格隆溴铵儿科糖浆治疗儿童咳嗽的疗效：一项随机、多中心、双盲、安慰剂对照的临床试验。
Efficacy of Grintuss® pediatric syrup in treating cough in children: a randomized, multicenter, double blind, placebo-controlled clinical trial.
机构信息
Department of Pediatrics, Immuno-Pneumo-Allergy Unit, University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
出版信息
Ital J Pediatr. 2014 Jun 10;40:56. doi: 10.1186/1824-7288-40-56.
BACKGROUND
Cough is an extremely common problem in pediatrics, mostly triggered and perpetuated by inflammatory processes or mechanical irritation leading to viscous mucous production and increased sensitivity of the cough receptors. Protecting the mucosa might be very useful in limiting the contact with micro-organisms and irritants thus decreasing the inflammation and mucus production. Natural molecular complexes can act as a mechanical barrier limiting cough stimuli with a non pharmacological approach but with an indirect anti-inflammatory action.
OBJECTIVE
Aim of the study was to assess the efficacy of a medical device containing natural functional components in the treatment of cough persisting more than 7 days.
METHODS
In this randomized, parallel groups, double-blind vs. placebo study, children with cough persisting more than 7 days were enrolled. The clinical efficacy of the study product was assessed evaluating changes in day- and night-time cough scores after 4 and 8 days (t4 and t8) of product administration.
RESULTS
In the inter-group analysis, in the study product group compared with the placebo group, a significant difference (t4 study treatment vs. t4 placebo, p = 0.03) was observed at t4 in night-time cough score.Considering the intra-group analysis, only the study product group registered a significant improvement from t0 to t4 in both day-time (t0 vs. t4, p = 0.04) and night-time (t0 vs. t4, p = 0.003) cough scores.A significant difference, considering the study product, was also found in the following intra-group analyses: day-time scores at t4 vs. t8 (p =0.01) and at t0 vs. t8 (p = 0.001); night-time scores at t4 vs. t8 (p = 0.05), and at t0 vs. t8 (p = 0.005). Considering a subgroup of patients with higher cough (≥ 3) scores, 92.9% of them in the study product group improved at t0 vs. t4 day-time.
CONCLUSIONS
Grintuss® pediatric syrup showed to possess an interesting profile of efficacy and safety in the treatment of cough persisting more than 7 days.
背景
咳嗽是儿科中非常常见的问题，主要由炎症过程或机械刺激引起，并持续存在，导致粘性粘液产生和咳嗽受体敏感性增加。保护黏膜可能非常有用，可以限制与微生物和刺激物的接触，从而减少炎症和粘液产生。天然分子复合物可以作为一种机械屏障，通过非药理学方法限制咳嗽刺激，同时具有间接的抗炎作用。
目的
本研究旨在评估含有天然功能成分的医疗器械在治疗持续超过 7 天的咳嗽中的疗效。
方法
在这项随机、平行组、双盲对照安慰剂研究中，纳入了持续咳嗽超过 7 天的儿童患者。通过评估产品给药后第 4 天（t4）和第 8 天（t8）的日夜间咳嗽评分变化，评估研究产品的临床疗效。
结果
在组间分析中，与安慰剂组相比，研究产品组在 t4 时夜间咳嗽评分有显著差异（t4 研究治疗与 t4 安慰剂，p = 0.03）。考虑到组内分析，只有研究产品组在日间（t0 与 t4，p = 0.04）和夜间（t0 与 t4，p = 0.003）咳嗽评分上均从 t0 到 t4 有显著改善。仅研究产品组在以下组内分析中也显示出显著差异：t4 与 t8 时日间评分（p = 0.01）和 t0 与 t8 时日间评分（p = 0.001）；t4 与 t8 时夜间评分（p = 0.05）和 t0 与 t8 时夜间评分（p = 0.005）。对于咳嗽（≥3）评分较高的患者亚组，研究产品组中有 92.9%的患者在 t0 与 t4 日间咳嗽时得到改善。
结论
Grintuss®儿科糖浆在治疗持续超过 7 天的咳嗽方面具有良好的疗效和安全性。
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