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前瞻性评估替普罗单抗所致耳科学不良事件:初步结果。

Prospective Assessment of Otologic Adverse Events due to Teprotumumab: Preliminary Results.

机构信息

Department of Otolaryngology-Head & Neck Surgery, NYU Grossman School of Medicine, New York, New York, USA.

Department of Ophthalmology, NYU Grossman School of Medicine, New York, New York, USA.

出版信息

Otolaryngol Head Neck Surg. 2023 May;168(5):1164-1169. doi: 10.1002/ohn.174. Epub 2023 Jan 19.

DOI:10.1002/ohn.174
PMID:36939482
Abstract

OBJECTIVE

To assess a series of patients receiving teprotumumab therapy and objectively quantify the rates of otologic adverse events.

STUDY DESIGN

A prospective cohort study of adult patients receiving teprotumumab between May 2020 and January 2022.

SETTING

Tertiary referral center.

METHODS

Prior to treatment initiation, an ototoxicity-specific audiometric battery was completed, which included conventional audiometry (frequencies 250-8000 Hz), ultrahigh-frequency audiometry (9000-20,000 Hz), tympanometry, speech discrimination scores, and distortion product otoacoustic emissions (DPOAEs). Testing was then repeated after treatment completion.

RESULTS

In total, 35 patients were recruited, with a median (range) age of 48.5 years (21-74), and 8 (22.8%) were male. The most common subjective symptom reported was a hearing decline (25.7%), followed by aural fullness (17.1%) and tinnitus (14.3%). Fourteen patients had both pre- and posttreatment audiometric data. Among them, 3 patients (21.4%) were found to have changes in standard frequency audiometry, and 10 (71.4%) had changes in high-frequency audiometry, with 2 patients having changes in both. Less than half (n = 5) of the 11 patients with changes in standard or high-frequency pure tone hearing noted subjective hearing decline. Changes in DPOAE were noted in 4 patients out of 13 (30.7%). Two patients discontinued treatment due to hearing decline. Finally, 3 patients (8.6%) were diagnosed with patulous eustachian tube (PET) by an otolaryngologist, and another 3 patients are suspected to have PET based on symptom description during ophthalmologic follow-up.

CONCLUSION

In our cohort, a high incidence of otologic symptoms was found to be associated with teprotumumab usage. Subjective hearing decline, changes in ultrahigh-frequency hearing as well as eustachian tube dysfunction may be encountered and suggest the potential ototoxicity of teprotumumab.

摘要

目的

评估一系列接受替普瑞酮治疗的患者,并客观量化耳毒性不良事件的发生率。

研究设计

这是一项 2020 年 5 月至 2022 年 1 月期间接受替普瑞酮治疗的成年患者的前瞻性队列研究。

设置

三级转诊中心。

方法

在开始治疗前,完成了一组特定于耳毒性的听力测试,包括常规听力测试(频率 250-8000 Hz)、超高频率听力测试(9000-20000 Hz)、鼓室图、语音辨别评分和畸变产物耳声发射(DPOAEs)。治疗完成后重复测试。

结果

共招募了 35 名患者,中位(范围)年龄为 48.5 岁(21-74 岁),8 名(22.8%)为男性。报告的最常见主观症状是听力下降(25.7%),其次是耳闷(17.1%)和耳鸣(14.3%)。14 名患者均有治疗前后的听力测试数据。其中,3 名患者(21.4%)标准频率听力测试有变化,10 名患者(71.4%)高频听力测试有变化,2 名患者两种测试均有变化。在 11 名标准或高频纯音听力变化的患者中,不到一半(n=5)有主观听力下降。在 13 名 DPOAE 有变化的患者中,有 4 名(30.7%)有变化。2 名患者因听力下降而停止治疗。最后,3 名患者(8.6%)被耳鼻喉科医生诊断为咽鼓管过度开放(PET),另有 3 名患者在眼科随访时根据症状描述怀疑患有 PET。

结论

在我们的队列中,发现使用替普瑞酮与高发生率的耳部症状相关。主观听力下降、超高频率听力变化以及咽鼓管功能障碍可能会遇到,并提示替普瑞酮可能具有耳毒性。

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