Fernández M, Madero R, González D, Camacho P, Villalpando J, Arriaga J
Clínica de Hipertensión Arterial, Instituto Nacional de la Nutrición Salvador Zubirán, México, D.F. Mexico 01040.
Hypertension. 1994 Jan;23(1 Suppl):I207-10. doi: 10.1161/01.hyp.23.1_suppl.i207.
The antihypertensive effect and safety of fosinopril and hydrochlorothiazide combined were compared with each drug singly and placebo in a controlled manner. After a 4- to 5-week placebo lead-in period, 67 mild to moderate essential hypertensive patients (seated diastolic blood pressure > or = 95 and < or = 110 mm Hg) were randomized in a double-blind fashion into four parallel treatment groups: 20 mg fosinopril plus 12.5 mg hydrochlorothiazide, 20 mg fosinopril, 12.5 mg hydrochlorothiazide, and placebo during 8 weeks. Patients were seen biweekly. Sitting diastolic blood pressure was the outcome variable defining therapeutic response. The efficacy of fosinopril plus hydrochlorothiazide as a combined therapy was superior to any single drug (P < .05) and placebo (P < .01) in the treatment of mild to moderate essential hypertension. Mean adjusted systolic/diastolic blood pressure decrements at week 8 were -18.8/-13.7, -12.9/-11.8, -8.5/-9.3, and -2.7/-6.9 mm Hg for the fosinopril plus hydrochlorothiazide, fosinopril, hydrochlorothiazide, and placebo groups, respectively. Clinical adverse events and laboratory changes documented throughout the study were similar to placebo and were mild in severity in all groups.
以对照方式比较了福辛普利与氢氯噻嗪联合用药、各单药及安慰剂的降压效果和安全性。在为期4至5周的安慰剂导入期后，67例轻度至中度原发性高血压患者（坐位舒张压≥95且≤110 mmHg）以双盲方式随机分为四个平行治疗组：20 mg福辛普利加12.5 mg氢氯噻嗪组、20 mg福辛普利组、12.5 mg氢氯噻嗪组和安慰剂组，治疗8周。每两周对患者进行一次访视。坐位舒张压是定义治疗反应的结局变量。在治疗轻度至中度原发性高血压方面，福辛普利加氢氯噻嗪联合治疗的疗效优于任何一种单药（P<0.05）和安慰剂（P<0.01）。在第8周时，福辛普利加氢氯噻嗪组、福辛普利组、氢氯噻嗪组和安慰剂组的平均调整后收缩压/舒张压下降幅度分别为-18.8/-13.7、-12.9/-11.8、-8.5/-9.3和-2.7/-6.9 mmHg。在整个研究过程中记录的临床不良事件和实验室检查变化与安慰剂相似，且所有组的严重程度均较轻。
