当前位置:文库下载 > 所有分类 > 医药卫生 > 临床医学 > 替奈普酶VS爱通立
免费下载此文档

替奈普酶VS爱通立

The new england journal of medicine

A Randomized Trial of Tenecteplase versus Alteplase for Acute Ischemic Stroke

Mark Parsons, M.D., Neil Spratt, M.D., Andrew Bivard, B.Sc., Bruce Campbell, M.D., Kong Chung, M.D., Ferdinand Miteff, M.D., Bill O’Brien, M.D., Christopher Bladin, M.D., Patrick McElduff, Ph.D., Chris Allen, M.D., Grant Bateman, M.D., Geoffrey Donnan, M.D.,

Stephen Davis, M.D., and Christopher Levi, M.D.

ABSTRACT

BACKGROUND

Intravenous alteplase is the only approved treatment for acute ischemic stroke. Tenec­teplase, a genetically engineered mutant tissue plasminogen activator, is an alterna­tive thrombolytic agent.

METHODS

In this phase 2B trial, we randomly assigned 75 patients to receive alteplase (0.9 mg per kilogram of body weight) or tenecteplase (0.1 mg per kilogram or 0.25 mg per kilo­gram) less than 6 hours after the onset of ischemic stroke. To favor the selection of patients most likely to benefit from thrombolytic therapy, the eligibility criteria were a perfusion lesion at least 20% greater than the infarct core on computed tomographic (CT) perfusion imaging at baseline and an associated vessel occlusion on CT angiog­raphy. The coprimary end points were the proportion of the perfusion lesion that was reperfused at 24 hours on perfusion­weighted magnetic resonance imaging and the extent of clinical improvement at 24 hours as assessed on the National Institutes of Health Stroke Scale (NIHSS, a 42­point scale on which higher scores indicate more severe neurologic deficits).

RESULTS

From the Departments of Neurology (M.P., N.S., A.B., K.C., F.M., B.O., C.L.), Clinical Research Design, Information Technology, and Statistical Support (P.M.), and Radiology (C.A., G.B.), John Hunter Hospital–Hunter Medical Re-search Institute, University of Newcastle, Newcastle, NSW; the Department of Neurology, Royal Melbourne Hospital (B.C., S.D.), and Florey Neuroscience In-stitutes (G.D.), University of Melbourne, Melbourne, VIC; and the Department of Neurosciences, Box Hill Hospital–Eastern Health, Monash University (C.B.), Mel-bourne, VIC — all in Australia. Address reprint requests to Dr. Parsons at the De-partment of Neurology, John Hunter Hos-pital, Locked Bag No. 1, Hunter Region Mail Centre, Newcastle, NSW 2310, Aus-tralia, or at mark.parsons@hnehealth.nsw .gov.au.

N Engl J Med 2012;366:1099-107.

Copyright © 2012 Massachusetts Medical Society.

The three treatment groups each comprised 25 patients. The mean (±SD) NIHSS score at baseline for all patients was 14.4±2.6, and the time to treatment was 2.9±0.8 hours. Together, the two tenecteplase groups had greater reperfusion (P=0.004) and clini­cal improvement (P<0.001) at 24 hours than the alteplase group. There were no significant between­group differences in intracranial bleeding or other serious ad­verse events. The higher dose of tenecteplase (0.25 mg per kilogram) was superior to the lower dose and to alteplase for all efficacy outcomes, including absence of seri­ous disability at 90 days (in 72% of patients, vs. 40% with alteplase; P = 0.02).

CONCLUSIONS

Tenecteplase was associated with significantly better reperfusion and clinical outcomes than alteplase in patients with stroke who were selected on the basis of CT perfusion imaging. (Funded by the Australian National Health and Medical Research Council; Australia New Zealand Clinical Trials Registry number, ACTRN12608000466347.)

1099

替奈普酶VS爱通立

n engl j med 366;12 http://www.wenkuxiazai.com march 22, 2012

第1页

免费下载Word文档免费下载:替奈普酶VS爱通立

(下载1-9页,共9页)

我要评论

返回顶部