摘要
目的 采用24 h动态血压监测观察阿雷地平肠溶胶囊治疗1、2级原发性高血压的效果和安全性.方法 开放试验.舒张压95～＜110 mm Hg和(或)收缩压140～＜180 mm Hg的高血压患者74例在2周安慰剂洗脱期后给予5 mg/d阿雷地平胶囊,4周后如诊室谷值坐位血压≥140/90 mm Hg者阿雷地平剂量增至10 mg/d.8周时诊室谷值坐位血压仍≥140/90 mm Hg者,阿雷地平剂量增加至20 mg/d服药至第12周.在第0周和第12周时分别各进行1次动态血压监测,评估其降压疗效和安全性.结果 治疗12周后,患者全天、日间、夜间平均收缩压/舒张压降低幅度分别为(13.8±12.6)/(11.1±9.3)、(14.2±12.8)/(11.6±10.2)、(12.9±16.2)/(10.2±10.9)mm Hg(均P＜0.05).不同剂量组(5、10、20 mg)治疗后第4、8、12周诊室平均坐位收缩压、舒张压及心率均低于基线水平(均P＜0.05).治疗12周后全部患者总体收缩压和舒张压谷峰比值(T/P)分别为75.31％和78.15％,收缩压平滑指数为8.48,舒张压为7.34.不良发应发生率为13.4％,主要有轻度头晕、面色潮红、心悸.结论 阿雷地平肠溶胶囊(5、10、20mg)治疗1、2级原发性高血压,可持续、平稳、有效地降低24 h血压,且有减慢心率的特点,安全性良好.
Abstract
Objective To evaluate the anti-hypertensive efficacy and safety of aranidipine in treating patients with grade 1-2 essential hypertension by ambulatory blood pressure monitoring (ABPM).Methods Open clinical trials were adopted.Seventy-four patients with diastolic blood pressure (DBP) 95-＜110 mm Hg and (or) systolic blood pressure (SBP) 140-＜180 mm Hg were enrolled and treated with aranidipine (5 mg/d) after a placebo washout period of two weeks.After four weeks of treatment,the dose of aranidipine for those with sitting SBP ≥140 mm Hg and DBP＜90 mm Hg was increased to 10 mg/d for another four weeks.At the eighth week,those with sitting SBP≥140 mm Hg and (or) DBP≥90 mm Hg were given aranidipine 20 mg/d for another four weeks.ABPM of 24 h was performed before and after 12 weeks of treatment.Results After 12 weeks of treatment,the mean 24 h,diurnal and nocturnal SBP/DBP were significantly reduced [(13.8 ± 12.6)/(11.1± 9.3)mm Hg,(14.2 ± 12.8)/(11.6±10.2)mm Hg,and (12.9±16.2)/(10.2±10.9)mm Hg,respectively] compared with those before the treatment (all P＜0.05).After 4,8 and 12 weeks of treatment with different doses of aranidipine (5,10 or 20 mg/d),the clinical SBP,DBP and heart rates were significantly decreased compared with those at the baseline (all P＜0.05).The trough/peak (T/P) ratios of SBP and DBP in all cases were 75.31％ and 78.15 ％ respectively after 12 weeks of treatment.The smoothness index (SI) for SBP and DBP were 8.48 and 7.34.The incidence of adverse events,including mild dizziness,flushing and palpitation,was 13.4％.Conclusion Aranidipine entericcoated capsules (5,10,20 mg) is safe and effective in treating patients with the first grade and second grade essential hypertension by slowing down heart rate and lowering blood pressure continuously,stably and effectively for 24 hours.
NETL
NSTL
维普
万方数据