Zachariah P K, Schwartz G L, Sheps S G, Schirger A, Carlson C A, Moore A G
Division of Hypertension and Internal Medicine, Mayo Clinic, Rochester, Minnesota 55905.
J Clin Pharmacol. 1990 Nov;30(11):1012-9. doi: 10.1002/j.1552-4604.1990.tb03588.x.
The blood pressure response to a new sustained-release formulation of nifedipine was evaluated in an 8-week, double-blind, placebo-controlled study. Twenty-nine patients with mild essential hypertension were randomized to receive placebo (N = 9), 30 mg nifedipine (N = 10), or 60 mg nifedipine (N = 10). During treatment, 30-mg and 60-mg doses of nifedipine administered once daily decreased office blood pressures from 137/98 +/- 8/2 mm Hg and 141/98 +/- 15/2 mm Hg at baseline, respectively, to 126/89 +/- 9/7 mm Hg and 126/86 +/- 6/7 mm Hg (P less than .005). Noninvasive automatic ambulatory blood pressure monitoring demonstrated a marginally significant (P less than .10) reduction in the mean 24-hour blood pressure of 2/6 +/- 8/8 mm Hg and 5/6 +/- 9/9 mm Hg for patients taking 30 mg and 60 mg nifedipine once daily, respectively. Diastolic blood pressure load (the percentage of ambulatory diastolic blood pressure readings greater than 90 mm Hg) during 24 hours was decreased by 41% and 35%, with 30 mg and 60 mg nifedipine administered once daily, respectively. No significant dose response to nifedipine at these dose levels was observed. Although the once-daily formulation of nifedipine achieved effective control of office blood pressure, similar control was not observed in awake and 24-hour periods in all patients.
在一项为期8周的双盲、安慰剂对照研究中,对一种新的硝苯地平缓释制剂的血压反应进行了评估。29例轻度原发性高血压患者被随机分为三组,分别接受安慰剂(N = 9)、30 mg硝苯地平(N = 10)或60 mg硝苯地平(N = 10)治疗。治疗期间,每日一次服用30 mg和60 mg剂量的硝苯地平,可使诊室血压从基线时的137/98±8/2 mmHg和141/98±15/2 mmHg分别降至126/89±9/7 mmHg和126/86±6/7 mmHg(P <.005)。无创自动动态血压监测显示,每日一次服用30 mg和60 mg硝苯地平的患者,其24小时平均血压分别显著降低2/6±8/8 mmHg和5/6±9/9 mmHg(P <.10)。24小时动态舒张压负荷(动态舒张压读数大于90 mmHg的百分比),每日一次服用30 mg和60 mg硝苯地平的患者分别降低了41%和35%。在这些剂量水平下,未观察到对硝苯地平有显著的剂量反应。虽然硝苯地平每日一次给药方案可有效控制诊室血压,但并非所有患者在清醒和24小时期间都能获得类似的控制效果。