Tatu-Chiţoiu G, Teodorescu Cristina, Dan Monica, Căpraru P, Guran Manuela, Istrătescu Oana, Tatu-Chiţoiu Alexandrina, Bumbu Aurelia, Dorobanţu Maria
Clinics of Cardiology, Floreasca Emergency Hospital, Bucharest, Romania.
Rom J Intern Med. 2003;41(4):395-408.
To compare the efficacy and safety of an accelerated streptokinase regimen (double bolus of 0.75 MU in 10 min) in combination with enoxaparin (SK0.75Enox regimen) with the one of the front loaded alteplase (t-PA 100 mg/90 min) plus heparin (the t-PAHep regimen) in patients (pts.) with ST-segment elevation acute myocardial infarction (STAMI).
One hundred seventy three pts. (age 18-74) treated within the first 6 hrs. after the onset of STAMI with the above two mentioned thrombolytic regimens were included. 1. The group SK0.75Enox (102 pts.) received an i.v. bolus of 40 mg Enox followed by 0.75 MU SK in 10 min. A second bolus of 0.75 MU SK would be administrated only if no bed-side signs of coronary reperfusion (CR) were detected within the next 50 min. After thrombolysis Enox was administered 1 mg/kg bodyweight every 12 hrs. for 5-7 days. 2. The group t-PAHep (71 pts.) received 15 mg oft-PA in bolus followed by 50 mg in 30 min and 35 mg within the next 60 min; t-PA was followed by heparin 1000 u/hour for the next 48-72 hours. All the patients received aspirin. Three noninvasive CR criteria were used: 1. Rapid cesation of the chest pain. 2. Rapid decrease of the ST segment elevation by more than 50% from the initial value. 3. Rapid increase of the CK and CK-MB with a peak within the first 12 hrs.
Two patients (2.85%) from the t-PAHep group had non-fatal stroke (one haemorrhagic, one ischemic). No other major haemoragical events were registered in both groups. During the thrombolytic infusion hypotension appeared more frequently in the SK0.75Enox group (31.4%) than in the t-PAHep one (8.5%) (p>0.0001) but without any consequence regarding the patients' outcome. The ratio of CR was 78.4% in the SK0.75Enox group and 70.4% in the t-PAHep one (p = 0.308). In-hospital reocclusion appeared in 4 pts. from the t-PAHep group (5.7%) but in none in the SK0.75Enox one. Six pts. (5.9%) from the SK0.75Enox group and 5 pts. from the t-PA one (7.04%) died within the first 30 days after the onset of STAMI (p = 0.993).
The combination SK0.75Enox is at least as safe and efficacious as the t-PAHep one.
比较加速链激酶方案(10分钟内静脉注射两次0.75MU)联合依诺肝素(SK0.75Enox方案)与先负荷剂量使用阿替普酶(t-PA 100mg/90分钟)加肝素(t-PAHep方案)治疗ST段抬高型急性心肌梗死(STAMI)患者的疗效和安全性。
纳入173例(年龄18 - 74岁)在STAMI发病后6小时内接受上述两种溶栓方案治疗的患者。1. SK0.75Enox组(102例患者)先静脉注射40mg依诺肝素,随后在10分钟内静脉注射0.75MU链激酶。仅当在接下来50分钟内未检测到冠状动脉再灌注(CR)的床边体征时,才给予第二次0.75MU链激酶静脉注射。溶栓后,每12小时给予依诺肝素1mg/kg体重,持续5 - 7天。2. t-PAHep组(71例患者)先静脉推注15mg t-PA,随后在30分钟内静脉注射50mg,在接下来60分钟内静脉注射35mg;t-PA注射后,接下来48 - 72小时给予肝素1000u/小时。所有患者均接受阿司匹林治疗。使用三项非侵入性CR标准:1. 胸痛迅速缓解。2. ST段抬高较初始值迅速下降超过50%。3. CK和CK-MB迅速升高,在最初12小时内达到峰值。
t-PAHep组有2例患者(2.85%)发生非致命性卒中(1例出血性,1例缺血性)。两组均未记录到其他重大出血事件。在溶栓输注期间,SK0.75Enox组低血压出现的频率(31.4%)高于t-PAHep组(8.5%)(p>0.0001),但对患者结局无任何影响。SK0.75Enox组的CR率为78.4%,t-PAHep组为70.4%(p = 0.308)。t-PAHep组有4例患者(5.7%)出现院内再闭塞,但SK0.75Enox组无此情况。SK0.75Enox组有6例患者(5.9%)和t-PA组有5例患者(7.04%)在STAMI发病后30天内死亡(p = 0.993)。
SK0.75Enox联合方案至少与t-PAHep方案一样安全有效。