鼓室内与静脉内皮质类固醇治疗糖尿病患者突发性聋：一项前瞻性、随机优势试验的研究方案建议。
Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial.
机构信息
Department of Otorhinolaryngology, Peking University Shenzhen Hospital, Shenzhen, China.
Hearing and Balance Function Medical Engineering Laboratory, Shenzhen, China.
出版信息
Trials. 2020 Feb 3;21(1):135. doi: 10.1186/s13063-020-4077-x.
BACKGROUND
Diabetes mellitus is associated with risk of sudden sensorineural hearing loss (SSNHL). Systemic and intratympanic corticosteroids are the two primary treatments for SSNHL in patients with diabetes mellitus. The benefit of intratympanic compared to systemic treatment is the reduced systemic steroid exposure and associated systemic adverse effects. Intratympanic corticosteroid administration may have potential benefits over standard systemic therapies.
METHODS/DESIGN: The proposed study is a prospective, randomized superiority trial. A total of 96 patients (48 in each group) will be randomized into the experimental or control group. Patients in the experimental group will receive four 1-mL doses of 40 mg/mL of methylprednisolone over a 1-week period, with a dose administered every 2 days via tympanic membrane injection into the middle ear. The control group will be administered intravenous methylprednisolone (1 mg/kg/day, maximal dose 60 mg/day) for 5 days. The primary outcome for this study is the change in hearing threshold from the first audiogram to the 30-day follow-up audiogram. Secondary outcome measures will include pure-tone average (PTA) at 90-day follow up, visual analog tinnitus scale, visual analog vertigo scale, visual analog aural fullness scale, fasting blood glucose and 2-h postprandial blood glucose during treatment, and the change in glycosylated hemoglobin (HbA1C) levels. Vital signs and otological physical examination will be performed at each follow-up visit.
DISCUSSION
The efficacy and safety of intratympanic methylprednisolone compared to intravenous methylprednisolone will be investigated in patients with diabetes mellitus and SSNHL. This trial may provide strong evidence for the efficacy and safety of intratympanic corticosteroid treatment and important clinical information for the treatment of patients with diabetes mellitus and SSNHL.
TRIAL REGISTRATION
ChiCTR, ChiCTR1800015954. Registered on 2 May 2018, Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=25326.
背景
糖尿病与突发性聋（SSNHL）的发病风险相关。对于糖尿病合并 SSNHL 患者，全身和鼓室内皮质类固醇是两种主要的治疗方法。与全身治疗相比，鼓室内治疗的优势在于减少了全身皮质类固醇暴露和相关的全身不良反应。鼓室内皮质类固醇给药可能比标准全身治疗具有潜在的益处。
方法/设计：拟进行一项前瞻性、随机优势试验。共 96 例患者（每组 48 例）将随机分为实验组或对照组。实验组患者将在 1 周内接受 4 次 1mL 剂量的 40mg/ml 甲泼尼龙，每 2 天通过鼓膜注射至中耳给药 1 次。对照组患者将接受静脉注射甲泼尼龙（1mg/kg/天，最大剂量 60mg/天）5 天。本研究的主要结局是从第一次听力图到 30 天随访听力图的听力阈值变化。次要结局指标包括 90 天随访时的纯音平均听阈（PTA）、耳鸣视觉模拟量表、眩晕视觉模拟量表、耳饱满感视觉模拟量表、治疗期间的空腹血糖和餐后 2 小时血糖，以及糖化血红蛋白（HbA1C）水平的变化。每次随访时都将进行生命体征和耳科学体格检查。
讨论
本试验旨在研究糖尿病合并 SSNHL 患者鼓室内甲泼尼龙与静脉内甲泼尼龙的疗效和安全性。该试验可能为鼓室内皮质类固醇治疗的疗效和安全性提供有力证据，并为糖尿病合并 SSNHL 患者的治疗提供重要的临床信息。
试验注册
ChiCTR，ChiCTR1800015954。注册于 2018 年 5 月 2 日，回顾性注册，网址：http://www.chictr.org.cn/showproj.aspx？proj=25326。
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