tailieunhanh - Báo cáo y học: "Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học Critical Care giúp cho các bạn có thêm kiến thức về y học đề tài: Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis. | Available online http content 7 2 155 Research Open Access 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 1 Director 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 Received 31 October 2002 Revisions requested 16 December 2002 Revisions received 8 February 2003 Accepted 20 February 2003 Published 28 February 2003 Critical Care 2003 7 155-163 DOI cc2167 This article is online at http content 7 2 155 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 article s original URL. Abstract Introduction Drotrecogin alfa activated recombinant activated protein C was shown to reduce 28day 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 12 April 2002. .

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