盐酸洛美沙星眼凝胶临床生物等效性试验  

A clinical equivalence observation of lomefloxacin hydrochloride ophthalmic gel

作　　者：朱承华[1] 谢莉娜[1] 王理理[2] 江天章[3] 梁慷[1] 张丽京[2] 刘爱平[3] 

机构地区：[1]中国南京医科大学附属第一医院眼科,210009 [2]中国南京军区南京总医院眼科,210002 [3]中国南京大学附属鼓楼医院眼科,210008

出　　处：《国际眼科杂志》2004年第3期441-444,共4页International Eye Science

摘　　要：目的:观察3g/L盐酸洛美沙星眼凝胶的临床疗效及安全性。方法:对128例(203眼)细菌性结膜炎和细菌性角膜炎患者采用多中心、随机分组、平行对照试验,观察其主要症状体征消失情况、角膜炎症面积缩小情况、病原菌清除效果和不良反应。试验组(testgroup,TG)65例(103眼),对照组(controlledgroup,CG)63例100眼,分别应用3g/L盐酸洛美沙星眼凝胶和3g/L盐酸洛美沙星滴眼液。结果:①TG治愈率(80.6%)高于CG治愈率(65.0%);②TG(细菌性结膜炎)眼痛异物感消失率和消失时间(83.7%,5.33±2.00d)优于CG(64.1%,6.36±1.50d);TG(细菌性结膜炎)流泪消失率(91.8%)高于CG(75.0%);③记分统计表明:TG(细菌性结膜炎)结膜充血改善(平均下降1.76分)明显优于CG(平均下降1.25分);TG畏光消失情况(平均下降1.24分)好于CG(平均下降0.87分);TG(细菌性结膜炎)分泌物消失情况(平均下降1.64分)好于CG(平均下降1.33分);④其他情况两组间无明显差异。结论:3g/L盐酸洛美沙星眼凝胶治疗眼前段细菌感染安全、有效,对结膜炎症状体征的改善优于滴眼液。AIM: To evaluate the therapeutic effect and safety of 3g/L lomefloxacin hydrochloride ophthalmic gel (LHOG).METHODS: In a multicenter, randomized group and parallel controlled trial, the disappearance of cardinal symptoms and signs, reduced areas of keratitis, the bacterial clearance and advertise drug reactions of 3g/L LHOG were compared with that of 3g/L lomefloxacin hydrochloride ophthalmic solution (LHOS) in patients of bacterial conjunctivitis and bacterial keratitis. The study included 203 eyes of 128 patients, among which 103 eyes of 65 patients were in Test Group (TG) and 100 eyes of 63 patients were in Control Group (CG).· RESULTS: ①The curative rate of TG (80.6%)was higher than that of CG(65.0%). ②Not only was the disappearing rate of pain and gritty sensation of TG in patients of bacterial conjunctivitis (83.7%) higher than that of CG (64.1%), but their average disappearing time of (5.33±2.00d) was earlier than that of CG (6.36±1.50d). Moreover, the disappearing rate of lachrymation of TG(91.8%)was higher than that of CG (75.0%). ③The statistics showed that the improvement of conjunctiva congestion of TG (dropping 1.76 scores on average) in patients with bacterial conjunctivitis, on one hand, is superior to that of CG (dropping 1.25 scores on average). On the other hand, the disappearance of photophobia of TG (dropping 1.24 scores on average) in patients with bacterial conjunctivitis was better than that of CG (dropping 0.87 scores on average). ④There was no significant difference between TG and CG in other aspects.· CONCLUSION: The 3g/L LHOG is an effective and safe antibacterial against infection of ophthalmic anterior segment, especially superior to 3g/L LHOS on improving symptoms and signs of conjunctivitis .

关 键 词：盐酸洛美沙星眼凝胶 生物等效性试验 细菌性角膜炎 细菌性结膜炎 

分 类 号：R965[医药卫生—药理学]