Strocchi E, Costa F V, Caldari R, Malini P L, Marata A M, Parini J, Ambrosioni E
Int J Clin Pharmacol Ther Toxicol. 1983 Oct;21(10):519-23.
The antihypertensive activity of a new vasodilating agent (ISF 2469) cadralazine (CD) was compared in a randomized, crossover, intrapatient study with that of hydralazine (HD) in 20 hypertensive patients whose diastolic blood pressure (BP) was greater than 95 mmHg during treatment with atenolol (AT), 100 mg 1 X daily. The initial dose of CD was 15 mg 1 X daily; after 15 days in case of poor response, the dose was increased to 20 mg 1 X daily. HD was given at a dose of 25 mg 3 X daily and was increased to 50 mg 2 X daily in case of poor response. BP values (standing) during AT were 174/108; they fell to 144/88 during CD and to 138/88 during HD. No significant difference was detected between the two drugs for both systolic and diastolic BP (supine and standing). Heart rate increased with both drugs, with a greater increase during CD. The difference was clinically nonsignificant. A total of 24 patients were enrolled, but 4 had to cease treatment because of side effects during HD. The overall prevalence of side effects was much higher during HD, especially during the first days of therapy. Also the severity of side effects was greater during HD. Our data show that CD has the same antihypertensive activity as HD with a lesser incidence of side effects and with a single dose/day administration in contrast with three administrations of HD. This can result in greater patient compliance.
在一项随机、交叉、自身对照研究中,对20例高血压患者使用新型血管扩张剂卡屈嗪(CD,ISF 2469)和肼屈嗪(HD)的降压活性进行了比较。这些患者在服用阿替洛尔(AT)100mg每日1次治疗期间,舒张压(BP)大于95mmHg。CD的初始剂量为每日1次15mg;若15天后效果不佳,剂量增至每日1次20mg。HD的给药剂量为每日3次25mg,若效果不佳则增至每日2次50mg。服用AT期间(站立位)血压值为174/108;服用CD期间降至144/88,服用HD期间降至138/88。两种药物在收缩压和舒张压(仰卧位和站立位)方面均未检测到显著差异。两种药物均可使心率增加,CD引起的心率增加幅度更大,但临床差异不显著。共有24例患者入组,但4例因服用HD期间出现副作用而不得不停止治疗。HD期间副作用的总体发生率更高,尤其是在治疗的最初几天。HD期间副作用的严重程度也更大。我们的数据表明,CD与HD具有相同的降压活性,但副作用发生率较低,且CD每日只需给药1次,而HD需给药3次。这可提高患者的依从性。