【摘要】 目的采用前瞻性临床研究方法观察倍他司汀治疗耳鸣的疗效。方法采用随机、双盲、对照临床研究方法探讨倍他司汀对耳鸣的治疗效果。60例以耳鸣为主诉的门诊患者,排除客观性耳鸣、外中耳疾病,随机分为2组,均给予盐酸氟桂利嗪作为基础用药,试验组加用倍他司汀,对照组加用维生素B6,观察治疗1周后的疗效。治疗前患者均填写耳鸣调查表,治疗前后均进行耳鸣匹配、纯音测听检查。结果以耳鸣匹配响度为疗效判定标准,倍他司汀与盐酸氟桂利嗪联合应用治疗耳鸣的疗效优于维生素B6与盐酸氟桂利嗪联合应用的效果。用服从方案完成及意向治疗方法计算倍他司汀组的有效率分别为65.5%、63.3%,对照组的有效率分别为39.3%、36.7%。按照耳鸣主观恢复为疗效判定标准,试验组和对照组的有效率差异无统计学意义。2组均未出现严重药物不良反应,倍他司汀与盐酸氟桂利嗪联合应用并没有增加或加重药物的不良反应,对听力没有帮助。结论倍他司汀可以作为临床上治疗主观性耳鸣药物的一种选择。但是倍他司汀治疗耳鸣的确切疗效还需大样本、安慰剂对照的长期观察研究。更多还原

【Abstract】 Objective To determine whether Betahistine mesilate is effective in treating tinnitus.Methods Randomized,prospective,double-blind,controlled trial was used in our study. The study group consisted of 60 adult patients who consulted our outpatient clinic complaining of subjective tinnitus,excluded objective tinnitus and the patients who had tinnitus caused by obvious diseases,such as outer and middle ear diseases.Thirty patients were given Betahistine mesilate and Flunarizine Hydrochloride as an experimental group,30 patients were given Vitamine B6 and Flunarizine Hydrochloride as a control group.After a week of treatment the efficacy of the medicines in two groups was observed.Tinnitus questionnaire was performed before the treatment,and pure tone audiogram,tinnitus pitch and loudness matching were performed both in the beginning and at the end of the treatment.Results Completion of treatment,tinnitus loudness matching assessment showed that the efficacy of the Betahistine mesilate group was better then the control group.The efficacy of treatment was respectively 65.5% by per protocol(PP) and 63.3% by intend to treat(ITT) in the Betahistine mesilate group and 39.3% by PP and 36.7% by ITT in the control group.The difference of tinnitus loudness improvement rate between the experimental group and control group was statistically significant.But the subjective tinnitus improvement rate showed no difference between two groups.There were not serious side effects in the two groups.Conclusions Betahistine mesilate can be a choice for tinnitus treatment clinically.Further studies of larger series and placebo-controlled trial are needed.更多还原