Scientific Affairs Department Schwabe Pharma Italia, Egna, BZ, Italy.
Pediatrician, Azienda Sanitaria Provinciale 5, Messina, Italy.
BMC Pediatr. 2021 Jan 11;21(1):29. doi: 10.1186/s12887-020-02490-2.
Acute cough in children often causes discomfort to children and parents, reducing their quality of life. Despite the extensive utilization of over-the-counter remedies for cough, the efficacy of most of these treatments in children has not been confirmed.
We conducted a randomized, double blind, placebo-controlled clinical trial of 106 children with acute cough to evaluate the efficacy and safety of KalobaTUSS®, a paediatric cough syrup based on acacia honey and on Malva sylvestris extract, Inula helenium extract, Plantago major extract, and Helichrysum stoechas extract by using a validated 6 points Likert scale.
Children were orally treated with KalobaTUSS® or placebo for 8 days. Children receiving KalobaTUSS® showed an early and significant reduction in night-time and day-time cough scores measured using a specific scale and a shorter duration of cough than children treated with the placebo.
KalobaTUSS® is well tolerated and produces positive effects by reducing the severity and shortening the duration of cough in children.
Clinicaltrials.gov no. NCT04073251 . Retrospectively registered.
儿童急性咳嗽常使儿童及其家长感到不适，降低其生活质量。尽管有大量非处方止咳药被广泛使用，但这些治疗方法对大多数儿童的疗效尚未得到证实。
我们对 106 名急性咳嗽儿童进行了一项随机、双盲、安慰剂对照的临床试验，以评估 KalobaTUSS®（一种基于阿拉伯胶蜂蜜和锦葵提取物、款冬提取物、车前草提取物和蜡菊提取物的儿科止咳糖浆）的疗效和安全性，使用经过验证的 6 分李克特量表进行评估。
儿童口服 KalobaTUSS®或安慰剂治疗 8 天。使用特定量表测量，与接受安慰剂治疗的儿童相比，接受 KalobaTUSS®治疗的儿童夜间和日间咳嗽评分更早且显著降低，咳嗽持续时间更短。
KalobaTUSS®耐受性良好，通过减轻咳嗽的严重程度和缩短咳嗽持续时间，对儿童产生积极影响。
Clinicaltrials.gov 编号：NCT04073251。回顾性注册。
