University of Arkansas for Medical Sciences, Arkansas Children's Hospital, Little Rock, AR, USA.
J Clin Hypertens (Greenwich). 2011 May;13(5):357-65. doi: 10.1111/j.1751-7176.2011.00432.x. Epub 2011 Mar 18.
The effectiveness and safety of valsartan have not been assessed in hypertensive children. Therefore, hypertensive patients aged 6 to 16 years (n=261) were randomized to receive weight-stratified low- (10/20 mg), medium- (40/80 mg), or high-dose (80/160 mg) valsartan for 2 weeks. After 2 weeks, patients were randomized to a 2-week placebo-controlled withdrawal phase. Dose-dependent reductions in sitting systolic blood pressure (SSBP) and sitting diastolic blood pressure (SDBP) were observed after 2 weeks (low dose, -7.9/-4.6 mm Hg; medium dose, -9.6/-5.8 mm Hg; high dose, -11.5/-7.4 mm Hg [P<.0001 for all groups]). During the withdrawal phase, SSBP and SDBP were both lower in the pooled valsartan group than in the pooled placebo group (SSBP, -2.7 mm Hg [P=.0368]; SDBP, -3.0 mm Hg [P=.0047]). Similar efficacy was observed in all subgroups. Valsartan was well tolerated and headache was the most commonly observed adverse event during both the double-blind and 52-week open-label phases.
缬沙坦在高血压儿童中的疗效和安全性尚未得到评估。因此，将 6 至 16 岁的高血压患者（n=261）随机分为接受低剂量（10/20mg）、中剂量（40/80mg）或高剂量（80/160mg）缬沙坦治疗 2 周。2 周后，患者随机进入为期 2 周的安慰剂对照停药阶段。治疗 2 周后，观察到坐位收缩压（SSBP）和坐位舒张压（SDBP）呈剂量依赖性下降（低剂量组分别下降-7.9/-4.6mmHg；中剂量组分别下降-9.6/-5.8mmHg；高剂量组分别下降-11.5/-7.4mmHg[所有组均 P<.0001]）。在停药阶段，缬沙坦组的 SSBP 和 SDBP 均低于安慰剂组（SSBP 下降-2.7mmHg，P=.0368；SDBP 下降-3.0mmHg，P=.0047）。所有亚组均观察到相似的疗效。缬沙坦耐受性良好，头痛是双盲和 52 周开放标签阶段最常见的不良反应。
