A randomized trial of recombinant human granulocyte-macrophage colony stimulating factor for patients with acute lung injury.
A randomized trial of recombinant human granulocyte-macrophage colony stimulating factor for patients with acute lung injury.
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DOI：
10.1097/ccm.0b013e31822d7bf0
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发表时间：
2012-01
影响因子：
8.8
通讯作者：
Hyzy RC
中科院分区：
文献类型：
--
作者：
Paine R 3rd;Standiford TJ;Dechert RE;Moss M;Martin GS;Rosenberg AL;Thannickal VJ;Burnham EL;Brown MB;Hyzy RC
Despite recent advances in critical care and ventilator management, acute lung injury (ALI) and the Acute Respiratory Distress Syndrome (ARDS) continue to cause significant morbidity and mortality. Granulocyte-macrophage colony stimulating factor (GM-CSF) may be beneficial for patients with ARDS. To determine whether intravenous infusion of GM-CSF would improve clinical outcomes for patients with ALI/ARDS. A randomized, double-blind, placebo-controlled clinical trial of human recombinant GM-CSF vs. placebo. The primary outcome was days alive and breathing without mechanical ventilatory support within the first 28 days after randomization. Secondary outcomes included mortality and organ failure free days. Medical and Surgical Intensive Care Units at three academic medical centers. One hundred-thirty individuals with ALI of at least three days duration were enrolled, out of a planned cohort of 200 subjects. Patients were randomized to receive human recombinant GM-CSF (64 subjects, 250 μg/M2) or placebo (66 subjects) by intravenous infusion daily for 14 days. Patients received mechanical ventilation using a lung protective protocol. There was no difference in ventilator-free days between groups (10.7 ± 10.3 days placebo vs. 10.8 ± 10.5 days GM-CSF, p=0.82). Differences in 28-day mortality (23% in placebo vs. 17% in patients receiving GM-CSF (p=0.31)) and organ failure free days (12.8 ± 11.3 days placebo vs. 15.7 ± 11.9 days GM-CSF, p=0.16) were not statistically significant. There were similar numbers of serious adverse events in each group. In a randomized phase II trial, GM-CSF treatment did not increase the number of ventilator free days in patients with ALI/ARDS. A larger trial would be required to determine whether treatment with GM-CSF might alter important clinical outcomes such as mortality or multiorgan failure. (ClinicalTrials.gov number, NCT00201409 [ClinicalTrials.gov])
