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非洛地平缓释制剂治疗轻度高血压:与安慰剂相比的疗效和耐受性

Felodipine ER formulation in the treatment of mild hypertension: efficacy and tolerability vs placebo.

作者信息

Bossini A, Di Veroli C, Cavallotti G, Cagli V

机构信息

Hypertension and Nephropathy Centre, Policlinico Umberto I Hospital, Rome, Italy.

出版信息

Br J Clin Pharmacol. 1990 Oct;30(4):567-71. doi: 10.1111/j.1365-2125.1990.tb03814.x.

DOI:10.1111/j.1365-2125.1990.tb03814.x
PMID:2291869
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1368246/
Abstract
  1. Felodipine is a new calcium-antagonist dihydropyridine derivative with a high degree of selectivity for smooth muscle of arteriolar resistance vessels, as opposed to cardiac cells. 2. In this double-blind, cross-over study the antihypertensive efficacy and tolerability of the new extended release (ER) formulation of felodipine 10 mg, once daily, in patients with mild essential hypertension was evaluated. After a 4-week single-blind placebo period 28 patients (15 males; mean age 48 +/- 12 years) were randomized to receive felodipine 10 mg ER once daily or placebo for 4 weeks and the alternative treatment for a further 4 weeks. Supine blood pressure and heart rate were measured in the out-patients department every 2 weeks, 22-24 h after the last drug administration. 3. Felodipine 10 mg ER induced a significant reduction in blood pressure in comparison with placebo (from 149 +/- 16/97 +/- 6 to 140 +/- 12/89 +/- 6 mm Hg). Heart rate remained unchanged. Seven patients dropped-out; five during felodipine ER administration and two during placebo. 4. A once daily dose of felodipine ER significantly reduces blood pressure in mild hypertensive patients 22-24 h after administration. It is well tolerated and the adverse events are related to its pharmacodynamic effects.
摘要
  1. 非洛地平是一种新型钙拮抗剂二氢吡啶衍生物,对小动脉阻力血管的平滑肌具有高度选择性,而对心肌细胞则不然。2. 在这项双盲交叉研究中,评估了非洛地平10毫克新的缓释(ER)制剂每日一次在轻度原发性高血压患者中的降压疗效和耐受性。经过4周的单盲安慰剂期后,28名患者(15名男性;平均年龄48±12岁)被随机分为接受非洛地平10毫克ER每日一次或安慰剂治疗4周,然后交替治疗4周。在门诊每2周测量一次仰卧位血压和心率,在最后一次给药后22 - 24小时测量。3. 与安慰剂相比,非洛地平10毫克ER可显著降低血压(从149±16/97±6降至140±12/89±6毫米汞柱)。心率保持不变。7名患者退出;5名在服用非洛地平ER期间退出,2名在服用安慰剂期间退出。4. 每日一次剂量的非洛地平ER在给药后22 - 24小时可显著降低轻度高血压患者的血压。耐受性良好,不良事件与其药效学作用有关。

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Felodipine ER formulation in the treatment of mild hypertension: efficacy and tolerability vs placebo.非洛地平缓释制剂治疗轻度高血压:与安慰剂相比的疗效和耐受性
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2
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引用本文的文献

1
The antihypertensive efficacy and tolerability of a low dose combination of ramipril and felodipine ER in mild to moderate essential hypertension.雷米普利与缓释非洛地平低剂量联合用药治疗轻至中度原发性高血压的降压疗效及耐受性
Br J Clin Pharmacol. 1993 Oct;36(4):323-30. doi: 10.1111/j.1365-2125.1993.tb00371.x.
2
Clinical pharmacokinetics of calcium antagonists. An update.钙拮抗剂的临床药代动力学。最新进展。
Clin Pharmacokinet. 1992 Jun;22(6):416-33. doi: 10.2165/00003088-199222060-00002.
3
Felodipine. A review of the pharmacology and therapeutic use of the extended release formulation in cardiovascular disorders.非洛地平。缓释制剂在心血管疾病中的药理学及治疗应用综述。
Drugs. 1992 Aug;44(2):251-77. doi: 10.2165/00003495-199244020-00008.

本文引用的文献

1
Short-term effects of felodipine, a new dihydropyridine, in hypertension.新型二氢吡啶类药物非洛地平在高血压治疗中的短期疗效
Br J Clin Pharmacol. 1984 Mar;17(3):257-63. doi: 10.1111/j.1365-2125.1984.tb02340.x.
2
Acute haemodynamic effects of felodipine during beta blockade in patients with coronary artery disease.非洛地平在冠状动脉疾病患者β受体阻滞剂治疗期间的急性血流动力学效应
Br Heart J. 1984 Oct;52(4):431-4. doi: 10.1136/hrt.52.4.431.
3
Felodipine--a new vasodilator, in addition to beta-receptor blockade in hypertension.
Eur J Clin Pharmacol. 1983;25(5):571-5. doi: 10.1007/BF00542340.
4
Electrophysiological effects of felodipine.非洛地平的电生理效应。
Drugs. 1985;29 Suppl 2:76-80. doi: 10.2165/00003495-198500292-00014.
5
Vascular selectivity of felodipine.非洛地平的血管选择性
Drugs. 1985;29 Suppl 2:46-58. doi: 10.2165/00003495-198500292-00011.
6
Acute diuretic/natriuretic properties of felodipine in man.非洛地平对人体的急性利尿/利钠特性。
Drugs. 1985;29 Suppl 2:176-84. doi: 10.2165/00003495-198500292-00032.
7
Effects of felodipine on rest and exercise heart rate and blood pressure in hypertensive patients.非洛地平对高血压患者静息及运动时心率和血压的影响。
Drugs. 1985;29 Suppl 2:154-7. doi: 10.2165/00003495-198500292-00026.
8
Treatment of essential hypertension with felodipine in combination with a diuretic.
Eur J Clin Pharmacol. 1986;30(2):133-9. doi: 10.1007/BF00614290.
9
Comparison of antihypertensive effect and pharmacokinetics of conventional and extended release felodipine tablets in patients with arterial hypertension.常规与缓释非洛地平片治疗动脉高血压患者的降压效果及药代动力学比较
Drugs. 1987;34 Suppl 3:125-31. doi: 10.2165/00003495-198700343-00027.
10
Hypertension in the elderly. Its diagnosis in general practice and treatment with felodipine and metoprolol.老年人高血压。其在全科医疗中的诊断以及使用非洛地平和美托洛尔的治疗。
Drugs. 1987;34 Suppl 3:149-50. doi: 10.2165/00003495-198700343-00031.