Abstract

Purpose of the Study. This study9s objective was to determine whether oral human serum immunoglobulin might be effective as a treatment of acute rotaviral gastroenteritis. Study Population. Ninety-eight children (age range, 2 to 36 months) with acute diarrhea were enrolled. Methods. A double-blind, placebo-controlled study was performed. Thirty-six children received a single oral dose of 300 mg/kg of human serum immunoglobulin (Sandoglobulin) within 24 hours of admission. The control group received a 5% glucose solution. A clinical scoring system, which included clinical status, stooling pattern, viral excretion, and length of hospital stay, was used to assess the efficacy of treatment. The immunoglobulin preparation was also assessed for neutralizing antibodies against rotavirus. Results. When compared by the clinical assessment score, patients receiving immunoglobulin had faster improvement in their clinical condition than controls. Children in the active treatment group had a decrease in the number of stools and a shorten hospital stay by 2 days. There were no cases of relapse 1 month after discharge. No side effects were reported in the treatment group. The immunoglobulin preparations had detectable neutralizing activity against all strains of rotavirus tested. Reviewer9s Comments. Only supportive therapy is currently avilable for treatment of notaviral infections, which are responsible for a significant amount of morbidity and mortality worldwide. This article presents a form of therapy that improves symptoms and reduces length of hospital stay. The cost of therapy (~$150 to 200) is offset by the decrease in the number of hospital days. In addition, oral immunoglobulin therapy has been reported to be successful in the treatment of some protein-losing enteropathies.

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