低中频下降型突发性聋药物治疗的多中心研究  

Multi-center clinical study on the treatment of the low-middle frequency sudden hearing loss

作　　者：郑亿庆[1] 区永康[1] 许耀东[1] 张雪媛[1] 孙建军[2] 刘阳[2] 林勇生[2] 刁明芳[2] 陈东兰[2] 无 

机构地区：[1]中山大学孙逸仙纪念医院耳鼻咽喉科,广州510120 [2]海军总医院全军耳鼻咽喉头颈外科中心 [3]中国突发性聋多中心临床研究协作组

出　　处：《中华耳鼻咽喉头颈外科杂志》2013年第5期362-367,共6页Chinese Journal of Otorhinolaryngology Head and Neck Surgery

摘　　要：目的探讨低中频下降型突发性聋患者药物治疗的疗效。方法采用国际通用的标准化临床研究方法，统一设计、统一方案进行前瞻性临床多中心研究。2007年8月至2011年10月间，全国33家协作医疗中心共收集低中频下降型突发性聋205例（250、500Hz两个频率或1000Hz下降15dBHL以上），根据统一设计的随机表，随机选取四种治疗方案中的一种进行治疗[糖皮质激素、银杏叶提取物（金纳多）、巴曲酶注射液（东菱迪芙）和金纳多＋激素联合治疗方案]，随访4周，对疗效进行统计分析。结果205例患者治疗后痊愈158例（77．07％）、显效9例（4．39％）、有效19例（9．27％）、无效19例（9．27％），总有效率为90．73％。四种方案的总有效率分别为：金纳多组（55例）87．27％，激素组（37例）89．19％，东菱迪芙组（41例）87．80％，金纳多＋激素组（72例）95．83％，组间比较，差异无统计学意义（X2=7．98，P=0．54）。四种方案的治愈率分别为：金纳多组81．01％，激素组76．36％，东菱迪芙组68．29％，金纳多＋激素组80．56％，各方案治愈率之间差异无统计学意义（P〉0．05）。结论低中频下降型突发性聋的预后较好，激素在治疗中发挥优良的效果，金纳多与激素联合用药可能是值得推荐的。Objective To investigate and compare the short-term outcome of patients with low- middle frequency sudden deafness treated with alone or combination treatment. Methods From August 2007 to October 2011, 205 patients with the diagnosis of low-middle frequency sudden deafness who were from 33 different clinical centers were recruited. All patients were followed up for four weeks from the initial examination. Patients were treated with steroid , Ginaton, batroxobin respectively, or Ginaton and steroid combination treatment. Results The total effective rate was 90.73%. In Ginaton group, the total effective rate was 87.27% , 89.19% in steroid group, 87.80% in batroxobin group, and 95.83% in Ginaton and steroid group. Considering the total effective rate, there was no statistical difference between four groups （X2 =7.98,P =0.54）. The clinical cure rate for steroid alone was 81.01% , Ginaton alone 76.36% , batroxobin alone 68.29%, and Ginaton and steroid combination treatment 80.56%. There were no clinically significant differences between the different treatments（P 〉 0.05 ）. Conclusions The low-middle frequency sudden deafness tends to have a relatively favorable prognosis. The steroid played a good effect in the treatment. But different treatments either improving the microcirculation of inner ear or alleviating edema blood has undifferentiated results. Therefore the combination therapy may be more effective.

关 键 词：听觉丧失 突发性 测听法 纯音 随机对照试验 药物疗法 

分 类 号：R764.437[医药卫生—耳鼻咽喉科]