关于非洲首例用于治疗分泌性中耳炎的耳石治疗的临床试验的最新进展[FCT/UATH/HREC/PR/330]。

Update on first African clinical trial on earpopper for the treatment of otitis media with effusion [FCT/UATH/HREC/PR/330].

机构信息

Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja; Division of Otorhinolaryngology, Garki Hospital, Abuja, Nigeria.

Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja, Abuja, Nigeria.

出版信息

Ann Afr Med. 2022 Jan-Mar;21(1):65-70. doi: 10.4103/aam.aam_17_21.

DOI:10.4103/aam.aam_17_21

PMID:35313408

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9020629/

Abstract

BACKGROUND

Otitis media with effusion (OME) is a middle ear condition characterized by the accumulation of serous fluid. It is common, though not exclusive; among children with its attendant developmental consequence if missed or untreated in early life. OME could be managed surgically, pharmacologically, or physiologically. EarPopper is a medical device developed for physiologic management of OME, Eustachian tube dysfunction, and related problems. We aim to ascertain the suitability/efficiency of EarPopper® device for the treatment of OME in our setting.

METHODOLOGY

This is a prospective interventional study of volunteers diagnosed with OME from four (4) medical centers in Abuja. Pneumatic otoscopy, video-otoscopy, tympanometry, and pure-tone audiometry were done to confirm the diagnosis. Serial EarPopper sessions were performed twice weekly for 2-12 weeks, and outcome was assessed using patients' reports. The reports include the EarPopper scoring system (ESS) and audiometric parameters (before and after therapy).

RESULTS

Forty-five patients (17 males and 28 females) aged between 3-56 years were enrolled. Thirty-five were diagnosed with bilateral OME and 10 unilateral. All patients had Type-B tympanometry tracing with mild-to-moderate conductive hearing losses and ESS of between 2.45% and 84%. Out of the 45 participants, 32 (71.1%) completed the treatment, whereas 13 (28.9%) were lost to follow-up. Duration of EarPopper treatment ranged from 2 to 12 weeks. The outcome revealed improvement in 26/32 (81.3%) with significant reduction in ESS (1% to 9.8%). Six patients 6/32 (18.9%) had persistence symptoms. These 18.9% had the propensity to progress to chronic OME.

CONCLUSION

This study highly suggests good prospect in using EarPopper for the management of OME among Africans.

摘要

背景

分泌性中耳炎（OME）是一种中耳疾病，其特征是浆液性液体积聚。它在儿童中较为常见，尽管并非排他性的；如果在早期生活中被忽视或未得到治疗，它会伴随发育后果。OME 可以通过手术、药物或生理方式进行治疗。EarPopper 是一种为生理治疗 OME、咽鼓管功能障碍和相关问题而开发的医疗设备。我们旨在确定 EarPopper®设备在我们的环境中治疗 OME 的适宜性/效率。

方法

这是一项在阿布贾的四个医疗中心诊断为 OME 的志愿者的前瞻性干预研究。通过气动耳镜检查、视频耳镜检查、鼓室图和声导抗测试来确认诊断。每周进行两次 EarPopper 治疗，共进行 2-12 周，通过患者报告评估结果。报告包括 EarPopper 评分系统（ESS）和听力参数（治疗前后）。

结果

共有 45 名（17 名男性和 28 名女性）年龄在 3-56 岁的患者入组。35 名患者被诊断为双侧 OME，10 名患者为单侧。所有患者的鼓室图均为 B 型，听力损失为轻度至中度传导性，ESS 在 2.45%-84%之间。45 名参与者中有 32 名（71.1%）完成了治疗，而 13 名（28.9%）失访。EarPopper 治疗时间从 2 周到 12 周不等。结果显示，32 名（81.3%）患者的病情得到改善，ESS 显著降低（1%-9.8%）。6 名患者（6/32，18.9%）症状持续存在。这些 18.9%的患者有进展为慢性 OME 的倾向。