Huckell V F, Bélanger L G, Kazimirski M, Subramanian T, Cox A J
University of British Columbia, Vancouver, Canada.
Clin Ther. 1993 Mar-Apr;15(2):407-22.
A postmarketing surveillance study in 2273 Canadian office practices provided the largest body of clinical experience to date with the angiotensin-converting enzyme (ACE) inhibitor lisinopril in the treatment of mild to moderate essential hypertension. The principal emphasis in this uncontrolled study was safety, assessed in 10,289 patients. Patients with a diastolic blood pressure > 90 mmHg were considered for the study. Both previously untreated patients and those who were experiencing adverse effects from their current antihypertensive regimen were included. Lisinopril was begun at a dose of 10 mg/day. Subsequent dose adjustments, to a maximum of 40 mg/day, were made to achieve optimal blood pressure control (diastolic blood pressure < or = 90 mmHg or > or = 10 mmHg below baseline for > or = 4 weeks at the same dose). Therapy was continued for a minimum of 4 weeks to a maximum of 12 weeks, with patients examined every 2 weeks. The frequencies of adverse effects and laboratory abnormalities were analyzed in all treated patients. All 10,289 patients enrolled were considered in the analysis of safety. One or more adverse effects were reported for 1593 (15.5%) patients, and 802 (7.8%) withdrew from the study because of adverse effects. The most frequent adverse effects were cough (4.0%), dizziness (2.3%), headache (2.1%), asthenia (1.7%), and nausea (1.0%). The physicians' global assessment rated overall tolerability as very good or good for 77.1% of the patients. Antihypertensive effect was evaluated in 5886 patients who met the criteria for efficacy analysis. The criterion response was attained in 5141 (87.3%) patients, with 68.6% responding to 10 mg/day of lisinopril, 26.3% to 20 mg/day, and 3.2% to 40 mg/day (the other 1.9% responded at nonstandard doses). Lisinopril was safe and well-tolerated. Except for cough, class effects of ACE inhibitors were rarely encountered. The results of the efficacy analysis confirm the established efficacy of lisinopril in patients with mild to moderate essential hypertension.
一项针对2273例加拿大门诊病例的上市后监测研究，提供了迄今为止血管紧张素转换酶（ACE）抑制剂赖诺普利治疗轻至中度原发性高血压的最大规模临床经验。这项非对照研究主要关注安全性，共评估了10289例患者。舒张压>90 mmHg的患者被纳入研究。研究对象包括既往未接受治疗的患者以及当前抗高血压治疗方案出现不良反应的患者。赖诺普利起始剂量为10 mg/天。随后根据需要调整剂量，最大剂量为40 mg/天，以实现最佳血压控制（舒张压<或=90 mmHg或比基线降低>或=10 mmHg，且在相同剂量下维持>或=4周）。治疗持续至少4周，最长12周，每2周对患者进行检查。分析了所有接受治疗患者的不良反应和实验室异常情况的发生频率。在安全性分析中纳入了所有10289例登记患者。1593例（15.5%）患者报告了一种或多种不良反应，802例（7.8%）患者因不良反应退出研究。最常见的不良反应为咳嗽（4.0%）、头晕（2.3%）、头痛（2.1%）、乏力（1.7%）和恶心（1.0%）。医生的整体评估显示，77.1%的患者总体耐受性为非常好或良好。在5886例符合疗效分析标准的患者中评估了抗高血压效果。5141例（87.3%）患者达到标准反应，其中68.6%的患者对10 mg/天的赖诺普利有反应，26.3%对20 mg/天有反应，3.2%对40 mg/天有反应（另外1.9%在非标准剂量下有反应）。赖诺普利安全且耐受性良好。除咳嗽外，很少出现ACE抑制剂的类效应。疗效分析结果证实了赖诺普利在轻至中度原发性高血压患者中的既定疗效。
