An economic evaluation of activated protein C treatment for severe sepsis.
An economic evaluation of activated protein C treatment for severe sepsis.
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DOI：
10.1056/nejmsa020969
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发表时间：
2002-09-26
影响因子：
158.5
通讯作者：
Donaldson, C
中科院分区：
文献类型：
--
作者：
Manns, BJ;Lee, H;Donaldson, C
背景：重组人活化蛋白C在严重脓毒症（Severe Sepsis）中的全球评估研究显示，重组人活化蛋白C可以降低严重脓毒症患者的死亡率。美国食品和药物管理局（FDA）对该研究数据的事后再分析表明，死亡率的降低仅限于急性生理和慢性健康评估（APACHE II）评分为25分或以上的患者。方法：与常规护理相比，我们评估了活化蛋白C治疗严重脓毒症患者的成本效益。我们对所有患者进行了经济分析，并根据年龄和疾病严重程度对亚组进行了分析。临床状态和资源使用估计之间转换的概率是从基于人群的严重脓毒症患者队列中得出的。我们使用了来自美国食品和药物管理局（FDA）的研究和分析的活性蛋白C的有效性数据。结果：用活化蛋白C治疗所有患者获得的每生命年成本为27,936美元。与APACHE II评分较低的患者（每生命年增加35,632美元）相比，治疗APACHE II评分为25或更高的患者（每生命年增加24,484美元）更具成本效益。当考虑到FDA对有效性的估计时，治疗APACHE II评分为24或更低的患者的成本效益增加到575,054美元/生命年。对于APACHE II评分为25或更高的患者，每个生命年的成本随着年龄的增长而增加（40岁以下的患者为16,309美元；80岁或以上的患者为28,100美元）。结论：对于严重脓毒症、病情严重程度更高（APACHE II评分为25分或更高）的患者，如果他们在脓毒症发作后存活，激活蛋白C相对具有成本效益。需要进一步的研究来确定活化蛋白C对脓毒症和较轻疾病患者的成本效益。
Background: Recombinant human activated protein C was shown in the Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study to reduce mortality among patients with severe sepsis. A post hoc reanalysis by the Food and Drug Administration (FDA) of data from this study suggested that the reduction in mortality was restricted to patients with Acute Physiology and Chronic Health Evaluation (APACHE II) scores of 25 or more.Methods: We estimated the cost effectiveness of activated protein C as compared with conventional care for patients with severe sepsis. We performed an economic analysis involving all patients, as well as analyses of subgroups defined according to age and severity of illness. The probabilities of transition between clinical states and the estimates of resource use were derived from a population-based cohort of patients with severe sepsis. We used data on the effectiveness of activated protein C from the PROWESS study and analyses by the FDA.Results: The cost per life-year gained by treating all patients with activated protein C was $27,936. It was more cost effective to treat patients with an APACHE II score of 25 or more ($24,484 per life-year gained) than those with a lower APACHE II score ($35,632 per life-year gained). The cost effectiveness of treating patients with an APACHE II score of 24 or less increased to $575,054 per life-year gained when the FDA's estimates of effectiveness were considered. For patients with an APACHE II score of 25 or more, the cost per life-year gained increased with age ($16,309 for patients less than 40 years of age; $28,100 for those 80 years of age or older).Conclusions: Activated protein C is relatively cost effective when targeted to patients with severe sepsis, greater severity of illness (an APACHE II score of 25 or more), and a reasonable life expectancy if they survive the episode of sepsis. Further research is needed to determine the cost effectiveness of activated protein C for patients with sepsis and less severe illness.