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比较鼓室内注射庆大霉素与甲基强的松龙治疗听力不可用的梅尼埃病的疗效

Comparing Intratympanic Gentamicin with Methylprednisolone in Meniere's Disease with Non-Serviceable Hearing.

作者信息

Thomas Leah, Lepcha Anjali, Reka K, Augustine Ann Mary, Alex Anu, Philip Ajay, Mammen Manju Deena

机构信息

Christian Medical College Vellore, Chittoor Campus, Chittoor, Andhra Pradesh India.

Department of ENT, Christian Medical College, Vellore, Tamil Nadu 632004 India.

出版信息

Indian J Otolaryngol Head Neck Surg. 2022 Dec;74(Suppl 3):3738-3745. doi: 10.1007/s12070-021-02528-6. Epub 2021 Apr 1.

Abstract

ABSTRACT

To compare the effectiveness of high dose fixed alternate day intratympanic gentamicin with methylprednisolone in the treatment of patients with unilateral, intractable Meniere's disease with poor hearing. Randomized single blind prospective parallel group trial in a tertiary referral centre. Twenty-two patients with definite unilateral Meniere's disease with average pure tone thresholds worse than 50 dB in the affected ear were enrolled. Eleven patients were treated with intratympanic buffered gentamicin and the other eleven were administered intratympanic methylprednisolone (both 4 injections, 40 mg/ml, on alternate days). Patients were assessed pre-intervention, 3 months post intervention and subsequently followed up for 2-4 years. Both groups of patients had significant control of vertigo, DHI scores and THI scores after treatment while the functional scores in the methylprednisolone group was not better than the pre- treatment scores in the long-term follow-up. 9 of 11(82%) patients in gentamicin group and 3 of 11(27%) patients in the methylprednisolone group achieved Class A vertigo control. The gentamicin group had better post intervention DHI scores ( = 0.016, 3 months and  = 0.046, long term) and Functional score ( = 0.014, 3 months and  = 0.05, long term). The hearing in both groups and THI scores, post intervention was similar between both groups. In patients with unilateral intractable MD with non-serviceable hearing, high fixed doses of both intratympanic gentamicin and methylprednisolone are effective in alleviating disease symptoms in long term follow-up. However, intratympanic gentamicin resulted in better control of vertigo, total DHI score and functional level scores than intratympanic methylprednisolone with no significant difference in hearing levels.

TRAIL REGISTRATION NUMBER

Clinical Trials Registry of India (CTRI- REF/2016/10/012363).

摘要

摘要

比较高剂量固定隔日鼓室内注射庆大霉素与甲基强的松龙治疗单侧、难治性梅尼埃病且听力较差患者的疗效。在一家三级转诊中心进行随机单盲前瞻性平行组试验。纳入22例确诊为单侧梅尼埃病且患耳平均纯音阈值高于50dB的患者。11例患者接受鼓室内注射缓冲庆大霉素治疗,另外11例接受鼓室内注射甲基强的松龙治疗(均为4次注射,40mg/ml,隔日一次)。在干预前、干预后3个月对患者进行评估,随后进行2至4年的随访。两组患者治疗后眩晕、DHI评分和THI评分均得到显著控制,但甲基强的松龙组的功能评分在长期随访中并不优于治疗前评分。庆大霉素组11例患者中有9例(82%)、甲基强的松龙组11例患者中有3例(27%)达到A级眩晕控制。庆大霉素组干预后的DHI评分更好(3个月时P = 0.016,长期时P = 0.046)以及功能评分更好(3个月时P = 0.014,长期时P = 0.05)。两组干预后的听力和THI评分相似。对于单侧难治性梅尼埃病且听力无用的患者,高固定剂量的鼓室内注射庆大霉素和甲基强的松龙在长期随访中均能有效缓解疾病症状。然而,鼓室内注射庆大霉素在眩晕控制、总DHI评分和功能水平评分方面比鼓室内注射甲基强的松龙更好,而听力水平无显著差异。

试验注册号

印度临床试验注册中心(CTRI-REF/2016/10/012363)

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本文引用的文献

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