A retrospective observational study of drotrecogin alfa (activated) in adults with severe sepsis: Comparison with a controlled clinical trial
A retrospective observational study of drotrecogin alfa (activated) in adults with severe sepsis: Comparison with a controlled clinical trial
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DOI：
10.1097/01.ccm.0000298309.73776.cb
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发表时间：
2008-01-01
影响因子：
8.8
通讯作者：
Zeckel, Michael
中科院分区：
文献类型：
--
作者：
Wheeler, Arthur;Steingrub, Jay;Zeckel, Michael
目标。目的：比较临床实践中接受屈曲可净阿尔法(DrotAA)治疗的患者和在III期随机对照试验(PROWESS)中接受治疗的患者的特征和结果。设计：回顾性收集接受DrotAA作为医生指导治疗的一部分的患者的观察数据。五个教学机构的重症监护室。病人。患者年龄为18岁，有严重的脓毒症(确诊/疑似感染有一个或多个败血症引起的器官功能障碍)，并接受DrotA干预。没有。测量和主要结果。报告了基线人口学、疾病严重程度、从器官功能障碍开始到接受DrotAA治疗的时间、器官功能障碍的每日评估、严重出血事件和住院死亡率。从严重脓毒症记录到开始DrotAA输注的时间被归类为：第0天(同一日历日)；第1天(下一个日历日)；和第2天(第二个日历日或更晚)。临床患者(n=274)比强效患者更年轻，有更多的合并症，病情严重程度更高(根据器官功能障碍或更多血管升压剂/呼吸机的使用来衡量)，并且接受DrotAA的时间较晚(均P&t；0.05)。临床实践患者的总体住院死亡率为42%，相比之下，接受DrotAA治疗的急性生理学和慢性健康评估11分=25的PROCESS患者的死亡率为37%。第0天、第1天和第2天的死亡率分别为33%、40%和52%。在PROCESS中，绝大多数患者是在第0天或第1天接受治疗的。4.0%的临床实践患者在输液过程中发生严重出血事件，而在急性生理学和慢性健康评估II评分为25分的PROWESS治疗患者中，这一比例为2.2%。结论：临床治疗的患者与PROCESS患者不同。患者更年轻，有更多的合并症，病情更严重，从严重脓毒症发病到开始DrotAA的平均时间更长。严重脓毒症发病后1天内接受治疗的患者的住院死亡率与接受DrotAA治疗的PROWESS患者相似。虽然严重出血事件的数量很少，因此无法进行明确的评估，但在临床实践患者中观察到的严重出血事件的发生率在数字上高于接受DrotAA治疗的PROCESS患者。
Objective. To compare characteristics and outcomes of patients treated with drotrecogin alfa (activated) (DrotAA) in clinical practice to those treated in a phase III randomized controlled trial (PROWESS).Design: Observational data were collected retrospectively from patients who received DrotAA as part of physician-directed treatment.Setting. Intensive care units of five teaching institutions.Patients. Patients were >= 18 yrs old, had severe sepsis (confirmed/suspected infection with one or more sepsis-induced organ dysfunctions), and received DrotAA.Interventions. None.Measurements and Main Results. Baseline demographics, severity of illness, time from organ dysfunction onset to DrotAA treatment, daily assessment of organ dysfunction, serious bleeding events, and in-hospital mortality were reported. Timing from severe sepsis documentation to start of DrotAA infusion was categorized: day 0 (same calendar day); day 1 (next calendar day); and day >= 2 (second calendar day or later). Clinical practice patients (n = 274) were younger, had more comorbidities, had higher severity of illness (as measured by organ dysfunction or greater vasopressor/ventilator use), and received DrotAA later than PROWESS patients (all p < .05). Overall hospital mortality for clinical practice patients was 42%, compared with 37% for DrotAA-treated PROWESS patients with Acute Physiology and Chronic Health Evaluation 11 score >= 25. Mortality for day 0, day 1, and day >= 2:2 groups was 33%, 40%, and 52%, respectively. In PROWESS, the vast majority were treated on day 0 or day 1. Serious bleeding events during infusion were noted in 4.0% of clinical practice patients compared with 2.2% of PROWESS DrotAA-treated patients with Acute Physiology and Chronic Health Evaluation II score >= 25.Conclusions: Patients treated in clinical practice differed from those in PROWESS. Patients were younger, had more comorbidities, had greater severity of illness, and had longer mean time from severe sepsis onset to the start of DrotAA. Hospital mortality for patients treated within 1 day of severe sepsis onset was similar to DrotAA-treated PROWESS patients. While the low number of serious bleeding events precludes a definitive assessment, the observed incidence of serious bleeding events in clinical practice patients was numerically higher than in DrotAA-treated PROWESS patients.