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A randomized, double-blind, phase 2 study of erythropoietin in optic neuritis
Suhs KW, Hein K, Sattler MB, Gorlitz A, Ciupka C, Scholz K, et al.,
Annals of Neurology. 2012;72((2):):199-210.
Abstract
OBJECTIVE Based on findings in animal models of autoimmune optic nerve inflammation, we have assessed the safety and efficacy of erythropoietin in patients presenting with a first episode of optic neuritis. METHODS Patients with optic neuritis who attended the University Hospitals of Homburg/Saar, Göttingen, or Hamburg (Germany) were included in this double-blind, placebo-controlled, phase 2 study (ClinicalTrials.gov, NCT00355095). They were randomly assigned to groups receiving either 33,000IU recombinant human erythropoietin intravenously daily for 3 days or placebo as an add-on therapy to methylprednisolone. The primary outcome parameter was change in retinal nerve fiber layer (RNFL) thickness after 16 weeks. Secondary outcome parameters included optic nerve atrophy as assessed by magnetic resonance imaging, and changes in visual acuity, visual field, and visual evoked potentials (VEPs). RESULTS Forty patients were assigned to the treatment groups (21/19 erythropoietin/placebo). Safety monitoring revealed no relevant issues. Thirty-seven patients (20/17 erythropoietin/placebo) were analyzed for the primary endpoint according to the intention-to-treat protocol. RNFL thinning was less apparent after erythropoietin treatment. Thickness of the RNFL decreased by a median of 7.5µm by week 16 (mean ± standard deviation, 10.55 ± 17.54µm) compared to a median of 16.0µm (22.65 ± 29.18µm) in the placebo group (p = 0.0357). Decrease in retrobulbar diameter of the optic nerve was smaller in the erythropoietin group (p = 0.0112). VEP latencies at week 16 were shorter in erythropoietin-treated patients than in the placebo group (p = 0.0011). Testing of visual functions revealed trends toward an improved outcome after erythropoietin treatment. INTERPRETATION These results give the first indications that erythropoietin might be neuroprotective in optic neuritis. Copyright © 2012 American Neurological Association.
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Randomised, open, prospective, multicenter pilot study to evaluate the efficacy and safety of activated recombinant factor Viia (Novoseven) in acute intracerebral haemorrhage in patients treated with oral anticoagulant or antiplatelet agents
Iorio A, Marchesini E, Falcou A, Caso V, Pastorello M, Tiscione V,, et al.,
ISTH Congress. 2007;: Abstract No. P-T-162.
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Hematide™, a synthetic peptide-based erythropoiesis stimulating agent (ESA), demonstrates erythropoietic activity in a phase 2 single dose, dose escalating study in patients with chronic kidney disease (CKD)
Duliege AM, Macdougall I, Duncan N, Wessels D, Iwashita J, Schatz P,, et al.,
Blood. 2005;106((11):): Abstract No. 3532.
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4.
Use of intravenous immunoglobulin for treatment of neurological conditions: a systematic review
Hutton B, Fergusson D, Sharma M, Tinmouth A, Wilson K, Cameron B,, et al.,
Blood. 2004;104((11):):990a.. Abstract No. 3642.
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Prestorage leukocyte reduction reduces macroaggregate in preoperative autologous blood of chronic rheumatoid arthritis
Kanai T, Kuribayashi T, Kawata N, Tsukimoto I, Tsutsuil T, Sugurol T,, et al.,
Vox Sanguinis. 2002;83((Suppl 1):):175. Abstract No. P-527.
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6.
Absence of HBV, HCV, HTLV and HHV-8 activation by allogeneic RBC transfusion of AIDS patients
Asmuth DM, Kalish LA, Laycock ME, Murphy EL, Mohr BA, Lee T,, et al.,
Transfusion. 2002;42((9S):):23S.. Abstract No. S81-040C.
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The clinical usefulness of high-dose intravenous immunoglobulin therapy for chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy Japanese
Kubori T, Mezaki T, Kaji R, Kimura J, Hamaguchi K, Hirayama K, Kanazawa I, Miyatake T, Mannen T, Kowa H, et al
No to Shinkei [Brain & Nerve]. 1999;51((2):):127-35.
Abstract
To explore the optimum dose of intravenous immunoglobulin (i.v.Ig) for treating patients with chronic inflammatory demyelinating polyrneuropathy and multifocal motor neuropathy, we compared the usefulness of i.v.Ig among 3 treatment doses. Fifty-nine patients were randomly divided into three treatment dosage groups: 20 patients for Group I using 50 mg/kg/day x 5 days, 19 patients Group II using 200 mg/kg/day x 5 days, and 20 patients Group III using 400 mg/kg/day x 5 days. We assessed clinically and electrophysiologically the effectiveness of the treatment at 5 weeks after the initial infusion. For patients in Group I and II who had not improved (or worsened) with the first treatment, we gave a one-step larger dose in the second treatment (i.e. 200 mg/kg/day x 5 days for those who had been given 50 mg/kg/day x 5 days, 400 mg/kg/day x 5 days for those who had been given 200 mg/kg/day x 5 days) after more than 9 weeks. We found that 15% of the patients in Group I, 21% in Group II and 60% in Group III improved dose-dependently with the first intravenous immunoglobulin treatment. Seven (47%) of 16 patients in Group I and 4 (40%) of 11 patients in Group II improved after the second treatment with larger doses. Adverse reactions including chill sensation, fever, skin eruption and increase in blood GOT and GPT levels were transient and mild. One patient in Group III developed left hemiparesis showing the small infarction in the right thalamus during the course of the treatment, but the symptom was mild. In conclusion, the high-dose intravenous immunoglobulin therapy (400 mg/kg/day x 5 days) is useful for treating patients with CIDP and MMN, although care must be taken of the risk of causing cerebral infarctions.
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8.
Virally inactivated fresh frozen plasma in the coagulopathy of liver disease/transplantation
Williamson LM, Ala FA, Allain JP, Baglin TP, Bellamy M, Freeman J,, et al.,
British Journal of Haematology. 1997;97((Suppl 1):):85. Abstract No. 311.
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Virally inactivated fresh frozen plasma (FFP) in the coagulopathy of liver disease/transplantation
Williamson LM, Ala FA, Allain JP, Baglin TP, Bellamy M, Freeman J,, et al.,
Transfusion Medicine. 1997;7((Suppl 1):):34. Abstract No. P47.
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10.
Immunoprophylaxis against klebsiella and pseudomonas aeruginosa infections. The Federal Hyperimmune Immunoglobulin Trial Study Group
Donta ST, Peduzzi P, Cross AS, Sadoff J, Haakenson C, Cryz SJ Jr, Kauffman C, Bradley S, Gafford G, Elliston D, et al
Journal of Infectious Diseases. 1996;174((3):):537-43.
Abstract
To determine if passive immunization could decrease the incidence or severity of Klebsiella and Pseudomonas aeruginosa infections, patients admitted to intensive care units of 16 Department of Veterans Affairs and Department of Defense hospitals were randomized to receive either 100 mg/kg intravenous hyperimmune globulin (IVIG), derived from donors immunized with a 24-valent Klebsiella capsular polysaccharide plus an 8-valent P. aeruginosa O-polysaccharide-toxin A conjugate vaccine, or an albumin placebo. The overall incidence and severity of vaccine-specific Klebsiella plus Pseudomonas infections were not significantly different between the groups receiving albumin and IVIG. There was some evidence that IVIG may decrease the incidence (2.7% albumin vs. 1.2% IVIG) and severity (1.0% vs. 0.3%) of vaccine-specific Klebsiella infections, but these reductions were not statistically significant. The trial was stopped because it was statistically unlikely that IVIG would be protective against Pseudomonas infections at the dosage being used. Patients receiving IVIG had more adverse reactions (14.4% vs. 9.2%).