全身炎症反应综合症与脓毒血症（下）.ppt

* Figure 2. Kaplan-Meier Estimates of Survival among 1316 Patients with Severe Sepsis in the Drotrecogin Alfa (Activated) (DrotAA) Group and 1297 Patients in the Placebo Group. There was no significant difference between the treatment groups in survival at 28 days (P=0.31 by the log-rank test). * * * * * * * * * * * Of the 499 patients, 233 (46.7%) did not have a response to ACTH (125 in HC and 108 in placebo) 254 patients had a response to ACTH (118 in HC and 136 in placebo) Results were unknown in 12 pts (8 in HC and 4 in placebo) * * Overall, there was no significant difference in mortality between the 2 groups: 34.3% in HC vs. 31.5% in placebo (p=0.51) * * Among non-responders, there was no significant difference in mortality: 39.2% in HC group vs. 36.1% in placebo. * * Among responders, there was also no significant difference in mortality: 28.8% in HC group vs. 28.7% in placebo. * * Time to shock reversal was faster in patients who received hydrocortisone whether or not they responded to the ACTH test * * * * * * On the basis of the Phase 2 trial results, a dose of 24 μg/kg/hr for a duration of 96 hrs was chosen for use in the randomized, double-blind, placebo-controlled Phase 3 trial of drotrecogin alfa (activated) in severe sepsis (PROWESS study). All patients received conventional care (eg, fluids, vasopressors, ventilatory support). Drotrecogin alfa (activated) or placebo was administered as a continuous IV infusion. Placebo consisted of .9% saline with or without .1% human serum albumin. In order to be included in the PROWESS study, patients had to have a known or suspected infection, evidence of a systemic inflammatory response (at least three of the four modified systemic inflammatory response syndrome [SIRS] criteria) and one or more of five sepsis-induced acute organ/system dysfunctions. Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety of recombinant human activated Protein C for severe sepsis. N Engl J Med 2001;344:699-709. * The