title: Safety and efficacy of a monomeric, functionally intact intravenous IgG preparation in patients with primary immunodeficiency syndromes.
abstract: Results of an open, phase II clinical trial on therapy with an iv IgG preparation in patients with primary antibody-deficiency syndromes are reported. Three hundred infusions of the product, an intact monomeric IgG preparation, were given to 16 patients for an average of 14 (+/- 0.7) months, the dose being 220 (+/- 26.9) mg/kg/month. Only two minor adverse reactions occurred. This preparation did not produce transient leukopenia on infusion. Preinfusion serum IgG levels increased continuously in the course of treatment (average values: 325 +/- 51 at the beginning of therapy, 438 +/- 59 at 6 months, 568 +/- 75 at 12 months, 631 +/- 52 at the end of treatment). The infusions were well accepted and well tolerated by the patients, and the clinical efficacy was highly superior to intramuscular immunoglobulin.
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D006801:Humans; D007116:Immunization, Passive / Q000009:adverse effects; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000096:biosynthesis; D007153:Immunologic Deficiency Syndromes / Q000097:blood / Q000276:immunology / Q000628:therapy*; D007263:Infusions, Parenteral; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged
chemical_list: D007074:Immunoglobulin G