{"title":"An overview of efficacy and safety of ambroxol for the treatment of acute and chronic respiratory diseases with a special regard to children.","authors":"Ahmad Kantar, Ludger Klimek, Dorotheea Cazan, Annette Sperl, Ulrike Sent, Margarida Mesquita","doi":"10.4081/mrm.2020.511","DOIUrl":null,"url":null,"abstract":"<p><p><b>Introduction:</b> Ambroxol (2-amino-3,5-dibromo-N-[trans-4-hydroxycyclohexyl]benzylamine), an over-the-counter product, is a mucoactive agent and has been used widely to treat both acute and chronic respiratory diseases since 1978. This review aims to provide an overview of the clinical evidence available on the use of ambroxol in children with acute and chronic respiratory diseases. Data for this review were obtained from both published and unpublished clinical studies, and real-world evidence studies. Although conducted prior to the introduction of Good Clinical Practice (GCP), these studies, representing almost 1,300 pediatric patients, report strong clinical outcomes following the use of ambroxol in pediatric patients. Furthermore, efficacy findings were consistent irrespective of age, including for patients as young as 1 month old. Additionally, the majority of studies found ambroxol to be well tolerated in children. Taken together, the clinical evidence for ambroxol shows treatment effects that offer significant benefits to pediatric patients for its licensed use as a secretolytic therapy in acute and chronic bronchopulmonary disorders associated with abnormal mucus secretion and impaired mucus transport. The findings from this review indicate that ambroxol, for its intended over-the-counter indications, is both efficacious and well tolerated in children and that the favorable benefit/risk profile of ambroxol reported in adults extends to the pediatric population, starting from early infancy, with acute and chronic respiratory diseases.</p>","PeriodicalId":49031,"journal":{"name":"Multidisciplinary Respiratory Medicine","volume":null,"pages":null},"PeriodicalIF":2.3000,"publicationDate":"2020-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5c/34/mrm-15-1-511.PMC7137760.pdf","citationCount":"32","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Multidisciplinary Respiratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4081/mrm.2020.511","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2020/1/28 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 32
Abstract
Introduction: Ambroxol (2-amino-3,5-dibromo-N-[trans-4-hydroxycyclohexyl]benzylamine), an over-the-counter product, is a mucoactive agent and has been used widely to treat both acute and chronic respiratory diseases since 1978. This review aims to provide an overview of the clinical evidence available on the use of ambroxol in children with acute and chronic respiratory diseases. Data for this review were obtained from both published and unpublished clinical studies, and real-world evidence studies. Although conducted prior to the introduction of Good Clinical Practice (GCP), these studies, representing almost 1,300 pediatric patients, report strong clinical outcomes following the use of ambroxol in pediatric patients. Furthermore, efficacy findings were consistent irrespective of age, including for patients as young as 1 month old. Additionally, the majority of studies found ambroxol to be well tolerated in children. Taken together, the clinical evidence for ambroxol shows treatment effects that offer significant benefits to pediatric patients for its licensed use as a secretolytic therapy in acute and chronic bronchopulmonary disorders associated with abnormal mucus secretion and impaired mucus transport. The findings from this review indicate that ambroxol, for its intended over-the-counter indications, is both efficacious and well tolerated in children and that the favorable benefit/risk profile of ambroxol reported in adults extends to the pediatric population, starting from early infancy, with acute and chronic respiratory diseases.
简介:氨溴索(2-氨基-3,5-二溴- n -[反式-4-羟基环己基]苄胺)是一种非处方药,自1978年以来广泛用于治疗急慢性呼吸系统疾病。本综述旨在概述氨溴索在急性和慢性呼吸系统疾病患儿中的临床应用。本综述的数据来自已发表和未发表的临床研究,以及真实世界的证据研究。虽然这些研究是在引入良好临床规范(GCP)之前进行的,但这些研究涵盖了近1300名儿科患者,报告了在儿科患者中使用氨溴索后的良好临床结果。此外,疗效结果与年龄无关,包括1个月大的患者。此外,大多数研究发现氨溴索在儿童中耐受性良好。综上所述,临床证据表明,氨溴索的治疗效果为儿科患者提供了显著的益处,因为它被许可用于与粘液分泌异常和粘液运输受损相关的急性和慢性支气管肺疾病的促分泌治疗。本综述的研究结果表明,作为非处方适应症,氨溴索在儿童中既有效又耐受性良好,并且在成人中报道的氨溴索有利的获益/风险特征延伸到儿童人群,从婴幼儿早期开始,患有急性和慢性呼吸道疾病。
期刊介绍:
Multidisciplinary Respiratory Medicine is the official journal of the Italian Respiratory Society - Società Italiana di Pneumologia (IRS/SIP). The journal publishes on all aspects of respiratory medicine and related fields, with a particular focus on interdisciplinary and translational research.
The interdisciplinary nature of the journal provides a unique opportunity for researchers, clinicians and healthcare professionals across specialties to collaborate and exchange information. The journal provides a high visibility platform for the publication and dissemination of top quality original scientific articles, reviews and important position papers documenting clinical and experimental advances.