摘要目的:基于“医-护-药”多学科合作模式，评估尼塞韦单克隆抗体（简称尼塞韦单抗）注射在预防婴幼儿呼吸道合胞病毒感染的短期安全性。方法:本研究为前瞻性观察性研究，纳入2024年9月至2025年8月于北京大学第三医院接受单次尼塞韦单抗注射的婴幼儿。组建儿科医师、护士、药师及产科医师团队，制订标准化药品管理、注射、随访流程及安全性评估表。采用描述性方法统计分析婴幼儿注射完成后30 min内现场观察结果及所有不良事件，并判断与药物的相关性。结果:共纳入331例，其中男性171例（51.7%）、女性160例（48.3%）；门诊注射225例（68.0%），住院注射106例（32.0%）。330例（99.7%）完成了1剂尼塞韦单抗注射，其中50 mg/支规格207例（62.7%）、100 mg/支规格123例（37.3%）；另1例（3岁11个月，体重19.0 kg）注射了2剂（100 mg/支）尼塞韦单抗。注射完成后在院30 min观察期间，共11例（3.3%）发生不良事件，表现为注射部位局部红晕，药品规格均为100 mg/支，未观察到系统不良事件或严重不良事件。上述症状于注射后30 min内自行缓解。经团队讨论判断，主要考虑可能与药物复温时间不足、注射体积较大或注射后按压力度大有关。结论:尼塞韦单抗在我国婴幼儿单次注射后短期安全性良好，多学科标准化流程可行，但仍需扩大样本量、完善随访，持续监测该药中长期及特殊人群的安全性。

abstractsObjective:To evaluate the short-term safety of Nirsevimab injection for preventing respiratory syncytial virus infections in infants through a physician-nurse-pharmacist collaborative model.Methods:This prospective observational study enrolled infants receiving single-dose Nirsevimab at Peking University Third Hospital from September 2024 to August 2025. A multidisciplinary team comprising pediatricians, nurses, pharmacists, and obstetricians was established to develop standardized protocols for medication management, injection procedures, follow-up processes, and safety assessment forms. Descriptive statistics analyzed on-site observations within 30 minutes post-injection and all adverse events, with causality assessment conducted.Results:Among 331 participants [171 males (51.7%), 160 females (48.3%)], 225 (68.0%) received outpatient injections and 106 (32.0%) inpatient injections. Successful administration was achieved in 330 cases (99.7%), including 207 (62.7%) receiving 50 mg/vial and 123 (37.3%) receiving 100 mg/vial formulations; one child (3 years 11 months, 19.0 kg) received two 100 mg doses. During the 30-minute observation, 11 cases (3.3%) experienced adverse events, all presenting as injection site erythema following 100 mg/vial administration, with no systemic or serious adverse events observed. All symptoms resolved spontaneously within 30 minutes. Multidisciplinary review suggested potential associations with insufficient rewarming time, larger injection volumes, or post-injection compression pressure.Conclusion:Nirsevimab demonstrated favorable short-term safety profiles in Chinese infants following single-dose administration, with feasible multidisciplinary standardized protocols, though larger sample sizes and extended follow-up are warranted for monitoring medium-to-long-term safety and special populations.