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一项随机、对照、单盲、多中心评估,旨在研究一种每周一次、含氟苯尼考、特比萘芬和倍他米松的两剂耳用凝胶治疗犬外耳炎的有效性和安全性。

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.

作者信息

King S B, Doucette K P, Seewald W, Forster S L

机构信息

Elanco Animal Health, 2500 Innovation Way, Greenfield, IN, 46140, USA.

Elanco Animal Health Inc., Mattenstrasse 24a, CH-4058, Basel, Switzerland.

出版信息

BMC Vet Res. 2018 Oct 11;14(1):307. doi: 10.1186/s12917-018-1627-5.

Abstract

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.

摘要

背景

外耳炎是小动物临床实践中的常见问题。患者对每日治疗的依从性是治疗失败的主要原因。本研究检验的假设是,一种新型耳用凝胶,每隔一周向耳道内给药两次,在治疗犬外耳炎方面与每日使用的耳用混悬液疗效相同。该研究纳入了286只患有外耳炎的家养犬。在这项单盲随机研究中,入选的犬只接受含1%氟苯尼考、1%特比萘芬和0.1%醋酸倍他米松的耳用凝胶,每隔一周给药两次,或接受含阿氯米松、咪康唑和庆大霉素的混悬液,每日给药一次,持续5天。在首次给药前,用生理盐水清洁耳道。在第0、7、28和56天,采用外耳炎指数评分(OTIS-3)、耳拭子培养及细胞学检查、疼痛和瘙痒情况以及对治疗的总体反应(主人和研究者评估)对犬只进行评估。观察指标为OTIS-3的改善情况以及各时间点临床症状缓解的犬只数量。

结果

在第28天和第56天,耳用凝胶组的OTIS-3分别显著降低(p < 0.0001)63%和64%,混悬液组分别降低63%和61%。在临床疗效、疼痛、瘙痒、总体评估或耳拭子细胞学检查及培养方面,两组在任何时间点均无显著差异。约四分之三的临床医生和主人认为治疗反应为优或良。两组在第56天的外耳炎复发率均为11%。未观察到耳部用药引起的不良事件。

结论

每隔一周使用耳用凝胶给药两次是治疗犬外耳炎的一种有效、安全且便捷的方法。

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