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氯沙坦和依那普利在减少 Alport 综合征患儿蛋白尿方面效果相当。

Losartan and enalapril are comparable in reducing proteinuria in children with Alport syndrome.

机构信息

Department of Paediatric Nephrology and Wellcome Trust Children's Clinical Research Facility, Manchester Academic Health Science Centre, Royal Manchester Children's Hospital, The University of Manchester, Manchester, UK.

出版信息

Pediatr Nephrol. 2013 May;28(5):737-43. doi: 10.1007/s00467-012-2372-9. Epub 2012 Dec 4.

Abstract

BACKGROUND

A previous subgroup analysis of a 12-week, double-blind study demonstrated that losartan significantly lowered proteinuria versus placebo and amlodipine and was well tolerated in children (1-17 years old) with proteinuria secondary to Alport syndrome. The present subgroup analysis of the open-label, extension phase of this study assessed the long-term efficacy and tolerability of losartan versus enalapril.

METHODS

Patients who had completed the double-blind study were re-randomized to losartan or enalapril and followed for proteinuria and renal function for up to 3 years.

RESULTS

Twenty-seven patients with Alport syndrome were randomized to losartan (0.44-2.23 mg/kg/day; n = 15) or enalapril (0.07-0.72 mg/kg/day; n = 12). The least-squares (LS) mean percent change from week 12 in urinary protein to creatinine ratio (UPr/Cr was +1.1 % in the losartan group versus a further 13.9 % reduction in the enalapril group (GMR [95 % CI] = 1.2 [0.7, 2.0]); the LS mean change from week 12 in estimated glomerular filtration rate (eGFR) was -6.4 ml/min/1.73 m(2) in the losartan group versus -9.1 ml/min/1.73 m(2) in the enalapril group. The adverse event incidence was low and comparable in both treatment groups.

CONCLUSIONS

In children with proteinuria secondary to Alport syndrome, losartan maintained proteinuria reduction, and enalapril produced a further proteinuria reduction over the 3-year study period. Both agents were generally well tolerated.

摘要

背景

一项为期 12 周的双盲研究的亚组分析表明,氯沙坦可显著降低蛋白尿,优于安慰剂和氨氯地平,并且在伴有蛋白尿的 Alport 综合征患儿(1-17 岁)中耐受性良好。本研究为该双盲研究开放标签扩展阶段的亚组分析,评估了氯沙坦与依那普利的长期疗效和耐受性。

方法

完成双盲研究的患者被重新随机分为氯沙坦或依那普利组,并随访蛋白尿和肾功能,最长达 3 年。

结果

27 例 Alport 综合征患者被随机分为氯沙坦(0.44-2.23mg/kg/天;n=15)或依那普利(0.07-0.72mg/kg/天;n=12)组。从第 12 周开始,尿蛋白与肌酐比值(UPr/Cr)的最小二乘(LS)均值变化,氯沙坦组增加 1.1%,依那普利组进一步减少 13.9%(GMR [95%CI]为 1.2 [0.7, 2.0]);LS 均值估计肾小球滤过率(eGFR)从第 12 周开始变化,氯沙坦组减少 6.4ml/min/1.73m(2),依那普利组减少 9.1ml/min/1.73m(2)。两组不良事件发生率均较低且相当。

结论

在伴有蛋白尿的 Alport 综合征患儿中,氯沙坦可维持蛋白尿减少,依那普利在 3 年研究期间进一步降低蛋白尿。两种药物通常均具有良好的耐受性。

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