Hollifield J W, Heusner J J, DesChamps M, Gray J, Spyker D A, Peace K E, Dickson B
Hypertension Center of Nashville, TN 37203.
Clin Pharm. 1988 Feb;7(2):129-34.
The clinical efficacy, safety, and tolerability of oral verapamil and diltiazem, at total daily dosages of equal weight, were evaluated in a placebo-controlled, double-blind crossover study. Thirty-six ambulatory patients with chronic, stable, mild to moderate hypertension (supine diastolic blood pressure of 94-116 mm Hg) received a dosage of either verapamil or diltiazem 80 mg t.i.d. as the hydrochloride salt for one week after an antihypertensive-drug washout period. Each then received 120 mg of the same drug t.i.d. for one week. After another two-week washout period, the patients were crossed over to the other drug. Each patient had a 12-lead electrocardiogram and measurement of supine and standing blood pressure weekly. In the 32 patients completing the study, low-dose verapamil reduced supine diastolic blood pressure (DBP) from a mean of 101.5 +/- 5.2 to 95.3 +/- 9.5 mm Hg; high dose verapamil reduced DBP to 90.9 +/- 7.4 mm Hg. Standing DBP was reduced to a similar degree. Diltiazem showed an almost identical effect: Supine DBP was reduced from a mean of 101.7 +/- 5.3 to 94.0 +/- 10.1 mm Hg with the low dose and to 91.0 +/- 8.6 mm Hg with the high dose, with similar effects on standing DBP. The high dose of both drugs significantly increased the QTc interval, and both doses of diltiazem significantly increased the PR interval compared with baseline. Both drugs exhibited consistent efficacy with minimal adverse effects. The electrophysiologic safety profile of verapamil was superior to that of diltiazem.
在一项安慰剂对照、双盲交叉研究中,评估了等量总日剂量的口服维拉帕米和地尔硫䓬的临床疗效、安全性和耐受性。36例慢性、稳定、轻度至中度高血压(仰卧位舒张压为94 - 116 mmHg)的门诊患者在停用抗高血压药物一段时间后,接受盐酸盐形式的维拉帕米或地尔硫䓬80 mg每日三次,持续一周。然后每人接受相同药物120 mg每日三次,持续一周。在又经过两周的洗脱期后,患者交叉使用另一种药物。每位患者每周进行一次12导联心电图检查,并测量仰卧位和站立位血压。在完成研究的32例患者中,低剂量维拉帕米使仰卧位舒张压(DBP)从平均101.5±5.2 mmHg降至95.3±9.5 mmHg;高剂量维拉帕米使DBP降至90.9±7.4 mmHg。站立位DBP也降低到类似程度。地尔硫䓬显示出几乎相同的效果:低剂量时仰卧位DBP从平均101.7±5.3 mmHg降至94.0±10.1 mmHg,高剂量时降至91.0±8.6 mmHg,对站立位DBP的影响相似。两种药物的高剂量均显著增加QTc间期,与基线相比,地尔硫䓬的两种剂量均显著增加PR间期。两种药物均显示出一致的疗效且不良反应最小。维拉帕米的电生理安全性优于地尔硫䓬。