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首页> 外文期刊>Advances in therapy. >Safety and efficacy of moxifloxacin-dexamethasone eyedrops as treatment for bacterial ocular infection associated with bacterial blepharitis
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Safety and efficacy of moxifloxacin-dexamethasone eyedrops as treatment for bacterial ocular infection associated with bacterial blepharitis

机译：莫西沙星地塞米松滴眼液治疗与细菌性睑缘炎相关的细菌性眼感染的安全性和有效性

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Introduction: Treatments that offer two medications in a fixed combination have the potential to offer efficacious and safe treatment with advantages such as a regimen that is simpler than administering two separate solutions. This study evaluated the safety and efficacy of fixed-combination versus concomitant moxifloxacin 0.5% and dexamethasone 0.1% ocular solutions for the treatment of bacterial ocular inflammation and infection. Methods: The clinical study design was a randomized, double-masked, active-controlled, parallel-group trial of 102 subjects with bacterial blepharitis in which two patients also had bacterial conjunctivitis. All subjects received two bottles of study medication: either a fixed combination of moxifloxacin 0.5%/ dexamethasone 0.1% ophthalmic solution and placebo eye drops (fixed-dose group), or moxifloxacin 0.5% ophthalmic solution and dexamethasone 0.1% (concomitant group). One drop of each study medication was instilled bilaterally four times per day for 7 days. 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 occurred similarly in both groups (81.6% of eyes, fixed-dose group; 82.3% of eyes, concomitant group). Moreover, the microbiological efficacy of the treatment was also similar for both the fixed-dose group (84%) and the concomitant group (83%). Ocular symptoms and signs improved over time, with no significant differences between groups after 7 days of treatment, except the fixed-dose group had significantly more eyes with clinical resolution in eyelid erythema (100%, n = 98/98, fixed-dose group; 92.7%, n = 89/96, concomitant group; P = 0.0194) and eyelid scaling/crusting (98%, n = 96/98, fixed-dose group; 89.6%; n = 86/96 eyes, concomitant group; P = 0.0337). Both regimens were safe and well tolerated. Conclusion: The fixed-dose combination of moxifloxacin, 0.5% and dexamethasone, 0.1% was therapeutically equivalent and as well tolerated as the concomitant dosage.
机译：简介：以固定组合方式提供两种药物的治疗方法有可能提供有效且安全的治疗方法，并且具有比实施两种单独解决方案更简单的优势。这项研究评估了固定组合与0.5％莫西沙星和0.1％地塞米松眼药液联合治疗细菌性眼部炎症和感染的安全性和有效性。方法：临床研究设计是一项针对102名细菌性睑缘炎患者的随机，双掩蔽，主动控制，平行分组的试验，其中两名患者也患有细菌性结膜炎。所有受试者均接受两瓶研究药物：莫西沙星0.5％/地塞米松0.1％眼药水和安慰剂滴眼液的固定组合（固定剂量组），或莫西沙星0.5％眼药水和地塞米松0.1％（并发组）。每天四次双侧滴入每种研究药物一滴，共7天。评估临床解决方案，体征，症状和安全性。在入组时和出诊时，从每位患者的每只眼的眼睑边缘和结膜中收集微生物标本。结果：两组患者的临床分辨情况相似（固定剂量组为81.6％的眼睛;伴随组为82.3％的眼睛）。此外，固定剂量组（84％）和伴随组（83％）的治疗微生物功效也相似。眼部症状和体征随时间改善，治疗7天后各组之间无显着差异，除了固定剂量组眼睑红斑的临床分辨率明显高于其他眼睛（100％，n = 98/98，固定剂量组; 92.7％，n = 89/96，并发组; P = 0.0194）和眼睑结垢/结rust（98％，n = 96/98，固定剂量组; 89.6％; n = 86/96眼，并发组; P = 0.0337）。两种方案均安全且耐受性良好。结论：莫西沙星（0.5％）和地塞米松（0.1％）的固定剂量组合在治疗上是等效的，并且作为伴随剂量耐受。

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