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氨氯地平对缺血性心脏病患者氯吡格雷抑制血小板作用的影响:一项随机对照试验。

Effect of amlodipine on platelet inhibition by clopidogrel in patients with ischaemic heart disease: a randomised, controlled trial.

机构信息

Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong, China.

出版信息

Heart. 2013 Apr;99(7):468-73. doi: 10.1136/heartjnl-2012-302801. Epub 2012 Oct 31.

Abstract

BACKGROUND

Amlodipine inhibits cytochrome P450 (CYP) enzyme and has the potential to reduce clopidogrel bioactivation in vivo. Reports in previous retrospective studies described greater platelet reactivity in patients on amlodipine.

OBJECTIVE

To evaluate the treatment effect of clopidogrel in patients on amlodipine versus not on calcium-channel blockers (CCBs).

DESIGN AND SETTING

Randomised, controlled, open-label trial conducted in a regional acute hospital.

PATIENTS AND INTERVENTIONS

98 patients on clopidogrel for ischaemic heart disease were recruited consecutively and randomised to take either amlodipine or drugs with inert CYP effects as controls. The P2Y12 reaction unit (PRU) was measured using whole blood obtained at baseline and on day 28.

MAIN OUTCOME MEASURES

The primary analysis involved the PRU values on day 28. The secondary analyses were percentage of platelet inhibition and poor response to clopidogrel as defined by PRU>235.

RESULTS

Both groups experienced comparable day 28 PRUs (amlodipine 227±84 vs control 214±90; mean difference 12.7, 95% CI -22 to +47). Percentage of platelet inhibition (amlodipine 33% vs control 38%, mean difference -4.5%, 95% CI -14% to +5%) and those with poor response on day 28 (amlodipine 49% vs control 45%; p=0.76) did not differ significantly.

CONCLUSIONS

Concomitant amlodipine has no negative impact on clopidogrel-mediated platelet inhibition in patients with ischaemic heart disease.

摘要

背景

氨氯地平抑制细胞色素 P450(CYP)酶,并有降低氯吡格雷体内生物活化的潜力。以前的回顾性研究报告称,服用氨氯地平的患者血小板反应性更高。

目的

评估氨氯地平对服用氯吡格雷的患者与未服用钙通道阻滞剂(CCB)患者的治疗效果。

设计和设置

在一家地区急性医院进行的随机、对照、开放标签试验。

患者和干预措施

连续招募了 98 例服用氯吡格雷治疗缺血性心脏病的患者,并随机分为服用氨氯地平或服用无 CYP 效应的药物作为对照组。使用基线和第 28 天采集的全血测量 P2Y12 反应单位(PRU)。

主要观察指标

主要分析包括第 28 天的 PRU 值。次要分析包括血小板抑制百分比和氯吡格雷反应不良,定义为 PRU>235。

结果

两组患者第 28 天的 PRU 相似(氨氯地平组 227±84 与对照组 214±90;平均差异 12.7,95%CI-22 至+47)。血小板抑制百分比(氨氯地平组 33%与对照组 38%,平均差异-4.5%,95%CI-14%至+5%)和第 28 天氯吡格雷反应不良的患者比例(氨氯地平组 49%与对照组 45%;p=0.76)无显著差异。

结论

在缺血性心脏病患者中,同时使用氨氯地平对氯吡格雷介导的血小板抑制无不良影响。

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