不同剂量布地奈德混悬液雾化吸入联合盐水鼻腔冲洗治疗腺样体肥大患儿的随机对照研究  

Different doses of budesonide nebulized inhalation and saline nasal irrigation in children with adenoid hypertrophy:A randomized controlled study

作　　者：张云飞[1] 黄钺[1] 段博 倪祎华 李琪 戴玉琼[1] 陈文霞[1] 许政敏[1] ZHANG Yun-fei;HUANG Yue;DUAN Bo(Department of Otorhinolaryngology Head and Neck Surgery,Children’s Hospital of Fudan University,Shanghai 201102,China)

机构地区：[1]复旦大学附属儿科医院耳鼻咽喉头颈外科,上海201102

出　　处：《中国实用儿科杂志》2023年第5期368-375,共8页Chinese Journal of Practical Pediatrics

基　　金：复旦大学附属儿科医院院级课题(EK00000712)。

摘　　要：目的探究不同剂量的布地奈德雾化吸入联合盐水鼻腔冲洗对腺样体肥大患儿干预治疗的临床疗效。方法收集2021年10月至2022年2月期间在复旦大学附属儿科医院耳鼻咽喉头颈外科门诊就诊的60例腺样体肥大患儿,按照随机数字表法,将患儿随机分配至布地奈德高剂量组(A组:布地奈德1mg/次+盐水鼻腔冲洗)、布地奈德低剂量组(B组:布地奈德0.5 mg/次+盐水鼻腔冲洗)、对照组(C组:盐水鼻腔冲洗)3组,每组20人,观察时间8周。采用χ^(2)检验、方差分析、重复测量方差分析对3组患儿的临床疗效进行比较。结果该研究共有54例患儿纳入统计分析。干预前,3组患儿的基线体重、身高、鼻咽腔前后径距离之比(A/N)值、视觉模拟量表(visual analogue score,VAS)评分(包括鼻塞、打鼾、咳嗽)、VAS评分总分、动脉血氧饱和度(SaO_(2))和脉搏差异不具有统计学意义(P>0.05),且所有病例均为Ⅲ度堵塞。随着干预时间的增加,VAS鼻塞评分(F=232.087,P<0.001)、打鼾评分(F=72.520,P<0.001)、咳嗽评分(F=10.636,P=0.002)、张口呼吸评分(F=95.325,P<0.001)和总分(F=295.633,P<0.001)都显著下降,SaO_(2)(F=161.575,P<0.001)逐渐上升。干预8周后,A、B组患儿的VAS总评分和A/N值和C组相比均显著降低(P<0.05);A组的SaO2和C组相比有所升高(P<0.05)。在整个试验过程中,不良事件共发生26例,其中,流行性感冒样症状是最常见的不良事件,共发生16例,占所有不良事件的61.53%。在整个研究期间,无严重不良事件发生,该试验药物在治疗期间安全性和耐受性良好。结论雾化吸入布地奈德混悬液联合盐水鼻腔冲洗治疗腺样体肥大患儿可以有效控制患儿症状、改善患儿的生活质量、降低部分患儿腺样体肥大程度,并且该治疗方案的耐受性良好,具有一定的临床推广价值,可以为患儿带来临床获益。但是该研究的样本量较小,后续还要大样本、多中心的试验来进一步Objective To study the clinical effect of different doses of budesonide nebulized inhalation and saline nasal irrigation in children with adenoid hypertrophy.Methods Sixty children(aged 2~5 years)with adenoid hypertrophy attending the outpatient clinic of the Department of Otolaryngology Head and Neck Surgery of the Affiliated Hospital of Fudan University from October 2021 to February 2022 were prospectively collected and randomly assigned to three groups(n=20 for each group)according to the random number table method:high-dose budesonide group(group A,budesonide 1 mg/dose+saline nasal irrigation),low-dose budesonide group(group B,budesonide 0.5 mg/dose+salin nasal irrigation)and control group(group C,salin nasal irrigation),with an observation period of 8 weeks.Theχ^(2)test,analysis of variance(ANOVA),and repeatedmeasures ANOVA were used to compare the clinical efficacy in the children in the three groups.Results A total of 54 patients were finally included in the statistical analysis.Before the intervention,there were no significant differences in baseline weight,height,A/N ratio,VAS score(including nasal congestion,snoring,cough),VAS total score,arterial oxygen saturation(SaO_(2))data or pulse among the three groups(P>0.05),and all cases were with nasal obstruction(levelⅢ).With the interventions performed,VAS score for nasal congestion(F=232.089,P<0.001),snoring(F=72.520,P<0.001),cough(F=10.636,P=0.002),open-mouth breathing(F=95.325,P<0.001)and total score(F=295.633,P<0.001)all decreased significantly,and SaO2 data(F=161.575,P<0.001)gradually increased.After 8 weeks of intervention,the VAS of nasal symptoms scores and A/N values of patients in group A and group B were significantly lower than those in group C(P<0.05).SaO_(2) in group A was higher than that in group C(P<0.05).A total of 26 adverse events were reported,including 16 cases(61.54%)of cold,which was the most common adverse event.No serious adverse events occurred throughout the study,and the investigated drugs were well-tolerated and safe.Conclus

关 键 词：腺样体肥大 布地奈德 鼻咽腔前后径距离之比 视觉模拟量表 鼻腔冲洗 

分 类 号：R72[医药卫生—儿科]