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Re: Эритропоэтин при травме?
Karim Brohi 19 Апрель 2004, 23:48
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Currently there hasn't been a RCT of erythropoietin in trauma patients.
However there is a randomized double-blind controlled trial of EPO in critically ill patients (JAMA 2002) which I've posted below. Basically this multicenter study randomized 1302 patients to EPO or placebo on ICU day 3 and continued weekly for 3 doses while the patients remained in hospital.
The primary endpoint for the study was transfusion independence, and they found EPO patients were less likely to receive a transfusion (60.4% placebo vs 50.5% rHuEPO; P<.001). Patients on EPO also received less transfusions and had a greater increase in haemoglobin from baseline. There was no difference in mortality or morbidity between the two groups.
In the fine print is that the transfusions saved amounted to approximately 1 unit of transfusion per patient, and this was over the whole hospital stay and not the ICU stay. Is this clinically significant? Probably not for the individual patient. But if each patient was saved 1 unit of blood then 650 units of blod were saved over the study, which does become significant, both from a cost and risk issue.
Is EPO indicated in trauma patients. Probably there is a group of patients who would benefit. Those long-term ICU patients who have to get topped up once or twice a week due to fluid administration, phlebotomy, 'critical illness anaemia' etc. The study needs to be done.
Karim
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Re: Эритропоэтин при травме?
Karim Brohi 19 Апрель 2004, 23:54
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Sorry - forgot the reference:
JAMA. 2002 Dec 11;288(22):2827-35.
Efficacy of recombinant human erythropoietin in critically ill patients: a randomized controlled trial.
Corwin HL, Gettinger A, Pearl RG, Fink MP, Levy MM, Shapiro MJ, Corwin MJ, Colton T; EPO Critical Care Trials Group.
Critical Care Medicine, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756, USA. howard.l.corwin@hitchcock.org
CONTEXT: Anemia is common in critically ill patients and results in a large number of red blood cell (RBC) transfusions. Recent data have raised the concern that RBC transfusions may be associated with worse clinical outcomes in some patients.
OBJECTIVE: To assess the efficacy in critically ill patients of a weekly dosing schedule of recombinant human erythropoietin (rHuEPO) to decrease the occurrence of RBC transfusion.
DESIGN: A prospective, randomized, double-blind, placebo-controlled, multicenter trial conducted between December 1998 and June 2001.
SETTING: A medical, surgical, or a medical/surgical intensive care unit (ICU) in each of 65 participating institutions in the United States.
PATIENTS: A total of 1302 patients who had been in the ICU for 2 days and were expected to be in the ICU at least 2 more days and who met eligibility criteria were enrolled in the study; 650 patients were randomized to rHuEPO and 652 to placebo.
INTERVENTION: Study drug (40 000 units of rHuEPO) or placebo was administered by subcutaneous injection on ICU day 3 and continued weekly for patients who remained in the hospital, for a total of 3 doses. Patients in the ICU on study day 21 received a fourth dose.
MAIN OUTCOME MEASURES: The primary efficacy end point was transfusion independence, assessed by comparing the percentage of patients in each
treatment group who received any RBC transfusion between study days 1 and 28. Secondary efficacy end points identified prospectively included cumulative RBC units transfused per patient through study day 28; cumulative mortality through study day 28; change in hemoglobin from baseline; and time to first transfusion or death.
RESULTS: Patients receiving rHuEPO were less likely to undergo transfusion (60.4% placebo vs 50.5% rHuEPO; P<.001; odds ratio, 0.67; 95% confidence interval [CI], 0.54-0.83). There was a 19% reduction in the total units of RBCs transfused in the rHuEPO group (1963 units for placebo vs 1590 units for rHuEPO) and reduction in RBC units transfused per day alive (ratio of transfusion rates, 0.81; 95% CI, 0.79-0.83; P =.04). Increase in hemoglobin from baseline to study end was greater in the rHuEPO group (mean [SD], 1.32 [2] g/dL vs 0.94 [1.9] g/dL; P<.001). Mortality (14% for rHuEPO and 15% for placebo) and adverse clinical events were not significantly different.
CONCLUSIONS: In critically ill patients, weekly administration of 40 000 units of rHuEPO reduces allogeneic RBC transfusion and increases hemoglobin.
Further study is needed to determine whether this reduction in RBC transfusion results in improved clinical outcomes.
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