Schulz M, Hämmerlein A, Hinkel U, Weis G, Gillissen A
Center for Drug Information and Pharmacy Practice, ABDA - Federal Union of German Associations of Pharmacists, Berlin, Germany.
Int J Clin Pharmacol Ther. 2006 Sep;44(9):409-21. doi: 10.5414/cpp44409.
Mucoactive substances such as ambroxol, available in several countries as over-the-counter (OTC) medicines, are used for the treatment of acute and chronic bronchitis.
This study was designed to evaluate the "real life" behavior of consumers with non-prescription access to an ambroxol cough syrup with special focus on tolerability and the pattern of product usage.
Customers who bought the ambroxol syrup were recruited in 300 community pharmacies in Germany. Baseline data were collected from the participants in the pharmacy. Completing a self-administered questionnaire, participants provided information on tolerability, self-perceived effectiveness and usage pattern.
2,707 participants were recruited in 266 pharmacies. 2,664 questionnaires were evaluable. At baseline, the respondents reported a complex pattern of symptoms. Productive cough, congested airways, dry cough, cough irritation in the throat and soreness in the throat were the most common ones. 67 patients (2.5%) reported a total of 81 adverse events (AE) which were usually mild in nature and mostly affecting the gastrointestinal tract (n = 53) followed by skin and subcutaneous tissue disorders (n = 9). No serious or unknown AE were reported. In general, 97% of the participants assessed the safety as "very good" (51%) or "good" (46%). Overall, the respondents complied with the indications for use and the recommended dosages, with only 0.7% of the participants using the maximum daily dose. 92% of the patients assessed the self-perceived effectiveness as "very good" (29%) or "good" (63%) and 89% were willing to purchase this ambroxol cough syrup again.
This study confirms that ambroxol is used according to the advice given in the patients' leaflet and supports the already established safety and efficacy of this product in acute bronchitis. It also demonstrates that the use of an OTC cough medication can be successfully monitored in a pharmacy-based cohort study.
氨溴索等黏液促排剂在多个国家作为非处方药（OTC）使用，用于治疗急慢性支气管炎。
本研究旨在评估非处方获取氨溴索止咳糖浆的消费者的“实际使用”行为，特别关注耐受性和产品使用模式。
在德国的300家社区药房招募购买氨溴索糖浆的顾客。在药房收集参与者的基线数据。参与者通过填写一份自我管理的问卷，提供有关耐受性、自我感知疗效和使用模式的信息。
在266家药房招募了2707名参与者。2664份问卷可用于评估。在基线时，受访者报告了复杂的症状模式。有痰咳嗽、气道阻塞、干咳、喉咙咳嗽刺激和喉咙疼痛是最常见的症状。67名患者（2.5%）报告了总共81例不良事件（AE），这些事件通常性质轻微，主要影响胃肠道（n = 53），其次是皮肤和皮下组织疾病（n = 9）。未报告严重或不明AE。总体而言，97%的参与者将安全性评估为“非常好”（51%）或“好”（46%）。总体而言，受访者遵守使用说明和推荐剂量，只有0.7%的参与者使用最大日剂量。92%的患者将自我感知疗效评估为“非常好”（29%）或“好”（63%），89%的患者愿意再次购买这种氨溴索止咳糖浆。
本研究证实氨溴索是按照患者说明书中的建议使用的，并支持该产品在急性支气管炎中已确立的安全性和有效性。它还表明，在基于药房的队列研究中，可以成功监测非处方止咳药物的使用情况。
