Y. Marushko, T. Hyshchak, T. Iovitsa, S. Yesipova, O. Khomych
{"title":"吸入6% n -乙酰半胱氨酸3% NaCL溶液(流感酰基支气管)治疗儿童急性支气管炎的临床评价","authors":"Y. Marushko, T. Hyshchak, T. Iovitsa, S. Yesipova, O. Khomych","doi":"10.15574/sp.2022.127.126","DOIUrl":null,"url":null,"abstract":"Purpose - to propose an optimization of treatment of acute bronchitis in children by introducing inhalation of FLU-ACIL broncho before therapy. Materials and methods. An open, prospective, multicenter, non-interventional, comparative (with active control) study with two therapeutic groups was conducted. The experience of therapy of 45 children with moderate acute bronchitis aged 2-12 years old was summarized. The main group included 30 children who received inhalation of Flu-Acyl Broncho in the complex treatment: 5 ml 2 times a day 3-4 hours before bedtime for 7-10 days; the comparison group included 15 children who received oral acetylcysteine/ambroxol for 7-12 days. If it is necessary, antipyretic therapy with ibuprofen or paracetamol was used. The period from the onset of the disease to participation in the study was about 2-4 days. The study did not include children with concomitant acute middle ear diseases, acute sinusitis, acute allergic diseases and children with symptoms of obstruction. The results of examination and treatment of patients were analyzed using the software package «Statistica 6.0 for Windows». Results and conclusions. Comprehensive treatment of acute bronchitis in children with the administration of the inhalation Flu-Acyl Broncho, sterile solution for nebulizer and instillation, has a positive clinical effect, leads to faster relief (p<0.01) and disappearance (p<0.05) of cough compared to oral mucolytics. The additional anti-inflammatory and mucolytic effect of the inhalation route of administration of Flu-Acyl Broncho on the nasopharyngeal mucosa improves the results of treatment of children with concomitant acute respiratory pathology of the upper respiratory tract. This is manifested in faster, compared to oral mucolytics, elimination of rhinitis (p<0.001) and sore throat (p<0.05). All studies were performed in accordance with the ethical principles adopted by the Declaration of Helsinki and Good Clinical Practice (GCP) for medical research conducted on human subjects. Approval was obtained from the ethics committee of the Children’s Clinical Hospital No. 5 of Sviatoshynskyi district of Kyiv. No conflict of interests was declared by the authors.","PeriodicalId":34724,"journal":{"name":"Suchasna pediatriia Ukrayina","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical evaluation of the use of inhalation of 6% N-acetylcysteine in 3% NaCL solution (Flu-Acyl Broncho) in the treatment of children with acute bronchitis\",\"authors\":\"Y. Marushko, T. Hyshchak, T. Iovitsa, S. Yesipova, O. Khomych\",\"doi\":\"10.15574/sp.2022.127.126\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Purpose - to propose an optimization of treatment of acute bronchitis in children by introducing inhalation of FLU-ACIL broncho before therapy. Materials and methods. An open, prospective, multicenter, non-interventional, comparative (with active control) study with two therapeutic groups was conducted. The experience of therapy of 45 children with moderate acute bronchitis aged 2-12 years old was summarized. The main group included 30 children who received inhalation of Flu-Acyl Broncho in the complex treatment: 5 ml 2 times a day 3-4 hours before bedtime for 7-10 days; the comparison group included 15 children who received oral acetylcysteine/ambroxol for 7-12 days. If it is necessary, antipyretic therapy with ibuprofen or paracetamol was used. The period from the onset of the disease to participation in the study was about 2-4 days. The study did not include children with concomitant acute middle ear diseases, acute sinusitis, acute allergic diseases and children with symptoms of obstruction. The results of examination and treatment of patients were analyzed using the software package «Statistica 6.0 for Windows». Results and conclusions. Comprehensive treatment of acute bronchitis in children with the administration of the inhalation Flu-Acyl Broncho, sterile solution for nebulizer and instillation, has a positive clinical effect, leads to faster relief (p<0.01) and disappearance (p<0.05) of cough compared to oral mucolytics. The additional anti-inflammatory and mucolytic effect of the inhalation route of administration of Flu-Acyl Broncho on the nasopharyngeal mucosa improves the results of treatment of children with concomitant acute respiratory pathology of the upper respiratory tract. This is manifested in faster, compared to oral mucolytics, elimination of rhinitis (p<0.001) and sore throat (p<0.05). 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引用次数: 0
摘要
目的:提出一种优化治疗儿童急性支气管炎的方法,在治疗前引入流感- acil支气管吸入。材料和方法。一项开放的、前瞻性的、多中心的、非干预性的、有两个治疗组的比较研究。总结45例2 ~ 12岁儿童中度急性支气管炎的治疗经验。主要组包括30名儿童,他们在复合治疗中吸入流感酰基支气管:5 ml,每天2次,睡前3-4小时,持续7-10天;对照组15例患儿口服乙酰半胱氨酸/氨溴索7-12天。如有必要,使用布洛芬或扑热息痛进行退热治疗。从发病到参与研究的时间约为2-4天。该研究不包括伴有急性中耳疾病、急性鼻窦炎、急性过敏性疾病和有梗阻症状的儿童。采用“Statistica 6.0 for Windows”软件包对患者的检查和治疗结果进行分析。结果和结论。综合治疗小儿急性支气管炎,给予氟酰基支气管吸入性、无菌液雾化、滴注,临床疗效积极,咳嗽缓解(p<0.01)和消失(p<0.05)快于口服解黏液。吸入途径给药流感酰支气管对鼻咽粘膜的额外抗炎和黏液溶解作用改善了伴有上呼吸道急性呼吸道病理的儿童的治疗结果。与口腔黏液溶解剂相比,这表现在更快地消除鼻炎(p<0.001)和喉咙痛(p<0.05)。所有的研究都是按照赫尔辛基宣言和良好临床规范(GCP)通过的关于人体医学研究的伦理原则进行的。已获得基辅Sviatoshynskyi区第五儿童临床医院伦理委员会的批准。作者未声明存在利益冲突。
Clinical evaluation of the use of inhalation of 6% N-acetylcysteine in 3% NaCL solution (Flu-Acyl Broncho) in the treatment of children with acute bronchitis
Purpose - to propose an optimization of treatment of acute bronchitis in children by introducing inhalation of FLU-ACIL broncho before therapy. Materials and methods. An open, prospective, multicenter, non-interventional, comparative (with active control) study with two therapeutic groups was conducted. The experience of therapy of 45 children with moderate acute bronchitis aged 2-12 years old was summarized. The main group included 30 children who received inhalation of Flu-Acyl Broncho in the complex treatment: 5 ml 2 times a day 3-4 hours before bedtime for 7-10 days; the comparison group included 15 children who received oral acetylcysteine/ambroxol for 7-12 days. If it is necessary, antipyretic therapy with ibuprofen or paracetamol was used. The period from the onset of the disease to participation in the study was about 2-4 days. The study did not include children with concomitant acute middle ear diseases, acute sinusitis, acute allergic diseases and children with symptoms of obstruction. The results of examination and treatment of patients were analyzed using the software package «Statistica 6.0 for Windows». Results and conclusions. Comprehensive treatment of acute bronchitis in children with the administration of the inhalation Flu-Acyl Broncho, sterile solution for nebulizer and instillation, has a positive clinical effect, leads to faster relief (p<0.01) and disappearance (p<0.05) of cough compared to oral mucolytics. The additional anti-inflammatory and mucolytic effect of the inhalation route of administration of Flu-Acyl Broncho on the nasopharyngeal mucosa improves the results of treatment of children with concomitant acute respiratory pathology of the upper respiratory tract. This is manifested in faster, compared to oral mucolytics, elimination of rhinitis (p<0.001) and sore throat (p<0.05). All studies were performed in accordance with the ethical principles adopted by the Declaration of Helsinki and Good Clinical Practice (GCP) for medical research conducted on human subjects. Approval was obtained from the ethics committee of the Children’s Clinical Hospital No. 5 of Sviatoshynskyi district of Kyiv. No conflict of interests was declared by the authors.