Use of granulocyte colony-stimulating factor in patients with severe sepsis or septic shock.

PURPOSE: The efficacy and safety of granulocyte colony-stimulating factor (G-CSF) in critically ill patients with severe sepsis or septic shock were evaluated.
SUMMARY: The medical literature was reviewed to identify published trials, case reports, and case series on the use of G-CSF in critically ill patients for treatment of severe sepsis or septic shock. G-CSF has been evaluated as an adjunct to standard care for critically ill patients. Initial studies involving critically ill patients with severe sepsis or septic shock found mortality benefits with G-CSF therapy; however, these findings are limited by factors such as small sample sizes, selection bias, and lack of an appropriate control group. Prospective, randomized, multicenter, double-blind studies failed to confirm the benefits in mortality for patients receiving G-CSF for the treatment of severe sepsis and septic shock. Due to the limitations in the design of the studies that report a mortality benefit and prospective, randomized, multicenter, double-blind studies that report the lack of a mortality benefit, a recommendation to add G-CSF as an adjunctive therapy in critically ill patients with severe sepsis and septic shock cannot be made at this time.
CONCLUSION: The available data, especially those from large, prospective, randomized, double-blind studies, do not support the use of G-CSF as an adjunct therapy to standard care for critically ill patients with severe sepsis or septic shock. Data from prospective, large, randomized, controlled, well-designed studies are needed to define the optimal G-CSF dosing regimen, the safety of this therapy, and the effects of G-CSF on patient morbidity and survival.