Efficacy and safety of single-bolus tenecteplase compared with front-loaded alteplase in Chinese pat

来源 :Journal of Geriatric Cardiology | 被引量 : 0次 | 上传用户:wangzhenx06
下载到本地 , 更方便阅读
声明 : 本文档内容版权归属内容提供方 , 如果您对本文有版权争议 , 可与客服联系进行内容授权或下架
论文部分内容阅读
Background and Objective Previous study showed tenecteplase and alteplaxe were equovalent for 30-day mortality in the treatment of acute myocardial infarction. The purpose of this open-label,randomized,multi-center,angiographic trial was to assess the efficacy and safety of tenecteplase compared with alteplase in Chinese patients with acute myocardial infarction. Methods We recruited patients with acute ST-elevation myocardial infarction presenting within 6 hours of symptom onset from October,2002 to March,2004,in 5 hospitals in Beijing. After giving informed consent,patients were randomly assigned a single-bolus injection of tenecteplase(30-50 mg according to body weight) or front loaded alteplase(100 mg) ,and underwent coronary angiography at 90 min after starting the study drug. All patients received aspirin and heparin(target activated partial thromboplastin time 50-70 s) . The primary efficacy end point was the rate of TIMI grade 3 flow at 90 minutes. Other efficacy end points included TIMI grade 2/3 flow at 90 minutes. Safety end points included all stroke,intracranial hemorrhage(ICH) ,moderate/severe hemorrhage(except for ICH) ,all-cause mortality at 30-days,and major non-fatal cardiac events at 30 days. Results Overall 110 patients were eligible for statistical analysis,with 58 patients assigned to receive tenecteplase and 52 patients to alteplase. Tenecteplase produced a rate of TIMI grade 3 flow at 90 minutes after the start of thrombolysis(68.4%) similar to that of alteplase(66.7%,P=1.0) ;the rates of TIMI grade 2 or 3 were similar for patients treated with tenecteplase versus alteplase(89.5% versus 80.4%,respectively,P=0.278) . At 30 days,rates for all strokes were similar for the two groups(5.17% for tenecteplase and 1.92% for alteplase,P=0.62) ;rates of ICH were 3.45% and 1.92%(tenecteplase and rt-PA,P=1.00) respectively. The rate of moderate/severe hemorrhage was 8.62% with tenecteplase and 5.77% with alteplase(P=0.72) ;total mortality was almost identical in the two groups(13.8% versus 9.6%,respectively,P=0.565) while the rates of non-fatal cardiac complications were 10.35% and 11.54%(tenecteplase and alteplase,P=1.0) . Conclusions The efficacy of a single-bolus,weight-adjusted tenecteplase fibrinolytic regimen is equivalent to front-loaded alteplase in terms of the rates of TIMI grade 3 flow,and TIMI 2 or 3 flow,but the 30-day mortality and ICH in both groups was so high that the use of tenecteplase is not permitted in China. These negative safety results might be due to the high rate of percutaneous coronary intervention(PCI) and high dose of bolus heparin and suboptimal concomitant medical therapy during hospitalization,so further studies are needed to confirm the safety for tenecteplase in Chinese patients. Background and Objective Previous study showed tenecteplase and alteplaxe were equovalent for 30-day mortality in the treatment of acute myocardial infarction. The purpose of this open-label, randomized, multi-center, angiographic trial was to assess the efficacy and safety of tenecteplase compared with Were Invited in Chinese patients with acute myocardial infarction. Methods We recruited patients with acute ST-elevation myocardial infarction presenting within 6 hours of symptom onset from October, 2002 to March, 2004, in 5 hospitals in Beijing. randomly assigned a single-bolus injection of tenecteplase (30-50 mg according to body weight) or orbital loading alteplase (100 mg), and underwent coronary angiography at 90 min after starting the study drug. All patients received aspirin and heparin (target activated partial thromboplastin time 50-70 s). The primary efficacy end point was the rate of TIMI grade 3 flow at 90 minutes. Other efficacy end points inc Safety end points included all stroke, intracranial hemorrhage (ICH), moderate / severe hemorrhage (except for ICH), all-cause mortality at 30-days, and major non-fatal cardiac events at 30 days. Results Overall 110 patients were eligible for statistical analysis, with 58 patients assigned to receive tenecteplase and 52 patients to alteplase. Tenecteplase produced a rate of TIMI grade 3 flow at 90 minutes after the start of thrombolysis (68.4%) similar to the rates of TIMI grade 2 or 3 were similar for patients treated with tenecteplase versus alteplase (89.5% versus 80.4%, respectively, P = 0.278). At 30 days, rates for all The rates of moderate / moderate adverse effects of strokes were similar for the two groups (5.17% for tenecteplase and 1.92% for alteplase, P = 0.62); rates of ICH were 3.45% and 1.92% (tenecteplase and rt-PA, severe hemorrhage was 8.62% with tenecteplase and 5.77% with alteplase (P = 0.72); total mortality was almost idenwhile the rates of non-fatal cardiac complications were 10.35% and 11.54% (tenecteplase and alteplase, P = 1.0). Conclusions The efficacy of a single- bolus, weight-adjusted tenecteplase fibrinolytic regimen is equivalent to front-loading alteplase in terms of the rates of TIMI grade 3 flow, and TIMI 2 or 3 flow, but the 30-day mortality and ICH in both groups was so high that the use of tenecteplase is not permitted in China. These negative safety results might be due to the high rate of percutaneous coronary intervention (PCI) and high dose of bolus heparin and suboptimal concomitant medical therapy during hospitalization, so further studies are needed to confirm the safety for tenecteplase in Chinese patients.
其他文献
【本刊讯】“中国七成以上的糖尿病患者都合并有高血压、血脂异常等心血管疾病的高危因素,但其中血压、血脂和血糖水平同时达标的患者仅有5.6%。”这是在中华医学会糖尿病学
目的:检测血清脂联素(APN)水平,分析血清APN浓度与血脂、血清载脂蛋白A5(apoA5)及2型糖尿病的关系。方法:收集2型糖尿病(T2DM)210例,健康体检者112例,采用ELISA法检测血浆脂
本文从教学体会角度入手,对鼻韵母üan 的主要元音 a 的音值进行分析,说明在汉语拼音里同一个符号 a,表示的实际音值是不同的,韵母的发音也要遵循理论指导实践的原则,并从实
参加福建首届艺术节展演的戏剧节目共五台,其中专业剧团演出的四台,民间职业剧团演出的一台,如果对这次参演的剧目,作一次粗略的巡礼,便可以发现这次所有参演剧目都共同具有
“市委宣传部要一如既往地支持新四军研究会的工作,按照韩正书记的批示精神,更好地发挥新四军研究会的作用。” “Propaganda Department of Municipal Party Committee sh
在“两学一做”学习教育中,大安市委针对党员干部接地气不够、农村工作经验不足、群众工作方法不多的实际,围绕举全市之力打赢脱贫攻坚战这一大局,创新开展了“千名干部驻百
自 13、14世纪意大利著名法律注释学家巴尔多鲁创立“法则区别说”至 19世纪末 ,国际私法已有近 60 0年的历史。在这 60 0年的动荡岁月中 ,国际社会经历了封建割据 ,经历了自
目的研究在人类胰岛nephrin的表达及糖尿病是否调控nephrin的表达,同时初步探索nephrin在β细胞中的功能。方法试验分糖尿病患者(n=5)和非糖尿病患者(n=7)组。采用western bl
"近年来,上海新四军研究会积极宣传新四军的光荣历史,努力弘扬新四军的革命传统,为发扬光大党的优良作风和爱国主义精神做了大量工作,产生了良好的社会效果。希望以纪念建军9