Chrysant S G, Cohen M
Oklahoma Cardiovascular and Hypertension Center, University of Oklahoma, Oklahoma City 73132-4904, USA.
Am J Hypertens. 1995 Jan;8(1):87-9. doi: 10.1016/0895-7061(94)00158-8.
The efficacy and safety of different doses of a new controlled release formulation of isradipine (isradipine-CR, ICR) were evaluated in patients with mild to moderate (stages 1 and 2) essential hypertension in a placebo-controlled study. Of 402 randomized patients, 384 completed the study (placebo = 77, 5 mg ICR = 76, 10 mg ICR = 76, 15 mg ICR = 78, 20 mg ICR = 77). All doses of ICR decreased the blood pressure and the effect was greater with doses of 10, 15, and 20 mg once daily (P < .001). The most common clinical side effect was mild ankle edema, which was dose dependent, occurring in 35.5% of the patients taking the 20-mg ICR dose. This study showed that ICR is long acting, effective, and well tolerated.
在一项安慰剂对照研究中，对不同剂量的新型控释伊拉地平制剂（伊拉地平控释片，ICR）在轻度至中度（1期和2期）原发性高血压患者中的疗效和安全性进行了评估。402例随机分组患者中，384例完成了研究（安慰剂组 = 77例，5 mg ICR组 = 76例，10 mg ICR组 = 76例，15 mg ICR组 = 78例，20 mg ICR组 = 77例）。所有剂量的ICR均能降低血压，每日一次服用10、15和20 mg剂量时效果更佳（P < .001）。最常见的临床副作用是轻度踝部水肿，其具有剂量依赖性，在服用20 mg ICR剂量的患者中发生率为35.5%。该研究表明，ICR作用持久、有效且耐受性良好。
