Authors: Akinori Kasahara Keiji Kita Eiichi Tomita Jouji Toyota Yasuharu Imai Hiromitsu Kumada
Publish Date: 2008/07/04
Volume: 43, Issue: 6, Pages: 464-472
Abstract
rHSA was administered to 423 cirrhosis patients with ascites or edema rHSA was administered three times over 3 days and each 3day treatment course was repeated at least three times with an interval of at least 2 weeks between courses Adverse drug reactions ADRs were monitored during and after repeated rHSA administration Specific antibody titers against Pichia yeast components were measured before and after treatment Efficacy was evaluated on the basis of changes in serum albumin level colloid osmotic pressure and body weightADRs were observed in 96 of 423 patients 227 with no serious allergy or difference in the incidence of ADRs observed among the first second and third administrations Specific IgE and IgG antibodies were detected before treatment in 19 and 422 patients respectively However allergic ADRs were observed in 14 patients in whom specific IgE antibodies were not detected No obvious relationship between allergic ADRs and specific IgE or IgG titers was identified Serum albumin levels and colloid osmotic pressure increased significantly P 00001 and body weight decreased significantly P 00001 after rHSA administration
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