Kantar Ahmad, Klimek Ludger, Cazan Dorotheea, Sperl Annette, Sent Ulrike, Mesquita Margarida
Pediatric Cough and Asthma Center, Istituti Ospedalieri Bergamaschi, University and Research Hospitals, Bergamo, Italy.
Wiesbaden Center for Rhinology and Allergology, Wiesbaden, Germany.
Multidiscip Respir Med. 2020 Mar 3;15(1):511. doi: 10.4081/mrm.2020.511. eCollection 2020 Jan 28.
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 Data for this review were obtained from both published and unpublished clinical studies, and real-world evidence studies.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.
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，是一种黏液溶解剂，自1978年以来已广泛用于治疗急性和慢性呼吸道疾病。本综述旨在概述有关氨溴索在患有急性和慢性呼吸道疾病儿童中应用的现有临床证据。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证据研究。尽管这些研究是在《药物临床试验质量管理规范》（GCP）出台之前进行的，但这些研究涉及近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，无论年龄大小，疗效结果都是一致的，包括1个月大的患者。此外，大多数研究发现儿童对氨溴索耐受性良好。综上所述，氨溴索的临床证据表明，其治疗效果对儿科患者具有显著益处，可作为黏液溶解疗法用于治疗与异常黏液分泌和黏液转运受损相关的急性和慢性支气管肺疾病。本综述的结果表明，就其预期的非处方适应症而言，氨溴索在儿童中既有效又耐受性良好，并且在成人中报告的氨溴索良好的效益/风险特征也适用于儿科人群，从婴儿早期开始，用于治疗急性和慢性呼吸道疾病。
