Abstract: Objective To evaluate the effectiveness and safety of rock salt aerosol inhalation therapy for communityacquired pneumonia in children. Methods A single-center， randomized， controlled clinical trial design was used，involving 60 hospitalized children aged 3-14 with community-acquired pneumonia， who were hospitalized for treatment in Pediatric Respiratory Department of Shengjing Hospital Affiliated to China Medical University from Jan. 2024 to Jun. 2024. These children were divided into control and experimental groups in a 1∶1 ratio. The experimental group received basic disease treatment along with rock salt aerosol inhalation， using the portable rock salt aerosol therapy device produced by Jiangsu Chunfan Biotechnology Co.， Ltd.（YQ-S101）， once a day， 30 minutes per time. The control group received basic disease treatment along with 1mg nebulized budesonide suspension for inhalation， twice a day. Treatment was ended after 7 days or when clinical symptom score reached 0. The efficacy and safety of rock salt aerosol therapy were observed. The symptom scores of daytime and nighttime cough， expectoration and wheezing before and after treatment were compared between the two groups. The changes in serum inflammatory factors（CRP， PCT， serum IL-4， IL-6， IL-10， IL-17， TNF-α， IFN-γ levels） were compared， and adverse reactions during medication were collected. Results Both the experimental and control groups showed a decrease in the symptom scores of cough， sputum and wheezing， and the total symptom scores after treatment compared to before （P<0.01）， but there was no significant difference between the two groups （P>0.05）. Through scatter plot analysis， it was found that 2 children in the experimental group（7.4%）and 7 children in the control group （24.1%）still had significant symptoms （both total scores>2） after treatment. Whether the total symptom score was greater than 2 was used as the dependent variable， and regression analysis was conducted， which revealed a negative correlation between the experimental group and symptom total score， but the correlation was not significant （r=-1.381，P=0.1057）. After treatment， the levels of CRP， PCT， and IL-6 significantly decreased in both the experimental and control groups compared to before treatment （P<0.01）， while other inflammatory factors （serum IL-4， IL-10， IL-17， TNF-α，IFN-γ levels） showed no significant differences before and after treatment （P<0.05）. Significant differences were observed in the change of PCT between the two groups before and after treatment （P=0.016）， while the changes in CRP and IL-6 were not significant （P>0.05）. No adverse events occurred in either group during the trial. Conclusion Rock salt aerosol inhalation therapy as an adjuvant treatment for community-acquired pneumonia in children is equivalent to nebulized budesonide suspension for inhalation in terms of efficacy， both demonstrating good effectiveness and safety.

Key words: rock salt aerosol inhalation therapy, community-acquired pneumonia, child

摘要： 目的 评估岩盐气溶胶吸入疗法辅助治疗儿童社区获得性肺炎的有效性及安全性。方法　采用单中心、随机、对照临床试验设计，选取2024年1月至2024年6月在中国医科大学附属盛京医院小儿呼吸内科住院治疗的3~14岁社区获得性肺炎患儿60例，按1∶1比例通过随机数字表法分为对照组和治疗组。其中治疗组治疗方案为疾病基础治疗 + 岩盐气溶胶吸入治疗，采用江苏春帆生物科技有限公司生产的便携式岩盐气溶胶治疗仪（YQ-S101），治疗每日1次，每次治疗满30 min；对照组治疗方案为：疾病基础治疗 + 布地奈德混悬液1 mg 雾化吸入，布地奈德混悬液治疗每日2次。两组患儿完成7 d 治疗或者临床症状评分为0可结束治疗。该研究观察岩盐气溶胶吸入治疗安全性及疗效，比较两组患儿治疗前、后日间及夜间咳嗽、咳痰、喘息症状评分，以及血清炎症因子水平变化［C 反应蛋白（CRP）、降钙素原（PCT）、血清白介素4（IL-4）、IL-6、IL-10、IL-17、肿瘤坏死因子 α（TNF-α）、干扰素 γ（IFN-γ）水平］、收集用药过程中出现的不良反应。结果 治疗组和对照组治疗后的咳嗽、咳痰和喘息症状及总症状评分较治疗前均下降（P<0.01），但是两组间对比差异无统计学意义（P>0.05）。通过绘制散点图发现，有2例治疗组患儿（7.4%）在治疗期后症状仍显著（总评分仍大于2分），7例对照组患儿（24.1%）在治疗期后症状仍显著（总评分仍大于2分）。将症状总评分是否大于2分作为因变量进行回归分析发现治疗组和症状总评分呈负相关，但是相关性不显著（r=-1.381，P=0.1057）。经治疗后，治疗组和对照组 CRP、PCT 和IL-6的水平较治疗前降低（P<0.01），其他炎症因子（血清 IL-4、IL-10、IL-17、TNF-α、IFN-γ 水平）治疗前后差异无统计学意义（P<0.05）。两组治疗前后的 PCT 变化率差异存在统计学意义（P=0.016），而 CRP 和 IL-6变化率差异无统计学意义（P>0.05）。研究期间两组患儿均无不良事件发生。结论 岩盐气溶胶吸入疗法辅助治疗儿童社区获得性肺炎与雾化吸入布地奈德混悬液等效，具有良好的安全性及有效性。

关键词: 岩盐气溶胶吸入疗法, 社区获得性肺炎, 儿童