No-reflow protection and long-term efficacy for acute myocardial infarction with Tongxinluo： a randomized double-blind placebo- controlled multicenter clinical trial （ENLEAT Trial）  

作　　者：ZHANG Hai-tao JIA Zhen-hua ZHANG Jian YE Zan-kai YANG Wei-xian TIAN Yue-qin JIA Xuan LI Wei WU Yi-ling YANG Yue-jin 

机构地区：[1]Department of Cardiology,Fuwai Hospital and Cardiovascular Institute,Peking Union Medical College and Chinese Academy of Medical Sciences,Beijing 100037,China [2]The Integration of Traditional and Western Medical Research Academy of Hebei Province,Shijiazhuang,Hebei 050035,China [3]Department of Echocardiography,Fuwai Hospital and Cardiovascular Institute,Peking Union Medical College and Chinese Academy of Medical Sciences,Beijing 100037,China [4]Department of Nuclear Medicine,Fuwai Hospital and Cardiovascular Institute,Peking Union Medical College and Chinese Academy of Medical Sciences,Beijing 100037,China [5]Department of Biostatistics,National Center for Cardiovascular Diseases,Beijing 100037,China

出　　处：《Chinese Medical Journal》2010年第20期2858-2864,共7页中华医学杂志（英文版）

摘　　要：Background 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.Methods 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 asprin 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.Results 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 repBackground 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.Methods 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 asprin 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.Results 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 rep

关 键 词：acute myocardial infarction NO-REFLOW percutaneous coronary intervention TONGXINLUO 

分 类 号：TQ463[化学工程—制药化工] R542.22[医药卫生—心血管疾病]