Glucocorticoid Postauricular Injection Treatment for Sudden Hearing Loss: a Multi-center, Opened, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Pure tone audiometry test
研究概览
简要总结
The incidence of sudden hearing loss is rising obviously resent year, Glucocorticoids have obtained obvious effect in the treatment of sudden deafness. Postauricular hypodermic injection is the latest findings in clinical work and a new noninvasive way of administration which is gradually expanding research. The aim of this experiment is to verify and explore the efficacy and safety of the postauricular injection treatment with different doses of Glucocorticoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years, less than 60 years old;
- •patient with unilateral or bilateral（occured successively) acute sensorineural hearing loss(ASNHL) with onset 72hours or less ago. Mean hearing loss compared with the unaffected contralateral ear of at leat 60 dB;
- •Primary presentation within 2weeks; standard treatment for 2 weeks;
- •After 2weeks of standard treatment, sensorineural hearing loss (SHL) curative effect evaluation damaged frequencies >/=30 dB better than before;
- •Written informed consent before participation in the study.
排除标准
- •SYSTEMIC DISEASE
- •History of tuberculosis or positive purified protein derivative (PPD);
- •Insulin-dependent diabetes mellitus;
- •Hypertension, poor control of BP(SBP/DBP)>=140mmHg);
- •History of rheumatic disease, e.g. rheumatoid arthritis, scleroderma, lupus, etc;
- •Serious psychiatric disease or psychiatric reaction to corticosteroids;
- •History of heart disease or transient ischemic attacks(TIAs);
- •Prior treatment with chemotherapeutic or immunosuppressive drugs;
- •Pancreatitis;
- •Active peptic ulcer disease or history of gastrointestinal bleeding;
- •History of HIV, Hepatitis B or C;
- •Chronic kidney failure;
- •Alcohol abuse;
- •Active shingles;
- •Severe osteoporosis or non-surgical aseptic necrosis of the hip;
- •Without contraindication with glucocorticoid, ginaton, Batroxobin.
- •OTOLOGIC DISEASE
- •History of Meniere's disease;
- •History of chronic ear infection;
- •Prior history of sudden sensorineural hearing loss (SSNHL);
- •History of fluctuating hearing loss.
研究组 & 干预措施
regular treatment comparator
Ginaton
干预措施: Ginaton (Drug)
Dexamethasone Phosphate low dose
5mg
干预措施: Dexamethasone Phosphate (Drug)
Dexamethasone Phosphate high dose
10mg
干预措施: Dexamethasone Phosphate (Drug)
结局指标
主要结局
Pure tone audiometry test
时间窗: Days 30
Average change in hearing loss in decibel(dB) between the baseline and D 30 for the three contiguous frequencies with the worst hearing loss, and the treatment efficiency of the 30th day.
次要结局
- Vertigo with Evaluation questionnaire(Day 14,30,90)
- Tinnitus with Evaluation questionnaire(days 14,30,90)
研究者
Li Sheng Yu
Professor
Peking University People's Hospital