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  

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

作　　者：蔡欣欣 吴夏阳 CAI Xinxin;WU Xiayang(Department of Pharmacy,Xiamen Children’s Hospital,Xiamen 361006,Fujian,China)

机构地区：[1]厦门市儿童医院药学部,福建厦门3610061

出　　处：《中国现代医生》2025年第9期55-58,112,共5页China Modern Doctor

摘　　要：目的对比国产与原研注射用阿奇霉素在小儿肺炎支原体肺炎(mycoplasma pneumoniae pneumonia,MPP)治疗中的有效性与安全性,为临床用药选择提供科学依据。方法回顾性收集2024年1月至7月厦门市儿童医院收治的MPP患儿的资料,根据用药类型分为国产组和原研组。对比两组患儿的时间指标和感染指标变化,通过Kaplan-Meier曲线分析累计有效率。采用多因素Logistic回归模型(逐步校正混杂因素),以有效结局为因变量计算OR及95%CI。结果基线校正后共纳入322例患儿,两组患儿的基线资料比较差异无统计学意义(P>0.05)。仿制药在住院时间、咳嗽持续时间及血常规恢复时间上长于原研药(P<0.05),但在治疗总时间、发热持续时间和肺部症状改善方面差异无统计学意义(P>0.05)。两组患儿的感染指标恢复率及累计临床有效率比较差异无统计学意义(P>0.05)。两组患儿的不良反应发生率比较差异无统计学意义(P>0.05)。结论国产注射用阿奇霉素在治疗儿童MPP时与原研药疗效相当且安全性良好,可作为经济性更优的替代药物。本研究为仿制药的临床合理应用提供证据支持,并扩展真实世界数据在儿科药物一致性评价中的方法。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.

关 键 词：阿奇霉素 国产仿制药 原研药 小儿肺炎支原体肺炎 真实世界数据 

分 类 号：R725.6[医药卫生—儿科]