Rougier Sandrine, Borell Daniela, Pheulpin Sandrine, Woehrlé Frédérique, Boisramé Bernard
Vétoquinol Research Centre, Magny Vernois, BP 189, 70204 Lure Cedex, France.
Vet Dermatol. 2005 Oct;16(5):299-307. doi: 10.1111/j.1365-3164.2005.00465.x.
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 (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. 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.
采用III期临床试验方案,比较了马波沙星-克霉唑-地塞米松耳用混悬液(MCD)与标准局部治疗的疗效和耐受性。共有140只患有急性或亚急性外耳炎临床症状的犬,在纳入研究时从采集的样本中分离出葡萄球菌、假单胞菌、肠杆菌科和马拉色菌以鉴定致病病原体;如果治疗失败或复发,以及对于在纳入研究时分离出假单胞菌属的犬(在第14天),则采集另外一份样本。一组每天一次接受MCD(每只患耳10滴),另一组每天两次接受舒洛兰(含多粘菌素B、咪康唑和泼尼松龙)(每只患耳5滴)。根据第7天的临床结果,每组接受7天或14天的治疗。对于接受14天治疗的犬,在第7天、14天以及必要时在第28天评估疗效和耐受性。该试验表明两种治疗在疗效方面相当,MCD的治愈率为58.3%,舒洛兰为41.2%。两种药物犬的耐受性均良好,但MCD在缓解疼痛、减少脓液量和气味、反应率以及第14天研究者评估方面更具优势。