안과영역에서의 CSA

Cyclosporine 란? 

 

수중 유적형oil-in-water emulsion: 수중에 기름 방울이 분산하고 있는 에멀전

환상 11 펩티드 물질Cyclic undecapeptide

곰팡이Tolypocladium inflatum & Beauveria nevus 로부터 생산

면역억제제Immunosuppressant: 장기 이식, 자가면역질환 치료

 

Cyclosporine의 기전

Cyclosporine 

 

Inhibition of activation of T lymphocytes

Inhibition of apoptosis

 

Cyclosporine 임상실험

1)

Subjects : 877 with moderate to severe dry eye

Substance : 0.05% or 0.1% Cyclosporine or vehicle

Methods & Assessment: instilled 1 drop twice daily in each eye for 6 months, Corneal fluorescein staining examined using slit-lamp evaluation with a yellow barrier filter and cobalt blue illumination, Oxford Scheme 6-point scale.

 

사이클로스포린 0.05%는 점안 4, 6개월 째 Vehicle대비 각막 염색점수가 통계적으로 유의하게 감소되었습니다. (p≤0.044, p<0.008)

 

 

2)

Subjects : 877 with moderate to severe dry eye

Substance : 0.05% or 0.1% Cyclosporine or vehicle

Methods & Assessment: instilled 1 drop twice daily in each eye for 6 months, with anesthesia, graded on a 5-point scale (1: <3mm/5min, 2: 3-6 mm/5min, 3: 7-10mm/5min, 4: 11-14mm/5min. 5: >14mm/5min).

 

사이클로스포린 0.05%는 점안 3, 6개월 째 Vehicle 대비 Schirmer score가 통계적으로 유의하게 증가되었습니다. (p=0.009 , p≤0.05)

 

3)

Subjects : 58 with moderate to severe dry eye (assigned to 3:2)

Substance : 0.05% Cyclosporine or Artificial Tears

Methods & Assessment: instilled 1 drop twice daily in each eye for 12 months, Evaluated TBUT using fluorescein dye at 4,8,12 month.

 

사이클로스포린 0.05%는 점안 8, 12개월 째 인공눈물대비 TBUT가 통계적으로 유의하게 증가되었습니다. (p=0.001, p<0.001)

 

4)

Subjects : 58 with moderate to severe dry eye (assigned to 3:2)

Substance : 0.05% Cyclosporine or Artificial Tears

Methods & Assessment: instilled 1 drop twice daily in each eye for 12 months, OSDI at 4,8,12 month.

 

사이클로스포린 0.05%는 점안 8, 12개월 째 인공눈물대비 OSDI score가 통계적으로 유의하게 감소되었습니다. (p=0.011, p < 0.001).