Gillis J C, Wagstaff A J, Goa K L
Adis International Limited, Auckland, New Zealand.
Drugs. 1995 Jul;50(1):102-36. doi: 10.2165/00003495-199550010-00008.
Alteplase (recombinant tissue-type plasminogen activator) stimulates the fibrinolysis of blood clots by converting plasminogen to plasmin. The efficacy of intravenous alteplase in the early treatment of patients with acute myocardial infarction has been unequivocally proven, and recent results from the GUSTO trial indicate a significant advantage in 30-day survival for alteplase in an accelerated dosage regimen (< or = 100mg infused over 90 minutes rather than 3 hours) over streptokinase. The advantage of the accelerated alteplase dosage regimen seems to be maintained for at least 1 year. The role of heparin as adjunctive therapy to thrombolysis remains to be fully defined but heparin administration appears to be more important in conjunction with alteplase than with streptokinase. Ideally, patients should receive alteplase as soon as possible after the onset of symptoms of acute myocardial infarction and, while therapy is most beneficial when administered early, survival is improved when the drug is administered up to 12 hours after symptom onset. The accelerated regimen of alteplase used in the GUSTO trial demonstrated a survival advantage in patients < or = 75 as well as those > 75 years of age which was at least as great as that seen with streptokinase. Similarly, alteplase reduces mortality in patients with both anterior and inferior infarctions; however, those with anterior wall infarctions show an improved outcome over those with inferior infarcts. On the basis of pharmacoeconomic analysis of GUSTO data, the accelerated alteplase regimen cost an estimated additional $US32,678 per year of life saved compared with a conventional streptokinase regimen. Cumulative 1-year costs were greater in patients who received the accelerated alteplase regimen but survival was significantly greater than in patients who received streptokinase. No difference in quality of life was evident in patients who received either treatment. The incidence of major haemorrhage associated with alteplase therapy appears to be similar to that seen with other fibrinolytic agents, increasing with increasing dose; however, the risk of stroke, particularly haemorrhagic stroke, is higher with alteplase than with streptokinase. Thus, alteplase has become firmly established as a first-line option in the management of acute myocardial infarction. On the basis of accumulated evidence, the greatest risk reduction with alteplase therapy may be in certain high risk groups, such as those with anterior infarcts, selected elderly patients and those who present late after symptom onset.
阿替普酶(重组组织型纤溶酶原激活剂)通过将纤溶酶原转化为纤溶酶来刺激血凝块的纤维蛋白溶解。静脉注射阿替普酶在急性心肌梗死患者早期治疗中的疗效已得到明确证实,GUSTO试验的最新结果表明,在加速给药方案(≤100mg在90分钟内输注而非3小时)下,阿替普酶在30天生存率方面比链激酶具有显著优势。加速阿替普酶给药方案的优势似乎至少能维持1年。肝素作为溶栓辅助治疗的作用仍有待充分明确,但肝素与阿替普酶联合使用时似乎比与链激酶联合使用更为重要。理想情况下,患者应在急性心肌梗死症状发作后尽快接受阿替普酶治疗,虽然早期治疗最有益,但在症状发作后12小时内给药也能提高生存率。GUSTO试验中使用的阿替普酶加速给药方案在≤75岁以及>75岁的患者中均显示出生存优势,且至少与链激酶相当。同样,阿替普酶可降低前壁梗死和下壁梗死患者的死亡率;然而,前壁梗死患者的预后优于下壁梗死患者。根据对GUSTO数据的药物经济学分析,与传统链激酶方案相比,阿替普酶加速给药方案每挽救一年生命估计额外花费32,678美元。接受阿替普酶加速给药方案的患者1年累计费用更高,但生存率显著高于接受链激酶治疗的患者。接受两种治疗的患者生活质量无明显差异。与阿替普酶治疗相关的严重出血发生率似乎与其他纤溶药物相似,且随剂量增加而增加;然而,阿替普酶导致中风尤其是出血性中风的风险高于链激酶。因此,阿替普酶已成为急性心肌梗死治疗中确立的一线选择。根据积累的证据,阿替普酶治疗最大的风险降低可能出现在某些高危人群中,如前壁梗死患者、部分老年患者以及症状发作较晚就诊的患者。