巴曲酶治疗老年突聋患者的安全性评估

Safety of batroxobin in treatment of sudden hearing loss in the elderly

目的 通过检测纤维蛋白原（FIB）评估巴曲酶治疗老年突聋患者的安全性.方法 选择2014年1月至2014年12月在北京大学人民医院康复医学科住院并接受巴曲酶治疗的患者111例,依据年龄分为老年组（≥60岁）与中青年组（20-59岁）.巴曲酶治疗方案为首剂10BU,如年龄＞70岁者,改为5BU.采集患者应用巴曲酶前、应用巴曲酶后次日或隔天静脉血,检测FIB结果及全身出血情况.结果 用药前中青年组FIB水平为（297.13±97.62） mg/dl,老年组为（302.38±53.08） mg/dl,两组间差异无统计学意义（P=0.812）;在治疗过程中两组间FIB水平及用药前后FIB下降程度差异均无统计学意义（P＞0.05）;用药期间老年组在第4天危机值的发生率明显高于中青年组,其他时间点差异无统计学意义.结论 巴曲酶治疗老年突聋患者,其安全性与在中青年患者中是无差异的.

Objective To evaluate the safety of batroxobin （defibrating therapy） in the treatment of sudden hearing loss in the elderly patients by detecting serum level of fibrinogen （FIB）. Methods A total of 111 patients suffering from hearing loss or tinnitus admitted in the Department of Rehabilitation of our hospital from January to December 2014 were recruited in this study. They were divided into 2 groups according to their age, the elderly group （age ≥ 60 years） and the young and middle-aged group （aged from 20 to 59 years）. Both of them received 10BU batroxobin on day 1 （if the patient was older than 70 years, the dose was 5BU） and other conventional therapies. The blood level of FIB was tested before, and at 1 st or 2nd day after batroxobin treatment. Their systematic bleeding was also observed. Results At the beginning of the treatment, there was no difference in the FIB level between the elderly and young and middle-aged groups [（302.38 ± 53.08） vs （297.13± 97.62）mg/dl, P = 0.812]. During the treatment, no difference was seen in FIB level and decline of FIB between the 2 groups. The incidence of crisis on the 4th day was obviously higher in the elderly group than in the young and middle-aged group, but no such difference was seen at other time points. Conclusion There is no difference in the safety of batroxobin in treatment of sudden hearing loss between the elderly and young and middle-aged patients.