吸入用盐酸氨溴索溶液治疗婴幼儿急性下呼吸道感染的有效性及安全性:一项多中心研究OA
Efficacy and Safety of Ambroxol Hydrochloride Solution for Inhalation in the Treatment of Acute Lower Respiratory Tract Infection in Infants and Young Children:a Multicenter Study
目的 评价吸入用盐酸氨溴索溶液治疗婴幼儿急性下呼吸道感染的有效性及安全性.方法 选取2021年4月—2022年4月在国家呼吸系统疾病临床医学研究中心及协同单位共51家医疗机构住院的765例急性下呼吸道感染婴幼儿作为研究对象.所有患儿接受吸入用盐酸氨溴索溶液雾化治疗,连续治疗7 d.比较患儿治疗前及治疗第3、5、7天心率、呼吸频率及咳嗽、喉中痰鸣、肺部听诊评分,治疗第7天咳嗽、喉中痰鸣、肺部听诊改善率及临床应答率;并记录患儿治疗期间不良反应发生率.结果 26例患儿退出研究,最终纳入739例患儿.患儿不同时间点心率、呼吸频率比较,差异无统计学意义(P＞0.05).与治疗前比较,患儿治疗第3、5、7天咳嗽、喉中痰鸣、肺部听诊评分降低(P＜0.05);与治疗第3天比较,患儿治疗第7天咳嗽、喉中痰鸣、肺部听诊评分降低(P＜0.05).治疗第7天,患儿咳嗽、喉中痰鸣、肺部听诊改善率分别为97.56%(721/739)、92.69%(685/739)、89.99%(665/739),临床应答率为96.75%(715/739).治疗期间,患儿不良反应发生率为0.81%(6/739).结论 吸入用盐酸氨溴索溶液可有效改善急性下呼吸道感染婴幼儿咳嗽、黏痰症状及肺部啰音情况,且安全性良好.
Objective To evaluate the efficacy and safety of ambroxol hydrochloride solution for inhalation in the treatment of acute lower respiratory tract infection in infants and young children.Methods A total of 765 infants and young children with acute lower respiratory tract infection who were hospitalized in 51 medical institutions in the National Clinical Research Center for Respiratory Diseases and Collaborative Units from April 2021 to April 2022 were selected as the research objects.All children received ambroxol hydrochloride solution for inhalation atomization treatment and continuous treatment for 7 days.The heart rate,respiratory rate and cough,sound of phlegm in the throat,lung auscultation scores before treatment and on the 3rd,5th and 7th day of treatment were compared.The improvement rate of cough,sound of sputum in the throat,and lung auscultation,and clinical response rate on the 7th day of treatment were recorded.The incidence of adverse reactions during the treatment was recorded.Results A total of 26 children withdrew from the study,and 739 children were finally included.There was no significant difference in heart rate and respiratory rate at different time points in children(P>0.05).Compared with those before treatment,the scores of cough,sound of phlegm in the throat and lung auscultation decreased on the 3rd,5th and 7th day of treatment in children(P<0.05).Compared with the 3rd day of treatment,the scores of cough,sound of phlegm in the throat and lung auscultation decreased on the 7th day of treatment in children(P<0.05).On the 7th day of treatment,the improvement rate of cough,sound of phlegm in the throat and lung auscultation was 97.56%(721/739),92.69%(685/739),89.99%(665/739),respectively,and the clinical response rate was 96.75%(715/739).During the treatment,and the incidence of adverse reactions of children was 0.81%(6/739).Conclusion Ambroxol hydrochloride solution for inhalation can effectively improve the symptoms of cough,sputum,pulmonary rales in infants and young children with acute lower respiratory tract infection,and has good safety.
高琦;徐保平;国家呼吸系统疾病临床医学研究中心及协同单位
医药卫生
呼吸道感染氨溴索婴幼儿治疗结果
Respiratory tract infectionsAmbroxolInfants and young childrenTreatment outcome
《实用心脑肺血管病杂志》 2026 (6)
71-74,4
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