Evaluation of the effectiveness and safety of generic and original azithromycin for the treatment of pediatric mycoplasma pneumonia

Corresponding author: Wu Xiayang, 56425477@qq.com

DOI: 10.12201/bmr.202501.00071

•  

  Abstract: Objective: Comparing the clinical presentation of injectable azithromycin generic drugs with the original drug to evaluate their efficacy and safety in the treatment of Mycoplasma pneumoniae pneumonia (MPP) in children, providing a reference for clinical medication selection. Methods: A retrospective collection of basic information and clinical data on MPP patients admitted to Xiamen Childrens Hospital from January to July 2024 was performed. Patients were divided into domestic and original-product groups based on the medication used. Comparison of relevant time indicators and infection indicators between the two groups was conducted, and Kaplan-Meier curves were plotted to compare the cumulative effective rate and cumulative adverse reaction incidence rate between the two groups. A logistic regression model was used, with stepwise adjustment of confounding factors, to analyze the effectiveness of the two medications using effective outcome as the dependent variable, and to calculate the odds ratio (OR) and corresponding 95% confidence interval (CI). Results: After propensity score matching (PSM) to balance baseline differences, a total of 322 children were included in the analysis. There were no significant differences between the two groups in baseline characteristics (P > 0.05). Regarding treatment duration, fever duration, and lung symptom improvement, the generic and original drugs showed comparable efficacy (P > 0.05). However, differences were observed in hospital stay, cough duration, and blood routine recovery time (P < 0.05). There were no statistically significant differences between the two groups in infection indicator recovery rate and cumulative clinical efficacy rate (P > 0.05). Furthermore, the adverse event rates in the domestic and original drug groups were both 38.51%, with no statistically significant difference (P > 0.05). Conclusion: Generic azithromycin for treating childhood MPP is comparable in efficacy and safety to the original drug, supporting its use as a lower-cost alternative. This study provides scientific evidence for promoting the rational use of generic drugs and optimizing healthcare resource allocation, and also offers a methodological reference for consistency evaluation of other drugs in pediatric clinical settings.

  Key words:

  Submit time: 23 January 2025

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
• html

• 图表

• YE Hongzhou, YUAN Chen. Risk factors of severe pneumonia in children with macrolide-resistant Mycoplasma pneumoniae pneumonia and the construction of prediction model. 2024. doi: 10.12201/bmr.202409.00021

  GENG Gang, LI Shaojun. Mycoplasma pneumoniae encephalitis in children: a case report and literature review. 2024. doi: 10.12201/bmr.202408.00042

  Li Feifan, Zhang shuitang. Impact of Mixed Infections and Antibiotic Resistance Genes on Clinical Features in Children with Mycoplasma pneumoniae Pneumonia. 2024. doi: 10.12201/bmr.202412.00025

  Lei Genping, #Wang Ting, Dong Sheng, Xie Jiongdong, Lu Xian, Yang Dong. Safety and effectiveness of traditional Chinese medicine compound in treating idiopathic membranous Nephropathy Network Meta-analysis. 2024. doi: 10.12201/bmr.202412.00003

  . 2024. doi: 10.12201/bmr.202411.00065

  renlei, xiejinping, yangyifan, shaorong. The Inspiration of the Design of Drug Medical Insurance Payment Standard System in typical countries and regions for China——From the perspective of original drug management. 2024. doi: 10.12201/bmr.202409.00048

  luhaipeng, lvcong, zengyuxin, luoxiu. . 2024. doi: 10.12201/bmr.202412.00055

  zhang lixin, sun haixia, tang mingkun, qian qing. A Review of Real World Electronic Medical Record Data Evaluation. 2021. doi: 10.12201/bmr.202106.00015

  YAN Jian-zhou, LI Da-shuang, Ding Wenjing, SHAO Rong. Comparative study of promoted generic substitution policies in China, USA and Japan based on full cycle management. 2023. doi: 10.12201/bmr.202305.00004

  quyanli. Efficacy and safety of preoperative chemotherapy in real world patients with locally advanced gastric/gastroesophageal junction adenocarcinoma. 2024. doi: 10.12201/bmr.202409.00052

• ID	Submit time	Number	Download
  1	2025-01-15	bmr.202501.00071V1	Download

• Public  Anonymous  To author only Submit Comments