Department of Cardiology, Fuwai Hospital and Cardiovascular Institute, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
Chin Med J (Engl). 2010 Oct;123(20):2858-64.
No-reflow after emergency percutaneous coronary intervention (PCI) for acute ST segment elevation myocardial infarction (STEMI) is related to the severe prognosis. The aim of this study was to evaluate the efficacy of Tongxinluo, a traditional Chinese medicine, on no-reflow and the infarction area after emergency PCI for STEMI.
A total of 219 patients (female 31, 14%) undergoing emergency PCI for STEMI from nine clinical centers were consecutively enrolled in this randomized, double-blind, placebo-controlled, multicenter clinical trial from January 2007 to May 2009. All patients were randomly divided into Tongxinluo group (n = 108) and control group (n = 111), given Tongxinluo or placebo in loading dose 2.08 g respectively before emergency PCI with aspirin 300 mg and clopidogrel 300 mg together, then 1.04 g three times daily for six months after PCI. The ST segment elevation was recorded by electrocardiogram at hospitalization and 1, 2, 6, 12, 24 hours after coronary balloon dilation to evaluate the myocardial no-flow; myocardial perfusion scores of 17 segments were evaluated on day 7 and day 180 after STEMI with static single-photon emission computed tomography (SPECT) to determine the infarct area.
There was no statistical significance in sex, age, past history, chest pain, onset-to-reperfusion time, Killip classification, TIMI flow grade just before and after PCI, either in the medication treatment during the follow up such as statin, β-blocker, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) between two groups. There was significant ST segment restoration in Tongxinluo group compared to the control group at 6 hours ((-0.22 ± 0.18) mV vs. (-0.18 ± 0.16) mV, P = 0.0394), 12 hours ((-0.24 ± 0.18) mV vs. (-0.18 ± 0.15) mV, P = 0.0158) and 24 hours ((-0.27 ± 0.16) mV vs. (-0.20 ± 0.16) mV, P = 0.0021) reperfusion; and the incidence of myocardial no-reflow was also reduced significantly at 24-hour reperfusion (34.3% vs. 54.1%, P = 0.0031). The myocardial perfusion scores of 17 segments evaluated by static SPECT was improved significantly on day 7 and day 180 after STEMI in Tongxinluo group compared to the control group (0.61 ± 0.40 vs. 0.76 ± 0.42, P = 0.0109 and 0.51 ± 0.42 vs. 0.66 ± 0.43, P = 0.0115, respectively). There was no significant difference in severe adverse events between two groups.
Tongxinluo as a kind of traditional Chinese medicine could reduce myocardial no-reflow and infarction area significantly after emergency PCI for STEMI with conventional medicine therapy.
急性 ST 段抬高型心肌梗死（STEMI）患者行急诊经皮冠状动脉介入治疗（PCI）后无复流与严重的预后相关。本研究旨在评估通心络这一中成药对 STEMI 患者急诊 PCI 后无复流和梗死面积的影响。
2007 年 1 月至 2009 年 5 月，来自 9 个临床中心的 219 例 STEMI 患者连续入组本随机、双盲、安慰剂对照、多中心临床试验。所有患者均随机分为通心络组（n=108）和对照组（n=111），分别在急诊 PCI 前给予负荷剂量 2.08 g 通心络或安慰剂，同时给予阿司匹林 300 mg 和氯吡格雷 300 mg，之后 PCI 后给予 1.04 g，每日 3 次，共 6 个月。入院时及冠状动脉球囊扩张后 1、2、6、12、24 小时记录心电图 ST 段抬高，评估心肌无复流；STEMI 后第 7 天和第 180 天行静息单光子发射计算机断层扫描（SPECT）评估 17 节段心肌灌注评分，以确定梗死面积。
两组患者在性别、年龄、既往史、胸痛、发病至再灌注时间、Killip 分级、PCI 前后 TIMI 血流分级、随访期间他汀类药物、β受体阻滞剂、血管紧张素转换酶抑制剂（ACEI）或血管紧张素受体阻滞剂（ARB）等药物治疗方面均无统计学意义。与对照组相比，通心络组在 6 小时（-0.22±0.18）mV 时、12 小时（-0.24±0.18）mV 时和 24 小时（-0.27±0.16）mV 时 ST 段恢复更明显（P=0.0394、P=0.0158 和 P=0.0021）；无复流的发生率也显著降低（24 小时时为 34.3% vs. 54.1%，P=0.0031）。与对照组相比，通心络组在 STEMI 后第 7 天和第 180 天静息 SPECT 评估的 17 节段心肌灌注评分显著改善（0.61±0.40 与 0.76±0.42，P=0.0109；0.51±0.42 与 0.66±0.43，P=0.0115）。两组严重不良事件无显著差异。
通心络作为一种中药，可显著减少 STEMI 患者急诊 PCI 后无复流和梗死面积。
