Abstract
Although recombinant human serum albumin (rHSA) has been recently developed from Pichia pastoris without using any animal-derived materials, its clinical use is yet limited especially in pediatric patients. We report our preliminary experience regarding the safety of rHSA in selected patients with nephrotic syndrome (NS). For the controlling refractory edema caused by NS, rHSA in combination with loop diuretics was administred to 6 NS patients, including one patient who received rHSA 3 times at every other month, from September 2008 to January 2009 in our hospital. One treatment course of rHSA was performed at least 3 consecutive days (3-22 days). Specific IgE antibody titers against Pichia yeast components measured before and after treatment remained negative all the study subjects. No allergic adverse events were observed. On the basis of changes in serum albumin level, urinary output, edema and body weight, the clinical usefulness seemed to be similar to that of conventional plasma-derived human serum albumin, as postulated in recent reports concerning the successful treatment of adult liver cirrhosis using rHSA. Our preliminary experience suggest that the safety and clinical usefulness of rHSA in the treatment of pediatric patients with NS. Further studies to confirm the long-term safety and clinical usefulness of rHSA in a large number of patients are, however, needed.
