title: A prospective controlled crossover trial of a new presentation (10% vs. 5%) of a heat-treated intravenous immunoglobulin.
abstract: Thirty-five patients with primary or secondary immunoglobulin deficiency were included in a crossover study to test the tolerance, clinical efficacy, and safety of a liquid pasteurized 10% concentrated intravenous gammaglobulin versus a 5% concentrated presentation. No statistically significant differences were found between these parameters. Total serum immunoglobulin-(Ig)G and IgG subclass levels were similar in both groups. No modifications in serum alanine transferase (ALT) levels and viral status (HBsAg, HCV-RNA, p24 antigen or RNA for HIV) were observed throughout treatment. Adverse reactions were reported in 3 out of 70 infusions (4.3%), 2 in the experimental group and 1 in the control group. The maximum recommended rate of infusion for the 10% gammaglobulin is the same as for the 5% gammaglobulin product (0.04 ml/kg/min); generally speaking, this means that infusion time is halved. We conclude that a 10% gammaglobulin product is a well-tolerated, clinically efficacious and safe intravenous preparation, and that it could be a short infusion time alternative for primary and secondary antibody deficiencies.
authors.affiliation: Servei d'Immunologia, Hospital Universitari Son Dureta, Andrea Doria, 55 07014 Palma de Mallorca, Spain. nmatamoros@hsd.es
authors.forename: Núria
authors.initials: N
authors.lastname: Matamoros
authors.forename: Javier
authors.initials: J
authors.lastname: De Gracia
authors.forename: Fernando
authors.initials: F
authors.lastname: Hernández
authors.forename: Jaume
authors.initials: J
authors.lastname: Pons
authors.forename: Antonio
authors.initials: A
authors.lastname: Alvarez
authors.forename: Víctor
authors.initials: V
authors.lastname: Jiménez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D018592:Cross-Over Studies; D005260:Female; D006678:HIV / Q000235:genetics; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006801:Humans; D007132:Immunoglobulin Isotypes / Q000097:blood; D007136:Immunoglobulins / Q000097:blood; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D016896:Treatment Outcome
chemical_list: D006514:Hepatitis B Surface Antigens; D007132:Immunoglobulin Isotypes; D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; D012367:RNA, Viral; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase