本文最初发表于European Archives of Oto-Rhino-Laryngology《欧洲耳鼻喉科学档案》，文章题录为：Shuna Li，Ilmari Pyykkö，Qing Zhang，Jun Yang，Maoli Duan.Consensus on intratympanic drug delivery for Menière's disease.European Archives of Oto-Rhino-Laryngology，2022.https://doi.org/10.1007/s00405-022-07374-y。根据Creative Commons Attribution 4.0国际许可，本文版权归全体作者所有，可以进行再发表。本文为全文翻译，保留原文所有内容。
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摘要: 目的 鼓室内(intratympanic，IT)注射药物治疗梅尼埃病(MD)因其疗效显著而备受关注。由于IT注射药物治疗MD的共识和新证据的发布，对IT注射药物治疗MD进行细节上的补充具有重要意义。方法 检索近二十年来有关IT注射药物治疗MD的文献，参考《梅尼埃病治疗国际共识(ICON)》(2018年)，《美国梅尼埃病临床实践指南》(2020年)和《梅尼埃病诊断治疗的欧洲立场声明》(2018)，并遵循来自欧洲、美国和中国的专家意见。结果 专家一致认为：①鼓室内注射甲泼尼龙(ITM)对眩晕控制的疗效优于鼓室内注射地塞米松(ITD)，ITM有恢复MD患者听力的可能性。②由于氨基糖甙类药物的耳毒性，鼓室内注射庆大霉素(ITG)在听力良好MD患者中的应用持谨慎态度。但也有研究表明，小剂量ITG对听力没有显著影响，还需要高水平证据的临床研究进一步证明。③目前普遍接受的ITG治疗终点是在12个月内无眩晕发作或受累耳客观检查提示前庭功能丧失。结论 对IT注射药物治疗MD的药物类型、疗效和治疗终点还需要更多高证据水平的研究进行评价。Abstract: Objective Intratympanic(IT) drug delivery receives attention due to its effectivity in treatment for Menière's disease(MD). Due to the release of the consensuses and new evidence on IT drug delivery for MD have been published, the review with a view to supplementing the details of IT treatment of MD is indispensable.Methods The literatures on IT injection for MD treatment over the last two decades are retrieved, International consensus(ICON) on treatment of Menière's disease(2018), Clinical Practice Guideline(2020) and European Position statement on Diagnosis and Treatment of Menière's disease(2018) are taken into account for reference, and follow advice from experts from Europe, USA and China.Results Experts agree on the following: ①The effectiveness of IT methylprednisolone(ITM) on vertigo control seems to be somewhat better than that of IT dexamethasone(ITD), and ITM can restore hearing in some cases. ②Due to the ototoxicity of aminoglycosides, the application of intratympanic gentamicin(ITG) in MD patients with good hearing is conservative. However, some studies suggest that ITG with low doses has no significant effect on hearing, which needs to be further proved by clinical studies with high levels of evidence. ③Currently, generally accepted treatment endpoint of ITG is no vertigo attack in a 12-month period or a vestibular loss in objective tests in the affected ear.Conclusion More studies with high level of evidence are needed to evaluate the drug type, efficacy, and therapeutic endpoint of IT therapy for MD.
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Key words:
- Menière's disease /
- intratympanic treatment /
- corticosteroid /
- methylprednisolone /
- dexamethasone /
- aminoglycoside /
- gentamicin
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表 1 ITC治疗MD的策略
药物 浓度 次数 频率 研究者 地塞米松 4 mg/dL 3 1周3次 Masoumi等，2017 地塞米松 1 mg/mL ≈45 3个月隔天1次 Sennaroglu等，2001 地塞米松 4 mg/mL 3 每天1次，连续3次 Albu等，2016 地塞米松 4 mg/mL 3 每3天1次 Casani等，2012 地塞米松 10 mg/mL ≤3 每周1次 James等，2019 甲泼尼龙 40 mg/dL 3 1周3次 Masoumi等，2017 甲泼尼龙 40 mg/mL 10 每天1次，连续10 d She等，2015 甲泼尼龙 62.5 mg/mL 3 3次，每周1次 Gabra等，2013 甲泼尼龙 62.5 mg/mL 2 2周1次 Patel等，2016 甲泼尼龙 62.5 mg/mL 2 2周1次 Harcourt等，2019 
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表 2 ITG治疗MD的剂量、治疗终点和效果
浓度/(mg· mL-1) 次数 频率 治疗终点 效果 研究者 眩晕 听力损失 26.7 1~3 每周1次 眩晕控制 眩晕控制率100% 无 Carey等，2002 26.7 3~4 每周1次 眩晕控制 眩晕减少87% 无 Paradis等，2013 26.7 ≤3 2周1次 无眩晕发作和/或前庭功能检测提示前庭功能丧失 2年中眩晕无发作 无 Naples等，2019 30 1~数次 显著听力下降，无眩晕发作，或眩晕发作每月少于1次 眩晕控制率66.8% 无 Gibson等，2019 40 2 2周1次 无眩晕发作 眩晕发作减少87% 无 Patel等，2016 40 1~5 2周1次 眩晕控制 每月眩晕发作次数从4.4降至0.52 无 Scarpa等，2019 40 1~2 5周1次 vHIT增益值低于正常范围最低值/PTA下降10 dB 眩晕控制率70% Martin-Sanz等，2019
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