0.05% 사이클로스포린 마이크로에멀젼과 나노에멀젼에서 치료 후 건성안 지표 및 점안감 비교
Comparison of Efficacy and Sensation of Instillation between 0.05% Cyclosporine Nanoemulsion and Microemulsion Type
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목적: 건성안증후군환자에게 나노에멀젼 방식과 마이크로에멀젼 방식의 0.05% 사이클로스포린 점안액을 사용한 후 건성안증후군 지표 변화 및 점안감 비교를 통한 나노에멀젼 방식의 효과를 확인하고자 하였다. 대상과 방법: 본 임상시험은 단일기관, 무작위배정, 이중 눈가림의 전향적 연구 방식을 채택하였다. 서면 동의를 받은 시험자 군에 대해 2주간의 휴약 기간을 가진 뒤 나노에멀젼 군과 마이크로에멀젼 군으로 무작위 배정하여 12주간 점안하였고, 인공눈물과 국소스테로이드 점안제를 건성안증후군 정도에 따라 병행하였다. 연구 시작 전, 연구 1달 뒤, 연구 3달 뒤의 눈물막파괴시간, 쉬르머검사, 각막염색지수, 안구표면질환지수를 기록하였고, 병행약물의 점안일지와 점안감에 대하여 기록하였다. 결과: 0.05% 사이클로스포린의 나노에멀젼 방식과 마이크로에멀젼 방식 모두 각 군 내 12주간 건성안증후군 지표가 개선되었으며, 두 군 간 변화를 비교 시 안구표면질환지수가 나노에멀젼 방식에서 더 많이 감소하였다. 연구 기간 동안 인공눈물 및 국소 스테로이드점안액 병용 평균 횟수는 두 군에서 유의한 차이가 없었다. 점안감은 마이크로에멀젼 군에서 이물감 점수가 높았다. 결론: 0.05% 사이클로스포린 나노에멀젼 방식은 마이크로에멀젼 방식의 대조약과 비교 시 건성안증후군 치료 효과가 비슷하며, 주관적 점안감이 좀 더 좋은 약제로 사료된다.
Abstract
Purpose: To evaluate and compare the efficacy and sensation of instillation between 0.05% cyclosporine nanoemulsion group and microemulsion group. Methods: This is a double-blind, prospective randomized clinical trial. Patients had 2 weeks of wash-out period before the study. They were randomly assigned to either nanoemulsion group or microemulsion group and treated with each group’s cyclosporine eye drop. Artificial eye drop and topical steroid were used together according to severity of dryness of cornea. We checked every patient’s Break-up time (BUT), Schirmer test, Staining Score and Ocular surface disease index (OSDI) on baseline, 1 month and 3 months after. Patients also self-checked frequency of use of artificial eye drop and topical steroid. Sensation of instillation was also checked. Results: Both nanoemulsion eye-drop and microemulsion eye-drop improved BUT, Schirmer test, Staining Score and OSDI throughout 12 weeks. The nanoemulsion type reduced OSDI significantly compared to the microemulsion type. The mean frequency of use of artificial tear and topical steroid was similar in both groups. Foreign body sense score was higher in microemulsion group. Conclusions: 0.05% cyclosporine nanoemulsion type has simillar efficacy and subjectively less foreign body sensation.
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