[A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].
OBJECTIVE
To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children.


METHODS
This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well.


RESULTS
The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P < 0.05) and except nasal congestion, the efficacy in all the other symptoms of trial group was better than that in the control group as well on the 7th day (P < 0.01). The improvement rate for combined symptoms of Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%.


CONCLUSIONS
Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.
Department of Pulmonology, Shanghai Children's Hospital Affliated to Shanghai Jiao Tong University, Shanghai, China. luquan-sh@vip.sina.com
Lu
Quan
Q
D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D004809:Ephedrine / Q000009:adverse effects / Q000627:therapeutic use*; D006140:Guaifenesin / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D011446:Prospective Studies; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D016037:Single-Blind Method; D016896:Treatment Outcome
D004338:Drug Combinations; D006140:Guaifenesin; D004809:Ephedrine