中华心血管病杂志
中華心血管病雜誌
중화심혈관병잡지
Chinese Journal of Cardiology
2009年
6期
514-517
,共4页
梁峰%王立中%胡大一%史旭波%魏嘉平%赵红%王雷%贾三庆%王宏宇%刘如辉%陈韵岱%卢燕玲
樑峰%王立中%鬍大一%史旭波%魏嘉平%趙紅%王雷%賈三慶%王宏宇%劉如輝%陳韻岱%盧燕玲
량봉%왕립중%호대일%사욱파%위가평%조홍%왕뢰%가삼경%왕굉우%류여휘%진운대%로연령
心肌梗死%组织型纤溶酶原激活物%治疗结果
心肌梗死%組織型纖溶酶原激活物%治療結果
심기경사%조직형섬용매원격활물%치료결과
Myocardial infarction%Tissue plasminogen activator%Treatment outcome
目的 本研究观察替奈普酶(TNK-tPA)对中国急性ST段抬高心肌梗死(STEMI)患者的疗效和安全性.方法 2002年10月至2004年3月,在北京市的宣武医院、同仁医院、人民医院、友谊医院和安贞医院,入组急性STEMI发病6h患者,随机给予TNK-tPA或重组组织型纤溶酶原激活剂(rt-PA),给药后90 min行冠状动脉造影.主要疗效指标为溶栓治疗90min时,梗死相关动脉TIMI 3级血流的患者百分数.其他指标包括90 min梗死相关动脉TIMI 2/3级血流率、30 d的病死率、中重度出血及脑出血发生率.共110例STEMI患者进行统计分析,其中TNK-tPA组58例,rt-PA组52例.结果 两组患者溶栓后90 min冠状动脉造影TIMI 3级血流率分别为68.4%(39/57)和66.7%(34/51,P=1.00);TIMI 2/3级血流分别为89.5%(51/57)和80.4%(41/51,P=0.278);30 d的病死率分别为13.8%(8/58)和9.6%(5/52,P=0.565);中重度出血及脑出血的发生率分别为8.6%(5/58)和5.8%(3/52,P=0.72)及3.5%(2/58)和1.9%(1/52,P=1.00).结论 TNK-tPA溶栓治疗90 min TIMI 3级血流率、TIMI 2/3级血流率、30 d病死率、中重度出血发生率与rt-PA相似;TNK-tPA30 d病死率及脑出血发生率虽与rt-PA无统计学差异,但似乎较高,有关TNK-tPA在中国的临床使用,需进一步研究.
目的 本研究觀察替奈普酶(TNK-tPA)對中國急性ST段抬高心肌梗死(STEMI)患者的療效和安全性.方法 2002年10月至2004年3月,在北京市的宣武醫院、同仁醫院、人民醫院、友誼醫院和安貞醫院,入組急性STEMI髮病6h患者,隨機給予TNK-tPA或重組組織型纖溶酶原激活劑(rt-PA),給藥後90 min行冠狀動脈造影.主要療效指標為溶栓治療90min時,梗死相關動脈TIMI 3級血流的患者百分數.其他指標包括90 min梗死相關動脈TIMI 2/3級血流率、30 d的病死率、中重度齣血及腦齣血髮生率.共110例STEMI患者進行統計分析,其中TNK-tPA組58例,rt-PA組52例.結果 兩組患者溶栓後90 min冠狀動脈造影TIMI 3級血流率分彆為68.4%(39/57)和66.7%(34/51,P=1.00);TIMI 2/3級血流分彆為89.5%(51/57)和80.4%(41/51,P=0.278);30 d的病死率分彆為13.8%(8/58)和9.6%(5/52,P=0.565);中重度齣血及腦齣血的髮生率分彆為8.6%(5/58)和5.8%(3/52,P=0.72)及3.5%(2/58)和1.9%(1/52,P=1.00).結論 TNK-tPA溶栓治療90 min TIMI 3級血流率、TIMI 2/3級血流率、30 d病死率、中重度齣血髮生率與rt-PA相似;TNK-tPA30 d病死率及腦齣血髮生率雖與rt-PA無統計學差異,但似乎較高,有關TNK-tPA在中國的臨床使用,需進一步研究.
목적 본연구관찰체내보매(TNK-tPA)대중국급성ST단태고심기경사(STEMI)환자적료효화안전성.방법 2002년10월지2004년3월,재북경시적선무의원、동인의원、인민의원、우의의원화안정의원,입조급성STEMI발병6h환자,수궤급여TNK-tPA혹중조조직형섬용매원격활제(rt-PA),급약후90 min행관상동맥조영.주요료효지표위용전치료90min시,경사상관동맥TIMI 3급혈류적환자백분수.기타지표포괄90 min경사상관동맥TIMI 2/3급혈류솔、30 d적병사솔、중중도출혈급뇌출혈발생솔.공110례STEMI환자진행통계분석,기중TNK-tPA조58례,rt-PA조52례.결과 량조환자용전후90 min관상동맥조영TIMI 3급혈류솔분별위68.4%(39/57)화66.7%(34/51,P=1.00);TIMI 2/3급혈류분별위89.5%(51/57)화80.4%(41/51,P=0.278);30 d적병사솔분별위13.8%(8/58)화9.6%(5/52,P=0.565);중중도출혈급뇌출혈적발생솔분별위8.6%(5/58)화5.8%(3/52,P=0.72)급3.5%(2/58)화1.9%(1/52,P=1.00).결론 TNK-tPA용전치료90 min TIMI 3급혈류솔、TIMI 2/3급혈류솔、30 d병사솔、중중도출혈발생솔여rt-PA상사;TNK-tPA30 d병사솔급뇌출혈발생솔수여rt-PA무통계학차이,단사호교고,유관TNK-tPA재중국적림상사용,수진일보연구.
Objective In this randomized,open-label,multicenter,angiographic trial,we compared the efficacy and safety of tenecteplase(TNK-tPA)with alteplase(rt-PA)in Chinese patients with acute myocardial infarction.Method Patients with acute ST-elevation myocardial infarction and pain to hospital time within 6 hours from October 2002,to March 2004 were randomly assigned a body weight adjusted bolus of TNK-tPA(0.53 ms/kg over more than 10 s,n=58) or front loaded rt-PA(≤100 mg,n=52).Coronary angeography was performed at 90 min after initiating study drugs.All patients received aspirin and heparin(target activated partial thromboplastin time:50-70 s).The primary end point of the trial was the rate of TIMI grade 3 flow at 90 minutes.Other end points included the rate of TIMI grade 2/3 flow at 90 minutes,all cause mortality at 30 days,the moderate/severe hemorrhage without intracranial hemorrhage(ICH) and ICH within 30 days.Results TIMI grade 3 flow at 90 minutes(68.4%vs.66.7%,P=1.00),TIMI grade 2 or 3 at 90 minutes(89.5%vs.80.4%,P=0.278).total mortality at 30 days(13.8%vs.9.6%,P=0.565),the rate of moderate/severe hemorrhage(8.6%vs.5.8%,P=0.72)and incidence of ICH(3.5%vs.1.9%.P=1.00)were all similar in TNK-tPA treated patients compared to rt-PA treated patients.Conclusion The efficacy of single-bolus,weight-adjusted TNK-tPA fibrinolytic regimen is equivalent to front-loaded alteplase in terms of the rates of TIMI grade 3 flow,TIMI 2 or 3 flow.Incidences of moderate/severe hemorrhage,ICH and 30-days mortality were similar in TNK-tPA and rt-PA treated patients.
