Evaluation of the effectiveness and safety of generic and original azithromycin for the treatment of pediatric mycoplasma pneumonia
10.3969/j.issn.1673-9701.2025.09.013
- VernacularTitle:国产与原研注射用阿奇霉素治疗儿童支原体肺炎的有效性与安全性评价
- Author:
Xinxin CAI
1
;
Xiayang WU
1
Author Information
1. 厦门市儿童医院药学部,福建厦门 361006
- Publication Type:Journal Article
- Keywords:
Azithromycin;
Domestic generic drugs;
Original drugs;
Pediatric mycoplasma pneumoniae pneumonia;
Real-world data
- From:
China Modern Doctor
2025;63(9):55-58,112
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the efficacy and safety of injectable azithromycin generics and originator in the treatment of mycoplasma pneumoniae pneumonia(MPP)in children,aiming to provide scientific evidence for clinical drug selection.Methods A retrospective collection of data from Xiamen Children's Hospital on children with MPP from January to July 2024,divided into domestic and original drug groups based on medication type.Comparing time indicators and infection indicators between two groups.Kaplan-Meier curves were used to analyze cumulative efficacy.A multivariable logistic regression model(stepwise adjustment of confounding factors)was used to calculate OR and corresponding 95％CI with effective outcomes as the dependent variable.Results After baseline correction,a total of 322 children were included.There were no significant differences in baseline characteristics between two groups(P＞0.05).The generic drug group had longer hospital stays,cough durations,and blood test recovery times compared to original drug group(P＜0.05),but there were no statistically significant differences in total treatment time,fever duration,or lung symptom improvement(P＞0.05).The recovery rates for infection indicators and cumulative clinical efficacy rates were similar in both groups(P＞0.05).Furthermore,there was no statistically significant difference in adverse event rates between domestic and original drug groups(P＞0.05).Conclusion The generic azithromycin is as effective as original drug in treating children with MPP and has good safety,making it an economically superior alternative medication.This study provides evidence to support the rational clinical use of generic drugs and expands the methodological reference value of real-world data in the consistency evaluation of pediatric drugs.
