目的 比较注射用阿奇霉素仿制药与原研药治疗儿童支原体肺炎的有效性和安全性。方法 采用回顾性队列研究，收集2023年1月1日—2025年1月31日于江苏省中医院（南京中医药大学附属医院）住院治疗的支原体肺炎儿童患者相关临床信息。根据其使用注射用阿奇霉素的厂家分为仿制药组和原研药组。采用倾向性评分匹配法（PSM），按照1∶ 1比例匹配两组患者，减少基线混杂偏倚。结果 PSM前仿制药组289例，原研药组47例，共336例，组间有差异。PSM后两组各有42例患者匹配成功，两组患者的基线特征及合并用药情况无明显差异，两组用药剂量、方法及疗程一致。仿制药组和原研药组在总有效率、退热时间、咳嗽消失时间、胸片恢复情况、肺部啰音消失时间、药物不良反应上无明显差异（P＞0.05）。结论 仿制药与原研药注射用阿奇霉素治疗儿童支原体肺炎轻症均有效，两者临床症状体征消失时间、胸片恢复情况、安全性相当。

Objective To compare the efficacy and safety of generic azithromycin for injection and original drug in the treatment of mycoplasma pneumonia in children. Methods A retrospective cohort study was used to collect clinical information on children with mycoplasma pneumonia hospitalized at Jiangsu Province Hospital of Traditional Chinese Medicine (Affiliated Hospital of Nanjing University of Traditional Chinese Medicine) from January 1st, 2023 to January 31st, 2025. They are divided into generic drug group and original drug group according to the manufacturer using azithromycin for injection. The propensity score matching method (PSM) was used to match the two groups of patients in a 1∶ 1 ratio to reduce baseline confounding bias. Results There were 289 cases in the pre-PSM generic drug group and 47 cases in the original drug group, totaling 336 cases, with differences between the groups. After PSM, 42 patients in each group were successfully matched, and there was no significant difference in baseline characteristics and concomitant medication between the two groups. There was no significant difference between the generic drug group and the original drug group in the total effective rate, fever time, cough disappearance time, recovery of chest radiographs, disappearance time of pulmonary rales, and adverse drug reactions (P > 0.05). Conclusion The generic drug and the original drug azithromycin for injection are effective in the treatment of mild mycoplasma pneumonia in children. The disappearance time of clinical symptoms and signs, chest radiograph recovery and safety of the two drugs are equivalent.

R974

江苏省中医药领军人才培养项目（SLJ0320）