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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。
OBJECTIVE: To compare the differences of adverse reactions such as edema between levamlodipine and amlodipine, nifedipine and felodipine. Methods: A multicenter, randomized, open, self-controlled study was performed. From June 2008 to March 2009, 83 patients with mild to moderate essential hypertension who had edema after taking amlodipine (38 cases), nifedipine (30 cases) and felodipine (15 cases) Included in the study. All patients discontinued the drug for 1 week, and then taking levamlodipine 2.5 ~ 5.0mg / d, a total of 8 weeks. Observed and compared edema and other adverse reactions before and after treatment, blood pressure, heart rate, body weight and blood, blood biochemical and other indicators. Results: The degree of dorsal foot edema in the first week before treatment was (2.69 ± 1.21) mm, and after 4 and 8 weeks of treatment, they were (1.63 ± 1.35) and (1.74 ± 1.90) mm, respectively. There was statistical significance (P <0.05). (37.73 ± 2.48) and (35.41 ± 2.85) cm, respectively, at 1 week before and 1 week after treatment, and were (37.18 ± 2.50) and (34.73 ± 2.96) cm respectively after 8 weeks of treatment, the difference was statistically significant (P <0.05, P <0.01). One week before foot neck circumference was (23.47 ± 2.19) cm after treatment and (22.83 ± 2.09) cm after 8 weeks treatment, the difference was statistically significant (P <0.01). The incidence of facial flushing was 15.7% 1 week before treatment and 7.3%, 2.5% and 1.3% after 2,4,8 weeks of treatment, respectively. The incidence of dizziness was 4.8% 1 week before treatment, and the incidences of 2,4,8 weeks were 2.4%, 0 and 1.3% respectively. Blood pressure began to be (140.59 ± 12.92) / (86.76 ± 9.63) mmHg before treatment, (125.76 ± 8.53) / (77.84 ± 6.46) mmHg after 8 weeks of treatment, and (70.93 ± 8.30) After treatment for 8 weeks (69.17 ± 6.52) times / min, the differences were statistically significant (P <0.001, P <0.05). The levels of erythrocyte and hemoglobin before treatment were (4.45 ± 0.60) × 1012 / L and (131.22 ± 14.95) g / L respectively, and were 4.66 ± 0.62 × 1012 / L and 138.09 ± 17.46 g / L, the differences were statistically significant (P <0.05, P <0.01). Body weight, blood and blood biochemical indicators before and after treatment was no significant difference (all P> 0.05). Conclusion: L-amlodipine is a safer antihypertensive drug compared with amlodipine, nifedipine and felodipine.