【摘要】 目的:研究鼓室内注射布地奈德(BUD)治疗12岁以上儿童及成人分泌性中耳炎(OME)患者的长期疗效及对主观症状的改善情况。方法:将180例OME患者按照单盲、随机、平行对照原则分为BUD组、地塞米松注射液组(DEX对照组)和0.9%NaCl溶液组(NS对照组),分别行鼓室内注射BUD(0.5 mg/ml)、DEX(5mg/ml)、NS(1ml),每周1次,同时记录每次治疗情况和患者主观症状评分,直至治愈或退出,治疗结束后随访3年。使用生存曲线图分析3组患者疗效差别,使用视觉模拟评分法(VAS)比较3组患者主观症状改善程度。结果:在控制了病程、抽出液体体积与抽出液体性状及其他因素的作用后,治疗方式为BUD组的患者治疗结果无效或复发的危险性是NS对照组患者的0.131倍(95%CI 0.053-0.354)。生存曲线示BUD组96.6%(57/59)的患者有效保持时间为3个月以上,83.1%(49/59)的患者有效保持时间为1年以上,81.4%(48/59)的患者有效保持时间为3年以上;DEX对照组73.2%(41/56)的患者有效保持时间为3个月以上,46.4%(26/56)的患者有效保持时间为1年以上,42.9%(24/56)的患者有效保持时间为3年以上;NS对照组50.8%(33/65)的患者有效保持时间为3个月以上,26.2%(17/65)的患者有效保持时间为1年以上,20.0%(13/65)的患者有效保持时间为3年以上。3种药物鼓室内注射对于OME的纵向疗效从高到低依次为BUD、DEX、NS(P<0.05)。BUD组在改善耳闷症状方面优于DEX组和NS组,同时前两者改善主观症状和提高生活质量方面均优于NS组(P<0.05)。试验过程中未出现严重并发症及后遗症。结论:鼓室内注射BUD是治疗12岁以上儿童及成人OME患者长期、有效和安全的治疗方法。更多还原

【Abstract】 Objective:To assess the longitudinal curative effect and improvement of subjective symptoms by using intratympanic injection of budesonide(BUD)for OME patients over 12 years old and adults.Method:One hundred and eighty patients who were diagnosed as OME were recruited.A single-blind,randomized,parallel-control prospective study was performed.Dexamethasone(DEX)and sodium chloride(NS)were served as controls.The patients were randomly assigned into three groups,which respectively received intratympanic injection of BUD(0.5mg/ml),DEX(5mg/ml)or 0.9% NS solution(1ml)once a week.Survival analysis was applied to compare the longitudinal curative effect among the three groups.Meanwhile,seven main subjective symptoms were scored by 10-point visual scale(VAS)and physician’s evaluations were preformed during treatment and follow-up.Result:After adjustement for course of disease,volume and characters of effusion,the relative risk(RR)of BUD was0.131(95%CI0.053-0.354)when compared with NS.Survival curve showed,in BUD group,about 96.6%(57/59)of patients maintained effectiveness more than 3months,83.1%(49/59)were more than 1year,and 81.4%(48/59)of the patients could sustain longer than 3years.In DEX group,73.2%(41/56)of patients showed effectiveness more than 3months,46.4%(26/56)were more than 1year,and 42.9%(24/56)of the patients could sustain longer than 3years.While in NS group,50.8%(33/65)of the patients showed effectiveness more than 3months,26.2%(17/65)were more than 1year,and 20.0%(13/65)of the patients could sustain longer than 3years.Survival curve demonstrated that the rank of longitudinal therapeutic efficacy was BUD,DEX and NS(P<0.05).Both BUD and DEX showed improvements in subjective symptoms and quality of life(except for mental stress)compared with NS(P<0.05).In the aspect of improving the symptom of stuffy ear,BUD showed advantage over both DEX and NS.During and after treatment,no serious complications or sequelae were observed.Conclusion:Intratympanic injection with BUD for OME patients showed advantages in improving long-term therapeutic efficacy,it was a safe as well as effective intervention for children over age of 12 and adults suffering from OME.更多还原