Artigou J Y, Benichou M, Berland J, Fressinaud P, Grollier G, Guéret P, Nguyen Cong Duc L
Hôpital Pitié-Salpêtriére, Paris.
Presse Med. 1990;19(1):13-6.
In a multicentre, randomized, double-blind, double-placebo therapeutic trial, the effectiveness and safety of enalapril and slow-release nifedipine were studied in two groups of ambulatory patients with mild to moderate essential hypertension. Following a 2-week placebo period, 136 patients were allocated at random to either enalapril 20 mg/day in one evening dose (group 1, n = 68) or to nifedipine 40 mg/day in two doses, one a.m. the other p.m. (group II). Each treatment was administered for 12 weeks. Patients in both groups whose diastolic arterial pressure remained above 90 mmHg were given hydrochlorothiazide 25 mg/day from the 4th week onward. When blood pressure did not return to normal, the dose of hydrochlorothiazide was increased to 50 mg/day in the 8th week. After 4 weeks of treatment, no significant difference in reduction of supine diastolic arterial pressure was observed between the two groups (- 12.1 +/- 9.9 mmHg in groups I vs - 10.3 +/- 9.0 mmHg in group II). At the end of the 12-week treatment the decrease of diastolic blood pressure was more pronounced in patients on enalapril than in those on nifedipine (- 16.3 +/- 8.0 mmHg vs - 13.9 +/- 7.1 mmHg), although the difference was not statistically significant (P = 0.06). The number of patients with undesirable side-effects was greater in the nifedipine group (33 patients; 48.5 per cent) than in the enalapril group (18 patients; 26.5 per cent). Treatment was discontinued on account of side-effects in 3 patients of the enalapril group and 10 patients of the nifedipine group.
在一项多中心、随机、双盲、双安慰剂治疗试验中，对两组轻至中度原发性高血压门诊患者研究了依那普利和硝苯地平缓释片的有效性和安全性。经过2周的安慰剂期后，136例患者被随机分为两组，一组为每晚服用依那普利20mg/天（第1组，n = 68），另一组为每日分两次服用硝苯地平40mg，一次上午服用，另一次下午服用（第II组）。每种治疗持续12周。两组中舒张压仍高于90mmHg的患者从第4周起给予氢氯噻嗪25mg/天。如果血压未恢复正常，则在第8周将氢氯噻嗪剂量增加至50mg/天。治疗4周后，两组间仰卧位舒张压降低无显著差异（第1组为-12.1±9.9mmHg，第II组为-10.3±9.0mmHg）。在12周治疗结束时，依那普利组患者的舒张压下降比硝苯地平组更明显（-16.3±8.0mmHg对-13.9±7.1mmHg），尽管差异无统计学意义（P = 0.06）。硝苯地平组出现不良副作用的患者数量（33例患者；48.5%）多于依那普利组（18例患者；26.5%）。依那普利组有3例患者、硝苯地平组有10例患者因副作用而停药。
