左旋氨氯地平与氨氯地平、硝苯地平、非洛地平所致不良反应的对比研究

Comparative study on adverse reactions of levamlodipine versus amlodipine,nifedipine,and felodipine

目的:比较左旋氨氯地平与氨氯地平、硝苯地平、非洛地平所致水肿等不良反应的差异。方法:采用多中心、随机、开放、自身对照研究方法。2008年6月至2009年3月,83例服用氨氯地平(38例)、硝苯地平(30例)、非洛地平(15例)后出现水肿的轻、中度原发性高血压患者纳入研究。全部患者停用上述药物1周,再服用左旋氨氯地平2.5～5.0mg/d,共治疗8周。观察和比较治疗前后水肿等不良反应程度,血压、心率、体重及血常规、血生化等指标。结果:足背水肿凹陷程度治疗前1周为(2.69±1.21)mm,治疗4、8周后分别为(1.63±1.35)和(1.74±1.90)mm,治疗4周与治疗前1周比较差异有统计学意义(P<0.05)。小腿围1及小腿围2治疗前1周分别为(37.73±2.48)、(35.41±2.85)cm,治疗8周后分别为(37.18±2.50)、(34.73±2.96)cm,差异有统计学意义(P<0.05,P<0.01)。足颈围治疗前1周为(23.47±2.19)cm,治疗8周后为(22.83±2.09)cm,差异有统计学意义(P<0.01)。面部潮红的发生率治疗前1周为15.7%,治疗2、4、8周后分别为7.3%、2.5%和1.3%。眩晕的发生率治疗前1周为4.8%,治疗2、4、8周的发生率分别为2.4%、0和1.3%。血压治疗开始前为(140.59±12.92)/(86.76±9.63)mmHg,治疗8周后为(125.76±8.53)/(77.84±6.46)mmHg,心率治疗开始前为(70.93±8.30)次/min,治疗8周后为(69.17±6.52)次/min,差异均有统计学意义(P<0.001、P<0.05)。红细胞、血红蛋白治疗开始前分别为(4.45±0.60)×1012/L、(131.22±14.95)g/L,治疗8周后分别为(4.66±0.62)×1012/L、(138.09±17.46)g/L,差异均有统计学意义(P<0.05、P<0.01)。体重、血常规和血生化各项指标治疗前后的差异无统计学意义(均P>0.05)。结论:左旋氨氯地平与氨氯地平、硝苯地平、非洛地平相比,为一种较为安全的降血压药物。

ABSTRACT Objective： To compare the differences in edema and other adverse reactions of levamlodipine versus amlodipine, nifedipine, and felodipine, nethods：A multicentre, randomized, open-label, self-control study was performed. Form June 2008 to March 2009, 83 patients with mild-to-moderate primary hypertension, who experienced edema after receiving amlodipine （38 cases）, nifedipine （30 cases）, and felodipine （ 15 cases）, were enrolled in the study. All above-mentioned medications were discontinued one week, then levamlodipine 2.5 - 5.0mg/d for 8 weeks was given. The observations and comparisons before and after levamlodipine treatment included ： the severity of edema and other adverse reactions ; the values of blood pressure; heart rate, and body weight ; the results of routine blood tests and bier.heroical blood tests. Results：The severity of pitting edema at insteps was （2.69 ± 1.21 ）mm one week before starting levamlodipine treatment and （ 1.63 ± 1.35 ） mm and （ 1.74 ± 1.90） mm after 4 and 8 weeks of treatment, respectively ; the difference between one week before starting treatment and after 4 weeks of treatment was statistically significant （ P 〈 0.05）. The calf circumference 1 and calf circumference 2 were respectively （37.73 ± 2.48 ） cm and （35.41 ± 2.85 ） cm one week before starting treatment and （37.18 ±2.50）cm and （34.73 ±2.96） cm after 8 weeks of treatment; the differences were statistically significant （ P 〈 0.05, P 〈 0.01 ）. The ankle circumference were （23.47 ± 2.19） cm 1 week before starting treatment and （22.83 ± 2.09） cm after 8 weeks of treatment; the difference was statistically significant （P 〈 0.01 ）. The incidence of facial flushing was 15.7% one week before starting treatment and 7.3% , 2.5% , and 1.3% after 2, 4, and 8 weeks of treatment, respectively. The incidence of dizziness was 4.8% one week before starting treatment and 2.4%, 0, and 1.3% after 2, 4, and 8 weeks of treatment. The blood pressure was （ 140.59 ± 12.92 ） / （ 86.76 ± 9.63 ） mm Hg before starting treatment and （ 125.76 ± 8.53 ） / （77.84 ± 6.46 ） mm Hg after 8 weeks of treatment, and heart rate was （70.93 ± 8.30）beats/rain before starting treatment and （69.17 ± 6.52） beats/ min after 8 weeks of treatment, respectively; the differences were statistically significant （ P 〈 0. 001, P 〈 0.05 ）. Red blood cell count and hemoglobin level were （4.45 ± 0. 60） ×10^12/L and （ 131.22 ± 14.95 ）g/L before starting treatment and （4.66 ± 0.62）×10^12/L and （ 138.09 ± 17.46） g/L after 8 weeks of treatment, respectively; the differences were statistically significant （ P 〈 0.05, P 〈 0.01 ）. No statistically significant difference in the indices of body weight, routine blood tests, and biochemical blood tests was found between before treatment and after treatment（ all P 〉 0.05 ）. Conclusion ： levamlodipine is a relatively safe agent for treatment of hypertension, compared with amlodipine, nifedipine, and felodipine.