Rocha-Gonçalves F, Mariano-Pego G, Viegas J, Correia J M, Botelho M A
Department of Cardiology, Faculty of Medicine, University of Oporto, Portugal.
J Cardiovasc Pharmacol. 1991;18 Suppl 3:S4-6.
The efficacy and safety of isradipine and nifedipine retard were compared in 51 patients with mild-to-moderate essential hypertension. A 4-week placebo run-in period was followed by an 8-week course of treatment. Patients were randomly allocated to either isradipine 1.25 mg twice daily (n = 24) or nifedipine 20 mg twice daily (n = 826); dosages were doubled if blood pressure was not normalized [diastolic blood pressure greater than or equal to 90 mm Hg) after 4 weeks of active treatment. Systolic/diastolic blood pressures were significantly reduced (p less than 0.01/p less than 0.01) by isradipine from 162/103 to 145/89 mm Hg, and by nifedipine from 162/104 to 143/88 mm Hg. Normalization rates were 79% with isradipine and 67% with nifedipine. It was necessary to double the dosage in seven of the patients taking isradipine and in three of those taking nifedipine; the mean final dosages were 1.63 mg and 22.4 mg twice daily, respectively. Heart rate did not change significantly with either treatment. There were drug-related adverse events in five patients (21%) taking isradipine (2 edema, 2 headache, 2 palpitations, 1 flushing) and in eight (30%) of those taking nifedipine (5 edema, 2 headache, 1 palpitations). Therapy was withdrawn in one patient in the isradipine group (1 headache) and two patients in the nifedipine group (1 edema, 1 headache). We conclude that isradipine is a highly effective and well tolerated antihypertensive agent.
对51例轻至中度原发性高血压患者比较了伊拉地平与缓释硝苯地平的疗效及安全性。先有4周的安慰剂导入期，随后是8周的治疗疗程。患者被随机分配至伊拉地平组（每日2次，每次1.25mg，n = 24）或硝苯地平组（每日2次，每次20mg，n = 26）；如果积极治疗4周后血压未恢复正常（舒张压大于或等于90mmHg），则剂量加倍。伊拉地平使收缩压/舒张压从162/103显著降至145/89mmHg（p<0.01/p<0.01），硝苯地平使收缩压/舒张压从162/104显著降至143/88mmHg。伊拉地平的血压正常化率为79%，硝苯地平为67%。服用伊拉地平的患者中有7例、服用硝苯地平的患者中有3例需要加倍剂量；最终平均剂量分别为每日2次，每次1.63mg和22.4mg。两种治疗方法均未使心率发生显著变化。服用伊拉地平的5例患者（21%）（水肿2例、头痛2例、心悸2例、面部潮红1例）和服用硝苯地平的8例患者（30%）（水肿5例、头痛2例、心悸1例）出现了与药物相关的不良事件。伊拉地平组有1例患者（头痛1例）、硝苯地平组有2例患者（水肿1例、头痛1例）停止治疗。我们得出结论，伊拉地平是一种高效且耐受性良好的抗高血压药物。
