阿雷地平对轻中度原发性高血压病患者动态血压和动态动脉僵硬度指数的影响研究  

Effect of Aranidipine on Ambulatory Blood Pressure and Ambulatory Arterial Stiffness Index in Patients with Mild to Moderate Essential Hypertension

作　　者：陈莉[1] 姜红[1] 华琦[2] 杨汉跃 郑家通 金浩 焦媛[1] 王云[1] 孙瑞华[1] 柯元南[1] 

机构地区：[1]卫生部中日友好医院心内科,北京市100029 [2]首都医科大学宣武医院 [3]江苏德源药业有限公司

出　　处：《中国全科医学》2013年第25期2972-2975,共4页Chinese General Practice

摘　　要：目的采用24 h动态血压监测研究阿雷地平肠溶胶囊对轻、中度原发性高血压病患者的降压疗效以及对动态动脉僵硬度指数(AASI)的影响。方法本研究为开放、剂量递增的临床研究。74例95 mm Hg≤舒张压<110mm Hg(1 mm Hg=0.133 kPa)和(或)140 mm Hg≤收缩压<180 mm Hg的轻、中度原发性高血压病患者在2周安慰剂清洗期后给予5 mg/d阿雷地平肠溶胶囊,4周后如诊室谷值坐位收缩压/舒张压<140/90 mm Hg,维持原剂量治疗,血压未达标者剂量增至10 mg/d。8周时诊室谷值坐位收缩压/舒张压<140/90 mm Hg者,维持原剂量5 mg/d或10 mg/d,血压未达标者剂量增至20 mg/d服药至第12周。在第0周(治疗前)和第12周(治疗后12周)时分别各进行一次动态血压监测,观察治疗前后动态血压及AASI的变化。结果试验共入组74例,脱落及剔除7例,意向性数据集(ITT)为67例。(1)阿雷地平肠溶胶囊治疗12周后,患者24 h平均收缩压、舒张压分别下降(14±13)mm Hg、11(-5,38)mm Hg,差异有统计学意义(P<0.05);全部病例总体收缩压和舒张压谷/峰比值分别为75.3%和78.2%。(2)阿雷地平肠溶胶囊治疗12周后,患者AASI的下降幅度为0.13(0.07,0.19),差异有统计学意义(P<0.01)。尤其是AASI异常增高的患者,患者AASI的下降幅度为(0.37±0.16),差异有统计学意义(P<0.01)。(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、中度原发性高血压病患者不仅能有效降低24 h血压,还能显著降低AASI,安全性良好。Objective By means of ambulatory blood pressure monitoring （ABPM） to evaluate the effect of Aranidip- ine enteric -coated capsules on blood pressure and ambulatory arterial stiffness index （AASI） in patients with mild to moderate essential hypertension. Methods Open clinical trials were adopted. After 2 weeks of placebo run - in period, Seventy - four pa- tients with 95 mm Hg ≤ diastolic blood pressure （DBP） 〈 110 mm Hg （ 1 mm Hg = 0. 133 kPa） and/or 140 mm Hg ≤ systolic blood pressure （SBP） 〈 180 mm Hg were treated by Aranidipine （ 5 rag/day ） for 4 weeks. If the clinical sitting SBP 〈 140 mm Hg and DBP 〈90 mm Hg at 4th week, Aranidipine dosage （5 mg/day） remained; if not, Aranidipine （ 10 mg/day） was given for another 4 weeks. If the SBP 〈 140 mm Hg and DBP 〈 90 mm Hg at 8th week, Aranidipine （Stag/day or 10 mg/day respectively） was given constantly; if not, Aranidipine （20 mg/day） was given for another 4 weeks. The 24 h ABPM was taken before and after the treatment respectively. Results Among the 74 cases, there were 7 shedding or deleted, and then 67 who were enrolled in the intention - to - treat analysis （ITT） . （ 1 ） After 12 weeks treatment with Aranidipine, the readings of mean 24 h SBP/DBP were significantly reduced by （ 14 ± 13 ） /11 （ - 5, 38 ） mm Hg, as compared with the baseline （ P 〈 0. 05 ）. Trough/peak （T/P） ratios of SBP and DBP in responders were 75.3% and 78.2%, respectively. （2） After 12 weeks treat- ment, AASI were significantly reduced by 0. 13 （0. 07,0. 19） , especially in the group of abnormally increased AASI by （0. 37 ±0. 16）, as compared with the baseline （P 〈0. 01 ） . （3） The incidence of adverse events was 13.4%, including mild dizziness and flushing and palpitation. Conclusion Aranidipine enteric - coated capsules can effectively control 24 h blood pressure and reduce AASI significantly in patients with mild to moderate essential hypertension. And administration of aranidipine i

关 键 词：高血压 阿雷地平 动态血压 动态动脉僵硬度指数 

分 类 号：R544.1[医药卫生—心血管疾病]