苯磺酸左旋氨氯地平治疗轻、中度原发性高血压临床观察

Clinical efficacy and safety of levamlodipine besylate in treatment of mild to moderate essential hypertension

目的探讨钙离子拮抗剂苯磺酸左旋氨氯地平对轻、中度原发性高血压的降压疗效及其安全性。方法采用自身对照开放试验方法。103例轻、中度原发性高血压患者经1~2周安慰剂导入期后口服苯磺酸左旋氨氯地平片（5 mg/d）,共8周,不服其他降压药,观察患者血压、心率及各项实验室检查指标的改变。结果治疗8周后：患者收缩压（SBP）由（154.59±12.16）mmHg降至（131.10±10.21）mmHg,舒张压（DBP）由（100.55±3.99）mmHg降至（82.79±7.01）mmHg,治疗前后差异有显著统计学意义（P〈0.01）;动态血压监测（ABPM）显示SBP、DBP谷/峰比分别为0.72±0.36、0.83±0.54。治疗期间未出现明显不良反应,疗程结束后复查血常规、血糖、血脂、血电解质、肝肾功能等实验室指标均未出现明显变化。结论苯磺酸左旋氨氯地平对轻、中度原发性高血压具有较好的疗效及安全性。

Objective To evaluate the clinical efficacy and safety of the calcium ion antagonist levamlodipine besylate in treatment of mild to moderate hypertension.Methods The method of self-controlled open trial was adopted in this study.Following a period of placebo introduction of 1-2 weeks,103 patients with mild to moderate essential hypertension underwent a regimen of oral administration of levamlodipine besylate tablets（5 mg/d） for 8 weeks without any other antihypertensive drugs.The changes in blood pressure,heart rate and laboratory results were observed.The levels of fasting blood glucose,cholesterol,triglyceride,aminotransferases,creatinine were determined before and after the treatment.Results At the end of 8-week treatment,the systolic blood pressure（SBP） decreased from 154.59±12.16 mmHg to 131.10±10.21 mmHg（P0.01）,and diastolic blood pressure（DBP） decreased from 100.55±3.99 mmHg to 82.79±7.01 mmHg（P0.01）.Ambulatory blood pressure monitoring（ABPM） showed the T/P ratio of SBP and DBP was 0.72±0.36 and 0.83±0.54,respectively.No evident adverse reactions were observed during the treatment,and at the end of the regimen laboratory indicators including blood routines,blood glucose,cholesterol,blood lipids,blood electrolytes,and liver and kidney functions did not have any significant changes,either.Conclusion Levamlodipine besylate tablets are effective,safe and well tolerated in patients with mild to moderate hypertension without affecting lipids and glucose levels.