那他霉素滴眼液治疗真菌性角膜炎的多中心临床对照研究

A multi-center control study of natamycin eyedrops for fungal keratitis

目的通过多中心临床对照研究评估国产那他霉素滴眼液治疗轻中度真菌性角膜炎的疗效及安全性。方法多中心、随机、对照性药物临床试验。选取2011年7月至2012年2月真菌性角膜炎患者108例(108眼),随机分为观察组(56例)和对照组(52例),分别给予华北制药那他霉素滴眼液和爱尔康公司那特真滴眼液局部滴眼治疗。治疗前后观察项目包括症状、视力、裂隙灯检查并评分,于治疗前、治疗后3 d、7 d、14 d、28 d、结束时进行评分,并观察临床疗效。结果观察组、对照组治疗前视力与治疗结束时比较差异均有统计学意义(均为P<0.05),两组治疗前和治疗后视力比较差异均无统计学意义(均为P>0.05)。观察组治疗前眼部评分为(3.85±3.14)分,治疗后3 d、7 d、14 d、28 d及治疗结束时分别为(3.35±2.12)分、(3.01±1.62)分、(2.65±1.35)分、(1.86±1.48)分、(1.15±1.21)分,治疗前与治疗结束时评分差异有统计学意义(P=0.004)。对照组治疗前眼部评分为(3.78±3.42)分,治疗后3 d、7 d、14 d、28 d及治疗结束时分别为(3.42±2.51)分、(2.98±1.91)分、(2.57±1.36)分、(1.76±1.35)分、(1.17±1.29)分,治疗前与治疗结束时评分差异有统计学意义(P=0.003)。观察组与对照组各时间点评分比较差异均无统计学意义(均为P>0.05)。治疗组37例(66.1%)痊愈,18例(32.1%)有效,1例(1.8%)无效,有效率98.2%;对照组32例(61.5%)痊愈,18例(34.6%)有效,2例(3.9%)无效,有效率96.1%;两组治疗有效率比较差异无统计学意义(P=0.35)。结论国产那他霉素滴眼液与那特真治疗轻、中度真菌性角膜炎疗效相当,无眼部及全身毒副作用,可以作为我国治疗轻、中度真菌性角膜炎的一线用药。

Objective To evaluate the efficacy and safety of natamycin eyedrops made in China for mild and moderate fungal keratitis by a multi-center control study. Methods Multi-center, random, controlled medical clinical trial. 108 patients （108 eyes）with mild or moderate fungal keratitis in our study centers from July 2011 to February 2012 were enrolled and divided into treatment group （55 eyes）and control group （52 eyes）, the patients were given natamycin eyedrops made in Huabei Pharma. or Alcon Co.. Symptoms, visual acuity, slim lamp examination and scoring were recorded before and 3 days, 7 days, 14 days, 28 days and termination after treatment. The clinical effects were ob- served. Results There were statistical difference in visual acuity between be- fore and after treatment of both two groups （ all P 〈 0.05 ）, but there was no sta- tistical difference in visual acuity before and after treatment between two groups （all P 〉0. 05 ）. The clinical ocular score before treatment in treatment group was 3.85 ±3.14, which at 3 days, 7 days, 14 days, 28 days and termination af- ter treatment were 3.35 ±2. 12, 3.01 ± 1.52, 2.55 ± 1.35, 1.85 ± 1.48, 1.15 ± 1.21, respectively, there was statistical difference between before treatment and termination （ P = 0. 004 ）. The clinical ocular score before treatment in control group was 3.78 ± 3.42, which at 3 days, 7 days, 14 days, 28 days and termina- tion after treatment were 3.42 ± 2.51, 2.98 ± 1.91, 2.57 ± 1.35, 1.75 ± 1.35, 1.17 ± 1.29, respectively, there was statistical difference between before treat- ment and termination（P = 0.003 ）. There was no statistical difference in clinical ocular scores at different time points between two groups （ all P 〉 0.05 ）. In treatment group, 37 cases（55. 1% ）were cured and 18 cases （32.1%）were ef- fective, and the effective rate was 98.2% ; In control group, 32 cases（51.5% ） were cured and 18 cases （ 34. 5% ） were effective, and the effective rate was 95.1% ; There was no statistical difference in effective rate between two groups （P = 0.35 ）. Conclusion Natamycin eyedrops made in China has the consider- able clinical effects with those made in foreign, can be used as the first-line medication for mild and moderate fungal keratitis since its efficacy and safety.