新生児の外眼部細菌感染症に対するトスフロキサシントシル酸塩水和物点眼液の有効性と安全性の検討

Efficacy and safety of tosufloxacin tosilate hydrate ophthalmic solution for bacterial external ocular infections in neonates

要約　目的：トスフロキサシントシル酸塩水和物0.3％点眼液の新生児に対する効果と安全性の報告。対象と方法：過去27か月間に外眼部細菌感染症の治療に本剤を投与した新生児48例を調査した。有効性は担当医の判定と評価基準に基づく改善率で評価した。結果：本剤に抗菌薬を併用した4例を除く44例を評価の対象とした。本剤は44例中43例（97.7％）で有効，32例中23例（71.9％）で改善と判定され，検出菌は16例中13例（81.3％）で消失した。未熟児を含む全48例に有害事象はなかった。結論：新生児の外眼部細菌感染症に対し，トスフロキサシントシル酸塩水和物0.3％点眼液は有効で安全であった。

Abstract.　Purpose：To report the effect and safety of tosufloxacin tosilate hydrate（TFLX）ophthalmic solution for bacterial external ocular infections in neonates. Cases and Method：This study was made on 48 neonates who received 0.3％ TFLX ophthalmic solution for bacterial external ocular infections. Effectiveness was evaluated by attending physicians. Improvement was determined according to evaluation criteria. Results：Effectiveness was determined in 44 cases after discarding 4 cases who were also receiving other antibiotics. Treatment was effective in 43 out of 44 cases（97.7％）. Improvement resulted in 23 out of 32 cases（71.9％）. Causative bacterial organisms disappeared in 13 out 16 cases（81.3％）. No adverse effect was observed throughout the 48 cases including premature infants. Conclusion：TFLX ophthalmic solution was effective for bacterial external ocular infections in overwhelming majority of neonates.