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[A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound

1, Quan Lu

  • 1Department of Pulmonology, Shanghai Children's Hospital Affliated to Shanghai Jiao Tong University, Shanghai, China. luquan-sh@vip.sina.com

Zhonghua Er Ke Za Zhi = Chinese Journal of Pediatrics
|April 30, 2010
PubMed

Insights

Guaifenesin compound pseudoephedrine hydrochloride oral solution effectively treated cold symptoms in children. This medication demonstrated superior efficacy and safety compared to ambroxol hydrochloride oral solution.

Area of Science:

  • Pediatric pharmacology
  • Respiratory medicine
  • Clinical trial methodology

Context:

  • Common cold and acute tracheobronchitis are frequent pediatric illnesses.
  • Symptomatic relief for cough, expectoration, and nasal congestion is crucial for pediatric care.

Purpose:

  • To assess the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution.
  • To compare its effectiveness against ambroxol hydrochloride oral solution in pediatric patients.

Summary:

  • A randomized, single-blind, multicenter study involving 412 children compared Guaifenesin compound pseudoephedrine hydrochloride oral solution with ambroxol hydrochloride oral solution over 7 days.
  • The Guaifenesin group showed significantly better improvement in most symptoms by day 3 and day 7.
  • The Guaifenesin compound pseudoephedrine hydrochloride oral solution achieved an 82.9% improvement rate for combined symptoms and an 89.3% overall efficacy rate with high compliance and a low adverse event rate (0.92%).

Impact:

  • Guaifenesin compound pseudoephedrine hydrochloride oral solution offers a safe and effective treatment option for pediatric upper respiratory symptoms.
  • The study provides evidence supporting its use in managing cough, expectoration, and nasal congestion in children.
  • Findings support enhanced clinical decision-making for pediatric respiratory infections.
Abstract

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