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Cytokines for Sepsis I
A randomized, Double-Masked, Placebo-Controlled Trial of Recombinant Granulocyte Colony-Stimulating Factor (rG-CSF) Administration to Preterm Infants with the Clinical Diagnosis of Early-Onset Sepsis. Miura E, Procianoy RS, Bittar C, et al. Pediatrics 2001; 107: 30-35.
Forty-four preterm neonates who had blood cultures obtained and antibiotics begun because of a clinical diagnosis of early-onset sepsis were randomized to receive rG-CSF (10 mcg/kg iv) or placebo once daily for 3 days. The treatment group (n=22) and placebo group (n=22) were similar with regard to gestational age, birth weight, APGAR scores and SNAP scores. The mortality rate was not different between groups. The occurance of subsequent nosocomial infections was lower in the rG-CSF recipients over the subsequent 2 weeks (RR = .19; 95% CI = .05 -.78). rG-CSF treatment did not alter the serum concentrations of cytokines measured (other than G-CSF). Serum G-CSF levels and blood neutrophil counts were higher in the treatment than placebo group 24 and 48 hours after dosing.
Comment. In this study, the diagnosis of sepsis was based on clinical and laboratory signs, however, only 6 of 44 (14%) study patients actually had positive blood cultures at study entry. The diagnosis of sepsis was therefore not confirmed in the vast majority of babies studied. Since the incidence of proven sepsis was so low and the mortality rate was comparable in both groups, it would have required a much larger study to demonstrate a reduction in mortality using rG-CSF. The finding of a decrease in nosocomial infections in the treatment group during the 2 weeks following treatment is encouraging. There were 9 babies with nosocomial infections (7 with positive blood cultures and 2 with NEC) in the placebo group, versus 2 cases of nosocomial sepsis in the treatment group. A larger clinical trial is needed to confirm or refute this finding, to establish the safety of rG-CSF for nosocomial sepsis prophylaxis in premature babies, and to look at the cost vs benefit issues. For now, it seems premature to recommend rG-CSF for clinical use in the treatment or prevention of infection in preterm neonates.