶的患者进行随访闪烁扫描。通过随访闪烁扫描6个月后的肾瘢痕形成率评估疗效。在219名急性期闪烁扫描有病灶的儿童中,152名完成了研究;80名(72名女性,中位年龄2.2岁)接受了头孢布烯治疗,72名(62名女性,中位年龄1.6岁)接受了头孢曲松/头孢布烯治疗。静脉/口服组患者在基线时C反应蛋白(CRP)浓度显著更高,急性期闪烁扫描显示的病灶更大。随访闪烁扫描显示,接受头孢布烯治疗的80名儿童中有21名出现肾瘢痕,接受头孢曲松/头孢布烯治疗的72名儿童中有33名出现肾瘢痕(p = 0.01)。然而,在对混杂变量(CRP和急性期病灶大小)进行调整后发现,两组之间肾瘢痕形成无显著差异(p = 0.2)。肾瘢痕形成与急性期病灶范围(r = 0.60,p < 0.0001)和膀胱输尿管反流分级(r = 0.31,p = 0.03)相关,且在有反流的肾单位中更常见(p = 0.04)。大多数患者,即口服组44名和静脉/口服组47名,作为门诊患者进行管理。未观察到副作用。从这项研究中,我们可以得出结论,对于有DMSA记录的急性肾盂肾炎的6个月至16岁儿童,每日一次口服头孢布烯14天与序贯头孢曲松/头孢布烯治疗效果相当,且大多数此类儿童可作为门诊患者进行管理。

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