Wells Thomas G, Portman Ronald, Norman Patricia, Haertter Sebastian, Davidai Giora
Arkansas Children's Hospital, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.
Clin Pediatr (Phila). 2010 Oct;49(10):938-46. doi: 10.1177/0009922810363609. Epub 2010 Aug 19.
To assess the safety, pharmacokinetics (PKs), and blood pressure (BP)-lowering efficacy of telmisartan in pediatric (6 to <18 years) patients with hypertension.
Patients with diagnosed hypertension were randomized to 4 weeks of treatment with placebo, or with 1 of 2 nominal telmisartan dose levels (1 mg/kg/d or 2 mg/kg/d). The primary end point was change in seated systolic BP (SBP) from baseline to study end.
A total of 77 patients were randomized and received at least 1 dose of study medication (placebo, n = 16; low-dose telmisartan, n = 30; high-dose telmisartan, n = 31). Adjusted mean changes (standard errors) in SBP from baseline to study end were -6 (2.4), -14 (1.7), and -9.7 (1.7) mm Hg, respectively, in the placebo, high-dose telmisartan, and low-dose telmisartan groups.
Telmisartan may be an appropriate therapy for treatment of pediatric hypertension, although more extensive studies are required in patients younger than age 12.
评估替米沙坦治疗6至<18岁高血压儿科患者的安全性、药代动力学（PKs）及降压疗效。
确诊为高血压的患者被随机分为接受4周安慰剂治疗，或接受2种替米沙坦标称剂量水平之一（1毫克/千克/天或2毫克/千克/天）的治疗。主要终点是从基线到研究结束时坐位收缩压（SBP）的变化。
共有77例患者被随机分组并接受了至少1剂研究药物治疗（安慰剂组，n = 16；低剂量替米沙坦组，n = 30；高剂量替米沙坦组，n = 31）。安慰剂组、高剂量替米沙坦组和低剂量替米沙坦组从基线到研究结束时SBP的调整后平均变化（标准误）分别为-6（2.4）、-14（1.7）和-9.7（1.7）毫米汞柱。
替米沙坦可能是治疗儿科高血压的一种合适疗法，不过12岁以下患者还需要更广泛的研究。
