메뉴 건너뛰기




Volumn 16, Issue 9, 2007, Pages 1038-1047

Tolerability and safety of the intravenous immunoglobulin Octagam®: A 10-year prospective observation study

Author keywords

Adverse drug reaction; Autoimmune disease; Immunodeficiency; IVIg; Prospective observation cohort study; Safety; Tolerability

Indexed keywords

IMMUNOGLOBULIN G;

EID: 34548708026     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1449     Document Type: Article
Times cited : (32)

References (38)
  • 1
    • 16444379271 scopus 로고    scopus 로고
    • Immunoglobulin replacement therapy in primaiy antibody deficiency diseases-maximizing success
    • Durandy A, Wahn V, Petteway S, et al. Immunoglobulin replacement therapy in primaiy antibody deficiency diseases-maximizing success. Int Arch Allergy Immunol 2005; 136: 217-229.
    • (2005) Int Arch Allergy Immunol , vol.136 , pp. 217-229
    • Durandy, A.1    Wahn, V.2    Petteway, S.3
  • 2
    • 0026422422 scopus 로고
    • Drug therapy: The use of intravenous immune globulin in immunodeficiency diseases
    • Buckley RH, Schiff RI. Drug therapy: the use of intravenous immune globulin in immunodeficiency diseases. New Engl J Med 1991; 325: 110-117.
    • (1991) New Engl J Med , vol.325 , pp. 110-117
    • Buckley, R.H.1    Schiff, R.I.2
  • 3
    • 0023764718 scopus 로고
    • Intravenous immunoglobulin for the prevention of infection in chronic lymphocytic leukemia. A randomized, controlled clinical trial
    • Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia
    • Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia. Intravenous immunoglobulin for the prevention of infection in chronic lymphocytic leukemia. A randomized, controlled clinical trial. N Engl J Med 1988; 319: 902-907.
    • (1988) N Engl J Med , vol.319 , pp. 902-907
  • 4
    • 0028230488 scopus 로고
    • Randomised trial of intravenous immunoglobulin as prophylaxis against infection in plateau-phase multiple myeloma. The UK Group for Immunoglobulin Replacement Therapy in Multiple Myeloma
    • Chapel HM, Lee M, Hargreaves R, et al. Randomised trial of intravenous immunoglobulin as prophylaxis against infection in plateau-phase multiple myeloma. The UK Group for Immunoglobulin Replacement Therapy in Multiple Myeloma. Lancet 1994; 343: 1059-1063.
    • (1994) Lancet , vol.343 , pp. 1059-1063
    • Chapel, H.M.1    Lee, M.2    Hargreaves, R.3
  • 5
    • 0025102027 scopus 로고
    • Immunomodulatory and antimicrobial efficacy of intravenous immunoglobulin in bone marrow transplantation
    • Sullivan KM, Kopecky KJ, Jocom J, et al. Immunomodulatory and antimicrobial efficacy of intravenous immunoglobulin in bone marrow transplantation. N Engl J Med 1990; 323: 705-712.
    • (1990) N Engl J Med , vol.323 , pp. 705-712
    • Sullivan, K.M.1    Kopecky, K.J.2    Jocom, J.3
  • 6
    • 0029914442 scopus 로고    scopus 로고
    • Immunomodulation in allogeneic marrow transplantation: Use of intravenous immune globulin to suppress acute graft-versus-host disease
    • Sullivan KM. Immunomodulation in allogeneic marrow transplantation: use of intravenous immune globulin to suppress acute graft-versus-host disease. Clin Exp Immunol 1996; 104 (Suppl. 1): 43-48.
    • (1996) Clin Exp Immunol , vol.104 , Issue.SUPPL. 1 , pp. 43-48
    • Sullivan, K.M.1
  • 7
    • 0031738320 scopus 로고    scopus 로고
    • The optimum use of intravenous immunoglobulin for prophylaxis of opportunistic infection in HIV-infected adults
    • Kiehl MG, Muller C. The optimum use of intravenous immunoglobulin for prophylaxis of opportunistic infection in HIV-infected adults. Biodrugs 1998; 10: 265-273.
    • (1998) Biodrugs , vol.10 , pp. 265-273
    • Kiehl, M.G.1    Muller, C.2
  • 8
    • 0025740950 scopus 로고    scopus 로고
    • The National Institute of Child Health and Human Developments Intravenous Immunoglobulin Study Group 2. Intravenous immune globulin for the prevention of bacterial infections in children with symptomatic human immunodeficiency virus infection. N Engl J Med 1991; 325: 73-80
    • The National Institute of Child Health and Human Developments Intravenous Immunoglobulin Study Group 2. Intravenous immune globulin for the prevention of bacterial infections in children with symptomatic human immunodeficiency virus infection. N Engl J Med 1991; 325: 73-80.
  • 9
    • 0024959076 scopus 로고
    • Idiopathic thrombocytopenic purpura (ITP): Immunomodulation by intravenous immunoglobulin (IVIg)
    • Imbach P, Morell A. Idiopathic thrombocytopenic purpura (ITP): immunomodulation by intravenous immunoglobulin (IVIg). Int Rev Immunol 1989; 5: 181-188.
    • (1989) Int Rev Immunol , vol.5 , pp. 181-188
    • Imbach, P.1    Morell, A.2
  • 10
    • 3042856624 scopus 로고    scopus 로고
    • The use of intravenous immunoglobulin in the treatment of autoimmune neuromuscular diseases: Evidence-based indications and safety profile
    • Dalakas MC. The use of intravenous immunoglobulin in the treatment of autoimmune neuromuscular diseases: evidence-based indications and safety profile. Pharmacol Ther 2004; 102: 177-193.
    • (2004) Pharmacol Ther , vol.102 , pp. 177-193
    • Dalakas, M.C.1
  • 11
    • 0033782797 scopus 로고    scopus 로고
    • Intravenous immunoglobulin treatment in peripheral nerve disorders - indications, mechanisms of action and side-effects
    • Hahn AF. Intravenous immunoglobulin treatment in peripheral nerve disorders - indications, mechanisms of action and side-effects. Curr Opin Neurol 2000; 13: 575-582.
    • (2000) Curr Opin Neurol , vol.13 , pp. 575-582
    • Hahn, A.F.1
  • 12
    • 0030006629 scopus 로고    scopus 로고
    • Pilot trial of immunoglobulin versus plasma exchange in patients with Guillain-Barre syndrome
    • Bril V, Ilse WK, Pearce R, et al. Pilot trial of immunoglobulin versus plasma exchange in patients with Guillain-Barre syndrome. Neurology 1996; 46: 100-103.
    • (1996) Neurology , vol.46 , pp. 100-103
    • Bril, V.1    Ilse, W.K.2    Pearce, R.3
  • 13
    • 0031001759 scopus 로고    scopus 로고
    • Clinical trial of plasma exchange and high-dose intravenous immunoglobulin in myasthenia gravis. Myasthenia Gravis Clinical Study Group
    • Gajdos P, Chevret S, Clair B, et al. Clinical trial of plasma exchange and high-dose intravenous immunoglobulin in myasthenia gravis. Myasthenia Gravis Clinical Study Group. Ann Neurol 1997; 41: 789-796.
    • (1997) Ann Neurol , vol.41 , pp. 789-796
    • Gajdos, P.1    Chevret, S.2    Clair, B.3
  • 14
    • 0029776819 scopus 로고    scopus 로고
    • Intravenous immunoglobulin treatment in chronic inflammatory demyelinating polyneuropathy. A double-blind, placebo-controlled, cross-over study
    • Hahn AF, Bolton CF, Zochodne D, et al. Intravenous immunoglobulin treatment in chronic inflammatory demyelinating polyneuropathy. A double-blind, placebo-controlled, cross-over study. Brain 1996; 119(Pt 4): 1067-1077.
    • (1996) Brain , vol.119 , Issue.PART 4 , pp. 1067-1077
    • Hahn, A.F.1    Bolton, C.F.2    Zochodne, D.3
  • 15
    • 0035957105 scopus 로고    scopus 로고
    • Randomized controlled trial of IVIg in untreated chronic inflammatory demyelinating polyradiculoneuropathy
    • Mendell JR. Barohn RJ, Freimer ML, et al. Randomized controlled trial of IVIg in untreated chronic inflammatory demyelinating polyradiculoneuropathy. Neurology 2001; 56: 445-449.
    • (2001) Neurology , vol.56 , pp. 445-449
    • Mendell, J.R.1    Barohn, R.J.2    Freimer, M.L.3
  • 16
    • 0026516454 scopus 로고
    • A randomized trial comparing intravenous immune globulin and plasma exchange in Guillain-Barre syndrome. Dutch Guillain-Barre Study Group
    • van der Meche FG, Schmitz PI. A randomized trial comparing intravenous immune globulin and plasma exchange in Guillain-Barre syndrome. Dutch Guillain-Barre Study Group. N Engl J Med 1992; 326: 1123-1129.
    • (1992) N Engl J Med , vol.326 , pp. 1123-1129
    • van der Meche, F.G.1    Schmitz, P.I.2
  • 17
    • 0031057970 scopus 로고    scopus 로고
    • Randomised placebo-controlled trial of monthly intravenous immunoglobulin therapy in relapsing-remitting multiple sclerosis. Austrian Immunoglobulin in Multiple Sclerosis Study Group
    • Fazekas F, Deisenhammer F, Strasser-Fuchs S, et al. Randomised placebo-controlled trial of monthly intravenous immunoglobulin therapy in relapsing-remitting multiple sclerosis. Austrian Immunoglobulin in Multiple Sclerosis Study Group. Lancet 1997; 349: 589-593.
    • (1997) Lancet , vol.349 , pp. 589-593
    • Fazekas, F.1    Deisenhammer, F.2    Strasser-Fuchs, S.3
  • 18
    • 5344219614 scopus 로고    scopus 로고
    • Intravenous immunoglobulin treatment following the first demyelinating event suggestive of multiple sclerosis: A randomized, double-blind, placebo-controlled trial
    • Achiron A, Kishner I, Sarova-Pinhas I, et al. Intravenous immunoglobulin treatment following the first demyelinating event suggestive of multiple sclerosis: a randomized, double-blind, placebo-controlled trial. Arch Neurol 2004; 61: 1515-1520.
    • (2004) Arch Neurol , vol.61 , pp. 1515-1520
    • Achiron, A.1    Kishner, I.2    Sarova-Pinhas, I.3
  • 19
    • 0030874547 scopus 로고    scopus 로고
    • A double-blind, cross-over trial of intravenous immunoglobulin G in multiple sclerosis: Preliminary results
    • Sorensen PS, Wanscher B, Schreiber K, et al. A double-blind, cross-over trial of intravenous immunoglobulin G in multiple sclerosis: preliminary results. Mult Scler 1997; 3: 145-148.
    • (1997) Mult Scler , vol.3 , pp. 145-148
    • Sorensen, P.S.1    Wanscher, B.2    Schreiber, K.3
  • 20
    • 0036835646 scopus 로고    scopus 로고
    • Intravenous immunoglobulin G for the treatment of relapsing-remitting multiple sclerosis: A meta-analysis
    • Sorensen PS, Fazekas F, Lee M. Intravenous immunoglobulin G for the treatment of relapsing-remitting multiple sclerosis: a meta-analysis. Eur J Neuro 2002; 9: 557-563.
    • (2002) Eur J Neuro , vol.9 , pp. 557-563
    • Sorensen, P.S.1    Fazekas, F.2    Lee, M.3
  • 21
    • 27644501947 scopus 로고    scopus 로고
    • The product: All intravenous immunoglobulins are not equivalent
    • Siegel J. The product: all intravenous immunoglobulins are not equivalent. Pharmacotherapy 2005; 25: 78S-84S.
    • (2005) Pharmacotherapy , vol.25
    • Siegel, J.1
  • 22
    • 34548729514 scopus 로고    scopus 로고
    • 9-Pharmacovigilance Medicinal Products for Human Use and Veterinary Medicinal Products. Rules governing Medicinal Products in the European Union 2004; 1-385.
    • Volume 9-Pharmacovigilance Medicinal Products for Human Use and Veterinary Medicinal Products. Rules governing Medicinal Products in the European Union 2004; 1-385.
  • 23
    • 0032886187 scopus 로고    scopus 로고
    • Adverse effects of intravenous immunoglobulin therapy
    • Nydegger UE, Sturzenegger M. Adverse effects of intravenous immunoglobulin therapy. Drug Saf 1999; 21: 171-185.
    • (1999) Drug Saf , vol.21 , pp. 171-185
    • Nydegger, U.E.1    Sturzenegger, M.2
  • 24
    • 0029759826 scopus 로고    scopus 로고
    • Clinical experience with Octagam, a solvent detergent (SD) virus inactivated intravenous gammaglobulin
    • Brenner B. Clinical experience with Octagam, a solvent detergent (SD) virus inactivated intravenous gammaglobulin. Clin Exp Rheumatol 1996; 14 (Suppl. 15): S115-S119.
    • (1996) Clin Exp Rheumatol , vol.14 , Issue.SUPPL. 15
    • Brenner, B.1
  • 26
    • 33644553448 scopus 로고    scopus 로고
    • Adverse events associated with intravenous immunoglobulin therapy
    • Hamrock DJ. Adverse events associated with intravenous immunoglobulin therapy. Int Immunopharmacol 2006; 6: 535-542.
    • (2006) Int Immunopharmacol , vol.6 , pp. 535-542
    • Hamrock, D.J.1
  • 27
    • 3543141237 scopus 로고    scopus 로고
    • The Octagam Study Group. Octagam® 5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases
    • Ochs HD, Pinciaro PJ. The Octagam Study Group. Octagam® 5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J Clin Immunol 2004; 24: 309-314.
    • (2004) J Clin Immunol , vol.24 , pp. 309-314
    • Ochs, H.D.1    Pinciaro, P.J.2
  • 28
    • 0042667057 scopus 로고    scopus 로고
    • Prospective audit of adverse reactions occurring in 459 primary antibody-deficient patients receiving intravenous immunoglobulin
    • Brennan VM, Salome-Bentley NJ, Chapel HM. Prospective audit of adverse reactions occurring in 459 primary antibody-deficient patients receiving intravenous immunoglobulin. Clin Exp Immunol 2003; 133: 247-251.
    • (2003) Clin Exp Immunol , vol.133 , pp. 247-251
    • Brennan, V.M.1    Salome-Bentley, N.J.2    Chapel, H.M.3
  • 29
    • 0034073949 scopus 로고    scopus 로고
    • The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy
    • Chapel HM, Spickett GP, Ericson D, et al. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol 2000; 20: 94-100.
    • (2000) J Clin Immunol , vol.20 , pp. 94-100
    • Chapel, H.M.1    Spickett, G.P.2    Ericson, D.3
  • 30
    • 33845512748 scopus 로고    scopus 로고
    • Intrainfusion and postinfusion adverse events related to intravenous immunoglobulin therapy in immunodeficiency states
    • Tcheurekdjian H, Martin J, Kobayashi R, et al. Intrainfusion and postinfusion adverse events related to intravenous immunoglobulin therapy in immunodeficiency states. Allergy Asthma Proc 2006; 27: 532-536.
    • (2006) Allergy Asthma Proc , vol.27 , pp. 532-536
    • Tcheurekdjian, H.1    Martin, J.2    Kobayashi, R.3
  • 31
    • 33746880669 scopus 로고    scopus 로고
    • A prospective study of the immediate and delayed adverse events following intravenous immunoglobulin infusions
    • Singh-Grewal D, Kemp A, Wong M. A prospective study of the immediate and delayed adverse events following intravenous immunoglobulin infusions. Arch Dis Child 2006; 91: 651-654.
    • (2006) Arch Dis Child , vol.91 , pp. 651-654
    • Singh-Grewal, D.1    Kemp, A.2    Wong, M.3
  • 32
  • 33
    • 0028604458 scopus 로고
    • Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: Frequency and risk factors
    • Sekul EA, Cupler EJ, Dalakas MC. Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: frequency and risk factors. Ann Intern Med 1994; 121: 259-262.
    • (1994) Ann Intern Med , vol.121 , pp. 259-262
    • Sekul, E.A.1    Cupler, E.J.2    Dalakas, M.C.3
  • 34
    • 34548799545 scopus 로고    scopus 로고
    • Wilhelm G, Schulze H. Massiver Hirninfarkt unter intravenöser Immunglobulintherapie. Arzneimitteltherapie 1997; 15 Jahrgang: 63-64.
    • Wilhelm G, Schulze H. Massiver Hirninfarkt unter intravenöser Immunglobulintherapie. Arzneimitteltherapie 1997; 15 Jahrgang: 63-64.
  • 35
    • 4844221605 scopus 로고    scopus 로고
    • Thromboembolic events as an emerging adverse effect during high-dose intravenous immunoglobulin therapy in elderly patients: A case report and discussion of the relevant literature
    • Hefer D, Jaloudi M. Thromboembolic events as an emerging adverse effect during high-dose intravenous immunoglobulin therapy in elderly patients: a case report and discussion of the relevant literature. Ann Hematol 2004; 83: 661-665.
    • (2004) Ann Hematol , vol.83 , pp. 661-665
    • Hefer, D.1    Jaloudi, M.2
  • 36
    • 33244467913 scopus 로고    scopus 로고
    • Severe eczematous skin reaction after high-dose intravenous immunoglobulin infusion: Report of 4 cases and review of the literature
    • Vecchietti G, Kerl K, Prins C, et al. Severe eczematous skin reaction after high-dose intravenous immunoglobulin infusion: report of 4 cases and review of the literature. Arch Dermatol 2006; 142: 213-217.
    • (2006) Arch Dermatol , vol.142 , pp. 213-217
    • Vecchietti, G.1    Kerl, K.2    Prins, C.3
  • 37
    • 33644886928 scopus 로고    scopus 로고
    • Vesicular and bullous eczema in response to intravenous immunoglobulins (IVIG)
    • Maetzke J, Sperfeld AD, Scharffetter-Kochanek K, et al. Vesicular and bullous eczema in response to intravenous immunoglobulins (IVIG). Allergy 2006; 61: 145-146.
    • (2006) Allergy , vol.61 , pp. 145-146
    • Maetzke, J.1    Sperfeld, A.D.2    Scharffetter-Kochanek, K.3
  • 38
    • 0036710650 scopus 로고    scopus 로고
    • Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions
    • Hasford J, Goettler M, Munter KH, et al. Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 2002; 55: 945-950.
    • (2002) J Clin Epidemiol , vol.55 , pp. 945-950
    • Hasford, J.1    Goettler, M.2    Munter, K.H.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.