探讨复方滴眼剂治疗眼部细菌感染的安全性和有效性  

Study on The Efficacy and Safety of Fixed-Combination Vesus Moxifloxacin and Dexamethasone Ocular Solutions for Treatment on Bacterial Ocular Inflammation and Infection

作　　者：蒋大义[1,2] 谢守霞[1,2] 马惠莱[1,2] 杨宏图[1,2] 孙业红[1,2] 

机构地区：[1]广东省深圳市人民医院 [2]暨南大学第二附属医院药学部,深圳518020

出　　处：《成都医学院学报》2012年第2期283-285,共3页Journal of Chengdu Medical College

摘　　要：目的通过对比研究0.5%莫西沙星和0.1%地塞米松组成的复方滴眼剂与0.5%莫西沙星和0.1%地塞米松滴眼液的使用效果,评价复方莫西沙星滴眼液治疗眼部细菌感染和炎症(睑缘炎、角膜炎、结膜炎)的安全性和有效性。方法 2007年1月～2011年12月在我院眼科就诊,年龄18岁以上诊断为睑缘炎、角膜炎或结膜炎患者纳入本研究,采用随机、双盲和平行对照试验。根据患者不同的给药方式分为复方药物组和对照组,评价药物的临床效果、体征、症状和安全性。结果两组药物的临床效果以及抗微生物疗效都没有显著统计学差异。两组患者眼睛症状和体征随着时间好转,治疗7d后无显著统计学差异,但复方药物组患者眼睑红斑临床疗效显著好于对照组(P=0.0194),眼睑蜕皮结痂疗效显著好于对照组(P=0.0337)。两种给药方法安全且耐受性好。结论 0.5%莫西沙星、0.1%地塞米松组成的复方药物与分开同时使用在疗效和耐受性等效。Objective To study the efficacy and safety treated of fixed combination vesus moxifloxacin 0.5 and dexamethasone 0.1% ocular solutions for the treatment of baeterial ocular inflammation and infection. Methods The design of the study was a randomized, double-blind, parallel trials. From January 2007 to December 2011, patients with the age over 18 years,diagnosed as blepharitis,keratitis or conjunctivitis in the Ophthalmology clinic of our hospital were enrolled in this study. According to the different delivery methods, patients were divided into the compound drug group and control group. Clinical resolution, signs, symptoms, and safety were assessed. Microbiological specimens were collected from the eyelid margin and conjunctivae of each eye from each patient at the time of enrollment and at the exit visit. Results Clinical resolution was good similarly in both groups and anti- microbiological efficacy was not different between the two groups. Ocular symptoms and signs improved over time with no significant differences between groups after 7 days of treatment,except the Compound Pharmacy Group had significantly more eyes with clinical resolution in eyelid erythema （ P = 0. 019 ） and eyelid scaling crusting （ P = 0. 034 ）. Both regimens were safe and well tolerated. Conclusions The compound pharmacy group which is combination of moxifloxacin,0. 5% and dexamethasone, 0. 1% has the same therapeutically equivalent and tolerated with the concomitant dosage.

关 键 词：睑缘炎 角膜炎 结膜炎 地塞米松 莫西沙星 

分 类 号：R978.1[医药卫生—药品] R971[医药卫生—药学]