摘要目的 采用24 h动态血压监测评价阿雷地平肠溶胶囊对轻、中度原发性高血压患者的降压疗效以及对血压变异性(BPV)的影响.方法 开放试验.对74例符合入选标准的轻、中度高血压患者给予5 mg/d阿雷地平肠溶胶囊,4周后如诊室坐位血压＜140/90 mm Hg(1 mm Hg =0.133kPa),维持原剂量治疗,血压未达标者剂量增至10 mg/d.8周时诊室坐位血压＜140/90 mmHg者,维持原剂量5 mg/d或10 mg/d,未达标者剂量增至20 mg/d服药至第12周.在第0周、12周时分别各进行1次动态血压监测,观察治疗前后动态血压和BPV的变化.结果 (1)阿雷地平肠溶胶囊治疗12周后,患者24 h平均血压下降(14±13)/(11 ±9) mm Hg,较治疗前有显著降低(P＜0.05)；全部病例总体收缩压和舒张压谷峰(T/P)比值分别为75.31％和78.15％.(2)阿雷地平肠溶胶囊治疗12周后,患者24h、日间、夜间平均血压的标准差分别从(25±3)／(14±4) mm Hg、(24±5)／(14±4) mm Hg、(10±3)／(8±4) mm Hg降至(11±3)／(8±2)mmHg、(11±3)／(8±2) mm Hg、(8±3)／(6 ±3) mm Hg,血压晨峰程度从(26± 11) mmHg降至(19 ±9)mm Hg,治疗前后差异均有统计学意义(P＜0.05).(3)阿雷地平的不良反应发生率为13.4％,主要是轻度的头晕、面色潮红和心悸.结论 阿雷地平肠溶胶囊治疗轻、中度原发性高血压患者不仅能有效降低24 h血压,还能显著降低血压变异性,安全性良好.

abstractsObjective To evaluate the effect of aranidipine enteric-coated capsules on 24 h blood pressure and blood pressure variability (BPV) in patients with mild to moderate essential hypertension.Methods This was an open clinical trial with 2 weeks of placebo run-in period.A total of 74 patients with blood pressure (140-180/95-110 mm Hg (1 mm Hg =0.133 kPa)were treated by aranidipine (5 mg/d) for 4 weeks.If clinical sitting blood pressure ＜ 140/90 mm Hg at 4th week,aranidipine at 5 mg/d would be continued for another 8 weeks.If not,the dosage would be increased to 10 mg/d.If blood pressure ＜ 140/90 mm Hg at 8th week,aranidipine at 5 mg/d or 10 mg/d would be given constantly.If not,the dosage would be increased to 20 mg/d and given for another 4 weeks.All patients performed 24 h ambulatory blood pressure monitoring (ABPM) before and after the treatment with BPV evaluated by the average 24 h per unit time blood pressure standard deviation and morning blood pressure surge (MBPS).Results (1) After 12 weeks' treatment with aranidipine,the mean 24 h blood pressure was reduced significantly compared with the baseline [(14 ± 13)/(11 ± 9) mm Hg,both P ＜ 0.05] with trough/peak (T/P) ratio of SBP and DBP in responders of 75.31％ and 78.15％,respectively.(2) After 12 weeks' treatment,standard deviations of 24 h,daytime SBP/DBP and nighttime SBP/DBP were reduced significantly[(25±3)/(14±4) mm Hg vs (11±3)/(8±2) mm Hg,(24 ±5)/(14 ±4) mm Hg vs (11 ±3)/(8 ±2) mm Hg,(10 ±3)/(8 ±4) mm Hg vs (8 ±3)/(6 ±3) mm Hg],respectively with all P ＜ 0.05.Significant decrease was shown in MBPS compared to the baseline [(27 ± 11) mm Hg vs (19 ±9) mm Hg,P ＜0.05].(3) The incidence of adverse events was 13.4％,including mild dizziness,flushing and palpitation.Conclusion Administration of aranidipine enteric-coated capsules can control 24 h blood pressure effectively and reduce BPV significantly in patients with mild to moderate essential hypertension with good safety profile.