生理性海盐水鼻腔冲洗对降低幼儿园中班儿童急性上呼吸道感染发生率有效性和安全性的随机对照试验  

Efficacy and safety of physiologic sea saline nasal irrigation in reducing the rate of acute upper respiratory tract infections in healthy preschoolers admitted to nurseries:A randomised controlled trial

作　　者：罗春绸 方琼 张丽芬 张淑芸 杨燕珍 林秀梅 严琳 LUO Chunchou;FANG Qiong;ZHANG Lifen;ZHANG Shuyun;YANG Yanzhen;LIN Xiumei;YAN Lin(Zhangzhou Municipal Hospital Affiliated to Fujian Medical University,Nursing Department,Zhangzhou 363000,China;Zhangzhou Municipal Hospital Affiliated to Fujian Medical University,Otolaryngology Department,Zhangzhou 363000,China;Zhangzhou Municipal Hospital Affiliated to Fujian Medical University,Ophthalmologic Department,Zhangzhou 363000,China;Zhangzhou Municipal Hospital Affiliated to Fujian Medical University,Pediatric Outpatient Clinic,Zhangzhou 363000,China;Zhangzhou Municipal Hospital Affiliated to Fujian Medical University,Pediatric Respiratory Medicine Department,Zhangzhou 363000,China)

机构地区：[1]福建医科大学附属漳州市医院护理部,漳州363000 [2]福建医科大学附属漳州市医院耳鼻喉科,漳州363000 [3]福建医科大学附属漳州市医院眼科,漳州363000 [4]福建医科大学附属漳州市医院儿科门诊,漳州363000 [5]福建医科大学附属漳州市医院儿童呼吸科,漳州363000

出　　处：《中国循证儿科杂志》2024年第1期7-11,共5页Chinese Journal of Evidence Based Pediatrics

基　　金：福建省自然科学基金资助项目:2023J011812。

摘　　要：背景学龄前儿童入幼儿园期间集体生活易引起较高的急性上呼吸道感染(AURTIs)的发生率。目的探讨生理性海盐水鼻腔冲洗对预防入幼儿园健康儿童发生AURTIs的效果研究,为托幼机构做好卫生保健提供理论基础。设计单中心RCT。方法以幼儿园中班健康儿童为研究对象,以班级为单位进行整群随机抽样分组,本研究实施过程不设盲。干预组予常温下使用生理性海盐水喷雾洗鼻液及喷雾器行鼻腔护理,每日入园前和出园前各喷雾1次,持续一个学期中的在园日(96天192次)。根据2023年版《鼻腔盐水冲洗在儿童上呼吸道感染的应用专家共识》推荐的操作方法。对照组班级每天不在入园和出园时有组织地干预。幼儿园保健医生登记每天2次鼻腔冲洗记录及不良反应,中断鼻冲洗时间、首次AURTIs上报时间,鼻部症状开始时间、缓解时间和消失时间,退出研究时间。数据剔除标准:CRF表中记录干预组中断鼻腔冲洗时间≥1周(包含周六和周日)的儿童;请假天数超过研究期间应上学天数的20%以上(≥19 d)的儿童;入组后中途退出(如转学等)的儿童;CRF表记录的研究期间有病历为依据的因非AURTIs疾病使用抗生素、抗病毒或抗支原体感染药物的儿童;CRF表中记录的首次发生AURTI或鼻部症状未在24 h内上报幼儿园的儿童。主要结局指标AURTIs发生率(入组48 h后首次发生AURTI人数/入组人数)。结果符合本研究纳入和排除标准的幼儿园中班儿童234名进入本文分析,干预组120名,对照组114名,两组儿童在性别、年龄、体重和实际在园天数差异均无统计学意义。干预组较对照组儿童在研究期间AURTIs发生率[55(45.8%)vs 81(71.0%)]和AURTIs平均次数[(0.7±1.0)vs(1.4±1.3)]差异均有统计学意义(P<0.05)。干预组男童女童、对照组男童女童AURTIs发生率差异均无统计学意义,干预组较对照组男童和女童AURTIs发生率差异均有统计Background The collective living environment during the preschool period is associated with a high incidence of acute upper respiratory tract infections(AURTIs).Objective To explore the effectiveness of physiological saline nasal irrigation(seawater)in preventing AURTIs in healthy preschool children entering childcare centers,providing a theoretical basis for improving hygiene and healthcare in childcare institutions.Design Single-center randomized controlled trial(RCT).Methods Healthy children in the middle class of kindergartens were selected as the study subjects,and cluster random sampling was conducted at the class level.The study was not blinded.The intervention group received nasal care with seawater nasal irrigation at room temperature,with one spray before entering and leaving the kindergarten each day,for a semester of kindergarten attendance(192 times over 96 days).The operation was performed according to the recommended methods in the Expert Consensus on Nasal Saline Irrigation in Children with Upper Respiratory Tract Infections(2023).The control group received organized interventions when entering and leaving the kindergarten each day.The kindergarten healthcare doctors recorded nasal irrigation twice daily and adverse reactions.Interrupted nasal irrigation time,the first report of AURTIs,onset time of nasal symptoms,relief time,disappearance time,and withdrawal time were also recorded.Those meeting the following criteria were excluded:children in the intervention group with nasal irrigation interruption≥1 week(including Saturdays and Sundays);children with absenteeism exceeding 20%of the school days during the study period(19 days);children who withdrew from the study halfway(e.g.,transferring schools);children who used antibiotics,antiviral drugs,or anti-chlamydial infection drugs based on medical records during the study period;children whose first occurrence of AURTI or nasal symptoms was not reported to the kindergarten within 24 hours according to the CRF table.Main outcome measures Incidence

关 键 词：生理性海盐水 鼻腔冲洗 健康学龄前儿童 急性上呼吸道感染 

分 类 号：R725.6[医药卫生—儿科]