吸入用盐酸氨溴索溶液改善儿童急性肺炎咳嗽、黏痰症状的临床有效性和安全性多中心研究

Clinical efficacy and safety of Ambroxol hydrochloride solution for inhalation on alleviating cough and mucous sputum symptoms in children with acute pneumonia:a multicenter study

目的评估吸入用盐酸氨溴索溶液改善儿童急性肺炎咳嗽及黏痰症状的有效性和安全性。方法本研究为前瞻性多中心研究。在2021年4月至2022年4月,纳入首都医科大学附属北京儿童医院等全国61家医院收治入院的6个月以上的急性肺炎患儿,经吸入用盐酸氨溴索溶液治疗7 d,通过咳嗽评分、喉中痰鸣评分、肺部听诊评分等进行临床用药效果评价,并进行用药安全监测。结果共2076例受试患儿用于有效性数据分析,年龄(3.67±2.51)岁;男1166例(56.17%),女910例(43.83%)。咳嗽改善率为96.87%(2011/2076),喉中痰鸣音改善率为90.46%(1878/2076),肺部听诊改善率为84.59%(1756/2076),临床应答率为94.99%(1972/2076);随用药时间延长,咳嗽症状、喉中痰鸣症状以及肺部听诊体征均呈好转趋势。用于安全性数据分析的安全数据集共2073例患儿,其中9例受试者发生药物相关不良反应,未见重度不良反应。结论吸入用盐酸氨溴索溶液可明显改善儿童急性肺炎咳嗽及黏痰症状,且安全性良好。

Objective To evaluate the efficacy and safety of Ambroxol hydrochloride solution for inhalation on alleviating cough and phlegm symptoms in children with acute pneumonia.Methods It was a prospective multicenter study.From April 2021 to April 2022,children with acute pneumonia who have been hospitalized for more than 6 months in 61 hospitals nationwide,including the Beijing Children′s Hospital,Capital Medical University were recruited.They were treated with Ambroxol hydrochloride solution for inhalation for 7 days.The clinical efficacy was evaluated by grading the scores of cough,phlegm rale in the throat and lung auscultation.The safety of drug use was monitored.Results A total of 2076 children with the age of(3.67±2.51)years were recruited for validity data analysis,including 1166 males(56.17%)and 910 females(43.83%).The improvement rate of cough,phlegm rate in the throat and lung auscultation were 96.87%(2011/2076),90.46%(1878/2076),and 84.59%(1756/2076),respectively.The clinical response rate was 94.99%(1972/2076).With the prolongation of medication,clinical symptoms of cough and phlegm rale in the throat,as well as clinical signs of lung auscultation were all alleviated.Clinical data of 2073 children were included in the safety dataset,involving 9 cases of adverse drug reactions.Severe adverse drug reactions were not reported.Conclusions Ambroxol hydrochloride solution for inhalation can effectively alleviate the cough and phlegm symptoms of children with acute pneumonia,with good safety.