The international PROGRESS registry of patients with severe sepsis: drotrecogin alfa (activated) use and patient outcomes.

The international PROGRESS registry of patients with severe sepsis: drotrecogin alfa (activated) use and patient outcomes.
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严重脓毒症患者的国际 PROGRESS 登记:drotrecogin alfa(激活)的使用和患者结果。

DOI:
10.1186/cc7936
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发表时间:
2009
期刊:
影响因子:
15.1
通讯作者:
Beale, Richard
Beale, Richard
中科院分区:
医学1区
文献类型:
--
作者:
Martin, Greg;Brunkhorst, Frank M.;Janes, Jonathan M.;Reinhart, Konrad;Sundin, David P.;Garnett, Kassandra;Beale, Richard

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自从推出drotrecogin alfaactivated (DrotAA)以来,各机构和各个国家都根据审计或注册数据发布了其在临床实践中的使用数据。这些研究的规模和地理区域受到限制,并且纳入的患者的疾病严重程度和死亡率均高于临床试验中的患者。本研究的目的是比较国际 PROGRESS(促进全球严重脓毒症研究卓越)严重脓毒症队列研究中接受或未接受 DrotAA 治疗的患者的基线特征和临床结果(使用适当的统计调整)。 PROGRESS 是一项全球性、非干预性、多中心、前瞻性、观察性研究,研究对象是在参与机构的重症监护病房接受治疗的诊断为严重脓毒症的患者。所有治疗方式均按照参与机构的护理标准。分析了基线特征和医院死亡率,并使用回归技术来开发倾向和结果模型,根据组间基线不平衡进行调整。总体而言,共有来自 37 个国家的 14,543 名患者入组,其中 12,492 名患者拥有完整的数据可供分析。德国是入组人数最多的国家(1,810 人;14.5%),美国的 DrotAA 患者最多(206 人,23.3%); 882 人 (7%) 总体接受了 DrotAA 治疗。 DrotAA 治疗的患者更年轻(中位年龄 58 岁 vs. 61 岁),器官功能障碍程度更高(心血管:90% vs. 74%;呼吸系统:90% vs. 81%;肾脏:60% vs. 45%;代谢:63% vs. 42%;3 个或更多器官功能障碍:84% vs. 67%),APACHE II 评分中位数较高(26% vs. 67%)。 23,全部 P < 0.001)。尽管DrotAA和未接受DrotAA治疗的患者的院内死亡率相似(分别为49.6%和49.7%),但在调整不平衡后,接受DrotAA的患者的死亡几率降低了28%(0.60至0.86,95%置信区间),相对风险降低了17%(P = 0.0003)。在 PROGRESS 登记中,与未接受 DrotAA 治疗的患者相比,接受 DrotAA 治疗的患者更年轻、病情更严重且合并症更少。调整组间差异后,与未接受 DrotAA 治疗的患者相比,接受 DrotAA 治疗的患者死亡几率显着降低。
Since the launch of drotrecogin alfa activated (DrotAA), institutions and individual countries have published data on its use in clinical practice, based on audit or registry data. These studies were limited in size and geographic locale and included patients with greater disease severity and higher mortality than those in clinical trials. The purpose of this study was to compare baseline characteristics and clinical outcomes (using appropriate statistical adjustments) of patients treated or not treated with DrotAA from the international PROGRESS (Promoting Global Research Excellence in Severe Sepsis) cohort study of severe sepsis. PROGRESS was a global, non-interventional, multi-center, prospective, observational study of patients having a diagnosis of severe sepsis treated in intensive care units at a participating institution. All treatment modalities were as per standard of care at the participating institutions. Baseline characteristics and hospital mortality were analyzed and regression techniques used to develop propensity and outcome models adjusted for baseline imbalances between groups. Overall, 14,543 patients from 37 countries were enrolled and 12,492 had complete data for analysis. Germany was the highest enrolling country (1,810; 14.5%) and the US had the most DrotAA patients (206, 23.3%); 882 (7%) overall received DrotAA therapy. DrotAA-treated patients were younger (median age 58 vs. 61 years), had greater organ dysfunction (cardiovascular: 90% vs. 74%; respiratory: 90% vs. 81%; renal: 60% vs. 45%; metabolic: 63% versus 42%; 3 or more organ dysfunctions: 84% vs. 67%) and had a higher median APACHE II score (26 vs. 23, all with P < 0.001). Although in-hospital mortality was similar for DrotAA and non-DrotAA-treated patients (49.6% vs. 49.7%, respectively), after adjusting for imbalances, patients receiving DrotAA had a 28% (0.60 to 0.86, 95% Confidence Intervals) reduction in the odds of death and a relative risk reduction of 17% (P = 0.0003). In the PROGRESS registry, DrotAA-treated patients were younger, more severely ill, and had fewer co-morbidities than patients not treated with DrotAA. After adjustment for group differences, a significant reduction in the odds of death was observed for patients that received DrotAA compared with those that did not.
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