Faust G
Johannes-Gutenberg-Universität, Mainz/Rhein, Germany.
J Cardiovasc Pharmacol. 1992;20 Suppl 6:S56-61.
In one multicenter, double-blind study, 659 hypertensive patients were treated for 16 weeks with either nilvadipine (n = 326) or nifedipine (n = 333). The major objective of the study was to compare the compatibility of the two calcium antagonists with regard to hepatic compatibility and side-effect profiles. The dosages were chosen so that the effective blood pressure reduction in both groups was equally good (mean decreases in systolic pressure of 27 +/- 12 mm Hg with nilvadipine and 26 +/- 15 mm Hg with nifedipine, and in diastolic pressure of 18 +/- 6 mm Hg with nilvadipine and 19 +/- 7 mm Hg with nifedipine). The mean heart rate was slightly lowered by about 2 beats/min by both substances. Although there was no effect on lipid or glucose levels, the serum glutamate-pyruvate transaminase (SPGT) levels were more often found to be raised in the nifedipine group than in the nilvadipine group (p < 0.05). The vasodilator effect of both calcium antagonists was responsible for side effects, of which the most common were flushing, edema, headache, and palpitations. The number of complaints was less in the group treated with nilvadipine than with nifedipine, especially flushing and edema. Significantly more patients in the nifedipine group withdrew from treatment due to undesirable side effects (p < 0.05).
在一项多中心双盲研究中,659名高血压患者分别接受尼伐地平(n = 326)或硝苯地平(n = 333)治疗16周。该研究的主要目的是比较这两种钙拮抗剂在肝脏耐受性和副作用方面的兼容性。选择的剂量使两组的有效血压降低效果同样良好(尼伐地平组收缩压平均降低27 +/- 12 mmHg,硝苯地平组为26 +/- 15 mmHg;尼伐地平组舒张压平均降低18 +/- 6 mmHg,硝苯地平组为19 +/- 7 mmHg)。两种药物均使平均心率略有降低,约2次/分钟。虽然对血脂或血糖水平没有影响,但硝苯地平组血清谷丙转氨酶(SPGT)水平升高的情况比尼伐地平组更常见(p < 0.05)。两种钙拮抗剂的血管舒张作用都导致了副作用,其中最常见的是潮红、水肿、头痛和心悸。尼伐地平治疗组的不适主诉数量比硝苯地平组少,尤其是潮红和水肿。硝苯地平组因不良副作用退出治疗的患者明显更多(p < 0.05)。