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缓释硝苯地平与标准硝苯地平治疗心绞痛的剂量比较及疗效:临床反应、运动表现和血浆硝苯地平水平

Comparative dosing and efficacy of continuous-release nifedipine versus standard nifedipine for angina pectoris: clinical response, exercise performance, and plasma nifedipine levels.

作者信息

Vetrovec G W, Parker V E, Alpert D A

机构信息

Department of Medicine, Medical College of Virginia, Richmond.

出版信息

Am Heart J. 1988 Apr;115(4):793-8. doi: 10.1016/0002-8703(88)90881-2.

Abstract

To assess the dosing equivalency and the early and late antianginal efficacy of a gastrointestinal therapeutic system for once-daily, continuous-release nifedipine (N-GITS), 10 patients with stable angina pectoris, who were previously receiving chronic treatment with nifedipine, completed a 12-week trial comparing N-GITS with standard nifedipine. All patients (nine men and one woman; mean age 54 +/- 2 [SEM] years) who were receiving standard nifedipine (mean dose 40 +/- 5 mg/24 hr) for more than 2 weeks (mean 8 +/- 2 months, range 2 to 36 months) were switched to an equivalent once-daily dose (39 +/- 5 mg/24 hr) of N-GITS. Standard nifedipine and N-GITS were compared by symptom-limited exercise treadmill tests with a baseline test (A) performed 3 hours after a standard dose of nifedipine. Exercise tests were also performed after 2 weeks of treatment with N-GITS 3 hours (B) and 24 hours (C) after the drug was given, and after 12 weeks of treatment with N-GITS, 24 hours after dosing (D). Results of exercise tests showed no significant difference in mean exercise time--(A) 422 +/- 25 vs (B) 426 +/- 36 vs (C) 438 +/- 35 vs (D) 487 +/- 37 seconds. Likewise, there was no significant mean difference in peak double product, resting heart rate, peak exercise heart rate, or resting or maximal systolic blood pressure for any of the exercise test points. Furthermore, five patients (50%) reported side effects with standard nifedipine (all vasodilator-flushing, dizziness, or both), which resolved after treatment with N-GITS (p +/- 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

为评估胃肠道治疗系统每日一次缓释硝苯地平(N - GITS)的剂量等效性以及早期和晚期抗心绞痛疗效,10例曾接受硝苯地平长期治疗的稳定型心绞痛患者完成了一项为期12周的试验,比较N - GITS与标准硝苯地平。所有接受标准硝苯地平(平均剂量40±5mg/24小时)超过2周(平均8±2个月,范围2至36个月)的患者(9名男性和1名女性;平均年龄54±2[SEM]岁)改为每日一次等效剂量(39±5mg/24小时)的N - GITS。通过症状限制性运动平板试验比较标准硝苯地平与N - GITS,在标准剂量硝苯地平给药3小时后进行基线测试(A)。在使用N - GITS治疗2周后,给药后3小时(B)和24小时(C)进行运动测试,以及在使用N - GITS治疗12周后,给药24小时后(D)进行运动测试。运动测试结果显示平均运动时间无显著差异——(A)422±25秒 vs (B)426±36秒 vs (C)438±35秒 vs (D)487±37秒。同样,在任何运动测试点,峰值双乘积、静息心率、运动峰值心率或静息或最大收缩压均无显著平均差异。此外,5例患者(50%)报告有标准硝苯地平的副作用(均为血管扩张性脸红、头晕或两者皆有),使用N - GITS治疗后症状缓解(p±0.05)。(摘要截短至250字)

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