Kirch W, Burger K J, Weidinger G, Welzel D
1 Medizinische Klinik, Christian-Albrechts-Universität, Kiel, F.R.G.
J Cardiovasc Pharmacol. 1990;15 Suppl 1:S55-9.
The antihypertensive efficacy and tolerability of the new calcium antagonist isradipine was assessed in 86 hypertensive patients who had pretreatment diastolic blood pressures (DBP) greater than or equal to 105 mm Hg and who were randomly allocated to a double-blind comparison of three different dosage regimens: 1.25 mg, 2.5 mg, and 5 mg b.i.d., and placebo. A 2-week run-in period was followed by a 4-week course of treatment. Isradipine reduced systolic and diastolic blood pressures dose-dependently; the normalization rate (DBP less than or equal to 90 mm Hg) was 5% with placebo and 29, 55, and 64% with isradipine 1.25, 2.5, and 5 mg b.i.d., respectively. The proportion of patients experiencing at least a 10 mm Hg reduction in sitting DBP was 29, 67, 86, and 91%, respectively. All three dosages proved to be significantly effective compared to placebo. Neither heart rate nor blood pressure regulation in orthostasis were influenced. The main side effects were headache, dizziness, and flushing; isradipine 1.25 and 2.5 mg b.i.d. were well tolerated (not significantly different from placebo). In conclusion, isradipine 2.5 mg b.i.d. appears to be the potential dose of first choice, exhibiting a favorable benefit-risk profile.
对86例高血压患者进行了研究，评估新型钙拮抗剂伊拉地平的降压疗效和耐受性。这些患者的治疗前舒张压（DBP）大于或等于105mmHg，他们被随机分配到三种不同剂量方案的双盲对照试验中：每日两次，每次1.25mg、2.5mg和5mg，以及安慰剂组。在为期2周的导入期后，进行为期4周的治疗。伊拉地平能使收缩压和舒张压呈剂量依赖性降低；安慰剂组的血压正常化率（DBP小于或等于90mmHg）为5%，伊拉地平每日两次，每次1.25mg、2.5mg和5mg组的血压正常化率分别为29%、55%和64%。坐位DBP至少降低10mmHg的患者比例分别为29%、67%、86%和91%。与安慰剂相比，所有三种剂量均被证明具有显著疗效。对心率和直立位血压调节均无影响。主要副作用为头痛、头晕和面部潮红；每日两次，每次1.25mg和2.5mg的伊拉地平耐受性良好（与安慰剂无显著差异）。总之，每日两次，每次2.5mg的伊拉地平似乎是首选的潜在剂量，具有良好的效益风险比。
