Samad A, Khan A H, Hashmi M S
Department of Cardiology, National Institute of Cardiovascular Diseases, Karachi, Pakistan.
Am J Hypertens. 1993 Mar;6(3 Pt 2):54S-56S. doi: 10.1093/ajh/6.3.54s.
This open-label trial of isradipine was carried out in 3422 outpatients by 893 general practitioners to assess the efficacy, safety, and tolerability of isradipine as monotherapy in mild-to-moderate hypertension. Patients received 2.5 mg isradipine twice daily as monotherapy for 6 weeks following a placebo wash-out period of 1 week. After 6 weeks of active treatment, diastolic blood pressure was significantly reduced from 106 +/- 7.7 to 89.4 +/- 8.0 mm Hg (P < .001). Systolic blood pressure also decreased significantly, from 166.8 +/- 19.6 to 141.8 +/- 15.7 mm Hg (P < .001). Blood pressure was normalized in 75.68% of the patients. A total of 629 patients (19%) reported adverse events, 79 (2.3%) of whom withdrew from the study for this reason. The most common side-effects were headache (8.7%), palpitations/tachycardia (3.8%), vertigo (2.89%) and flushing (1.00%). In conclusion, 2.5 mg isradipine twice daily is a safe, effective, and well tolerated form of monotherapy in the treatment of hypertension in general practice in a developing country (Pakistan).
893名全科医生对3422名门诊患者进行了这项关于伊拉地平的开放标签试验，以评估伊拉地平作为轻度至中度高血压单一疗法的疗效、安全性和耐受性。在经过1周的安慰剂洗脱期后，患者接受每日两次2.5毫克伊拉地平单一疗法治疗，为期6周。经过6周的积极治疗后，舒张压从106±7.7显著降至89.4±8.0毫米汞柱（P<.001）。收缩压也显著下降，从166.8±19.6降至141.8±15.7毫米汞柱（P<.001）。75.68%的患者血压恢复正常。共有629名患者（19%）报告了不良事件，其中79名（2.3%）因此退出研究。最常见的副作用是头痛（8.7%）、心悸/心动过速（3.8%）、眩晕（2.89%）和脸红（1.00%）。总之，在发展中国家（巴基斯坦）的全科医疗中，每日两次服用2.5毫克伊拉地平是治疗高血压的一种安全、有效且耐受性良好的单一疗法。
