苯磺酸左旋氨氯地平治疗轻中度原发性高血压的疗效和安全性  

The effectiveness and safety of L-amlodipine besylate for blood pressure control in patients with mild to moderate essential hypertension

作　　者：贾坦[1] 张李军[1] 战义强[1] 余金明[1] 胡大一[2] 

机构地区：[1]复旦大学公共卫生学院公共卫生安全教育部重点实验室,上海200032 [2]北京大学人民医院心脏中心

出　　处：《中华心血管病杂志》2013年第4期301-303,共3页Chinese Journal of Cardiology

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（2．5mg／d，左旋氨氯地平2．5mg组），高剂量左旋氨氯地平（5．0mg／d，左旋氨氯地平5．0mg组）和马来酸氨氯地平（5．0mg/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2．5nag组、左旋氨氯地平5．0mg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5．0mg组的达标率高于马来酸氨氯地平组和左旋氨氯地平2．5mg组，差异均有统计学意义（P均〈0．01），而左旋氨氯地平2．5mg组和马来酸氨氯地平5．0mg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5．0mg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5．0mg/d治疗原发性高血压疗效优于马来酸氨氯地平5．0mg/d和左旋氨氯地平2．5mg/d，左旋氨氯地平2．5mg／d的疗效与马来酸氨氯地平5．0mg／d的疗效相当，它们的安全性良好。Objective 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-close 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.

关 键 词：高血压 氨氯地平 随机对照试验 

分 类 号：R544[医药卫生—心血管疾病]