Smith Peter K, Datta Santanu K, Muhlbaier Lawrence H, Samsa Gregory, Nadel Andrea, Lipscomb Joseph
Division of Thoracic Surgery, Duke University Medical Center, Durham, North Carolina, USA.
Ann Thorac Surg. 2004 Feb;77(2):635-42; discussion 642-3. doi: 10.1016/j.athoracsur.2003.06.008.
The full kallikrein-inhibiting dose of aprotinin has been shown to reduce blood loss, transfusion requirements, and the systemic inflammatory response associated with cardiopulmonary bypass graft surgery (CABG). A half-dose regimen, although having a reduced delivery cost, inhibits plasmin and fibrinolysis without substantially effecting kallikrein-mediated inflammation associated with bypass surgery. The differing pharmacologic effects of the two regimens impact the decision-making process. The current study assessed the medical cost offset of full-dose and half-dose aprotinin from short- and long-term perspectives to provide a rational decision-making framework for clinicians.
To estimate CABG admission costs, resource utilization and clinical data from aprotinin clinical trials were combined with unit costs estimated from a Duke University-based cost model. Lifetime medical costs of stroke and acute myocardial infarction were based on previous research.
Relative to placebo, the differences in total perioperative cost for primary CABG patients receiving full-dose or half-dose aprotinin were not significant. When lifetime medical costs of complications were considered, total costs in full-dose and half-dose aprotinin-treated patients were not different relative to that of placebo. Total perioperative cost was significantly lower for repeat CABG patients treated with aprotinin, with savings of $2,058 for full-dose and $2,122 for half-dose patients when compared with placebo. Taking lifetime costs of stroke and acute myocardial infarction into consideration, the cost savings estimates were $6,044 for full-dose patients and $4,483 for half-dose patients, due to substantially higher lifetime stroke costs incurred by the placebo patients.
Using this cost model, use of full-dose and half-dose aprotinin in primary CABG patients was cost neutral during hospital admission, whereas both dosing regimens were significantly cost saving in reoperative CABG patients. Additional lifetime cost savings were realized relative to placebo due to reduced complication costs, particularly with the full-dose regimen. As the full kallikrein-inhibiting dose of aprotinin has been shown to be safe and effective, the current results support its use in both primary and repeat CABG surgery. No demonstrable economic advantage was observed with the half-dose aprotinin regimen.
已证明抑肽酶的全量激肽释放酶抑制剂量可减少失血量、输血需求以及与冠状动脉搭桥术(CABG)相关的全身炎症反应。半量方案虽然降低了给药成本,但可抑制纤溶酶和纤维蛋白溶解,而对与搭桥手术相关的激肽释放酶介导的炎症影响不大。这两种方案不同的药理作用影响了决策过程。本研究从短期和长期角度评估了全量和半量抑肽酶的医疗成本抵消情况,为临床医生提供合理的决策框架。
为估算CABG住院费用,将抑肽酶临床试验的资源利用和临床数据与基于杜克大学成本模型估算的单位成本相结合。中风和急性心肌梗死的终身医疗成本基于先前的研究。
相对于安慰剂,接受全量或半量抑肽酶的初次CABG患者围手术期总成本差异不显著。当考虑并发症的终身医疗成本时,全量和半量抑肽酶治疗患者的总成本与安慰剂组无差异。接受抑肽酶治疗的再次CABG患者围手术期总成本显著降低,与安慰剂相比,全量患者节省2058美元,半量患者节省2122美元。考虑到中风和急性心肌梗死的终身成本,全量患者成本节省估计为6044美元,半量患者为4483美元,这是因为安慰剂组患者终身中风成本大幅更高。
使用该成本模型,初次CABG患者使用全量和半量抑肽酶在住院期间成本无差异,而两种给药方案在再次CABG患者中均显著节省成本。由于并发症成本降低,相对于安慰剂还实现了额外的终身成本节省,尤其是全量方案。由于已证明抑肽酶的全量激肽释放酶抑制剂量安全有效,目前的结果支持其在初次和再次CABG手术中的应用。未观察到半量抑肽酶方案有明显的经济优势。