A randomized, controlled, single-blinded, multicenter evaluation of the efficacy and safety of a once weekly two dose otic gel containing florfenicol, terbinafine and betamethasone administered for the treatment of canine otitis externa
A randomized, controlled, single-blinded, multicenter evaluation of the efficacy and safety of a once weekly two dose otic gel containing florfenicol, terbinafine and betamethasone administered for the treatment of canine otitis externa
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DOI：
10.1186/s12917-018-1627-5
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发表时间：
2018-10-11
影响因子：
2.6
通讯作者：
Forster, S. L.
中科院分区：
文献类型：
--
作者：
King, S. B.;Doucette, K. P.;Forster, S. L.
背景：外耳炎是小动物实践中的常见问题。日常治疗的依从性是治疗失败的主要原因。测试的假设是，一种新型耳用凝胶在耳道上涂抹两次，间隔一周，在治疗犬外耳炎方面与每日耳用悬浮液一样有效。该研究包括 286 只患有外耳炎的私人饲养的狗。在这项单盲随机研究中，入组的狗接受两次含有 1% 氟苯尼考、1% 特比萘芬和 0.1% 醋酸倍他米松的耳用凝胶，间隔一周，或每天接受含有氢化可的松醋丙酯、咪康唑和庆大霉素的混悬液，持续 5 天。在给予第一剂药物之前用盐水清洁耳朵。在第 0、7、28 和 56 天 (D) 对狗进行耳炎指数评分 (OTIS-3)、耳培养和细胞学、疼痛和瘙痒以及对治疗的总体反应（主人和研究者评估）进行评估。结果指标是 OTIS-3 的改善和每个时间点临床缓解的狗的数量。结果：OTIS-3 在第 28 天和第 56 天，耳用凝胶显着降低了 63% 和 64%，悬浮液显着降低了 63% 和 61%（p < 0.0001）。在任何时间点，各组之间在临床成功、疼痛、瘙痒、总体评估或耳细胞学和培养方面没有显着差异。大约四分之三的临床医生和业主认为治疗反应非常好或良好。第 56 天，两组中耳炎复发率为 11%。没有发现因耳部药物引起的不良事件。结论：每隔一周使用耳用凝胶两次是治疗犬外耳炎的有效、安全和方便的方法。
Background: Otitis externa is a common problem in small animal practice. Compliance with daily treatment is a major cause of treatment failure. The hypothesis tested is that a novel otic gel applied to the ear canal twice with a one-week interval is as efficacious as a daily otic suspension in the treatment of canine otitis externa. The study included 286 privately owned dogs with otitis externa.In this single blinded randomized study, enrolled dogs received either an otic gel containing 1% florfenicol, 1% terbinafine and 0.1% betamethasone acetate twice with a one-week interval or a suspension containing hydrocortisone aceponate, miconazole and gentamicin daily for 5 days. Ears were cleaned with saline prior to administration of the first dose of medication. Dogs were evaluated at day (D) 0, 7, 28 and 56 with an otitis index score (OTIS-3), otic culture and cytology, pain and pruritus, and overall response to treatment (owner and investigator evaluation). Outcome measures were improvement of the OTIS-3 and number of dogs in clinical remission at each time point.Results: OTIS-3 decreased significantly (p < 0.0001) by 63 and 64% for the otic gel and by 63 and 61% for the suspension on D28 and D56 respectively. There was no significant difference between groups at any time point with regard to clinical success, pain, pruritus, overall assessments or otic cytology and culture. The treatment response was considered excellent or good by approximately three quarters of both the clinicians and Owners. Otitis recurrence at D56 was seen in 11% of both groups. Adverse events attributable to the ear medications were not noted.Conclusions: Administering an otic gel twice at a one-week interval is an effective, safe and convenient way to treat canine otitis externa.