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全聋型突发性聋药物治疗的多中心研究

Multi-center study on the treatment of sudden total deafness

摘要目的 探讨全聋型突发性聋的药物治疗.方法 采用前瞻性临床多中心、随机、单盲法研究,纳入年龄18 ~ 65周岁,病程2周内,未经任何相关医疗处理的全聋型突发性聋患者(纯音测听全部频率听阈升高,500、1000、2000、4000 Hz平均听阈≥81 dB HL).按各分中心随机数字表,随机选取四种治疗方案(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)中的一种对患者进行治疗.结果 2007年8月至2011年10月,全国33家医院按标准共纳入符合条件的单侧全聋型突发性聋276例,其中男135例(48.91%),女141例(51.09%);平均年龄(41.7±13.3)岁.治疗后,听力痊愈40例(14.49%),显效78例(28.26%),有效76例(27.54%),无效82例(29.71%),总有效率为70.29%.四种治疗方案中,总有效率分别为73.33%、61.43%、78.31%和67.95%,组间比较差异无统计学意义(x2=9.97,P=0.62).四组中耳聋痊愈率分别为11.11%、12.86%、16.87%和15.38%,使用激素的两组好于未使用者.全聋型突发性聋患者中耳鸣伴发率为92.39%,晕(头晕或眩晕)伴发率为44.93%,耳闷伴发率为50.36%;这些伴发症状的疗效在四种治疗方案中,组间差异无统计学意义(P值均>0.05).结论 全聋型突发性聋患者听力损失重,治疗有效率达70%,值得积极治疗;但痊愈率仅14%,医患对此应有合理预期.激素对提高耳聋痊愈率可能有一定作用,推荐使用.

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abstractsObjective To assess the results of drug therapy in patients with severe idiopathic sudden sensorineural hearing loss (ISSHL) with total frequency hearing loss.Methods A prospective randomized,single blind,multi-center clinical trial was designed.The untreated patients with ISSHL were included,who had severe hearing loss (pure tone audiometry showed patients had total frequency hearing loss,and their mean auditory threshold of 500,1000,2000,4000 Hz was beyond 81 dB HL),age between 18 to 65 years old,and within 14 days of the onset.The patients were divided into one of the four drug groups [batroxobin,batroxobin + ginkgo biloba leaves extract (EGb),batroxobin + EGb + glucocorticoids,EGb + glucocorticoids] according to the random table,and receive treatment.Results Totally 276 patients with unilateral severe ISSHL were included from 33 hospitals,from August 2007 to October 2011.Among them,male patients accounted for 135 (48.91%),female 141 (51.09%) ; the average age was (41.7 ± 13.3)years.Forty cases were recovered (14.49%),78 cases had marked effective (28.26%),76cases were effective (27.54%),82 cases were in-effective (29.71%),and the total effective rate was 70.29%.Among four drug groups,the separate effective rate were 73.33%,61.43%,78.31% and 67.95 % respectively,no significant difference was found between groups (x2 =9.97,P =0.62).Among the four groups,the separate cure rate for hearing loss were 11.11%,12.86%,16.87% and 15.38%,the glucocorticoid groups were significantly better than those not used.Among severe sudden deafness patients,92.39% cases accompanied with tinnitus,44.93% with dizziness (or vertigo),50.36% with ear stuffy.There had no significant difference between the four groups with accompanied symptoms (all P > 0.05).Conclusions It is value to give active treatment to sever sudden deafness patients because of an effective rate of 70%.However,the doctors and patients should be mind of a cure rate of only 14%.Steroids are recommended bacause it may play a role in the improvement rate.

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