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

发布时间：2018-08-01 16:44

【摘要】：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P0.05),两组治疗前和治疗后视力比较差异均无统计学意义(均为P0.05)。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P0.05)。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。
[Abstract]:Objective to evaluate the efficacy and safety of natamycin eye drops in the treatment of mild to moderate fungal keratitis. Methods multicenter, randomized, controlled drug clinical trial. 108 cases (108 eyes) of fungal keratitis from July 2011 to February 2012 were randomly divided into observation group (56 cases) and control group (52 cases). The observation items before and after treatment included symptom, visual acuity, slit lamp examination and score. Before treatment, 3 days after treatment and 3 days after treatment, 14 days and 28 days after treatment, the symptoms, visual acuity and slit lamp were evaluated, and the clinical curative effect was observed. Results the visual acuity of the observation group and the control group were significantly different before and after treatment (P0.05), but there was no significant difference between the two groups before and after treatment (P0.05). The eye score of the observation group was (3.85 卤3.14) points before treatment, (3.35 卤2.12), (3.01 卤1.62) points, (2.65 卤1.35) points, (1.86 卤1.48) points, (1.15 卤1.21) points at the end of treatment and 3 days after treatment. There was significant difference between before treatment and at the end of treatment (P0.004). The eye score of the control group was (3.78 卤3.42) before treatment, (3.42 卤2.51), (2.98 卤1.91), (2.57 卤1.36), (1.76 卤1.35), (1.17 卤1.29) at the end of the treatment and at the end of the treatment. There was significant difference between before and after treatment (P0.003). There was no significant difference between the observation group and the control group in each time point score (P0.05). 37 cases (66.1%) were cured in the treatment group, 18 cases (32.1%) were cured and 1 case (1.8%) was ineffective and the effective rate was 98.2%, while in the control group, 32 cases (61.5%) were cured, 18 cases (34.6%) were cured, 2 cases (3.9%) were ineffective and the effective rate was 96.1.There was no significant difference between the two groups (P < 0.35). Conclusion Natamycin eye drops made in China are similar to natamycin in the treatment of mild and moderate fungal keratitis, and can be used as a first-line drug for the treatment of mild and moderate fungal keratitis in China.
【作者单位】：武汉爱尔眼科医院;第三军医大学西南眼科医院;吉林大学第一医院眼科;重庆爱尔眼科医院;沈阳何氏眼科医院;大连市第三人民医院眼科;吉林大学中日联谊医院眼科;长沙爱尔眼科医院;武汉大学人民医院眼科;重庆医科大学附属第二医院眼科;
【分类号】：R772.21

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