A comparative study of two antimicrobial/anti-inflammatory formulations in the treatment of canine otitis externa
A comparative study of two antimicrobial/anti-inflammatory formulations in the treatment of canine otitis externa
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DOI：
10.1111/j.1365-3164.2005.00465.x
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发表时间：
2005-10-01
影响因子：
1.4
通讯作者：
Boisramé, B
中科院分区：
文献类型：
--
作者：
Rougier, S;Borell, D;Boisramé, B
采用III期临床试验方案，比较了马波那星-克霉唑-地塞米松耳用混悬液（MCD）与标准外用治疗的疗效和耐受性。在总共140只具有急性或亚急性外耳炎临床体征的犬中，从入选时采集的样品中分离葡萄球菌属、假单胞菌属、肠杆菌科和马拉色菌属，以鉴定致病病原体;在失败或复发的情况下，以及从入选时分离出假单胞菌属的犬（第14天）中采集进一步样品。一组接受MCD（每只患耳10滴）每日一次，另一组接受Surolan（R）（含多粘菌素B、咪康唑和泼尼松龙）（每只患耳5滴）每日两次。根据第7天的临床结果，每组接受7或14天的治疗。对于给药14天的犬，在第7、14和28天（如有必要）评价疗效和耐受性。该试验证明了两种治疗在疗效方面的等效性，MCD的治愈率为58.3%，Surolan（R）为41.2%。两种药物在犬中的耐受性相同，但MCD在第14天的疼痛缓解、脓量和气味减少、缓解率和研究者评估方面更优上级。
The efficacy and tolerability of a marbofloxacin-clotrimazole-dexamethasone otic suspension (MCD) was compared with a standard topical treatment using a phase III clinical trial protocol. In a total of 140 dogs with clinical signs of acute or subacute otitis externa, Staphylococcus, Pseudomonas, Enterobacteriaceae and Malassezia were isolated from samples taken at inclusion to identify the causative pathogen; a further sample was collected in the event of failure or relapse, and from dogs (at day 14) for which Pseudomonas species had been isolated at inclusion. One group received MCD (10 drops per affected ear) once daily and a second received Surolan (R) (containing polymyxin B, miconazole and prednisolone) (5 drops per affected ear), twice daily. Each group received treatment for 7 or 14 days according to the clinical outcome on day 7. Efficacy and tolerability were evaluated on days 7, 14 and, if necessary, 28 for dogs treated for 14 days. The trial demonstrated equivalence of both treatments in terms of efficacy, with a cure rate of 58.3% for MCD and 41.2% for Surolan (R). Both medications were equally well tolerated by dogs, but MCD was superior in terms of pain relief, decrease in pus quantity and smell, response rate and investigator's assessment on day 14.