A registry of patients treated with drotrecogin alfa (activated) in belgian intensive care units - An observational study
A registry of patients treated with drotrecogin alfa (activated) in belgian intensive care units - An observational study
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DOI：
10.1179/acb.2008.004
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发表时间：
2008-01-01
影响因子：
1.6
通讯作者：
Janes, J.
中科院分区：
文献类型：
--
作者：
Vincent, J. -L.;Laterre, P. -F.;Janes, J.
背景：Drotrecogin α（活化）11 [DrotAA]是唯一被证明可以降低死亡率的特异性脓毒症治疗药物。本研究的目的是记录比利时重症监护病房（icu）中接受DrotAA治疗的患者的概况，使用的数据来自比利时药品报销条件数据库的一部分，并比较这些患者观察到的住院死亡率与他们的预期死亡率，计算数据来自PROGRESS比利时部分的未接受DrotAA治疗的患者。国际败血症登记处收集严重败血症患者的数据。材料和方法：使用来自未接受drotaa治疗的进展患者的数据来计算比利时登记处接受drotaa治疗的患者的预期死亡率。使用逻辑回归方程，这些比率受到年龄和5个器官系统中器官功能障碍的存在或不存在的控制。采用相同的逻辑回归技术来控制比利时登记的接受drotaa治疗的患者的年龄和5种器官功能障碍的存在与否的死亡率。调整后的预期死亡率和观察到的医院死亡率可以进行比较。结果：比利时共有436例DrotAA患者。几乎所有患者（99.5%）至少发生2次器官衰竭，住院死亡率为51.6%。286名患者有足够的基线数据纳入回归模型。使用PROGRESS非DrotAA患者的数据，比利时注册患者在未接受DrotAA治疗的情况下，在控制年龄和器官功能障碍的情况下，预计的住院死亡率为63.5%。观察到的286名比利时登记患者的医院死亡率（同样受年龄和器官功能障碍的影响）为50.7%，这意味着调整后的绝对死亡率降低了12.8%。结论：将比利时报销登记数据与自愿登记的严重脓毒症数据进行比较，支持了DrotAA降低严重脓毒症和感染性休克死亡率的观察结果。
Background: Drotrecogin alfa (activated) 11 [DrotAA] is the only specific sepsis therapy that has been shown to reduce mortality. The objectives of this study were to document the profile of patients treated with DrotAA in Belgian intensive care units (ICUs), using data from a database established as part of drug reimbursement conditions in Belgium, and to compare the observed hospital mortality of these patients with their expected mortality, calculated using data from non-DrotAA-treated patients from the Belgian section of PROGRESS, a separate, voluntary, international sepsis registry collecting data from patients with severe sepsis.Material and methods: Data from the non-DrotAA-treated patients in PROGRESS were used to calculate the expected mortality rates for DrotAA-treated patients in the Belgian registry. Using a logistic regression equation, these rates were controlled for age and the presence or absence of organ dysfunction in each of 5 organ systems. The same logistic regression technique was used to control the mortality rates observed in the DrotAA-treated patients from the Belgian registry for age and the presence or absence of each of the 5 organ dysfunctions. Adjusted expected and observed hospital mortality rates could then be compared.Results: There were 436 DrotAA patients in the Belgian registry. Almost all the patients (99.5%) had at least 2 organ failures and the hospital mortality was 51.6%. Two hundred and eighty-six of the patients had enough baseline data to be included in the regression model. Using data from the PROGRESS non-DrotAA patients, the predicted hospital mortality, controlled for age and organ dysfunction, of Belgian registry patients, had they not been treated with DrotAA, was 63.5%. The observed hospital mortality, again controlled for age and organ dysfunction, of the 286 Belgian registry patients was 50.7%, implying an adjusted absolute mortality reduction of 12.8%.Conclusions: Comparing Belgian reimbursement registry data with those of a voluntary severe sepsis register provides support for the observation that DrotAA reduces mortality rates in severe sepsis and septic shock.