摘要
目的:对卡马西平治疗主观性耳鸣的疗效进行初步观察。方法:采用前瞻性随机双盲对照方法观察卡马西平治疗主观性耳鸣的疗效。100例以耳鸣为主诉的门诊患者,排除客观性耳鸣和外中耳疾病,随机分为2组,均给予盐酸氟桂利嗪作为基础用药,研究组加用卡马西平,对照组加用维生素B6,观察治疗1周后的疗效。入选者填写耳鸣调查表,治疗前后进行耳鸣匹配、纯音测听检查。结果:以耳鸣匹配响度为疗效判定标准,用意向治疗(intend to treat,ITT)分析及服从方案完成(per protocol,PP)方法计算卡马西平组的有效率分别为26%、28.3%,对照组的有效率分别为26%、27.7%,卡马西平与盐酸氟桂利嗪合用治疗耳鸣与对照组疗效相同。经统计学检验2组疗效差异无统计学意义。以患者耳鸣主观恢复为疗效判定标准,2组药物治疗耳鸣的有效率亦相同。纯音听阈在治疗前后波动在10 dB以内。研究组和对照组不良反应发生率分别为55.3%、16.7%,差异有统计学意义。结论:本研究提示盐酸氟桂利嗪联合卡马西平治疗耳鸣的疗效与对照组相近,对听力无改善作用,联合用药后不良反应增加,故而在临床中不推荐用于治疗主观性耳鸣。
Objective： To determine whether carbamazepine is effective in treating the subjective tinnitus. Method： Randomized, prospective, double-blind, controlled trial was used in our study. The study group consisted of 100 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, 50 patients were given carbamazepine and Flunarizine Hydrochloride, 50 patients were given Vitamin B6 and Flunarizine Hydrochloride. After a week the effect of the different group of medicines was observed. Tinnius questionnaire was performed before the treatment, and pure tone audiogram, tinnitus pitch and loudness matching were performed at the end of the treatment. Result： Completion of treatment, tinnitus loudness matching assessment showed that the efficacy of the carbamazepine group was similar to that of the control group. The efficacy of treatment was respectively 26 % by intend to treat （ITT） and 28.3 % by per protocol （PP） in the carbamazepine group and 26 % by ITT and 27.7% by PP in the control group. The efficacy of treatment has no statistically significance for tinnitus loudness of the experimental group and the control group. The subjective tinnitus improvement rate showed no difference between two groups. Pure tone thresholds fluctuated within 10 dB in the beginning and at the end of the treatment. There were serious side effects in the carbamazepine group. The side effects rates were respectively 55. 3% and 16.7% in the carbamazepine group and the control group, respectively. The difference had statistical significance. Conclusion：Our results showed that the efficacy of carbamazepine combined with Flunarizine Hydrochloride is similar to that of the control group. There was no improvement in listening. But the side effects of it were more serious than that of the control group. It should not be recommended for the treatment of tinnitus.
出处
《临床耳鼻咽喉头颈外科杂志》
CAS
CSCD
北大核心
2008年第22期1016-1018,1022,共4页
Journal of Clinical Otorhinolaryngology Head And Neck Surgery
关键词
耳鸣
卡马西平
随机对照研究
Tinnius
Carbamazepine
Randomized controlled trials
