平坦型突发性聋药物治疗的多中心研究

Multi-center study of clinical treatment on the flat type of sudden hearing loss

目的探讨平坦型突发性聋不同药物治疗方案的疗效。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。收集年龄在18～65周岁，病程在2周以内，未经任何相关医疗处理的平坦型突发性聋病例『纯音测听所有频率听力均下降，平均听阈（500、1000、2000、4000Hz）≤80dBHL]。采用四种不同治疗方案，根据统一设计的随机表，随机选取其中 一种方案进行治疗（巴曲酶，巴曲酶＋银杏叶提取物，巴曲酶＋银杏叶提取物＋糖皮质激素和银杏叶提取物＋糖皮质激素）。结果2007年8月至2011年10月，全国33家医院共收集符合入组条件的平坦型突发性聋患者402例（占患者总数的39．26％）。其中男219例（54．48％），平均年龄（42．7±12．9）岁；女183例（45．52％），平均年龄（43．7±12．3）岁。治疗后，听力恢复痊愈139例（34．58％），显效118例（29．35％）；有效75例（18．66％），无效70例（17．41％），总有效率为82．59％。四种治疗方案的总有效率分别为77．78％、80．61％、87．39％和83．04％，其中含有激素的治疗方案效果稍好，联合用药有效率最高，但统计学分析组间差异无统计学意义（X2=10．95，P=0．28）。平坦型患者中伴有头晕或眩晕者104例（25．88％），伴耳鸣373例（92．79％），伴有耳闷231例（57．46％），这些伴发症状的疗效在四种治疗方案中，组问差异均无统计学意义（P值均〉0．05）。结论平坦型突发性聋的总体治疗效果较好；改善内耳血液流变学和（或）降低血液纤维蛋白原以及糖皮质激素治疗均有效，联合用药可能效果更好。

Objective To investigate the effect of different treatment options for the flat type of sudden bearing loss. Methods Prospective, muhi-center clinical study was carried out using internationally used standardized clinical research method. Patients with the flat type of sudden hearing loss between 18 and 65 years old, within two weeks duration, and without any medical treatment were recruited. Treatment options were randomly selected according to the designed random table. Results From August 2007 to October 2011 , 402 patients with the flat type of sudden hearing loss who met the criteria （account for 39.26% of the total number of patients）from the 33 hospitals were collected; the total effective rate was 82. 59% , and no significant difference was detected between different treatments, （ X2 = 10.95,P = 0.28）. In the 402 cases, 139 were cured （34.58%） ; 118 were markedly improved （29.35%） ; 75 were effective （ 18.66% ） ; 70 were invalid （ 17.41% ）. Conclusions The therapeutic efficacy of flat type of sudden hearing loss overall is good; the treatment of improving the inner ear blood rheology and/or reducing blood fibrinogen has clinical significance; the therapeutic efficacy of using glucocorticoid systemically is good as well ;there is no obvious difference between combination and single medication.