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一项针对稳定性心绞痛患者,每日一次服用缓释地尔硫䓬胶囊与每日一次服用氨氯地平片的疗效及耐受性的随机双盲对照研究。

A randomized, double-blind comparison of the efficacy and tolerability of once-daily modified-release diltiazem capsules with once-daily amlodipine tablets in patients with stable angina.

作者信息

Chugh S K, Digpal K, Hutchinson T, McDonald C J, Miller A J, Lahiri A

机构信息

Department of Cardiac Research, Northwick Park Hospital, Harrow, Middlesex, UK.

出版信息

J Cardiovasc Pharmacol. 2001 Sep;38(3):356-64. doi: 10.1097/00005344-200109000-00004.

Abstract

A randomized, double-blind, parallel-group study comparing the efficacy and tolerability of once-daily diltiazem capsules with amlodipine tablets in patients with stable angina. After a run-in period of 1 to 3 weeks, 34 patients received once-daily diltiazem and 33 patients received amlodipine. Patients received either diltiazem, 240 mg/day, or amlodipine, 5 mg/day, for 2 weeks followed by diltiazem, 360 mg/day, or amlodipine, 10 mg/day, for 2 weeks. Standard treadmill exercise testing was the primary efficacy assessment. Patients also recorded incidence of angina attacks and use of glyceryl trinitrate spray. Both treatments gave significant improvement in time to onset of angina and time to maximal exercise. With the exception of amlodipine, 5 mg/day, both treatments gave significant increases in time to 1-mm ST segment depression. Diltiazem, 360 mg/day, gave a significant decrease in rate pressure product. There were no significant treatment differences in any of the exercise test parameters. Both treatments reduced incidence of angina attacks and use of glyceryl trinitrate spray. The incidence of edema was significantly less in patients receiving diltiazem. In conclusion, both treatments were effective in controlling patients' angina, but diltiazem was better tolerated, with a lower incidence of edema.

摘要

一项随机、双盲、平行组研究,比较了每日一次的地尔硫䓬胶囊与氨氯地平片对稳定型心绞痛患者的疗效和耐受性。在1至3周的导入期后,34例患者接受每日一次的地尔硫䓬治疗,33例患者接受氨氯地平治疗。患者接受地尔硫䓬240毫克/天或氨氯地平5毫克/天治疗2周,随后接受地尔硫䓬360毫克/天或氨氯地平10毫克/天治疗2周。标准平板运动试验是主要疗效评估指标。患者还记录了心绞痛发作的发生率和硝酸甘油喷雾剂的使用情况。两种治疗方法在心绞痛发作时间和最大运动时间方面均有显著改善。除了氨氯地平5毫克/天外,两种治疗方法在ST段压低1毫米的时间方面均有显著增加。地尔硫䓬360毫克/天使心率血压乘积显著降低。在任何运动试验参数方面,两种治疗方法均无显著差异。两种治疗方法均降低了心绞痛发作的发生率和硝酸甘油喷雾剂的使用情况。接受地尔硫䓬治疗的患者水肿发生率显著较低。总之,两种治疗方法在控制患者心绞痛方面均有效,但地尔硫䓬耐受性更好,水肿发生率更低。

相似文献

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An 8-week double-blind study of amlodipine and diltiazem in patients with stable exertional angina pectoris.
J Cardiovasc Pharmacol. 1991;17 Suppl 1:S53-6. doi: 10.1097/00005344-199117001-00017.
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A double-blind, placebo-controlled, parallel dose-response study of amlodipine in stable exertional angina pectoris.
J Cardiovasc Pharmacol. 1991;17 Suppl 1:S46-9. doi: 10.1097/00005344-199117001-00015.

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