Albu Silviu, Chirtes Felician, Trombitas Veronica, Nagy Alina, Marceanu Luigi, Babighian Gregorio, Trabalzini Franco
Second Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania; Ro-Neuro Clinic Cluj-Napoca, Romania.
Second Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania.
Am J Otolaryngol. 2015 Mar-Apr;36(2):205-9. doi: 10.1016/j.amjoto.2014.10.032. Epub 2014 Oct 30.
The objective of our randomized, double-blind study was to compare the effectiveness of intratympanic (IT) dexamethasone versus high-dosage of betahistine in the treatment of patients with intractable unilateral Meniere disease (MD).
Sixty six patients with definite unilateral MD were randomly divided in two groups: Group A received a combination of IT dexamethasone (DX) and identical-appearing placebo pills while Group B received a combination of high-dosage betahistine and IT saline. Intratympanic injections were repeated for three times with an interlude of 3days. High-dosage of betahistine entailed 144mg/day. Mean outcome measures consisted of vertigo control, pure tone average (PTA), speech discrimination score, Functional Level Score, Dizziness Handicap Inventory and Tinnitus Handicap Inventory.
Fifty nine patients completed the study and were available at 12months for analysis. In Group A complete vertigo control (class A) was attained in 14 patients (46.6%) and substantial control (class B) in 7 patients (20%). In Group B, 12 patients (41%) achieved complete vertigo control (class A), 5 patients (17%) substantial control (class B). There is no statistical difference in vertigo control between the two treatment groups. In Group A hearing was unchanged in 14 patients and improved in 4 patients, while in Group B hearing was unchanged in 16 patients and improved in 2 patients.
Our preliminary results demonstrate that high-dosage of betahistine achieved similar outcomes as IT dexamethasone in the control of vertigo and hearing preservation.
我们这项随机双盲研究的目的是比较鼓室内注射地塞米松与高剂量倍他司汀治疗难治性单侧梅尼埃病（MD）患者的疗效。
66例确诊为单侧MD的患者被随机分为两组：A组接受鼓室内注射地塞米松（DX）与外观相同的安慰剂丸剂联合治疗，而B组接受高剂量倍他司汀与鼓室内注射生理盐水联合治疗。鼓室内注射重复3次，间隔3天。高剂量倍他司汀为每日144mg。平均观察指标包括眩晕控制、纯音平均听阈（PTA）、言语识别率、功能水平评分、头晕残障量表和耳鸣残障量表。
59例患者完成研究，可在12个月时进行分析。A组中，14例患者（46.6%）实现了完全眩晕控制（A级），7例患者（20%）实现了显著控制（B级）。B组中，12例患者（41%）实现了完全眩晕控制（A级），5例患者（17%）实现了显著控制（B级）。两组治疗在眩晕控制方面无统计学差异。A组中，14例患者听力未变，4例患者听力改善；而B组中，16例患者听力未变，2例患者听力改善。
我们的初步结果表明，高剂量倍他司汀在眩晕控制和听力保留方面取得了与鼓室内注射地塞米松相似的效果。
