No-reflow protection and long-term efficacy for acute myocardial infarction with Tongxinluo: a randomized double-blind placebo-controlled multicenter clinical trial (ENLEAT Trial).
Abstract | BACKGROUND: 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 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. 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 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. CONCLUSION:
|
Authors | Hai-tao Zhang, Zhen-hua Jia, Jian Zhang, Zan-kai Ye, Wei-xian Yang, Yue-qin Tian, Xuan Jia, Wei Li, Yi-ling Wu, Yue-jin Yang |
Journal | Chinese medical journal
(Chin Med J (Engl))
Vol. 123
Issue 20
Pg. 2858-64
(Oct 2010)
ISSN: 2542-5641 [Electronic] China |
PMID | 21034597
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Chemical References |
- Drugs, Chinese Herbal
- tongxinluo
|
Topics |
- Acute Disease
- Aged
- Coronary Circulation
- Double-Blind Method
- Drugs, Chinese Herbal
(therapeutic use)
- Electrocardiography
- Female
- Humans
- Male
- Medicine, Chinese Traditional
- Middle Aged
- Myocardial Infarction
(drug therapy, physiopathology)
- Tomography, Emission-Computed, Single-Photon
|
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|