马来酸左旋氨氯地平和苯磺酸氨氯地平治疗高血压合并冠状动脉粥样硬化性心脏病的疗效对比  

Comparison of effect of levoamlodipine maleate and amlodipine besylate in patients with hypertension complicated with coronary heart disease

作　　者：杨帆[1] 洪涛[1] 龚艳君[1] 马为[1] 霍勇[1] YANG Fan;HONG Tao;GONG Yan-jun;MA Wei;HUO Yong(Cardiovascular Department,Peking University First Hospital,Beijing,100034,China)

机构地区：[1]北京大学第一医院心血管内科,北京100034

出　　处：《中华高血压杂志》2022年第6期551-556,共6页Chinese Journal of Hypertension

摘　　要：目的 对比马来酸左旋氨氯地平和苯磺酸氨氯地平在高血压合并冠状动脉粥样硬化性心脏病(冠心病)患者中的治疗效果及副作用发生情况。方法 从马来酸左旋氨氯地平与苯磺酸氨氯地平治疗高血压的疗效比较研究(LEADER)入选的患者中筛选出高血压合并冠心病患者,根据患者使用降压药的情况分为使用苯磺酸氨氯地平组(666例)和使用马来酸左旋氨氯地平组(648例)。比较两组不良心脑血管事件(MACCE)、血压变化以及不良反应的发生情况,并采用多因素Cox模型分析MACCE事件的影响因素。结果 随访到12个月时,苯磺酸氨氯地平组和马来酸左旋氨氯地平组复合终点事件的发生率分别为5.7%和3.2%(χ^(2)=4.643,P=0.031)。Cox分析发现降压药种类[HR(95%CI)为0.56(0.32~0.96),P=0.034]、糖尿病[2.48(1.48~4.17),P=0.001]、冠心病家族史[2.04(1.08~3.86),P=0.028]以及血压控制达标[0.39(0.22~0.71),P=0.002]是MACCE事件的独立预测因素。与基线相比,两组治疗后收缩压和舒张压均下降,马来酸左旋氨氯地平组下降较苯磺酸氨氯地平组更明显[12个月时,收缩压下降值中位数(P_(25)~P_(75)):-17.5(-30.0~-4.0)比-10.0(-22.5~-1.0)mm Hg,Z=4.997,P<0.001;舒张压下降值:-7.5(-15.0~0)比-5.0(-11.0~0)mm Hg,Z=3.510,P<0.001]。苯磺酸氨氯地平组和马来酸左旋氨氯地平组不良反应发生率分别为7.4%和3.4%(χ^(2)=10.088,P=0.001),并且马来酸左旋氨氯地平组下肢水肿(0.5%比2.3%,χ^(2)=7.783,P=0.005)、头晕(1.1%比2.7%,χ^(2)=4.632,P=0.031)、疲劳的发生率(0比0.9%,P_(Fisher)=0.031)低于苯磺酸氨氯地平组。结论 与苯磺酸氨氯地平相比,用马来酸左旋氨氯地平对高血压合并冠心病患者进行治疗效果良好,且安全性较高。Objective To compare the effects of levoamlodipine maleate and amlodipine besylate in patients with hypertension complicated with coronary heart disease and the incidence of side effects.Methods Patients with hypertension complicated with coronary heart disease were enrolled from the participants of LEADER(levamlodipine maleate or amlodipine besylate for treatment of hypertension:a comparative effectiveness research) study.According to the antihypertensive drugs,patients were divided into amlodipine besylate group(666 cases) and levoamlodipine maleate group(648 cases).Major adverse cardiac cerebrovascular events(MACCE),blood pressure changes,and adverse reactions were compared between the two groups.Cox regression model was used to analyze the influencing factors of MACCE.Results At 12 months,the incidence of MACCE in amlodipine besylate group and levamlodipine maleate group was 5.7% and 3.2%,respectively(χ~2=4.643,P=0.031).Cox analysis revealed that use of levamlodipine maleate [HR(95%CI) 0.56(0.32-0.96),P=0.034],diabetes [2.48(1.48-4.17),P=0.001],family history of coronary heart disease [2.04(1.08-3.86),P=0.028] and control of blood pressure [0.39(0.22-0.71),P=0.002] were independent influencing factors of MACCE.Compared with baseline,systolic and diastolic blood pressure decreased significantly in both groups,and the decrease in levamlodipine maleate group was more significant than that in amlodipine besylate group during follow-up [at the 12 months,median(P_(25) to P_(75)) value of systolic blood pressure decrease:-17.5(-30.0 to-4.0) vs-10.0(-22.5 to-1.0) mm Hg,Z=4.997,P<0.001;diastolic blood pressure decrease:-7.5(-15.0 to 0) vs-5.0(-11.0 to 0)mm Hg,Z=3.510,P<0.001].The incidence of adverse reaction in amlodipine besylate and levamlodipine maleate group was 7.4% and 3.4%(χ~2=10.088,P=0.001),and the incidence of lower extremity edema(0.5% vs 2.3%,χ~2=7.783,P=0.005),dizziness(1.1% vs 2.7%,χ~2=4.632,P=0.031) and fatigue(0 vs 0.9%,P_(Fisher)=0.031) in levamlodipine maleate group was significantly lower than

关 键 词：马来酸左旋氨氯地平 苯磺酸氨氯地平 高血压 冠心病 不良心脑血管事件 不良反应 

分 类 号：R544.1[医药卫生—心血管疾病] R541.4[医药卫生—内科学]