摘要目的 评价苯磺酸左旋氨氯地平(左旋氨氯地平)治疗轻、中度原发性高血压的疗效和安全性.方法 采用随机、开放、平行对照的方法,从22个研究中心选取1051例轻、中度原发性高血压患者,分别给予低剂量左旋氨氯地平(2.5 mg/d,左旋氨氯地平2.5 mg组),高剂量左旋氨氯地平(5.0 mg/d,左旋氨氯地平5.0 mg组)和马来酸氨氯地平(5.0 mg/d,马来酸氨氯地平组)治疗8周,观察其疗效和安全性.结果 左旋氨氯地平2.5 mg组、左旋氨氯地平5.0 mg组和马来酸氨氯地平组入选高血压患者分别为351、350和350例,完成8周治疗的患者分别为322、312和303例,收缩压和舒张压均显著下降,血压达标率分别为72.4％、85.6％和76.2％.左旋氨氯地平5.0 mg组的达标率高于马来酸氨氯地平组和左旋氨氯地平2.5 mg组,差异均有统计学意义(P均＜0.01),而左旋氨氯地平2.5 mg组和马来酸氨氯地平5.0 mg组组间差异无统计学意义(P=0.28).在轻度和中度高血压患者中,左旋氨氯地平5.0 mg组达标率也显著高于其他两组.三组不良反应发生率分别为4.3％、4.6％和5.1％,差异无统计学意义(P=0.84).结论 左旋氨氯地平5.0 mg/d治疗原发性高血压疗效优于马来酸氨氯地平5.0 mg/d和左旋氨氯地平2.5 mg/d,左旋氨氯地平2.5 mg/d的疗效与马来酸氨氯地平5.0 mg/d的疗效相当,它们的安全性良好.

abstractsObjective To evaluate the effectiveness and safety of L-amlodipine besylate for blood pressure control in patients with mild to moderate essential hypertension.Method A total of 1051 mild to moderate essential hypertensives were recruited from 22 centers and randomized into three groups and were given low-dose L-amlodipine besylate (2.5 mg/d),high-dose L-amlodipine besylate (5.0 mg/d),and amlodipine maleate (5.0 mg/d) on the principle of open-label and parallel control.The study drugs were administered for 8 weeks.Results After 8 weeks treatments,the response rate of the three groups were 72.4％,85.6％,and 76.2％,respectively.The rate difference between high-dose L-amlodipine besylate group and the other two groups were statistically significant (P ＜ 0.01),while the rate difference between low-dose L-amlodipine besylate group and amlodipine maleate group was similar (P =0.28).The event rates of the three groups were similar (4.3％,4.6％,and 5.1％,respectively,P =0.84).Conclusion High-dose L-amlodipine besylate is superior to the other 2 groups on blood pressure control.The efficacy profiles of amlodipine maleate and low-dose L-amlodipine besylate are equivalent.Safety profiles of these three groups are comparable.