Long-Term Follow-Up of Intratympanic Methylprednisolone Versus Gentamicin in Patients With Unilateral Meniere's Disease
Long-Term Follow-Up of Intratympanic Methylprednisolone Versus Gentamicin in Patients With Unilateral Meniere's Disease
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DOI：
10.1097/mao.0000000000002108
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发表时间：
2019-04-01
影响因子：
2.1
通讯作者：
Bronstein, Adolfo Miguel
中科院分区：
文献类型：
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作者：
Harcourt, Jonny Philip;Lambert, Aileen;Bronstein, Adolfo Miguel
目的：确定梅尼埃病患者的症状性眩晕是否能得到持续的长期（>48 个月）控制，这些试验是通过先前的鼓室内甲基泼尼松龙与庆大霉素的比较试验得出的，以及两种治疗方法在长期随访中是否保持无显着差异。研究设计：记录前 1 个月和 6 个月眩晕频率的邮件调查、接受的进一步鼓室内治疗以及经过验证的症状问卷。地点：门诊医院诊所患者：患有明确的单侧难治性梅尼埃病的成年患者，之前在比较试验中接受过鼓室内治疗。干预：对接受鼓室内庆大霉素（40 mg/mL）或甲基泼尼松龙（62.5 mg/mL）的试验参与者进行调查。结果指标：主要：接受本调查前 6 个月内与第一次试验注射前 6 个月相比，眩晕发作次数。过去1个月内眩晕发作的次要次数；验证了耳鸣、头晕、眩晕、听觉饱胀感和功能障碍的症状问卷评分。结果：60 名原始试验患者中有 46 名 (77%) 完成了调查，其中 24 名来自庆大霉素组，22 名来自甲泼尼龙组。自第一次治疗注射起平均随访时间为 70.8 个月（标准差 17.0）。与基线相比，两个药物组在接受本次调查之前 6 个月内的眩晕发作次数均减少了 95%（意向治疗分析，均 p < 0.001）。药物之间的主要和次要结局没有发现显着差异。八名参与者（甲基强的松龙 = 5 和庆大霉素 = 3）在完成最初的试验后需要进一步注射以防止复发。结论：鼓室内甲基强的松龙治疗可有效、持久地缓解眩晕，且没有与庆大霉素相关的已知内耳毒性。在长期随访中，两种治疗之间没有显着差异。
Objectives: To determine whether long term (>48 months) symptomatic vertigo control is sustained in patients with Meniere's disease from a previous comparative trial of intratympanic methylprednisolone versus gentamicin, and if the two treatments remain nonsignificantly different at long-term follow-up.Study Design: Mail survey recording vertigo frequency in the previous one and six months, further intratympanic treatment received, and validated symptom questionnaires.Setting: Outpatient hospital clinic setting.Patients: Adult patients with definite unilateral refractory Meniere's disease, who previously received intratympanic treatment in a comparative trial.Intervention: A survey of trial participants who received intratympanic gentamicin (40 mg/mL) or methylprednisolone (62.5 mg/mL).Outcome measures: Primary: number of vertigo attacks in the 6 months prior to receiving this survey compared with the 6 months before the first trial injection. Secondary number of vertigo attacks over the previous 1 month; validated symptom questionnaire scores of tinnitus, dizziness, vertigo, aural fullness, and functional disability.Results: Forty six of the 60 original trial patients (77%) completed the survey, 24 from the gentamicin and 22 from the methylprednisolone group. Average follow-up was 70.8 months (standard deviation 17.0) from the first treatment injection. Vertigo attacks in the 6 months prior to receiving the current survey reduced by 95% compared to baseline in both drug groups (intention-to-treat analysis, both p < 0.001). No significant difference between drugs was found for the primary and secondary outcomes. Eight participants (methylprednisolone = 5 and gentamicin = 3) required further injections for relapse after completing the original trial.Conclusion: Intratympanic methylprednisolone treatment provides effective long-lasting relief of vertigo, without the known inner-ear toxicity associated with gentamicin. There are no significant differences between the two treatments at long term follow-up.