Gillis J C, Goa K L
Adis International Limited, Auckland, New Zealand.
Pharmacoeconomics. 1996 Sep;10(3):281-310. doi: 10.2165/00019053-199610030-00009.
Thrombolytic therapy with streptokinase and other agents reduces mortality and is now well accepted as the mainstay of revascularisation options for most patients after an acute myocardial infarction. Streptokinase is as efficacious as alteplase (recombinant tissue plasminogen activator; rt-PA) when given as a 3-hour infusion, anistreplase, reteplase and saruplase in reducing mortality. However, in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial, an accelerated alteplase regimen (1.5-hour infusion) plus intravenous heparin demonstrated a statistically significant 1% absolute mortality reduction compared with streptokinase plus heparin. Treatment with streptokinase is consistently clinically superior to conventional treatment and is cost effective: the marginal cost per year of life saved (cost/YLS) is less than $US/$Can20,000 (1990 or 1991 currency) assuming 5-year survival. In addition, streptokinase treatment is associated with fewer intensive care days and total days spent in hospital and a decrease in the use of intensive care services compared with conventional therapy. Importantly, the cost/YLS of treating older patients (70 to 80 years) with streptokinase is similar to that in younger patients (approximately $US22,000, 1990 currency). In 1 study, the cost of in-hospital treatment and associated 1-year follow-up costs did not differ significantly regardless of whether patients received streptokinase or anistreplase. In the most comprehensive cost-effectiveness analysis to date, GUSTO investigators determined that the incremental cost/YLS in patients who received the accelerated alteplase regimen instead of streptokinase was $US32,678 (1993 currency); the projected life expectancy was about 15 years. Thrombolytic therapy is generally more cost effective in patients at high risk than in those at low risk. The cost effectiveness of streptokinase is dependent on infarct location and time to treatment, but is more favorable in patients with anterior than inferior infarctions and those treated as soon as possible after symptom onset. There are as yet no comparative data to indicate a clinical benefit for one thrombolytic agent over another in patients treated more than 6 hours after symptom onset; therefore, in all likelihood, streptokinase will be preferred on the basis of cost minimisation. Streptokinase is associated with a slightly higher rate of severe bleeding than alteplase but a lower incidence of stroke. Although quality-of-life information comparing thrombolytics is unavailable, most patients who received streptokinase or alteplase rated their quality of life as high on the basis of results from time trade-off assessments and health surveys. In summary, streptokinase is undeniably cost effective compared with conventional treatment. It is up to individual healthcare systems to determine whether the mortality advantage and cost differential of the accelerated alteplase regimen over streptokinase, as seen in the GUSTO trial, are affordable and justifiable. However, it is important to realise that treatment options may be limited by healthcare resources; thus, streptokinase can be regarded as a cost-effective thrombolytic strategy which is both efficacious and affordable within the constraints of most healthcare budgets.
使用链激酶及其他药物进行溶栓治疗可降低死亡率,目前已被广泛认可为大多数急性心肌梗死后患者血管再通治疗的主要手段。当进行3小时输注时,链激酶在降低死亡率方面与阿替普酶(重组组织型纤溶酶原激活剂;rt-PA)、茴酰化纤溶酶原链激酶激活剂复合物、瑞替普酶和替奈普酶疗效相当。然而,在全球应用链激酶和组织型纤溶酶原激活剂治疗闭塞冠状动脉(GUSTO)试验中,与链激酶加肝素相比,加速阿替普酶方案(1.5小时输注)加静脉肝素在统计学上显示绝对死亡率显著降低1%。链激酶治疗在临床上始终优于传统治疗且具有成本效益:假设生存5年,每年挽救生命的边际成本(成本/挽救生命年)低于20,000美元/加元(1990年或199l年货币)。此外,与传统治疗相比,链激酶治疗导致的重症监护天数和住院总天数更少,且重症监护服务的使用减少。重要的是,用链激酶治疗老年患者(70至80岁)的成本/挽救生命年与年轻患者相似(约22,000美元,1990年货币)。在1项研究中,无论患者接受链激酶还是茴酰化纤溶酶原链激酶激活剂复合物治疗,住院治疗费用及相关的1年随访费用均无显著差异。在迄今为止最全面的成本效益分析中,GUSTO研究人员确定,接受加速阿替普酶方案而非链激酶治疗的患者每挽救1年生命的增量成本为32,678美元(1993年货币);预计预期寿命约为15年。溶栓治疗通常在高危患者中比在低危患者中更具成本效益。链激酶的成本效益取决于梗死部位和治疗时间,但在前壁梗死患者中比下壁梗死患者更有利,且在症状发作后尽快接受治疗的患者中更有利。目前尚无比较数据表明在症状发作6小时后接受治疗的患者中,一种溶栓药物比另一种具有临床益处;因此,很可能基于成本最小化原则首选链激酶。链激酶导致严重出血的发生率略高于阿替普酶,但中风发生率较低。尽管尚无比较溶栓药物的生活质量信息,但根据时间权衡评估和健康调查结果,大多数接受链激酶或阿替普酶治疗的患者对其生活质量评价较高。总之,与传统治疗相比,链激酶无疑具有成本效益。如GUSTO试验所示,加速阿替普酶方案相对于链激酶的死亡率优势和成本差异是否可承受且合理,应由各个医疗保健系统自行决定。然而,重要的是要认识到治疗选择可能受到医疗资源的限制;因此,链激酶可被视为一种具有成本效益的溶栓策略,在大多数医疗保健预算的限制范围内既有效又经济实惠。