七叶皂苷钠治疗梅尼埃病的临床初步研究报告

Preliminary Results of Sodium Aescinate in Treatment of Meniere’s Disease

目的初步探讨七叶皂苷钠治疗梅尼埃病后的症状改善情况及药物安全性。方法选取2019年7月-2020年7月到各中心耳鼻喉科就诊的单侧发病的梅尼埃病确诊患者为研究对象,男女不限。给予七叶皂苷钠片剂口服,治疗周期为8周,随访6个月。记录并计算患者治疗前后的眩晕发生率,听力、耳鸣、耳胀满感症状的改善情况。结果一共26名单侧梅尼埃病患者纳入本研究并随访6个月。治疗后眩晕症状发生率有所下降,与治疗前88.5%相比,随访的第8周降低到23.8%,随访3个月时下降到21.1%。治疗后听力水平有所改善,尤其对于低中频听力改善明显(从100%下降到46.2%)。其他症状如耳闷胀和耳鸣症状发生率均比治疗前有所下降。研究期间仅有个别患者有胃肠道不适,无其他不良反应发生。结论七叶皂苷钠能部分缓解梅尼埃病眩晕发作频率和症状,也能改善和稳定低中频听力下降情况,同时减轻耳闷胀及耳鸣症状,提高患者的生活质量,无严重不良事件发生。此研究为梅尼埃病的内科治疗提供了新的药物选择方向,也将为下一步的深入研究打下良好基础。

Objective To report efficacy and safety of sodium aescinate in the treatment of Meniere’s disease.Methods Patients with unilateral Meniere’s disease who visited the authors’departments from July 2019 to July 2020were included in this study.Oral sodium aescinate was given for 8 weeks,with 6 months follow-up.Vertigo attacks,hearing changes,and other symptoms before and after treatment were recorded and analyzed.Results A total of 26 patients were entered into this study.The incidence of spontaneous vertigo attacks decreased from 88.5%before treatment to 23.8%at 8 weeks and to 21.1%at 3 months follow-up.Hearing complaints(especially in low-and mid-frequency)improved over the period of 6 months(from 100%to 46.2%).The incidence of other symptoms such as aural fullness and tinnitus all decreased compared to before treatment.Only a few patients reported gastrointestinal discomfort during the study period,wih no other adverse reactions.Conclusions Sodium aescinate can effectively reduce vertigo severity and frequency and may improve or preserve hearing loss,with potential positive effects on aural fullness,tinnitus and quality of life.This study provides a new drug selection option for medical treatment of Meniere’s disease and lays a solild foundation for further in-depth research.