Department of Paediatric Nephrology, Royal Manchester Children's Hospital, Manchester M13 9WL, United Kingdom.
Clin J Am Soc Nephrol. 2010 Mar;5(3):417-24. doi: 10.2215/CJN.06620909. Epub 2010 Jan 14.
No large, randomized, double-blind trials in children with proteinuria treated with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers have previously been reported.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This 12-week, double-blind, multinational study investigated the effects of losartan 0.7 to 1.4 mg/kg per day compared with placebo (normotensive stratum) or amlodipine 0.1 to 0.2 mg/kg per day up to 5 mg/d (hypertensive stratum) on proteinuria (morning-void urinary protein-creatinine ratio, baseline > or =0.3 g/g) in 306 children up to 17 years of age.
Twelve weeks of treatment with losartan significantly reduced proteinuria compared with amlodipine/placebo: losartan -35.8% (95% confidence interval: -27.6% to -43.1%) versus amlodipine/placebo 1.4% (95% confidence interval: -10.3% to 14.5%), P < or = 0.001. Significance remained after adjustment for differences across treatment groups in change in BP (losartan produced incremental systolic and diastolic BP reductions versus amlodipine of 5.4 and 4.6 mmHg, respectively; and versus placebo of 3.8 and 4.0 mmHg, respectively). Proteinuria reduction was consistently observed in the normotensive (-34.4% losartan; 2.6% placebo) and hypertensive (-41.5% losartan; 2.4% amlodipine) strata, and in all prespecified subgroups, including age, gender, race, Tanner stage, weight, prior therapy with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, as well as among the most common etiologies of proteinuria. Adverse event incidence was low and comparable in all groups.
Losartan significantly lowered proteinuria and was well tolerated after 12 weeks in children aged 1 to 17 years with proteinuria with or without hypertension, a population that has not previously been rigorously studied.
以前没有报道过用血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂治疗蛋白尿的儿童进行的大型、随机、双盲试验。
设计、设置、参与者和测量：这项为期 12 周、双盲、多国研究调查了氯沙坦 0.7 至 1.4mg/kg/天与安慰剂（血压正常组）或氨氯地平 0.1 至 0.2mg/kg/天（直至 5mg/d 高血压组）对 306 名 17 岁以下蛋白尿（晨尿尿蛋白/肌酐比值，基线>或=0.3g/g）的影响。
与氨氯地平/安慰剂相比，12 周的氯沙坦治疗显著降低蛋白尿：氯沙坦-35.8%（95%置信区间：-27.6%至-43.1%），而氨氯地平/安慰剂 1.4%（95%置信区间：-10.3%至 14.5%），P<或=0.001。在调整治疗组之间血压变化的差异后，这种差异仍然存在（氯沙坦与氨氯地平相比，收缩压和舒张压分别分别增加 5.4 和 4.6mmHg；与安慰剂相比，收缩压和舒张压分别增加 3.8 和 4.0mmHg）。在血压正常（氯沙坦-34.4%；安慰剂 2.6%）和高血压（氯沙坦-41.5%；氨氯地平 2.4%）亚组以及所有预先指定的亚组中，包括年龄、性别、种族、性发育阶段、体重、既往使用血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂，以及蛋白尿最常见的病因中，均观察到蛋白尿的减少。不良事件发生率低，且在所有组中相似。
在 1 至 17 岁有蛋白尿伴或不伴高血压的儿童中，氯沙坦在 12 周后显著降低蛋白尿，且耐受性良好，以前尚未对这一人群进行严格研究。
