Vision Institute, Federal University of São Paulo, Rua Botucatu 822, 04023-062, São Paulo, Brazil.
Adv Ther. 2012 May;29(5):416-26. doi: 10.1007/s12325-012-0018-8. Epub 2012 May 3.
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.
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.
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.
The fixed-dose combination of moxifloxacin, 0.5% and dexamethasone, 0.1% was therapeutically equivalent and as well tolerated as the concomitant dosage.
提供两种药物固定组合的治疗方法具有提供有效且安全治疗的潜力，其优势在于方案比分别施用两种溶液更简单。本研究评估了固定组合与莫西沙星 0.5%和地塞米松 0.1%的联合使用治疗细菌性眼部炎症和感染的安全性和疗效。
这是一项随机、双盲、阳性对照、平行组临床试验，共纳入 102 例细菌性睑缘炎患者（其中 2 例患者还患有细菌性结膜炎）。所有患者均接受两种研究药物治疗：莫西沙星 0.5%/地塞米松 0.1%的固定组合滴眼液和安慰剂滴眼液（固定剂量组），或莫西沙星 0.5%滴眼液和地塞米松 0.1%（联合组）。两组患者均每天双侧滴注 4 次，每次 1 滴，持续 7 天。评估临床缓解情况、体征、症状和安全性。在每位患者的入组时和出组时，从每个患者的眼睑边缘和结膜采集微生物标本。
两组患者的临床缓解情况相似（固定剂量组 81.6%的眼睛，联合组 82.3%的眼睛）。此外，固定剂量组（84%）和联合组（83%）的治疗微生物学疗效也相似。眼部症状和体征随时间改善，治疗 7 天后两组之间无显著差异，但固定剂量组在眼睑红斑（100%，n = 98/98，固定剂量组；92.7%，n = 89/96，联合组；P = 0.0194）和眼睑鳞屑/结痂（98%，n = 96/98，固定剂量组；89.6%，n = 86/96，联合组；P = 0.0337）方面有更多的眼睛达到临床缓解。两种方案均安全且耐受良好。
莫西沙星 0.5%和地塞米松 0.1%的固定剂量组合在治疗上等效，且与联合剂量一样耐受良好。
