盐酸左氧氟沙星滴眼液治疗细菌性结膜炎及角膜炎随机双盲对照临床研究

目的　比较北京医工生物技术研究所研制的 15mg/5mL盐酸左氧氟沙星滴眼液和海伦滴眼液治疗细菌性结膜炎、角膜炎的疗效和安全性。方法　用随机、双盲、平行研究。共选择 60例患者分为试验组和对照组各 3 0例。疗程 3～ 14d ,主要疗效参数为治疗第 7、14d的临床疗效。结果　用药 7d细菌性结膜炎和角膜炎试验组总有效率为 72 %( 18/2 5 ) ;对照组总有效率为 84 62 % ( 2 2 /2 6)。用药 14d细菌性结膜炎和角膜炎试验组总有效率为 10 0 % ( 2 5 /2 5 ) ;对照组总有效率为 96 15 % ( 2 5 /2 6) ,两组间细菌性结膜炎和角膜炎总有效率无统计学差异。试验组和对照组对细菌性结膜炎和角膜炎的疗效相当。细菌性结膜炎和角膜炎试验组细菌清除率为 10 0 % ;对照组总清除率 98 0 4% ,两组间清除率比较无显著性差异 (P >0 0 5 )。试验组与对照组均有良好的耐受性 ,无明显不良反应发生。结论　盐酸左氧氟沙星滴眼液治疗细菌性结膜炎和细菌性角膜炎有效且安全。

A randomized double-blind control clinical study on levofloxacin eye drops for bacterial conjunctivitis and keratitis

ObjectiveTo compare the efficacy and safety of 0.3% levofloxacin eye drops (LFED) with Hailun eye drops for treatment of bacterial conjunctivitis and keratitis.MethodsA randomized,double-blind and parallel study was conducted on 60 cases with conjunctivitis and keratitis.0.3% of levofloxacin eye drops was topically used for 3-14 days.The clinical effectiveness and reaction to drug at 7 and 14 days after administration were assessed as the observation indexes.ResultsThe clinical effective rate in 30 subjects in the trial group and 30 control individuals at 7 days were 72%(18/25) and 84.62%(22/26),respectively (P>0.05),and that at 14 days was 100%(25/25) and 96.15%(25/26) in the trial group and the control group,respectively(P>0.05).The bacterial eradication rate was 100% in the trial group and 98.04% in the control group (P>0.05).Both drugs were well-tolerated with a low incidence of adverse events.Conclusion0.3% levofloxacin eye duops is effective and safe for the treatment of bacterial conjunctivitis and keratitis.