地塞米松注射液通过耳后骨膜与鼓膜穿刺给药治疗突发性耳聋伴2型糖尿病的临床研究

Clinical trial of dexamethasone injection in the treatment of sudden deafness with type 2 diabetes mellitus by posterior auricular periosteum and tympanic membrane

目的比较地塞米松注射液通过耳后骨膜与鼓膜穿刺给药治疗突发性耳聋伴2型糖尿病的临床疗效及安全性。方法将124例突发性耳聋伴2型糖尿病患者随机分为对照组和试验组,每组62例。对照组予以地塞米松每次2. 5mg,qod,于患耳鼓膜穿刺给药;试验组予以地塞米松每次5. 0 mg,qod,于患耳后骨膜下注药。2组患者给药4次为1个疗程,均治疗1～2个疗程。比较2组患者的临床疗效、纯音听力测试(PTA)改善程度、血糖指标,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为80. 65%(50例/62例)和85. 48%(53例/62例),差异无统计学意义(P> 0. 05)。治疗后,试验组和对照组的PTA改善程度分别为(33. 08±5. 93)和(32. 04±5. 30) dBHL,空腹血糖分别为(10. 95±2. 45)和(11. 02±2. 52) mmol·L^(-1),餐后2 h血糖分别为(13. 21±2. 59)和(13. 29±2. 62) mmol·L^(-1),糖化血红蛋白分别为(9. 58±2. 32)%和(9. 67±2. 39)%,差异均无统计学意义(均P> 0. 05)。试验组的药物不良反应主要有眩晕和烧灼感,对照组的药物不良反应主要有眩晕、中耳感染、鼓膜穿孔和烧灼感。试验组和对照组的总药物不良反应发生率分别为3. 23%和14. 52%,差异有统计学意义(P <0. 05)。结论地塞米松注射液通过耳后骨膜与鼓膜穿刺给药治疗突发性耳聋伴2型糖尿病的临床疗效相当,但耳后骨膜下注药方式的药物不良反应发生率较低。

Objective To compare the clinical efficacy and safety of dexamethasone injection in the treatment of sudden deafness with type 2 diabetes by posterior auricular periosteum and tympanic membrane.Methods A total of 124 sudden deafness patients with type 2 diabetes were randomly divided into control and treatment groups with 62 cases per group. Control group was given dexamethasone 2. 5 mg per time,qod,tympanic membrane puncture. Treatment group was given dexamethasone5. 0 mg per time,qod,posterior periosteal injection. Two groups of patients were administered 4 times for one course of treatment,all of which were treated for 1 to 2 courses. The clinical efficacy,improvement of pure tone average（ PTA）,blood glucose indexes and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 80. 65%（ 50 cases/62 cases） and 85. 48%（ 53 cases/62 cases） without significant difference（ P〉0. 05）. After treatment,the main indexes of treatment and control groups were compared： improvement of PTA were（ 33. 08 ± 5. 93） and（ 32. 04 ± 5. 30） dBHL,fasting blood glucose were（ 10. 95 ± 2. 45） and（ 11. 02 ± 2. 52） mmol·L^-1,2-hour postprandial blood glucose were（ 13. 21 ± 2. 59） and（ 13. 29 ± 2. 62） mmol · L^-1,glycosylated hemoglobin A1c were（ 9. 58 ± 2. 32） % and（ 9. 67 ± 2. 39） %. The differences were not statistically significant（ all P〉0. 05）. The adverse drug reactions of treatment group were dizziness and burning sensation,which in control group were dizziness,middle ear infection,tympanic membrane perforation and burning sensation. The total incidences of adverse drug reactions in treatment and control groups were 3. 23% and 14. 52%,with significant difference（ P〈0. 05）. Conclusion Dexamethasone injection through posterior auricular periosteum and tympanic membrane for sudden deafness with type 2 diabetes mellitus has considerable therapeutic effect,but the adverse reactions of posterior auricular periosteum are low.