国产苯磺酸氨氯地平治疗轻中度原发性高血压临床疗效观察

Observation of clinical efficacy of mild to moderate essential hypertension treated witt Homemade Amlodipine

目的：评价国产苯磺酸氨氯地平（安内真）治疗轻、中度原发性高血压的疗效和安全性。方法：45例轻、中度原发性高血压患者随机分为安内真组或进口苯磺酸氨氯地平（络活喜）组,分别服用安内真或络活喜5 mg 1次/d,治疗4周末坐位DBP〈90mmHg者继续原剂量治疗至8周末;坐位DBP≥90 mmHg者剂量分别加倍至10mg,1次/d,治疗至8周末。于治疗前及治疗2、4、6、8周末测量诊室血压、心率、心律及体征并记录不良反应。试验开始前及结束时进行实验室检查。结果：两组服药后2、4、6、8周坐位收缩压和舒张压与服药前比较均有明显降低,差别有统计学意义（P〈0.01）;两组服药后2、4,6、8周坐位收缩压和舒张压下降幅度组间比较无统计学差异（P〉0.05）;服药8周后,安内真组和络活喜组总有效率分别为88%和90%,组间比较无统计学差异;两组不良反应轻而少,组间比较无显著性差别;两组试验结束时主要实验室检查指标与试验前比较无统计学差异。结论：安内真5-10 mg,1次/d,治疗轻、中度原发性高血压安全有效。

Objective： To evaluate the effect and safety of homemade amlodipine（Anneizhen）in patients with mild-tomoderate essential hypertension and compare with the effect of imported amlodipine（Novasc）. Methods： 45 patients with mild-to-moderate essential hypertension were randomly assigned to receive Anneizhen 5 mg or Novasc 5mg once daily for 4 weeks. At the end of 4 weeks,doses were maintained in patients having seated DBP〈90mmHg or were titrating to 10mg/d for another 4 weeks in patients having seated DBP〉90mmHg. Seated blood pressure, heart rates examinations were performed at baseline and the end of the trial. Results ：At the end of 2,4,6,8 weeks, seated systolic blood pressure（SBP） and diastolic blood pressure（DBP） were significantly lowered compared with those at baseline （P〈0. 01）. There was no significant difference in the reduction of seated DBP between the two groups at the end of 2,4,6, 8 weeks （P〉0.05）. At the end of 8 weeks, the response rate was 88% in Anneizhen group and 90% in Novasc group. Side effects were comparable during the period of treatment. At the end of 8 weeks, no difference was found in laboratory findings compared with those at the beginning in the two groups （P〉0. 05）. Conclusion：Homemade amlodipine （Anneizhen） 5 mg or 10mg once daily is as effective and safe as imported Amlodipine （Novasc）in patients with mild to moderate essential hypertension.