tetano
Editor, Senior Moderator
Chest. 2013 Feb 28. doi: 10.1378/chest.12-2907. [Epub ahead of print]
Hyperimmune Intravenous Immunoglobulin Treatment: A Multicentre Double-Blind Randomized Controlled Trial for Patients with Severe A(H1N1)pdm09 Infection.
Hung IF, To KK, Lee CK, Lee KL, Yan WW, Chan K, Chan WM, Ngai CW, Law KI, Chow FL, Liu R, Lai KY, Lau CC, Liu SH, Chan KH, Lin CK, Yuen KY.
Abstract
ABSTRACT BACKGROUND Experience from influenza pandemics suggested that convalescent plasma treatment given within 4 to 5 days of symptom onset might be beneficial. However, robust treatment data is lacking. METHODS This is a multicentre prospective double-blind randomized controlled trial. Convalescent plasma from patients who recovered from the 2009 pandemic influenza [A(H1N1)pdm09] infection was fractionated to hyperimmune intravenous immunoglobulin (H-IVIG) by CSL Biotherapies, Australia. Patients with severe A(H1N1)pdm09 infection on standard antiviral treatment requiring intensive care and ventilatory support were randomized to receive H-IVIG or normal IVIG manufactured before 2009 as control. Clinical outcome and adverse effects were compared. RESULTS Between 2010 and 2011, thirty-five patients were randomized to receive H-IVIG (17 patients) or IVIG (18 patients). One defaulted patient was excluded from analysis. No adverse event related to treatment was reported. Baseline demographics and viral load before treatment were similar between the two groups. Serial respiratory viral load demonstrated that H-IVIG treatment was associated with significantly lower day 5 and 7 post-treatment viral load when compared to the control (p=0.04 and p=0.02 respectively). The initial serum cytokine level was significantly higher in the H-IVIG group but fell to similar level 3 days after treatment. Subgroup multivariate analysis of the 22 patients who received treatment within 5 days of symptom onset demonstrated that H-IVIG treatment was the only factor which independently reduced mortality [OR:0.14, 95% CI, 0.02-0.92; p=0.04]. CONCLUSIONS Treatment of severe A(H1N1)pdm09 infection with H-IVIG within 5 days of symptom onset was associated with a lower viral load and reduced mortality.ClinialTrials.gov (NCT01617317).
PMID:
23450336
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23450336
Hyperimmune Intravenous Immunoglobulin Treatment: A Multicentre Double-Blind Randomized Controlled Trial for Patients with Severe A(H1N1)pdm09 Infection.
Hung IF, To KK, Lee CK, Lee KL, Yan WW, Chan K, Chan WM, Ngai CW, Law KI, Chow FL, Liu R, Lai KY, Lau CC, Liu SH, Chan KH, Lin CK, Yuen KY.
Abstract
ABSTRACT BACKGROUND Experience from influenza pandemics suggested that convalescent plasma treatment given within 4 to 5 days of symptom onset might be beneficial. However, robust treatment data is lacking. METHODS This is a multicentre prospective double-blind randomized controlled trial. Convalescent plasma from patients who recovered from the 2009 pandemic influenza [A(H1N1)pdm09] infection was fractionated to hyperimmune intravenous immunoglobulin (H-IVIG) by CSL Biotherapies, Australia. Patients with severe A(H1N1)pdm09 infection on standard antiviral treatment requiring intensive care and ventilatory support were randomized to receive H-IVIG or normal IVIG manufactured before 2009 as control. Clinical outcome and adverse effects were compared. RESULTS Between 2010 and 2011, thirty-five patients were randomized to receive H-IVIG (17 patients) or IVIG (18 patients). One defaulted patient was excluded from analysis. No adverse event related to treatment was reported. Baseline demographics and viral load before treatment were similar between the two groups. Serial respiratory viral load demonstrated that H-IVIG treatment was associated with significantly lower day 5 and 7 post-treatment viral load when compared to the control (p=0.04 and p=0.02 respectively). The initial serum cytokine level was significantly higher in the H-IVIG group but fell to similar level 3 days after treatment. Subgroup multivariate analysis of the 22 patients who received treatment within 5 days of symptom onset demonstrated that H-IVIG treatment was the only factor which independently reduced mortality [OR:0.14, 95% CI, 0.02-0.92; p=0.04]. CONCLUSIONS Treatment of severe A(H1N1)pdm09 infection with H-IVIG within 5 days of symptom onset was associated with a lower viral load and reduced mortality.ClinialTrials.gov (NCT01617317).
PMID:
23450336
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23450336