Ardissino D, Savonitto S, Mussini A, Zanini P, Rolla A, Barberis P, Sardina M, Specchia G
Divisione di Cardiologia, Policlinico San Matteo, Università degli Studi di Pavia, Italy.
Am J Cardiol. 1991 Dec 15;68(17):1587-92. doi: 10.1016/0002-9149(91)90314-b.
In 30 consecutive patients with Prinzmetal's angina pectoris, the antiischemic effect of felodipine, a new long-acting vasoselective calcium antagonist, administered at doses of 10 and 20 mg once daily was compared with that of the well-established therapeutic regimen with nifedipine administered at a dose of 20 mg 4 times daily. Twenty-four-hour Holter monitoring was performed during a 2-day placebo run-in and at the end of each of 3 consecutive 6-day periods during which the 3 active treatments were administered in randomized sequence. Three patients withdrew, whereas 27 completed the study. The therapeutic regimens tested proved to be similarly effective; primary end points (ischemic episodes recorded by Holter monitoring, and anginal attacks reported on diary cards) occurred in 5 patients (19%) during nifedipine treatment, and in 7 (26%) and 3 (11%) during felodipine treatment with 10 and 20 mg, respectively (p = not significant). The distribution of residual ischemic episodes demonstrated that treatment with felodipine once daily provides 24-hour antiischemic protection. Twenty-six patients were followed up with 20 mg of felodipine once daily for a mean of 6 +/- 5 months, and 21 of them (81%) remained free of symptoms and Holter-recorded ischemic attacks. It is concluded that for Prinzmetal's angina pectoris, 24-hour antiischemic protection may be achieved with administration of felodipine once daily. The availability of a simplified therapeutic approach may constitute a real advantage in terms of patient compliance and improving the quality of life.
在30例连续性变异型心绞痛患者中,比较了新型长效血管选择性钙拮抗剂非洛地平每日一次10毫克和20毫克剂量给药的抗缺血作用,与已确立的治疗方案硝苯地平每日4次、每次20毫克给药的抗缺血作用。在为期2天的安慰剂导入期以及连续3个6天治疗期结束时进行24小时动态心电图监测,这3个治疗期内3种活性治疗药物按随机顺序给药。3例患者退出研究,27例完成研究。所测试的治疗方案证明效果相似;硝苯地平治疗期间5例患者(19%)出现主要终点事件(动态心电图监测记录的缺血发作和日记卡上报的心绞痛发作),非洛地平10毫克和20毫克治疗期间分别有7例(26%)和3例(11%)出现主要终点事件(p=无显著性差异)。残余缺血发作的分布情况表明,非洛地平每日一次给药可提供24小时抗缺血保护。26例患者接受每日一次20毫克非洛地平随访,平均随访时间为6±5个月,其中21例(81%)无症状且动态心电图未记录到缺血发作。结论是,对于变异型心绞痛,每日一次给予非洛地平可实现24小时抗缺血保护。就患者依从性和改善生活质量而言,简化治疗方法的可用性可能具有实际优势。