Kardos Peter, Beeh Kai-Michael, Sent Ulrike, Mueck Tobias, Gräter Heidemarie, Michel Martin C
Group Practice, Center for Allergy, Respiratory and Sleep Medicine, Red Cross Maingau Hospital, Frankfurt am Main, Germany.
insaf Respiratory Resarch Institute, Wiesbaden, Germany.
BMC Pharmacol Toxicol. 2018 Jul 4;19(1):40. doi: 10.1186/s40360-018-0229-y.
Ambroxol relieves cough symptoms based on its secretagogue, anti-inflammatory, anti-oxidant, anti-bacterial, anti-viral, immunomodulatory and local anesthetic effects. The present study was designed to explore differential patient profiles and efficacy against acute respiratory symptoms of four formulations registered as over-the-counter medicines.
Nine hundred sixty-five pharmacy customers purchasing one of four branded ambroxol formulations (extended release capsules, adult syrup, pediatric syrup and soft pastilles) filled a questionnaire including a patient-adapted version of the Bronchitis Severity Scale, several questions on degree of impairment by acute cough, time to onset of symptom relief and duration of treatment. Data on pediatric syrup users were entered by their parents. Based on the exploratory character of the study, no hypothesis-testing statistical analysis was applied.
Users of the pediatric syrup and the pastilles reported somewhat less severe baseline symptoms. The patient-adapted Bronchitis Severity Scale proved feasible as a self-administered tool. Among BSS items, ambroxol formulations improved chest pain while coughing to the largest and sputum to smallest degree (- 75% vs. -40%). Reported efficacy was comparable among formulations with minor differences in favor of the pediatric syrup. Time to onset of symptom relief was less than 60 min in more than 90% of patients and occurred prior to known systemic t. Time to onset was the parameter with the greatest differences between formulations, being reported fastest with pastilles and pediatric syrup and, as expected, slowest with extended release capsules. All ambroxol formulations were well tolerated.
We conclude that over-the-counter formulations of ambroxol exhibit comparable user profiles and efficacy. Differences in speed of onset of symptom relief may involve not only those in systemic pharmacokinetics but also local anesthetic effects of immediate release formulations. Differences between pediatric and adult syrup may in part reflect reporting bias.
氨溴索基于其促分泌、抗炎、抗氧化、抗菌、抗病毒、免疫调节和局部麻醉作用来缓解咳嗽症状。本研究旨在探讨四种作为非处方药注册的制剂在治疗急性呼吸道症状方面的不同患者特征和疗效。
965名购买四种品牌氨溴索制剂（缓释胶囊、成人糖浆、儿童糖浆和软糖）之一的药房顾客填写了一份问卷，其中包括一个适用于患者的支气管炎严重程度量表、几个关于急性咳嗽造成的损害程度、症状缓解开始时间和治疗持续时间的问题。儿童糖浆使用者的数据由其父母录入。基于该研究的探索性特征，未应用假设检验统计分析。
儿童糖浆和软糖的使用者报告的基线症状稍轻。适用于患者的支气管炎严重程度量表被证明是一种可行的自我管理工具。在支气管炎严重程度量表的各项中，氨溴索制剂对咳嗽时胸痛的改善程度最大，对痰液的改善程度最小（-75%对-40%）。各制剂报告的疗效相当，略有差异，儿童糖浆稍占优势。超过90%的患者症状缓解开始时间少于60分钟，且发生在已知的全身起效时间之前。症状缓解开始时间是各制剂之间差异最大的参数，软糖和儿童糖浆报告的起效最快，正如预期的那样，缓释胶囊最慢。所有氨溴索制剂耐受性良好。
我们得出结论，非处方的氨溴索制剂表现出相似的用户特征和疗效。症状缓解速度的差异可能不仅涉及全身药代动力学的差异，还涉及速释制剂的局部麻醉作用。儿童糖浆和成人糖浆之间的差异可能部分反映了报告偏差。
