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卡维地洛与美托洛尔治疗稳定型心绞痛的安全性及疗效比较。

Comparison of safety and efficacy of carvedilol and metoprolol in stable angina pectoris.

作者信息

van der Does R, Hauf-Zachariou U, Pfarr E, Holtbrügge W, König S, Griffiths M, Lahiri A

机构信息

IST Studien Therapeutica GmbH, Mannheim, Germany.

出版信息

Am J Cardiol. 1999 Mar 1;83(5):643-9. doi: 10.1016/s0002-9149(98)00960-6.

Abstract

In a double-blind, randomized, 3-month multicenter study, the safety and tolerability and the antianginal and anti-ischemic efficacy of carvedilol 25 to 50 mg twice daily were assessed in comparison with metoprolol 50 to 100 mg twice daily in younger and elderly patients with stable angina. After a 7-day placebo run-in at the end of which a symptom-limited bicycle ergometric exercise was performed, 368 patients were randomly allocated to the parallel treatment groups. After 4 weeks of therapy with a low dose, a further exercise test was performed and patients were titrated in single-blind fashion to the higher dose if the increase in total exercise time was < 1 minute, and there was no safety concern. After a further 8 weeks of treatment a third exercise test was performed. Carvedilol low dose/high dose was shown to be at least as safe and well tolerated as metoprolol low dose/high dose both in younger and elderly patients. There were no hitherto unknown adverse events and no marked change in the types of events after increase of the doses. Early adverse events after treatment initiation or uptitration were equal with both medications, indicating no particular risk associated with carvedilol's vasodilatory action. No rebound phenomena were observed. Both drugs showed good antianginal and anti-ischemic efficacy, with marked increases on uptitration including patients > or = 65 years of age. However, in the doses selected, which appeared equipotent with respect to beta blockade, carvedilol's improvement of time to 1-mm ST-segment depression was statistically significantly greater than that of metoprolol. This could be due to its additional vasodilatory or antioxidative actions. Based on the safety and efficacy data of the present study, use of the higher of the 2 recommended doses of carvedilol and metoprolol appears justified in younger and elderly patients without adequate therapeutic control at lower doses.

摘要

在一项双盲、随机、为期3个月的多中心研究中,对年龄较轻和年长的稳定型心绞痛患者,评估了每日两次服用25至50毫克卡维地洛的安全性、耐受性以及抗心绞痛和抗缺血疗效,并与每日两次服用50至100毫克美托洛尔进行了比较。在为期7天的安慰剂导入期结束时进行了症状限制性自行车测力计运动测试,之后368名患者被随机分配至平行治疗组。在低剂量治疗4周后,进行了进一步的运动测试,如果总运动时间增加<1分钟且无安全问题,则以单盲方式将患者滴定至更高剂量。在进一步治疗8周后进行了第三次运动测试。结果显示,卡维地洛低剂量/高剂量在年轻和老年患者中至少与美托洛尔低剂量/高剂量一样安全且耐受性良好。没有出现此前未知的不良事件,剂量增加后事件类型也没有明显变化。治疗开始或滴定后早期不良事件在两种药物中相当,表明卡维地洛的血管舒张作用没有特别风险。未观察到反跳现象。两种药物均显示出良好的抗心绞痛和抗缺血疗效,滴定后包括年龄≥65岁的患者在内均有显著增加。然而,在所选的似乎在β受体阻滞方面等效的剂量下,卡维地洛在1毫米ST段压低时间方面的改善在统计学上显著大于美托洛尔。这可能归因于其额外的血管舒张或抗氧化作用。根据本研究的安全性和疗效数据,对于年轻和老年患者,如果低剂量治疗时未达到充分的治疗控制,使用卡维地洛和美托洛尔两种推荐剂量中较高的剂量似乎是合理的。

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