国产那他霉素滴眼液治疗真菌性角膜溃疡的临床研究

Clinical study of domestic natamycin medication for the treatment of fungal corneal ulcer

目的:评价国产那他霉素滴眼液与进口那他霉素滴眼液对真菌性角膜溃疡的临床疗效。方法:采用随机、对照和双盲方法随机选择2010-09/2011-03在沈阳爱尔眼科医院及哈尔滨爱尔眼科医院诊断明确的真菌性角膜溃疡患者20例20眼,以随机数字表法随机分为两组,治疗组12例应用50g/L国产那他霉素滴眼液,对照组8例应用50g/L进口那他霉素滴眼液。开始应用剂量,每30min滴眼1次共3d;如有效,则调整为每小时1次共2d;每2h1次共5d;每3h1次共2wk,疗程21～30d,两组均联合全身应用抗真菌药物。局部治疗7d若患眼体征恶化或不见好转者,更换抗真菌药物或联合其它药物治疗。分别在用药后3,5,7d对临床疗效进行评估。采用Fisher精确检验对数据进行统计学分析两组之间的疗效差异。结果:治疗组临床治疗有效率为58.3%,对照组有效率75%,Fisher精确检验结果显示组间治疗有效率无统计学差异(P>0.05)。结论:国产那他霉素滴眼液能够有效治疗真菌性角膜溃疡。

AIM： To study the clinical outcome of domestic natamycin medication for the treatment of fungal corneal ulcer comparing with imported natamycin. METHODS： Twenty eyes of 20 patients from two eye hospitals who were diagnosed as fungal corneal ulcer participated in a randomized, controlled and blinded trial （September, 2010, through March, 2011 ）. Twelve eyes were treated with domestic natamycin eye drops （treatment group）, whereas other eight eyes were treated with imported natamycin eye drops （control group）. Both groups received eye drops combined with anti-fungal systematic medication at the same dosage, once 0.5 hour for 12 days, once 1 hour for2 days, once 2 hours for 5 days and once 3 hours for 2 weeks. The clinical efficacy was evaluated between two groups after 3, 5 and 7 days of treatment. Fisher precise test was statistically analyzed for differences. RESULTS： The clinical effective rate in treatment group was 58.3%, which showed no significant difference with the 75% rate in control group （P〉0.05）. CONCLUSION： Domestic natamycin eye drops is effective in the treatment of fungal corneal ulcer.