通讯作者: 吴夏阳, 56425477@qq.com

DOI：10.12201/bmr.202501.00071

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

• 摘要：目的：对比注射用阿奇霉素仿制药与原研药的临床表现,以评估其在小儿支原体肺炎(Mycoplasma pneumoniae pneumonia,MPP)治疗中的有效性与安全性,为临床用药选择提供参考依据。方法：回顾性收集2024年1月至7月期间厦门市儿童医院收治的MPP患儿的基本信息和临床资料,根据所用药物分为国产组和原研组。对比两组患儿的相关时间指标和感染指标变化,绘制Kaplan-Meier曲线以比较两组患儿的累计有效率和累计不良反应发生率。采用Logistic回归模型并逐步调整混杂因素,以有效结局为因变量分析两组药物的有效性,并计算优势比(OR)及对应95%置信区间(CI)。结果：通过倾向评分匹配(PSM)方法,平衡基线差异后,共纳入322例患儿进行分析,两组患儿在基线资料方面无显著差异(P＞0.05)。在治疗时间、发热持续时间和肺部症状改善方面,仿制药与原研药效果相当(P＞0.05),但在住院时间、咳嗽持续时间及血常规恢复时间上存在差异(P?＜0.05)。在感染指标恢复率和累计临床有效率上,两组差异无统计学意义(P＞0.05)。此外,国产组与原研组的不良反应发生率均为38.51%,差异无统计学意义(P＞0.05)。 结论：仿制阿奇霉素在治疗儿童MPP方面与原研药疗效相当,安全性良好,支持其作为成本更低的替代选择。该研究为促进仿制药的合理使用及优化医疗资源配置提供了科学依据,同时为其他药物在儿科临床中的一致性评价研究提供了方法参考。

  关键词： 阿奇霉素,仿制药,原研药,小儿肺炎支原体肺炎,真实世界数据

   

  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:

  提交时间：2025-01-23

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• 序号	提交日期	编号	操作
  1	2025-01-15	bmr.202501.00071V1	下载

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