Petkar S, Sethi K K, Sudha R, Sharma S M, Arora R, Khalilullah M
G.B. Pant Hospital, New Delhi.
Indian Heart J. 1994 Mar-Apr;46(2):85-8.
The efficacy and safety of amlodipine was evaluated in 20 patients with stable exertional angina. Patients with > or = 3 anginal attacks per week in the placebo run-in phase were admitted into a 4 weeks active treatment phase. Amlodipine was administered at a starting dose of 5 mg once daily at bed time, which could be adjusted after 2 weeks to 10 mg once daily if the patient continued to have even a single anginal attack/week. Four weeks of treatment with amlodipine produced a significant (p < 0.05) reduction from baseline in both the mean (+/- SE) number of anginal attacks/week (from 13.3 +/- 1.5 to 1.6 +/- 0.5) and the mean (+/- SE) number of isosorbide dinitrate tablets consumed per week (12.1 +/- 1.5 to 2.6 +/- 0.8). Eighty three percent of patients required an increase in dose to 10 mg daily. No significant change in heart rate, blood pressure, ECG and laboratory results were observed. One patient was withdrawn because of deteriorating angina and sinus tachycardia secondary to beta blocker withdrawal. Worsening of ankle odema was reported in 2 (10%) patients, which was tolerated and disappeared on completing therapy. Thus amlodipine is safe and effective when used as monotherapy in the treatment of chronic stable angina.
对20例稳定型劳力性心绞痛患者评估了氨氯地平的疗效和安全性。在安慰剂导入期每周有≥3次心绞痛发作的患者进入为期4周的积极治疗阶段。氨氯地平起始剂量为每日5毫克,睡前服用,若患者每周仍有哪怕一次心绞痛发作,2周后剂量可调整为每日10毫克。氨氯地平治疗4周后,每周心绞痛发作的平均(±标准误)次数(从13.3±1.5降至1.6±0.5)以及每周硝酸异山梨酯片的平均(±标准误)服用量(从12.1±1.5降至2.6±0.8)均较基线有显著(p<0.05)降低。83%的患者需要将剂量增至每日10毫克。未观察到心率、血压、心电图和实验室检查结果有显著变化。1例患者因心绞痛恶化以及停用β受体阻滞剂后继发窦性心动过速而退出研究。2例(10%)患者报告踝部水肿加重,但可耐受,治疗结束后消失。因此,氨氯地平作为单一疗法用于治疗慢性稳定型心绞痛时安全有效。