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马来酸左旋氨氯地平与苯磺酸氨氯地平治疗基线血压达标的原发性高血压长期疗效比较

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摘要:

目的 比较马来酸左旋氨氯地平和苯磺酸氨氯地平单一药物治疗基线血压达标的原发性高
血压患者长期治疗效果。方法 选取LEADER研究中仅使用单一药物(马来酸左旋氨氯地平或苯磺酸氨氯
地平)治疗基线血压控制达标的3302例原发性高血压患者作为研究对象,根据降压药物使用情况分为苯
磺酸氨氯地平组(n=708)和马来酸左旋氨氯地平组(n=555)。比较两组患者随访24个月期间平均血压
及血压的控制情况、主要不良心脑血管事件(MACCE)以及不良反应情况。结果 24个月内,马来酸左
旋氨氯地平组血压平均水平的大部分随访节点均低于苯磺酸氨氯地平组(P<0.05),两组间12个月时的
血压达标率无明显差异(P=0.717),马来酸左旋氨氯地平组24个月时的血压达标率较高(P=0.023)。
12个月马来酸左旋氨氯地平组和苯磺酸氨氯地平组中保持使用单一药物的患者比例分别为92.42%和
90.00%,24个月时这一比例为92.72%和90.66%,均无明显差异。12个月及24个月时保持使用单一药物治
疗的这部分患者中马来酸左旋氨氯地平组的血压平均水平均低于苯磺酸氨氯地平组,但两组间血压达标
率无显著差异(P>0.05)。两组患者复合终点事件发生率(P=0.225)及不良反应发生率(P=0.181)均
无显著差异,与苯磺酸氨氯地平组相比,马来酸左旋氨氯地平组下肢水肿发生率较低(P=0.021)。结
论 基线血压控制达标的原发性高血压患者长期服用马来酸左旋氨氯地平单药治疗的血压控制达标率良
好,且水肿的发生率低于苯磺酸氨氯地平组,临床安全性较高。

Abstract:

Objective To compare the therapeutic effects of levoamlodipine maleate and amlodipine besylate on hypertensive patients with controlled baseline blood pressure. Methods A total of 3302 essential hypertensive patients were included for subgroup analysis. All patients were treated with levoamlodipine maleate or amlodipine besylate and baseline blood pressure were controlled. The patients were grouped according to their use of antihypertensive drugs. 708 patients taking amlodipine besylate were included in the amlodipine besylate group, and 555 patients taking levoamlodipine maleate were included in the levoamlodipine maleate group. The average blood pressure level, blood pressure control status, major adverse cardiovascular and cerebrovascular events (MACCE), and adverse reactions were compared between the two groups of patients during the 24-month follow-up. Results Within 24 months, the average blood pressure of patients in the levamlodipine maleate group was lower than that in the amlodipine besylate group at most follow-up points (P<0.05). There was no significant difference in the blood pressure compliance rate between the two groups at 12 months (P=0.717). The blood pressure compliance rate in the levamlodipine maleate group was higher than amlodipine besylate group at 24 months (P=0.023). Further analysis showed that the proportions of patients who maintained monotherapy in the levamlodipine maleate group and amlodipine besylate group at 12 months were 92.42 % and 90.00 % at 12 months and that at 24 months were 92.72 % and 90.66 %, respectively, with no significant difference. The average blood pressure in the levamlodipine maleate group was lower than that in the amlodipine besylate group, however, there was no significant difference in the blood pressure compliance rate between the two groups (P>0.05). There was no significant difference in the incidence of MACCE (P=0.225) and the incidence of total adverse reactions (P=0.181) between the two groups. However, compared with the amlodipine besylate group, the incidence of lower limb edema in the levamlodipine maleate group was lower (P=0.021). Conclusion Long-term use of levamidopine maleate in hypertensive patients with controlled baseline blood pressure can increase the rate of blood pressure compliance, with a lower incidence of lower limb edema and higher clinical safety.

基金项目:

国家科技重大专项课题(2012ZX09101101)

参考文献:

  • 2008

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