ENT Institute and Otorhinolaryngology Department, Affiliated Eye and ENT Hospital, State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Fudan University, 83 Fenyang Road, Shanghai, 200031, People's Republic of China.
NHC Key Laboratory of Hearing Medicine, Fudan University, Shanghai, 200031, People's Republic of China.
J Neurol. 2022 Jan;269(1):72-86. doi: 10.1007/s00415-020-10320-9. Epub 2021 Jan 2.
Intratympanic therapies, usually including glucocorticoid and gentamicin, are becoming worldwide used in clinical practice of Ménière's disease today. However, clinical efficacy and safety of these two therapies are still in controversial.
Electronic searches in PubMed, CENTRAL, Web of Science, EMBASE, CINAHL, ClinicalTrials.gov and the European Union Clinical Trials Register were conducted from inception until September 2020.
The pre-specified protocol of this systematic review and meta-analysis has been registered and published in November 2018 (PROSPERO Identifier: CRD42018114389). All randomized controlled trials of intratympanic gentamicin or glucocorticoids for Ménière's disease, compared with each other or placebo, were considered for this review.
Ten studies with 455 patients met the inclusion criteria. Pooled results indicated significant advantage of intratympanic gentamicin and glucocorticoids over placebo treatments in vertigo control (gentamicin vs placebo: risk rate, RR, 2.56; 95% CI 1.18-5.54; glucocorticoids vs placebo: RR, 3.02; 95% CI 1.36-6.73). There was no significant difference between gentamicin and glucocorticoids in vertigo control (gentamicin vs placebo: RR, 1.18; 95% CI 0.97-1.45). Intratympanic glucocorticoids showed better hearing protective results than gentamicin (change of pure tone audiometric, PTA, mean difference, MD, - 6.48 dB; 95% CI - 11.84 to - 1.13 dB; change of speech discrimination scale, SDS, MD 7.69%; 95% CI 0.83-14.55%).
Intratympanic gentamicin and glucocorticoids are two effective approaches to control vertigo symptoms for Ménière's disease. Glucocorticoids showed a potentially better hearing protective role over gentamicin.
鼓室内治疗，通常包括糖皮质激素和庆大霉素，目前已在全球范围内用于梅尼埃病的临床实践。然而，这两种疗法的临床疗效和安全性仍存在争议。
从建库至 2020 年 9 月，我们在 PubMed、CENTRAL、Web of Science、EMBASE、CINAHL、ClinicalTrials.gov 和欧盟临床试验注册中心进行了电子检索。
本系统评价和荟萃分析的预设定方案已于 2018 年 11 月注册并发表（PROSPERO 标识符：CRD42018114389）。所有比较鼓室内庆大霉素或糖皮质激素治疗梅尼埃病与各自对照或安慰剂的随机对照试验均纳入本综述。
符合纳入标准的 10 项研究共 455 例患者。汇总结果表明，与安慰剂治疗相比，鼓室内庆大霉素和糖皮质激素治疗在眩晕控制方面具有显著优势（庆大霉素 vs 安慰剂：风险比 RR 2.56；95%CI 1.18-5.54；糖皮质激素 vs 安慰剂：RR 3.02；95%CI 1.36-6.73）。庆大霉素与糖皮质激素在眩晕控制方面无显著差异（庆大霉素 vs 安慰剂：RR 1.18；95%CI 0.97-1.45）。鼓室内糖皮质激素较庆大霉素在听力保护方面有更好的效果（纯音听阈平均变化，MD，-6.48dB；95%CI-11.84 至-1.13dB；言语辨别率平均变化，MD 7.69%；95%CI 0.83-14.55%）。
鼓室内庆大霉素和糖皮质激素是控制梅尼埃病眩晕症状的两种有效方法。糖皮质激素在听力保护方面的作用可能优于庆大霉素。
