플루오로퀴롤론 점안약의 안구 내 수술에서의 예방적 사용의 효과와 안정성에 대한 연구 결과
A Randomized, Prospective Clinical Comparison of the Efficacy and Safety of Topical Fluoroquinolone Antibiotics in Ophthalmologic Microsurgery
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목적: 안구내 미세수술에서 예방적 목적의 플루오로퀴롤론(FQ; 레보플록사신 0.5%, 가티플록사신 0.3%, 목시플록사신 0.5%) 항생제점안약에 대한 비교 임상시험 결과를 보고하고자 한다. 대상과 방법: 2007년 5월부터 2010년 4월까지 임상 1시험은 유리체강내 주입술을 시행하는 211명 214안을 세 개의 FQ 항생제를 하루4회 수술 3일 전부터 점안한 치료군과 전처치를 하지 않는 대조군으로 분류 후 군별 결막찰과표본의 배양률을 비교하였다. 임상 2시험은 백내장 수술을 받는 159명 159안을 세 개의 FQ 항생제를 동일한 방식으로 점안한 치료군으로 분류 후 수술 중 채취한 방수내 항생제농도를 비교하였다. 결과: 레보플록사신 군의 균양성률은 48.9%, 가티플록사신 군은 38.3%, 목시플록사신 군은 23.4%, 대조군은 70.2%이었다. 항생제안약을 점안한 군이 통계적으로 유의하게 대조군에 비해 균배양률이 적었다. 레보플록사신 군의 방수내 잔류 항생제 농도는 평균 0.37± 0.49 μg/ml, 가티플록사신 군 0.31 ± 0.37 μg/ml, 목시플록사신 군 0.59 ± 0.72 μg/ml으로 측정되었다. 전방내 잔류항생제 농도는각 군 간에 통계적으로 유의한 차이를 얻을 수 없었다. 시험기간 내 약물 사용의 부작용은 보고되지 않았다. 결론: 안내수술 3일 전부터 사용한 새로운 세대의 FQ 항생제 안약점안은 수술 후 세균성 안내염 예방을 위한 안전하고 효과적인 방법이라 생각한다.
Abstract
Purpose: To report the results of a clinical comparison study of a prophylactic new generation fluoroquinolone (FQs; levofloxacin 0.5%, gatifloxacin 0.3% and moxifloxacin 0.5%) topical antibiotic regimen administered prior to intraocular microsurgery. Methods: From May 2007 to April 2010, Trial 1, 214 eyes of 211 patients scheduled for intravitreal injection were randomized into one of three FQ-treated groups or the control (non-treated) group. Patients who were randomized into FQ-treated groups were treated with eye drops containing one of three FQ antibiotics (levofloxacin 0.5%, gatifloxacin 0.3% and moxifloxacin 0.5%) preoperatively four times a day for three days before surgery. The rate of positive bacterial cultures from conjunctival scrapings were assessed and compared. Trial 2, 159 eyes of 159 patients scheduled for cataract surgery were randomized into one of three FQ-treated groups, and treated with eye drops as same method in trial 1. The concentration of antibiotics in the anterior chamber of the eye were measured and compared. Results: The positive bacterial culture rates of trial 1 were 48.9%, 38.3%, 23.4% in the levofloxacin-treated group, the gatifloxacin-group, and the moxifloxacin-treated group, respectively. These rates were all significantly lower than the 70.2%positivity rate observed in the control group. Average antibiotic residue concentrations in the aqueous humor measured in trial 2 were 0.37 ± 0.49 μg/ml in the levofloxacin-treated group, 0.31 ± 0.37 μg/ml in the gatifloxacin-treated group and 0.59± 0.72 μg/ml in the moxifloxacin-treated group. These concentrations were not significantly different. There were no reported side effects during the study period. Conclusions: Eye drops containing new generation FQ antibiotics instilled three days before microscopic ophthalmic surgery can be used safely and effectively for the prevention of postoperative endophthalmitis.
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