アレルギー性結膜炎患者に対するエピナスチン点眼液の改良製剤の検討

Effect of new formulation of epinastine hydrochloride ophthalmic solution in patients with allergic conjunctivitis

要約　目的：ベンザルコニウム塩化物（BAK）非含有製剤に処方変更されたエピナスチン塩酸塩点眼液の有効性と安全性を検討した。

方法：アレルギー性結膜炎患者50例の両眼に1日4回4週間点眼し，自覚症状および他覚所見の改善効果および角結膜上皮への影響を評価した。また，ソフトコンタクトレンズ（SCL）装用者と非装用者に分けて比較検討した。

結果：BAK非含有エピナスチン塩酸塩点眼液は，眼瘙痒感などの自覚症状および他覚所見スコアを有意に低下させ，SCL装用群と非装用群の群間で差はなかった。角結膜上皮への影響はなかった。

結論：BAK非含有エピナスチン塩酸塩点眼液はアレルギー性結膜炎への良好な改善効果と安全性を示し，SCL装用の有無による影響はなかった。

Abstract　Objectives: To study the efficacy and safety of epinastine hydrochloride ophthalmic solution of which formula was changed to that without benzalkonium chloride（BAK）.

Methods: Epinastine hydrochloride ophthalmic solution without BAK was administered to 50 patients with allergic conjunctivitis for 4 weeks. The improvement effects on subjects symptoms and objective findings were evaluated；further, the effect on the corneal and conjunctival epithelium was assessed. These findings were compared between patients who wore soft contact lenses（SCLs）and those who did not.

Results: Epinastine hydrochloride ophthalmic solution without BAK significantly reduced symptoms and objective findings such as eye itchiness. No significant differences were observed between patients who wore SCLs and those who did not. There was no damage on the corneal and conjunctival epithelium.

Conclusions: Epinastine hydrochloride ophthalmic solution without BAK improved symptoms and was safe for patients with allergic conjunctivitis；SCL wearing had no effect.