Center for Quality of Care Research, Baystate Medical Center, Springfield, MA, USA.
Crit Care Med. 2010 Apr;38(4):1101-7. doi: 10.1097/CCM.0b013e3181d423b7.
Evidence regarding the efficacy and safety of human recombinant activated protein C in severe sepsis is limited, especially outside of clinical trials. We sought to compare the outcomes of patients with septic shock who received early treatment with activated protein C to those who did not.
DESIGN, SETTING, AND PATIENTS: A retrospective cohort study at 404 U.S. hospitals. We studied 33,749 patients with sepsis who were admitted to intensive care and administered antibiotics and vasopressors within 2 days of admission.
Hospital mortality, intracranial and gastrointestinal hemorrhage, major transfusion. Compared to the entire cohort, the 1576 activated protein C-treated patients included in the matched analysis were younger (mean age, 61 vs. 67), more likely to be white (70% vs. 63%), and had fewer comorbidities. Treated patients were more likely to require mechanical ventilation (77% vs. 48%), to be administered two or more vasopressors (68% vs. 41%), to undergo pulmonary artery catheterization (9% vs. 4%), and to die in the hospital (40.7% vs. 38.1%). In a propensity-matched sample in which all covariates achieved balance, receipt of activated protein C was associated with reduced hospital mortality (40.7% vs. 46.6%; risk ratio, 0.87; 95% confidence interval, 0.80-0.95). This result was insensitive to a hypothetical unmeasured confounder. A similar pattern was observed across groups stratified by age and number of organ-supportive therapies. Four activated protein C-treated patients (0.25%) had hemorrhagic stroke, 107 (6.8%) had gastrointestinal bleeding, and five (0.3%) required major transfusion.
Among patients presenting with septic shock, early treatment with activated protein C may be associated with reduced hospital mortality.
关于人重组活化蛋白 C 在严重脓毒症中的疗效和安全性的证据有限，尤其是在临床试验之外。我们旨在比较接受早期蛋白 C 治疗与未接受治疗的脓毒性休克患者的结局。
设计、地点和患者：在美国 404 家医院进行的回顾性队列研究。我们研究了 33749 例败血症患者，这些患者在入院后 2 天内接受了重症监护、抗生素和血管加压素治疗。
医院死亡率、颅内和胃肠道出血、主要输血。与整个队列相比，在匹配分析中纳入的 1576 例接受蛋白 C 治疗的患者更年轻（平均年龄 61 岁 vs. 67 岁）、更可能是白人（70% vs. 63%）、合并症较少。治疗组更可能需要机械通气（77% vs. 48%）、使用两种或更多种血管加压素（68% vs. 41%）、进行肺动脉导管检查（9% vs. 4%），以及院内死亡（40.7% vs. 38.1%）。在一个所有协变量均达到平衡的倾向匹配样本中，接受蛋白 C 治疗与降低的医院死亡率相关（40.7% vs. 46.6%；风险比 0.87；95%置信区间 0.80-0.95）。这一结果对假设的未测量混杂因素具有稳健性。在按年龄和器官支持治疗数量分层的组中，观察到了类似的模式。4 例蛋白 C 治疗患者（0.25%）发生出血性卒中，107 例（6.8%）发生胃肠道出血，5 例（0.3%）需要大量输血。
在出现脓毒性休克的患者中，早期接受蛋白 C 治疗可能与降低医院死亡率相关。
