Masotti G, Poggesi L, Castellani S, Morettini A, Galanti G, Scarti L
Int J Clin Pharmacol Res. 1984;4(1):71-9.
The antihypertensive activity of nifedipine in medium-term treatment has been studied in 30 patients affected by II and III WHO grade essential hypertension. After a 6-day period of placebo, patients were randomly allotted to group A (treated with single 10-mg doses of nifedipine) and group B (treated with single 20-mg doses). Treatment with nifedipine continued for 18 days. Patients in both groups were given one daily dose during the first 6 days, two daily doses in the following 6 days and three daily doses in the last 6 days. 1. Antihypertensive effect: In both groups, only three daily doses gave a satisfactory 24-hour antihypertensive activity. Nifedipine as monotherapy administered in single doses of both 10 mg (group A) and 20 mg (group B) normalized blood pressure (BP) and the measured antihypertensive effect was not statistically different in the two groups. The antihypertensive effect lasted between 7 and 8 hours after drug administration (both doses) and did not diminish with increasing duration of treatment or number of daily doses. 2. Change in heart rate: Nifedipine induced an increase in HR which diminished with shortening of the time interval between daily administrations. The effect on HR was unaltered throughout the whole experimental period. 3. Side-effects: Nifedipine did not induce orthostatic hypotension in any patient. Eleven of the 30 patients complained of side-effects, the most common being headache and palpitations. Incidence and severity of side-effects were not correlated with dose, whereas duration was longer with 20 mg. Side-effects never necessitated withdrawal of the drug.
已对30例世界卫生组织II级和III级原发性高血压患者进行了硝苯地平中期治疗的降压活性研究。在6天的安慰剂期后，患者被随机分配到A组（接受单次10毫克剂量的硝苯地平治疗）和B组（接受单次20毫克剂量治疗）。硝苯地平治疗持续18天。两组患者在前6天每天服用一剂，接下来的6天每天服用两剂，最后6天每天服用三剂。1. 降压效果：在两组中，仅每日三剂能产生令人满意的24小时降压活性。作为单一疗法，10毫克（A组）和20毫克（B组）单次剂量的硝苯地平均可使血压正常化，两组测得的降压效果无统计学差异。给药后（两种剂量）降压效果持续7至8小时，且不随治疗持续时间或每日剂量数的增加而减弱。2. 心率变化：硝苯地平导致心率增加，随着每日给药时间间隔的缩短，这种增加会减弱。在整个实验期间，对心率的影响保持不变。3. 副作用：硝苯地平未在任何患者中引起体位性低血压。30例患者中有11例抱怨有副作用，最常见的是头痛和心悸。副作用的发生率和严重程度与剂量无关，而20毫克剂量时副作用持续时间更长。副作用从未导致停药。
