Post-marketing evaluation of Fuganlin Oral Liquid in treatment of acute upper respiratory infection
10.7501/j.issn.0253-2670.2017.09.020
- Author:
Si-Yuan HU
1
Author Information
1. First Teaching Hospital of Tianjin University of TCM
- Publication Type:Journal Article
- Keywords:
Acute upper respiratory infection;
Clinical efficacy;
Fuganlin Oral Liquid;
Post-marketing evaluation;
Safety
- From:
Chinese Traditional and Herbal Drugs
2017;48(9):1829-1833
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To evaluate the clinical efficacy and safety of Fuganlin Oral Liquid in treatment of acute upper respiatory infection (AURI) in pratical application. Methods: A multi-centered observational study was conducted. Total 2124 patients were administrated with Fuganlin Oral Liquid for one week, and observed the cure rate and the occurrence rate of complications in different levels, and the safety was evaluated. Results: The total cure rate was 95.12%, and there was no significant difference on it among different dosage and diagnosis groups, while patients (younger than one year old) took Fuganlin Oral Liquid alone had higher cure rate. The occurrence rate of complications was 0.24%, and there was no statistical difference among different dosage, age, and diagnosis groups, while patient took Fuganlin Oral Liquid alone had lower rate than combination therapy. The rateS of adverse events and adverse reaction were 1.37% and 1.04%, there was statistical difference except in different dosage groups. Conclusion: Fuganlin Oral Liquid has high cure rate and low complication rate. It has a good clinical efficacy, especially in young age groups. The efficacy of Qi deficiency group and wind heat syndrome group, even the disease diagnosis group was similar. A few clinical adverse events and adverse reaction was founded, high dosage group was as safe as the low dosage group. Above all, Fuganlin Oral Liquid has widely applied prospect in clinical practice.
