中国循证儿科杂志 ›› 2024, Vol. 19 ›› Issue (1): 7-11.DOI: 10.3969/j.issn.1673-5501.2024.01.002

• 论著 • 上一篇    下一篇

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

罗春绸1 方琼2 张丽芬3 张淑芸4 杨燕珍5 林秀梅5 严琳5   

  1. 福建医科大学附属漳州市医院 漳州,363000;1 护理部,2 耳鼻喉科,3眼科,4 儿科门诊,5儿童呼吸科
  • 收稿日期:2023-11-23 修回日期:2024-01-19 出版日期:2024-02-25 发布日期:2024-02-25
  • 通讯作者: 方琼

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

LUO Chunchou1, FANG Qiong2, ZHANG Lifen3, ZHANG Shuyun4, YANG Yanzhen5, LIN Xiumei5, YAN Lin5   

  1. Zhangzhou Municipal Hospital Affiliated to Fujian Medical University, Zhangzhou 363000, China; 1 Nursing Department, 2 Otolaryngology Department, 3 Ophthalmologic Department, 4 Pediatric Outpatient Clinic, 5 Pediatric Respiratory Medicine Department
  • Received:2023-11-23 Revised:2024-01-19 Online:2024-02-25 Published:2024-02-25
  • Contact: FANG Qiong

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学意义。干预组较对照组儿童首次出现鼻部症状的缓解时间[(2.3±1.0)d vs (2.8±0.9)d ]和消失时间[(5.4±1.1)d vs (5.8±1.0)d]差异均有统计学意义。干预组3例发生轻微鼻出血,因儿童能耐受,故继续鼻腔冲洗干预,均未发生鼻部刺激感和耳痛等不良反应。 结论 生理性海盐水鼻腔喷雾冲洗护理可降低入幼儿园健康儿童AURTIs发生率及发生次数,同时可有效缓解AURTIs鼻部症状,缩短症状存在时间,临床操作简单方便,不良反应少。

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

Abstract: 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 of AURTIs (the number of children who developed AURTI within 48 hours of enrollment divided by the number of enrollees). Results A total of 234 children in the middle class of kindergartens who met the inclusion and exclusion criteria were included in the analysis, with 120 in the intervention group and 114 in the control group. There were no statistically significant differences in gender, age, weight, and actual days in kindergarten between the two groups of children. The incidence of AURTIs during the study period [55 (45.8%) vs. 81 (71.0%)]and the average number of AURTIs [(0.7±1.0) vs. (1.4±1.3)] in the intervention group were significantly lower than those in the control group (P<0.05). There were no statistically significant differences in the incidence of AURTIs between boys and girls in the intervention group. It is the same with the control group. However, there were statistically significant differences in the incidence of AURTIs between two groups in both boys and girls. The intervention group showed statistically significant differences in the relief time [(2.3±1.0 days) vs. (2.8±0.9 days)] and disappearance time [(5.4±1.1 days) vs. (5.8±1.0 days)] of nasal symptoms compared to the control group. Three cases of mild nasal bleeding occurred in the intervention group, but nasal irrigation intervention continued because of the children's tolerance, and no nasal irritation or ear pain was found. Conclusion Physiological seawater nasal irrigation can reduce the incidence and frequency of AURTIs in healthy preschool children entering childcare centers. It can also effectively relieve nasal symptoms associated with AURTIs and shorten the duration of symptoms. The clinical operation is simple and convenient with few adverse reactions.

Key words: Physiological sea salt water, Nasal irrigation, Healthy preschoolers, Acute upper respiratory tract infection