Welzel D, Burger K J, Weidinger G
Department of Pharmacology, University of Regensburg, F.R.G.
J Cardiovasc Pharmacol. 1990;15 Suppl 1:S70-4.
The new calcium antagonist isradipine was compared with nifedipine retard in a multicenter, double-blind, placebo-controlled, randomized study involving 159 patients with mild hypertension. A 2-week run-in period was followed by a 6-week course of treatment with the possibility of dose doubling after 3 weeks, depending on blood pressure (BP) response (target diastolic BP less than 90 mm Hg). Systolic and diastolic BPs were reduced by isradipine (mean dose of 3.6 mg daily) from 151/101 to 136/89 mm Hg, by nifedipine (mean dose of 50 mg daily) from 155/101 to 144/90 mm Hg, and by placebo from 155/101 to 154/99 mm Hg. Normalization rates were 64% with isradipine, 56% with nifedipine, and 16% with placebo. Adverse events consisted mainly of flushing, headache, edema, and dizziness. Altogether, 8 patients receiving isradipine experienced adverse events in comparison to 21 taking nifedipine and 4 taking placebo. The superior tolerability of isradipine was paralleled by a significant improvement in the subjective well-being of the patients as assessed by the von Zerssen questionnaire (List of Complaints). With nifedipine and placebo, no statistically significant improvement was observed.
在一项涉及159例轻度高血压患者的多中心、双盲、安慰剂对照、随机研究中，将新型钙拮抗剂伊拉地平与缓释硝苯地平进行了比较。在为期2周的导入期之后，进行为期6周的治疗，根据血压（BP）反应（目标舒张压低于90 mmHg），3周后有可能将剂量加倍。伊拉地平（每日平均剂量3.6 mg）使收缩压和舒张压从151/101 mmHg降至136/89 mmHg，硝苯地平（每日平均剂量50 mg）使其从155/101 mmHg降至144/90 mmHg，安慰剂使其从155/101 mmHg降至154/99 mmHg。伊拉地平的血压正常化率为64%，硝苯地平为56%，安慰剂为16%。不良事件主要包括脸红、头痛、水肿和头晕。总共，接受伊拉地平治疗的8例患者出现了不良事件，相比之下，服用硝苯地平的有21例，服用安慰剂的有4例。通过冯·泽尔森问卷（投诉清单）评估，伊拉地平的耐受性更好，同时患者的主观幸福感也有显著改善。使用硝苯地平和安慰剂时，未观察到统计学上的显著改善。
