动态血压监测比较贝尼地平与氨氯地平的降压疗效和安全性

Efficacy of Benidipine and Amlodipine by ABPM

目的:用动态血压监测(ABPM)的方法比较两种钙拮抗剂(贝尼地平与氨氯地平)治疗原发性高血压的疗效。方法:选择原发性高血压患者44例,随机分为贝尼地平组20例,氨氯地平组24例。分别观察服药前和服药后(8周末)的24 h、白昼、夜间及各时点的动态血压变化。结果:(1)贝尼地平组和氨氯地平组服药前后(8周末)的24h、白昼和夜间的平均收缩压/舒张压均明显下降(P均<0.05)。贝尼地平组和氨氯地平组服药后(8周末)绝大部分时点收缩压和舒张压均较服药前下降(P<0.05)。24h、白昼和夜间的平均收缩压/舒张压下降值在贝尼地平组分别为(9.52±4.21)/(6.34±3.08),(11.63±3.32)/(7.46±2.80),(5.30±2.04)/(4.11±2.40)mmHg(p<0.05);在氨氯地平组则分别为(12.36±1.99)/(7.95±1.84),(11.97±1.84)/(8.24±1.66),(12.69±2.08)/(6.90±1.34)mmHg(P<0.05)。但两组间上述指标比较无显著性差异(P>0.05)。(2)谷峰比:贝尼地平组和氨氯地平组SBP分别为:65％、95％;DBP分别为62％,69％。(3)不良反应发生率:贝尼地平组低于氨氯地平组,但两组间差异无统计学意义。结论:贝尼地平(4—8mg/d)或氨氯地平(5～10mg/d),对每日1次口服治疗原发性高血压患者均可以维持24小时平稳降压。

Objective: To compare the clinical efficacy of two calium antagonists (Benidipine and Amlodipine) on the treatment of essential hypertension using ambulatory blood pressure monitoring (ABPM). Methods: It was a randomized, double blind, single - center, controlled clinical trial. After 2 weeks of wash - out period, patients with 24h mean diastolic blood pressure (DBP) ≥ 85mmHg were randomly treated with either Benidipine 4 - 8mg/d or Amlodipine 5 - 10mg/d (once a day) for 8 weeks. The dosage was titrated at the end of the 2th week. ABPM was conducted at the end of wash - out period and 8 th week after treatment. Results: ( 1) At the end of the 8th week, In Benidipine group the mean level of SBP/DBP of 24hour, day - time and night - time dropped by (9.52±4.21)/ (6.34±3.08),(11.63±3.32)/(7.46±2.80),(5.30±2.04)/(4.11±2.40)mmHg (P < 0.05) respectively. In Amilodip-ine group the mean level of SBP/DBP of 24hour, day - time and night - time were (12.36 ±1.99) /(7.95 ± 1.84), (11. 97 ± 1.84) / (8.24± 1.66), (12.69±2.08)/(6.90± 1.34)mmHg (P<0.05), respectively. The levels of SBP/DBP were decreased at most time point of 24h - ABPM during treatment in both groups, but there was no significant difference between two groups. (2)The mean trough/peak ratio(TPR) in Benidipine group and Amilodipine group for SBP were 65% and 95% ,DBP were 62% and 69% , respectively. (3)There was a tendency that the rate of adverse reaction in Benidipine group was lower than that in Amilodipine group,but without difference significantly. Conclusion: Benidipine (4- 8mg/d, once a day) can keep the same speed to decrease blood pressure smoothly for 24hrs as Amlodipine (5 -10mg/d,once a day) .Both medicine are safe and effective in the treatment of hypertension.