title: Prophylactic effect of self-administered pump-driven subcutaneous IgG infusion in patients with antibody deficiency: a triple-blind cross-over study comparing P-IgG levels of 3 g l-1 versus 6 g l-1.
abstract: Eight adult patients with hypoimmunoglobulinaemia were randomly allocated to initiation of low- or high-level IgG-substitution. IgG was administered subcutaneously, at 50 or 150 mg ml-1, 20 ml per infusion, by means of a pocket-portable electric infusion pump. Infusions were given 2 to 4 times weekly for 24 months, with a change of dose regimen after 12 months. The desired plasma IgG levels were reached after a mean lag phase of 3 months (range 1-5 months). The median (and ranges) of the individual mean plasma IgG levels during the ensuing 9-month periods were as follows: high-level period, 6.5 g l-1 (range 6.2-7.8 g l-1); low-level period, 3.2 g l-1 (range 3.0-4.0 g l-1). During the high-level period, compared to the low-level period, there was a significant decrease in the following parameters: 'days in bed at home', 'days missed work' and 'days with fever'. No serious side-effects were observed. It is concluded that a plasma IgG concentration of 6 g l-1 can readily be achieved by subcutaneous IgG substitution, and the prophylactic effect is superior to that obtained with a plasma IgG concentration of 3 g l-1.
authors.affiliation: Department of Medicine TTA, Rigshospitalet, Copenhagen, Denmark.
authors.forename: L
authors.initials: L
authors.lastname: Remvig
authors.forename: V
authors.initials: V
authors.lastname: Andersen
authors.forename: N E
authors.initials: NE
authors.lastname: Hansen
authors.forename: H
authors.initials: H
authors.lastname: Karle
mesh_terms: D000328:Adult; D000361:Agammaglobulinemia / Q000628:therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007116:Immunization, Passive / Q000379:methods*; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000627:therapeutic use; D007260:Infusion Pumps; D008297:Male; D008875:Middle Aged; D012646:Self Administration; D013997:Time Factors
chemical_list: D007074:Immunoglobulin G