Duffy J, Macdonald G
Medical Department, Bayer UK Ltd., Newbury, England.
Curr Med Res Opin. 1987;10(8):566-72. doi: 10.1185/03007998709108967.
A multi-centre study in general practice involving 3242 hypertensive patients, aged up to 70 years, was carried out to evaluate the efficacy and tolerability of nifedipine used alone or in combination with other antihypertensive agents in step-care treatment. Patients were treated for up to 8 weeks with one of four regimens: nifedipine monotherapy; diuretic and nifedipine; beta-blocker plus nifedipine; and nifedipine added to a combination of diuretic and beta-blocker. All patients received 20 mg nifedipine, in slow-release tablet form, twice daily; at Week 4, dosage was increased to 40 mg twice daily in 8.5% patients because their supine diastolic blood pressure still exceeded 95 mmHg. Changes in mean blood pressure of the total study group for systolic and diastolic, supine and standing, were highly significant both from baseline (Week 0) to Week 4 (p less than 0.0001) and from baseline to Week 8 (p less than 0.0001). Mean blood pressure reduction was 29/18 mmHg supine and 27/18 mmHg standing. Statistical differences in blood pressure response between age, sex and treatment groups were not of clinical significance. Statistically significant reductions in heart rate (mean 1.9 beats/min, p less than 0.001) and body weight (mean 0.48 kg, p less than 0.001) were noted, but were not of clinical relevance. Nifedipine produced a net increase of 12% in side-effects at Week 4 compared to the profile at entry.
一项在全科医疗中开展的多中心研究纳入了3242例年龄在70岁及以下的高血压患者,旨在评估硝苯地平单药治疗或与其他抗高血压药物联合用于阶梯治疗的疗效和耐受性。患者接受以下四种治疗方案之一,治疗时长可达8周:硝苯地平单药治疗;利尿剂与硝苯地平联合治疗;β受体阻滞剂加硝苯地平;硝苯地平添加至利尿剂与β受体阻滞剂的联合治疗方案中。所有患者均每日两次服用20mg缓释片硝苯地平;在第4周时,8.5%的患者因仰卧位舒张压仍超过95mmHg,剂量增加至每日两次40mg。从基线(第0周)到第4周(p<0.0001)以及从基线到第8周(p<0.0001),整个研究组仰卧位和站立位收缩压和舒张压的平均血压变化均非常显著。仰卧位平均血压降低29/18mmHg,站立位平均血压降低27/18mmHg。年龄、性别和治疗组之间血压反应的统计学差异无临床意义。心率(平均降低1.9次/分钟,p<0.001)和体重(平均降低0.48kg,p<0.001)有统计学意义的降低,但无临床相关性。与入组时相比,硝苯地平在第4周时副作用净增加了12%。