Group Practice for Allergy, Respiratory and Sleep Medicine, Red Cross Maingau Hospital, Frankfurt am Main, Germany.
Clinical & Scientific Affairs, Bionorica SE, Neumarkt i.d.OPf, Germany.
Curr Med Res Opin. 2021 Oct;37(10):1837-1844. doi: 10.1080/03007995.2021.1960493. Epub 2021 Aug 13.
Efficacy and safety of an oral thyme/ivy syrup for the treatment of acute cough was previously demonstrated in a randomized clinical trial. Here, we present real-life data from a pharmacy-based, observational study on the effectiveness and tolerability of another thyme/ivy combination (BNO 1200, Bronchipret drops).
This observational, prospective, uncontrolled study was conducted in 305 German pharmacies. Cough and associated symptoms, cough severity and health related quality of life (HRQoL) were assessed at baseline, after 4 days and at individual end of treatment (EoT) in patients with acute cough due to upper respiratory tract infections who bought BNO 1200. Patients took BNO 1200 until resolution of cough and completed three validated questionnaires: patient-adapted Bronchitis Severity Score (BSS), cough severity visual analogue scale (VAS) and the Leicester Cough Questionnaire (LCQ-acute). They also rated speed of onset of treatment action on a VAS and tolerability.
A total of 749 patients participated in the study; 730 were included in the analysis. Mean treatment duration was 7.0 ± 3.6 days. Symptom severity assessed by BSS improved from 8.7 ± 3.8 score points (baseline) to 2.4 ± 2.6 at EoT ( < .0001). Clinically relevant improvements (MCID = 17 mm) in cough severity were reported by 87.2% of patients at EoT. HRQoL improved significantly (12.2 ± 3.3 points at baseline vs. 18.5 ± 2.7 at EoT; < .0001), exceeding the MCID (=2 points) in 90.0% of patients. Tolerability was rated "good" or "very good" by 98.0% of patients. No adverse drug reactions were reported.
Patients with acute cough taking BNO 1200 had a significant reduction in BSS, cough severity and improvement in HRQoL confirming RCT data with the syrup formulation. BNO 1200 was well tolerated.
先前的一项随机临床试验已经证实，一种口服百里香/常春藤糖浆治疗急性咳嗽的疗效和安全性。在此，我们展示了另一款百里香/常春藤合剂（BNO 1200，Bronchipret 滴剂）基于药房的观察性研究的真实数据，评估其有效性和耐受性。
这是一项在 305 家德国药店进行的观察性、前瞻性、非对照研究。患有上呼吸道感染引起的急性咳嗽的患者购买 BNO 1200 后，在基线、第 4 天和个体治疗结束（EoT）时评估咳嗽和相关症状、咳嗽严重程度以及健康相关生活质量（HRQoL）。患者在咳嗽缓解前一直使用 BNO 1200，并完成了三个经过验证的问卷：患者适应性支气管炎严重程度评分（BSS）、咳嗽严重程度视觉模拟量表（VAS）和莱斯特咳嗽问卷（LCQ-急性）。他们还在 VAS 上对治疗起效速度进行评分，并评价耐受性。
共有 749 名患者参与了研究，730 名患者纳入分析。平均治疗持续时间为 7.0±3.6 天。BSS 评估的症状严重程度从基线时的 8.7±3.8 分改善至 EoT 时的 2.4±2.6（ < .0001）。EoT 时 87.2%的患者报告咳嗽严重程度有临床相关改善（MCID=17 mm）。HRQoL 显著改善（基线时为 12.2±3.3 分，EoT 时为 18.5±2.7 分； < .0001），90.0%的患者超过 MCID（=2 分）。98.0%的患者认为耐受性为“良好”或“非常好”。没有报告药物不良反应。
服用 BNO 1200 的急性咳嗽患者 BSS、咳嗽严重程度显著降低，HRQoL 改善，证实了糖浆制剂的 RCT 数据。BNO 1200 具有良好的耐受性。
