Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis 英文参考文献.docVIP

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Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis 英文参考文献.doc

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Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis 英文参考文献

Available online /content/7/2/155 Open Access Research Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis Gordon R Bernard1, William L Macias2, David E Joyce3, Mark D Williams3, Joan Bailey4 and Jean-Louis Vincent5 1Director, Division of Allergy, Pulmonary and Critical Care, Vanderbilt University School of Medicine, Nashville, Tennessee, USA 2Medical Director, Eli Lilly and Company, Indianapolis, Indiana, USA 3Clinical Research Physician, Eli Lilly and Company, Indianapolis, Indiana, USA 4Clinical Research Associate, Eli Lilly and Company, Indianapolis, Indiana, USA 5Head, Department of Intensive Care, Erasme University Hospital, Brussels, Belgium Correspondence: Gordon Bernard, gordon.bernard@ Received: 31 October 2002 Critical Care 2003, 7:155-163 (DOI 10.1186/cc2167) This article is online at /content/7/2/155 Revisions requested: 16 December 2002 Revisions received: 8 February 2003 Accepted: 20 February 2003 ? 2003 Bernard et al., licensee BioMed Central Ltd (Print ISSN 1364-8535; Online ISSN 1466-609X). This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the articles original URL. Published: 28 February 2003 Abstract Introduction Drotrecogin alfa (activated; recombinant activated protein C) was shown to reduce 28- day all-cause mortality in patients with severe sepsis and to have an acceptable safety profile in 1690 patients studied in the F1K-MC-EVAD (PROWESS) trial. We analyzed all available data on the safety of treatment with drotrecogin alfa (activated) in 2786 adult patients with severe sepsis enrolled in all phase 2 and 3 clinical trials, and in an estimated 3991 patients receiving the drug in commercial use. Patients and method Mortality and safety analyses were performed on all available data from adult severe sepsis patients enrolled in seven clinical trials as of