Hannedouche T, Fillastre J P, Mimran A, de Tréglodé D, Schardt F, Rosenthal T, Grossman E, Rocco S
Service de néphrologie, Centre Hospitalier, Bois Guillaume, France.
J Cardiovasc Pharmacol. 1987;10 Suppl 3:S107-12.
The serotonergic antagonist ketanserin (K) was compared to nifedipine (N) in a five-center international study on hypertensive patients over the age of 50 years. After a 4-week placebo run-in period, patients were randomly assigned to receive for 3 months either ketanserin (40 mg b.i.d. after 2 weeks of 20 mg b.i.d.) or nifedipine (20 mg N retard b.i.d.). After 1 month, monotherapy patients whose blood pressure was not sufficiently reduced received a diuretic in combination therapy. At the end of the active treatment period, patients who had remained on monotherapy received placebo until hypertension returned or for a maximum of 2 months. One hundred and seventeen patients were entered in the study, 58 on K and 59 on N. More patients switched to combination with a diuretic in the K group (14 patients) than in the N group (6 patients). The overall reduction in blood pressure was similar for K and N. Total response rate was high (96%) for the two drugs. Blood pressure was reduced both at peak and trough drug levels. No orthostatic reactions were observed, and no rebound hypertension occurred at discontinuation of therapy. Ketanserin monotherapy slightly decreased heart rate (-1 beats/min). whereas N produced a significant increase (+6 beats/min). Body weight significantly increased with K (+1.1 kg) and was unchanged with N. More patients complained of adverse reactions during N monotherapy (47%) than during K monotherapy (34%). Flushing and leg edema were more frequent with N.
在一项针对50岁以上高血压患者的五中心国际研究中，将血清素能拮抗剂酮色林（K）与硝苯地平（N）进行了比较。在为期4周的安慰剂导入期后，患者被随机分配接受3个月的治疗，其中一组接受酮色林（在2周的每日两次20毫克剂量后，每日两次40毫克），另一组接受硝苯地平（每日两次20毫克缓释制剂）。1个月后，血压未充分降低的单药治疗患者接受联合利尿剂治疗。在积极治疗期结束时，一直接受单药治疗的患者接受安慰剂治疗，直至高血压复发或最长持续2个月。117名患者进入该研究，58名接受K治疗，59名接受N治疗。与N组（6名患者）相比，K组（14名患者）有更多患者转为联合使用利尿剂。K和N的总体血压降低情况相似。两种药物的总有效率都很高（96%）。在药物浓度峰值和谷值时血压均降低。未观察到体位性反应，治疗中断时也未发生反弹性高血压。酮色林单药治疗使心率略有下降（-1次/分钟），而N使心率显著增加（+6次/分钟）。使用K治疗后体重显著增加（+1.1千克），使用N治疗后体重无变化。与K单药治疗期间（34%）相比，N单药治疗期间更多患者抱怨有不良反应（47%）。N治疗时潮红和腿部水肿更为常见。
