部分耳聋患者在人工耳蜗植入过程中通过医疗器械INCAT(内耳导管)向内耳局部输送类固醇——初步结果和可行性研究

Expert opinion on drug delivery Pub Date : 2025-04-01 Epub Date: 2025-02-25 DOI:10.1080/17425247.2025.2466773
Magdalena B Skarżyńska, Elżbieta Gos, Piotr H Skarżyński, Artur Lorens, Adam Walkowiak, Henryk Skarżyński
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引用次数: 0

摘要

背景:本研究的主要目的是评估三种使用类固醇和内耳导管(INCAT) Medel®治疗部分耳聋患者人工耳蜗植入术的有效性和安全性。第二个目的是评估INCAT深度对人工耳蜗植入术后听力保护的影响。研究设计与方法:采用三种给药算法:1)甲泼尼龙62.5 mg/ml(溶液),3例;2)甲基强的松龙40 mg/ml(混悬液),4例;3)地塞米松4mg /ml(溶液),3例。术前、术后1、6个月分别进行纯音测听(0.125 ~ 8 kHz)。听力保存情况按照HEARRING组公式进行评估。分别于术后2天、1个月和6个月进行阻抗测量。结果:使用甲基强的松龙40 mg/ml混悬液治疗的患者术后1个月听力保存最佳(50%完全保存和50%部分保存),此后仍保持最佳状态。术后1个月和6个月,本组阻抗最低。较短的INCAT插入深度比较长的INCAT插入深度更有利。结论:我们的研究结果表明,与其他两种药物相比,使用甲基强的松龙40mg /ml(混悬液)治疗的患者听力效果更好。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Local delivery of steroids to inner ear via medical device INCAT (the Inner Ear Catheter) in partial deafness patients during cochlear implantation - preliminary results and a feasibility study.

Background: The primary aim was to assess the effectiveness and safety of three different algorithms of using steroids and inner ear catheter (INCAT) MED-EL® in partial deafness patients who underwent cochlear implantation. The secondary goal was the assessment of the impact of the depth of INCAT on hearing preservation after cochlear implantation.

Research design and methods: There were three algorithms of steroid administration: 1) methylprednisolone 62.5 mg/ml (solution), 3 patients; 2) methylprednisolone 40 mg/ml (suspension), 4 patients; 3) dexamethasone 4 mg/ml (solution), 3 patients. Pure tone audiometry (0.125-8 kHz) was performed preoperatively, 1 and 6 months post-op. Hearing preservation was assessed according to the HEARRING group formula. Impedance measurements were taken at two days, 1 and 6 months after surgery.

Results: Patients treated with methylprednisolone 40 mg/ml in suspension showed the best hearing preservation (50% complete and 50% partial preservation) 1 month post-op and later remained the most favorable. The lowest impedance was found in this group both 1 and 6 months post-op. A shorter INCAT insertion depth appeared to be more favorable than a longer one.

Conclusion: Our results suggest that patients treated with methylprednisolone 40 mg/ml (suspension) had better hearing outcomes compared to the other two medications.

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