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非洛地平与单硝酸异山梨酯作为β受体阻滞剂辅助药物用于65岁以上心绞痛患者的比较。

Comparison between felodipine and isosorbide mononitrate as adjunct to beta blockade in patients > 65 years of age with angina pectoris.

作者信息

de Vries R J, Dunselman P H, van Veldhuisen D J, van den Heuvel A F, Wielenga R P, Lie K I

机构信息

Department of Cardiology, Ignatius Hospital, Breda, The Netherlands.

出版信息

Am J Cardiol. 1994 Dec 15;74(12):1201-6. doi: 10.1016/0002-9149(94)90548-7.

DOI:10.1016/0002-9149(94)90548-7
PMID:7977090
Abstract

Coronary artery disease is an increasingly common medical problem in the elderly, and relatively few studies investigating drug therapy focus on this population. To assess the efficacy and safety of the calcium channel blocker, felodipine, and isosorbide mononitrate (ISMN), as adjunct to optimal beta-blocker therapy in elderly patients, a placebo-controlled, double-blind study was conducted in 46 patients, aged between 65 and 80 years, with documented stress-induced angina pectoris and myocardial ischemia. With use of a latin-square design, with 3 periods of 4 weeks each, exercise testing was performed after each period. Felodipine, 5 mg once daily, significantly improved both time to ischemic threshold and pain threshold (p = 0.02 and p = 0.003, respectively, vs placebo), and tended to increase total exercise time (p = 0.06 vs placebo). In contrast, ISMN, 20 mg twice daily, did not significantly affect these parameters. Comparison of the 2 active treatment arms showed that, overall, felodipine was more effective than ISMN, with a statistically significant difference for time to ischemic threshold (p = 0.02). With regard to safety, felodipine was also better tolerated than ISMN, which led to more patients discontinuing study medication with ISMN (p < 0.05 between ISMN and felodipine). It is concluded that in elderly patients who are treated with optimal beta blockade, felodipine, but not ISMN, leads to an additional significant reduction in ischemic parameters during exercise.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

冠心病在老年人中是一个日益常见的医学问题,而针对药物治疗的研究相对较少关注这一人群。为评估钙通道阻滞剂非洛地平与单硝酸异山梨酯(ISMN)作为老年患者最佳β受体阻滞剂治疗辅助药物的疗效和安全性,对46例年龄在65至80岁之间、有应激性心绞痛和心肌缺血记录的患者进行了一项安慰剂对照、双盲研究。采用拉丁方设计,每个阶段为期4周,共3个阶段,每个阶段后进行运动试验。非洛地平每日一次,每次5mg,显著改善了缺血阈值时间和疼痛阈值(分别与安慰剂相比,p = 0.02和p = 0.003),并倾向于增加总运动时间(与安慰剂相比,p = 0.06)。相比之下,ISMN每日两次,每次20mg,对这些参数没有显著影响。两个活性治疗组的比较表明,总体而言,非洛地平比ISMN更有效,缺血阈值时间有统计学显著差异(p = 0.02)。在安全性方面,非洛地平的耐受性也优于ISMN,这导致更多患者停用ISMN研究药物(ISMN与非洛地平之间p < 0.05)。结论是,在接受最佳β受体阻滞剂治疗的老年患者中,非洛地平而非ISMN能在运动期间使缺血参数进一步显著降低。(摘要截短至250字)

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