Devantier Louise, Callesen Henriette Edemann, Jensen Lasse Rehné, Mirian Christian, Ovesen Therese
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Department of Audiology, Aarhus University Hospital, Aarhus, Denmark.
Heliyon. 2022 Feb 15;8(2):e08955. doi: 10.1016/j.heliyon.2022.e08955. eCollection 2022 Feb.
The standard treatment of idiopathic sudden sensorineural hearing loss (ISSNHL) constitutes of systemic oral corticosteroid. Although oral corticosteroid might revert the acute deafness, some patients with ISSNHL display a more treatment refractory course. For these patients, corticosteroid installed directly into the middle ear has become a more frequent treatment, due to the potential benefits of a high, local concentration compared to a systemic administration. As such, for patients being refractory to standard treatment, intratympanic injection of a high dosage of corticosteroid as salvage therapy may be beneficial.
To evaluate the efficacy of intratympanic corticosteroid (ITC) as a salvage treatment of ISSNHL.
A systematic literature search was performed in relevant databases. Both randomized trials and observational studies were considered for inclusion. The risk of bias was evaluated using the Cochrane risk of bias tool (randomized trials) or ROBINS-I tool (observational studies). Meta-analysis was performed to investigate the improvement of PTA (dB) and number of patients displaying recovery following salvage ITC injections. Occurrence of serious side effects was investigated. Finally, the certainty of the evidence was evaluated using the GRADE approach.
Eleven relevant studies were identified (4 randomized trials and 7 observational studies). Both observational and randomized trials showed that salvage ITC significantly increased the number of patients displaying recovery. No serious adverse events were identified in any of the included studies. The certainty of evidence ranged from moderate to very low, due to risk of bias, imprecision, and heterogeneity.
Collectively, our findings indicate that salvage ITC treatment may be a beneficial and safe treatment for patients with sudden hearing loss, who otherwise are refractory to standard treatment approaches. However, the evidence level indicates need for a cautious interpretation of especially the magnitude of effect and thus the extrapolation on how much the individual may improve from this treatment. Furthermore, it remains to be investigated whether treatment outcomes may vary across different patient groups presenting with ISSNHL. This potential variation in treatment response should be kept in mind, when counselling the patient.
The protocol is registered in PROSPERO. Registration number: CRD42019130586.
特发性突发性感音神经性听力损失（ISSNHL）的标准治疗方法是全身性口服皮质类固醇。尽管口服皮质类固醇可能会使急性耳聋恢复，但一些ISSNHL患者的病程对治疗更具难治性。对于这些患者，与全身给药相比，由于中耳直接注入皮质类固醇具有高局部浓度的潜在益处，因此这种治疗方法变得更加常用。因此，对于对标准治疗难治的患者，鼓膜内注射高剂量皮质类固醇作为挽救疗法可能有益。
评估鼓膜内注射皮质类固醇（ITC）作为ISSNHL挽救治疗的疗效。
在相关数据库中进行系统的文献检索。纳入随机试验和观察性研究。使用Cochrane偏倚风险工具（随机试验）或ROBINS-I工具（观察性研究）评估偏倚风险。进行荟萃分析以研究挽救性ITC注射后纯音平均听阈（PTA，dB）的改善情况以及听力恢复的患者数量。调查严重副作用的发生情况。最后，使用GRADE方法评估证据的确定性。
共确定了11项相关研究（4项随机试验和7项观察性研究）。观察性研究和随机试验均表明，挽救性ITC显著增加了听力恢复的患者数量。在所纳入的任何研究中均未发现严重不良事件。由于存在偏倚风险、不精确性和异质性，证据的确定性从中度到极低不等。
总体而言，我们的研究结果表明，挽救性ITC治疗对于突发听力损失且对标准治疗方法难治的患者可能是一种有益且安全的治疗方法。然而，证据水平表明需要谨慎解释尤其是疗效的大小，从而推断个体从这种治疗中可能改善的程度。此外，不同的ISSNHL患者群体的治疗结果是否存在差异仍有待研究。在为患者提供咨询时，应牢记这种潜在的治疗反应差异。
该方案已在PROSPERO注册。注册号：CRD42019130586。
