Izvorni znanstveni članak
Decreasing mortality with drotrecogin alfa in high risk septic patients A meta-analysis of randomized trials in adult patients with multiple organ failure and mortality >40%
GIOVANNI LANDONI
orcid.org/0000-0002-8594-5980
; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60 Milan 20132 Italy
MASSIMILIANO GRECO
; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60 Milan 20132 Italy
LEDA NOBILE
; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60 Milan 20132 Italy
GIACOMO MONTI
; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60 Milan 20132 Italy
LAURA PASIN
; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60 Milan 20132 Italy
LUCA CABRINI
; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60 Milan 20132 Italy
ALBERTO ZANGRILLO
; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60 Milan 20132 Italy
CAETANO NIGRO
; Dante Pazzanese Institute of Cardiology, São Paulo, Brasil
Sažetak
Objective. Sepsis is a complex inflammatory disease, rising in response to infection. Drotrecogin alfa, approved in 2001 for
severe sepsis, has been withdrawn from the market. The aim of this study was to assess if drotrecogin alfa-activated can
reduce mortality in the more severe septic patients.
Methods. We searched PubMed, Embase, Scopus, BioMedCentral, and in Clinicaltrials. gov databases to identify every
randomized study performed on drotrecogin alfa-activated in any clinical setting in humans, without restrictions on dose or
time of administration. Our primary end-point was mortality rate in high risk patients. Secondary endpoints were mortality in
all patients, in patients with an Acute Physiology and Chronic Health Evaluation (APACHE) 2 score ≥ 25 and in those with
an APACHE 2 score ≤25.
Results. Five trials were identified and included in the analysis. They randomized 3196 patients to drotrecogin alfa and 3111
to the control group. Drotrecogin alfa was associated with a reduction in mortality (99/263 [37.6%] vs 115/244 [47.1%], risk
ratios (RR) = 0.80[0.65; 0.98], p = 0.03) in patients with multiple organ failure and a mortality risk in the control group of
>40%, but not in the overall population or in lower risk populations.
Conclusions. In high risk populations of patients with multiple organ failure and a mortality of >40% in the control group,
Drotrecogin alfa may still have a role as a lifesaving treatment. No beneficial effect in low risk patients was found. An individual
patient meta-analysis including all randomized controlled trial on sepsis is warranted, along with new studies on similar
drugs such as protein C zymogen.
Ključne riječi
sepsis; shock; intensive care; critically ill; mortality; drotrecogin alfa; recombinant human activated protein C
Hrčak ID:
134088
URI
Datum izdavanja:
1.10.2013.
Posjeta: 1.419 *