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[维拉帕米LI 120毫克每日3次与维拉帕米LP 120毫克每日2次治疗稳定型劳力性心绞痛的对比研究。一项多中心研究]

[Comparative study of verapamil LI 120 mg 3 times a day and verapamil LP 120 mg twice a day in stable exertion-induced angina. A multicenter study].

作者信息

Belin A, Prost P L, Mercadier G, Grollier G, Lablanche J M

机构信息

Centre de Réadaptation cardiaque, Trouville-sur-mer.

出版信息

Ann Cardiol Angeiol (Paris). 1995 Sep;44(7):365-71.

PMID:8561442
Abstract

A multicentre, open, crossover study in 27 patients with exertional angina compared the efficacy of verapamil LP 120 mg twice a day (VP LP 120) with that of verapamil LI 120 mg 3 times a day (VP LI 120) by means of stress tests. The study procedure was as follows: 7-day selection period during which the patient received placebo, and two 21-day treatment periods by VP LI 120 or VP LP 120 according to the crossover principle. At the end of each treatment phase, a stress test was performed at the trough serum concentration for each substance. VP LP 120 mg and VP LI 120 mg both improved exercise capacity compared to placebo. Comparison of VP LP 120 and VP LI 120 did not reveal any significant difference for stress test parameters (total duration of effort: 12 +/- 3.2 min with placebo, 13.3 +/- 3.7 min for the VP LI phase, 13.9 +/- 3.2 min for the VP LP phase; % FMT reached: 87.2% +/- 7.2 for VP LI, 89% +/- 7.3 for VP LP; time to onset of significant ST depression: 10 min +/- 2.9 for VP LI, 11 min 3.6 for VP LP). The efficacy of VP LP 120 in exertional angina is therefore identical to that of VP LI 120, despite a reduction of the total dose and serum levels.

摘要

一项针对27例劳力性心绞痛患者的多中心、开放性交叉研究,通过负荷试验比较了每日两次服用120毫克维拉帕米长效制剂(VP LP 120)与每日三次服用120毫克维拉帕米普通制剂(VP LI 120)的疗效。研究程序如下:7天的筛选期,在此期间患者服用安慰剂,然后根据交叉原则,分别进行两个为期21天的VP LI 120或VP LP 120治疗期。在每个治疗阶段结束时,在每种药物的谷血清浓度下进行负荷试验。与安慰剂相比,VP LP 120毫克和VP LI 120毫克均提高了运动能力。VP LP 120与VP LI 120在负荷试验参数方面未显示出任何显著差异(总运动持续时间:安慰剂组为12±3.2分钟,VP LI阶段为13.3±3.7分钟,VP LP阶段为13.9±3.2分钟;达到的最大心率百分比:VP LI为87.2%±7.2,VP LP为89%±7.3;出现明显ST段压低的时间:VP LI为10分钟±2.9,VP LP为11分钟±3.6)。因此,尽管总剂量和血清水平有所降低,但VP LP 120在劳力性心绞痛中的疗效与VP LI 120相同。

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