A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Study of the Effects of Tongxinluo Capsules in Acute Coronary Syndrome Patients with High On-Treatment Platelet Reactivity.
A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Study of the Effects of Tongxinluo Capsules in Acute Coronary Syndrome Patients with High On-Treatment Platelet Reactivity.
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DOI：
10.4103/0366-6999.226064
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发表时间：
2018-03-05
影响因子：
6.1
通讯作者：
Han YL
中科院分区：
文献类型：
--
作者：
Zhang L;Li Y;Yang BS;Li L;Wang XZ;Ge ML;Jing QM;Ma YY;Wang G;Liu HW;Zhao X;Wang B;Xu K;Han YL
氯吡格雷治疗期间高血小板反应性（HPR）强烈且独立地预测经皮冠状动脉介入治疗（PCI）后缺血事件。通心络胶囊是一种抗血小板治疗的中药制剂。然而，其对HPR的疗效尚不清楚。本研究的目的是评估TC在急性冠状动脉综合征（ACS）患者HPR中的作用。这项多中心、随机、双盲、安慰剂对照研究前瞻性分析了136例接受PCI治疗的HPR ACS患者。患者于2013年11月至2014年5月入组，随机接受安慰剂或TC，以及阿司匹林和氯吡格雷的标准双联抗血小板治疗（DAPT）。主要终点是30天时HPR的患病率和基线与30天时P2 Y12反应单位（PRU）的平均变化。生存曲线用Kaplan-Meier估计构建，并通过对数秩检验比较两组之间的差异。与基线相比，两组在30天时的HPR患病率均显著降低，但TC组与安慰剂组相比降低幅度更大（15.8% vs. 24.8%，P = 0.013），尤其是在具有一个细胞色素P450 2C 19功能丧失（LOF）等位基因的患者中（χ2= 2.931，P = 0.047）。TC组的HPR患病率较低（33.3%vs.54.2%，t = 5.284，P = 0.022），光透射聚集测定法的表现上级，高敏C反应蛋白（hsCRP）水平较高，但缺血性事件的复合患病率无显著差异（χ2= 1.587，P = 0.208）。除了阿司匹林和氯吡格雷的标准DAPT外，TC还可进一步降低PRU和hsCRP水平，尤其是在仅携带一个LOF等位基因的患者中。这些数据表明，TC可用于ACS合并HPR行PCI患者的联合治疗。
High platelet reactivity (HPR) during clopidogrel treatment predicts postpercutaneous coronary intervention (PCI) ischemic events strongly and independently. Tongxinluo capsules (TCs) are a traditional Chinese medicine formulation used as antiplatelet treatment. However, its efficacy against HPR is not known. The aim of the present study was to evaluate the effects of TCs in acute coronary syndrome (ACS) patients with HPR. This multicenter, randomized, double-blind, placebo-controlled study prospectively analyzed 136 ACS patients with HPR who underwent PCI. The patients were enrolled from November 2013 to May 2014 and randomized to receive placebo or TCs in addition to standard dual antiplatelet therapy (DAPT) with aspirin and clopidogrel. The primary end points were the prevalence of HPR at 30 days and the mean change in P2Y12 reaction units (PRUs) between baseline and 30 days. Survival curves were constructed with Kaplan-Meier estimates and compared by log-rank tests between the two groups. Both groups had a significantly reduced prevalence of HPR at 30 days versus baseline, but the TC group, compared with the placebo group, had greater reduction (15.8% vs. 24.8%, P = 0.013), especially among patients with one cytochrome P450 2C19 loss of function (LOF) allele (χ2= 2.931, P = 0.047). The TC group also had a lower prevalence of HPR (33.3% vs. 54.2%, t = 5.284, P = 0.022) and superior performance in light transmittance aggregometry and higher levels of high-sensitivity C-reactive protein (hsCRP), but the composite prevalence of ischemic events did not differ significantly (χ2= 1.587, P = 0.208). In addition to standard DAPT with aspirin and clopidogrel, TCs further reduce PRU and hsCRP levels, especially in patients carrying only one LOF allele. The data suggest that TCs could be used in combination therapy for ACS patients with HPR undergoing PCI.
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影响因子：
6.7
作者：
Gurbel, P. A.;Bliden, K. P.;Tantry, U. S.
通讯作者：
Tantry, U. S.
通心络逆转心脏微血管内皮细胞缺氧抑制的Claudin-9
影响因子：
6.1
作者：
Liu K;Wang XJ;Li YN;Li B;Qi JS;Zhang J;Wang Y
通讯作者：
Wang Y
通心络抑制环氧合酶2、诱导型一氧化氮合酶、缺氧诱导因子2α/血管内皮生长因子以对抗缺氧刺激的心脏微血管内皮细胞损伤
影响因子：
6.1
作者：
Li YN;Wang XJ;Li B;Liu K;Qi JS;Liu BH;Tian Y
通讯作者：
Tian Y
影响因子：
168.9
作者：
Collet, Jean-Philippe;Hulot, Jean-Sebastien;Montalescot, Gilles
通讯作者：
Montalescot, Gilles
降低功能的CYP2C19基因型和氯吡格雷治疗的患者中主要患有PCI的患者的不良临床结局的风险：一项荟萃分析。
DOI：
10.1001/jama.2010.1543
发表时间：
2010-10-27
期刊：
JAMA
影响因子：
--
作者：
Mega JL;Simon T;Collet JP;Anderson JL;Antman EM;Bliden K;Cannon CP;Danchin N;Giusti B;Gurbel P;Horne BD;Hulot JS;Kastrati A;Montalescot G;Neumann FJ;Shen L;Sibbing D;Steg PG;Trenk D;Wiviott SD;Sabatine MS
通讯作者：
Sabatine MS