巴曲酶联合银杏达莫注射液治疗突发性耳聋的临床疗效及安全性评价

Clinical efficacy and safety of batroxobin combined with gingko injection in the treatment of sudden deafness

目的评价巴曲酶联合银杏达莫注射液治疗突发性耳聋的临床疗效及安全性。方法将118例突发性耳聋患者随机分为对照组59例和试验组59例。对照组予以巴曲酶10 BU＋0.9%氯化钠100 mL,隔天一次;试验组在对照组的基础上,静脉注射银杏达莫注射液15 mL＋5%葡萄糖10-25 mL,每天两次。2组患者均治疗10 d。比较2组患者的临床疗效、纤维蛋白原水平、血流动力学、凝血功能以及不良反应发生率。结果治疗后,试验组的总有效率为93.22%显著高于对照组的83.05%（P〈0.05）。治疗后,2组患者的纤维蛋白原水平、血流动力学、凝血功能均明显优于治疗前（P〈0.05）,且试验组上述指标的改善程度明显优于对照组（P〈0.05）。对照组和试验组的不良反应发生率分别为5.08%和10.07%（P〉0.05）,但试验组的不良反应恢复时间明显短于对照组（P〈0.05）。结论巴曲酶联合银杏达莫注射液治疗突发性耳聋的临床疗效确切,可明显降低纤维蛋白原水平,改善血流动力学指标和凝血功能,且不增加不良反应的发生率。

Objective To evaluate the clinical efficacy and safety of batroxobin combined with gingko injection in the treatment of sudden deafness. Methods A total of 118 patients with sudden deafness were randomly divided into control group（n = 59） and treatment group（n = 59）. Control group was received batroxobin 10 BU ＋0. 9% NaCl 100 mL,every other day. Treatment group was given 5% glucose 10-25 mL ＋gingko injection 15 mL,twice a day,on the basis of control group. The course of treatment for two groups was 10 d. The clinical efficacy,fibrinogen levels,hemodynamics,blood coagulation,and the incidence of adverse drug reactions were compared between two groups. Results After treatment,total effective rate in treatment group was significantly higher than that in control group（93. 22% vs 83. 05%,P〈0. 05）. After treatment,the fibrinogen levels,blood rheology and coagulation of the two groups were better than those before treatment with significant difference（P〈0. 05）,and the degree of improvement in treatment group were significantly better than that in control group（P〈0. 05）. The incidence of adverse drug reactions of control group and treatment grou were 5. 08%,10. 07%,respectively without statistically significant difference（P〉0. 05）.The recovery time of adverse drug reactions of treatment group was shorter than that of control group with statistically significant difference（P〈0. 05）. Conclusion Batroxobin combined with ginkgo injection has a definitive clinical efficacy for the treatment of sudden deafness,it can significantly reduce fibrinogen levels,improve hemodynamics and blood coagulation,without increasing the incidence of adverse drug reactions.