【摘要】 目的对中药新药骨参舒耳片治疗感音神经性耳聋耳鸣的疗效进行Ⅱ期临床研究。方法 120例感音神经性耳聋耳鸣病人,随机分为双盲治疗组、对照组和开放治疗组,每组患者各40例,分别给予骨参舒耳片和对照药进行治疗。用药前后分别检测血、尿常规和肝肾功能以评价其安全性,观察比较中医临床症状、纯音听阈和耳鸣疗效以评价其有效性。结果治疗组耳聋总有效率42.2%,愈显率4.6%;对照组总有效率18.7%,愈显率0%;开放治疗组耳聋总有效率58.7%,愈显率6.3%;治疗组耳鸣总有效率89.2%,愈显率59.5%;对照组耳鸣总有效率30.8%,愈显率5.1%;开放治疗组耳鸣总有效率74.3%,愈显率57.1%。统计学分析结果显示,治疗组与对照组疾病疗效及中医症候疗效差异均具有统计学意义。用药过程中无不良反应出现。结论骨参舒耳片治疗感音神经性耳聋耳鸣的疗效及安全性均较好。更多还原

【Abstract】 Objective To investigate the therapeutic effects of Gushen Shuer Pian(GSSEP) on sensorineural deafness and tinnitus based on a phase II clinical trial.Methods One hundred and twenty patients with sensorineural hearing loss and tinnitus were randomly divided into 3 groups,i.e.treatment group(TG),control group(CG) and open-treatment group(OTG),treated by GSSEP or controlling preparations respectively.Then,determined were blood routine,urine routine,liver function and kidney function to evaluate the safety of GSSEP,and the changes in hearing level and tinnitus loudness and symptoms improving effects in terms of TCM to assess the efficacy of this preparation on the lesion evaluated in a comparative way.Results For hearing loss,the total effective rate was 42.2%and significantly effective rate was 4.6%in TG,they were 18.7%and 0%in CG,and 58.7%and 6.3%in OTG respectively.For tinnitus,these two indexes were 89.2%and 59.5%,30.8%and 5.1%,74.3%and 57.1%for TG,CG and OTG respectively.The differences in therapeutic effects,either for lesion or for symptoms,among them were statistically significant.Conclusions Based on the results of this study,Gushen Shuer Pian should be safe and effective for the treatment of sensorineural hearing loss and tinnitus.更多还原