Comparative study of tosufloxacin tosilate fine granules 15% for pediatrics: MEIJI~? versus Ozex~?

摘要

In this study, we compared the efficacy, adverse event incidences, and medication compliance of MEIJI? (T group) with those of Ozex? (O group) tosufloxacin tosilate fine granules. Tosufloxacin tosilate fine granule was effective in all but one case (32/33) while the time to defervescence was within 2 days of drug administration in both groups (T and O groups, 1.31 and 1.92 days, respectively). The time to cough improvement was within 3 days of drug administration in both groups (T and O groups, 2.27 and 2.64 days, respectively). Adverse events were observed in 7.3% and 14.1% of the T and O groups (6/82 and 10/71), respectively. The medication compliance was good in both groups and, overall, the mean rate of administration of the T and O groups was 93.8% and 97.0%, respectively. The rate of complete administration was 87.8% (72/82) and 91.5% (65/71) in the T and O groups, respectively. No significant changes were observed between the two groups in efficacy, adverse event incidences, and medication compliance. Therefore, tosufloxacin tosilate fine granule 15% for pediatrics (MEIJI~?) may be equivalent to tosufloxacin tosilate hydrate 15% for pediatrics (Ozex~?) in efficacy, adverse event incidences, and medication compliance.