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拉西地平与硝苯地平缓释片治疗高血压的对比研究:一项意大利多中心研究。意大利北部拉西地平治疗高血压研究组。

Comparative study of lacidipine and nifedipine SR in the treatment of hypertension: an Italian multicenter study. The Northern Italian Study Group of Lacidipine in Hypertension.

作者信息

Leonetti G

机构信息

Center of Clinical Physiology and Hypertension, Hospital Policlinic, Milan, Italy.

出版信息

J Cardiovasc Pharmacol. 1991;17 Suppl 4:S31-4. doi: 10.1097/00005344-199117041-00007.

DOI:10.1097/00005344-199117041-00007
PMID:1726003
Abstract

The aim of this study was to compare the antihypertensive efficacy and tolerability of lacidipine, a new dihydropyridine calcium antagonist, and slow-release nifedipine (SR) in patients with mild-to-moderate essential hypertension. After a 1-month placebo run-in period, 435 patients were randomized into a double-blind, parallel-group study to receive either 4 mg of lacidipine once daily (n = 220) or 20 mg of nifedipine twice daily (n = 215). After 4 weeks, the doses for "nonresponders" were increased to 6 mg of lacidipine once daily (n = 82) and to 40 mg of nifedipine SR twice daily (n = 62). After 4 weeks, 50 mg of atenolol once daily was added to the regimens of patients still uncontrolled by lacidipine (n = 32) and nifedipine SR (n = 23) as monotherapy. Sitting blood pressure and heart rate were measured at 22-24 h after lacidipine and 10-12 h after nifedipine SR. Both calcium antagonists similarly and significantly reduced the blood pressure at rest (sitting) and on exercise, while the heart rate did not change significantly. The nature and incidence of side effects and withdrawals also did not differ between the two. In conclusion, lacidipine once daily is as effective and well tolerated as nifedipine SR twice daily in patients with mild-to-moderate essential hypertension.

摘要

本研究旨在比较新型二氢吡啶类钙拮抗剂拉西地平与缓释硝苯地平在轻至中度原发性高血压患者中的降压疗效及耐受性。经过1个月的安慰剂导入期后,435例患者被随机分为一项双盲、平行组研究,分别接受每日一次4 mg拉西地平(n = 220)或每日两次20 mg硝苯地平(n = 215)治疗。4周后,“无反应者”的剂量分别增至每日一次6 mg拉西地平(n = 82)和每日两次40 mg缓释硝苯地平(n = 62)。4周后,对于单药治疗仍未得到控制的拉西地平组患者(n = 32)和缓释硝苯地平组患者(n = 23),在其治疗方案中添加每日一次50 mg阿替洛尔。在服用拉西地平后22 - 24小时及服用缓释硝苯地平后10 - 12小时测量坐位血压和心率。两种钙拮抗剂均能相似且显著地降低静息(坐位)血压及运动时血压,而心率无显著变化。两组间副作用及撤药的性质和发生率也无差异。总之,对于轻至中度原发性高血压患者,每日一次拉西地平与每日两次缓释硝苯地平的疗效相当且耐受性良好。

相似文献

1
Comparative study of lacidipine and nifedipine SR in the treatment of hypertension: an Italian multicenter study. The Northern Italian Study Group of Lacidipine in Hypertension.拉西地平与硝苯地平缓释片治疗高血压的对比研究:一项意大利多中心研究。意大利北部拉西地平治疗高血压研究组。
J Cardiovasc Pharmacol. 1991;17 Suppl 4:S31-4. doi: 10.1097/00005344-199117041-00007.
2
A long-term study comparing lacidipine and nifedipine SR in hypertensive patients: safety data.一项比较拉西地平与硝苯地平缓释片治疗高血压患者的长期研究:安全性数据。
J Cardiovasc Pharmacol. 1994;23 Suppl 5:S108-10. doi: 10.1097/00005344-199423005-00024.
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A double-blind comparison of the efficacy and safety of lacidipine and hydrochlorothiazide in essential hypertension. The Southern Italy Lacidipine Study Group.拉西地平与氢氯噻嗪治疗原发性高血压的疗效及安全性双盲比较。意大利南部拉西地平研究组。
J Cardiovasc Pharmacol. 1991;17 Suppl 4:S35-7.
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Remodeling of left ventricular geometry and function induced by lacidipine and nifedipine SR in mild-to-moderate hypertension.拉西地平与硝苯地平缓释片对轻至中度高血压患者左心室几何形态及功能的重塑作用
J Cardiovasc Pharmacol. 1991;17 Suppl 4:S68-74.
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A double-blind comparison of the efficacy and safety of lacidipine with atenolol in the treatment of essential hypertension. The United Kingdom Lacidipine Study Group.拉西地平与阿替洛尔治疗原发性高血压的疗效及安全性双盲比较。英国拉西地平研究组。
J Cardiovasc Pharmacol. 1991;17 Suppl 4:S27-30.
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Effects of lacidipine and nifedipine on lower limb veins in nonphlebopathic patients.拉西地平与硝苯地平对非静脉病患者下肢静脉的影响。
J Cardiovasc Pharmacol. 1994;23 Suppl 5:S111-2. doi: 10.1097/00005344-199423005-00025.
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Long-term antihypertensive treatment with lacidipine, a new long-acting calcium antagonist.使用新型长效钙拮抗剂拉西地平进行长期抗高血压治疗。
J Cardiovasc Pharmacol. 1991;18 Suppl 11:S22-5. doi: 10.1097/00005344-199102001-00005.
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Efficacy and safety of lacidipine, a new long-lasting calcium antagonist, in elderly hypertensive patients.
J Cardiovasc Pharmacol. 1991;17 Suppl 4:S38-43; discussion S43-4.
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Clinical position of lacidipine, a new dihydropyridine calcium antagonist, in the treatment of hypertension.新型二氢吡啶类钙拮抗剂拉西地平在高血压治疗中的临床地位。
J Cardiovasc Pharmacol. 1991;18 Suppl 11:S18-21. doi: 10.1097/00005344-199102001-00004.

引用本文的文献

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Comparative peripheral edema for dihydropyridines calcium channel blockers treatment: A systematic review and network meta-analysis.二氢吡啶类钙通道阻滞剂治疗的外周性水肿比较:系统评价和网络荟萃分析。
J Clin Hypertens (Greenwich). 2022 May;24(5):536-554. doi: 10.1111/jch.14436. Epub 2022 Mar 2.
2
Modified-release nifedipine: a review of the use of modified-release formulations in the treatment of hypertension and angina pectoris.缓释硝苯地平:关于缓释制剂在高血压和心绞痛治疗中应用的综述
Drugs. 2006;66(4):497-528. doi: 10.2165/00003495-200666040-00007.
3
Lacidipine: a review of its use in the management of hypertension.
拉西地平:用于高血压管理的综述
Drugs. 2003;63(21):2327-56. doi: 10.2165/00003495-200363210-00008.
4
Dose linearity of lacidipine pharmacokinetics after single and repeated oral doses in healthy volunteers.健康志愿者单次及多次口服拉西地平后药代动力学的剂量线性关系。
Clin Pharmacokinet. 2003;42(1):99-106. doi: 10.2165/00003088-200342010-00004.
5
Lacidipine. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in the treatment of hypertension.拉西地平。对其药效学、药代动力学特性及治疗高血压的潜力的综述。
Drugs. 1994 Aug;48(2):274-96. doi: 10.2165/00003495-199448020-00010.