Maclean D
Department of Clinical Pharmacology, Ninewells Hospital, Dundee, Scotland, United Kingdom.
Am J Cardiol. 1994 Jan 27;73(3):55A-58A. doi: 10.1016/0002-9149(94)90276-3.
This study was conducted to assess the therapeutic utility of combining amlodipine with captopril in patients with moderate-to-severe hypertension. Patients had hypertension of WHO grades I-III, with initial mean sitting and standing diastolic blood pressure of 100-119 mm Hg (phase V) after 2-4 weeks on placebo, and had remained uncontrolled (diastolic blood pressure > 95 mm Hg) despite a further 4 weeks on low-dose captopril. Twenty-nine patients entered the computer-randomized, double-blind, placebo-controlled, 2-way crossover comparison of either amlodipine 10 mg once daily or matching placebo added to continued therapy with captopril 25 mg twice daily for 4 weeks. Patients then acted as their own control and received the alternative amlodipine/placebo treatment plus their continued captopril therapy for another 4 weeks. Once-daily amlodipine was shown to be effective when combined with captopril. Mean baseline supine systolic blood pressure decreased from 167 to 149 mm Hg and standing systolic blood pressure from 167 to 144 mm Hg. Mean supine diastolic blood pressure decreased from 105 to 92 mm Hg, and standing diastolic blood pressure decreased from 110 to 96 mm Hg. The placebo-corrected amlodipine differences in mean changes from captopril baseline were -18/-12.2 mm Hg for supine and -20.1/-11.9 mm Hg for standing systolic and diastolic blood pressures, respectively (p < 0.001 for all 4 measurements). The most common side effects encountered with amlodipine were flushing and pedal edema. The combination of amlodipine and captopril was well tolerated, and no patient discontinued therapy. No significant treatment-related effects on biochemical and hematologic parameters were noted.
本研究旨在评估氨氯地平与卡托普利联合应用于中重度高血压患者的治疗效用。患者患有世界卫生组织I - III级高血压,在服用安慰剂2 - 4周后,初始平均坐位和立位舒张压为100 - 119 mmHg(第V期),且在继续服用低剂量卡托普利4周后血压仍未得到控制(舒张压>95 mmHg)。29例患者进入计算机随机、双盲、安慰剂对照的双向交叉比较试验,试验内容为每日一次服用10 mg氨氯地平或匹配的安慰剂,并继续每日两次服用25 mg卡托普利治疗4周。然后患者作为自身对照,接受另一种氨氯地平/安慰剂治疗并继续服用卡托普利治疗4周。结果显示,氨氯地平与卡托普利联合使用时有效。平均基线仰卧位收缩压从167 mmHg降至149 mmHg,立位收缩压从167 mmHg降至144 mmHg。平均仰卧位舒张压从105 mmHg降至92 mmHg,立位舒张压从110 mmHg降至96 mmHg。与卡托普利基线相比,安慰剂校正后的氨氯地平平均变化差异在仰卧位收缩压和舒张压分别为-18/-12.2 mmHg,立位收缩压和舒张压分别为-20.1/-11.9 mmHg(所有4项测量p<0.001)。氨氯地平最常见的副作用是面部潮红和足部水肿。氨氯地平与卡托普利联合使用耐受性良好,无患者停药。未观察到对生化和血液学参数有显著的治疗相关影响。