目的 通过对新生儿药物不良反应（ADE）风险信号进行挖掘，了解新生儿ADE发生的特点及规律，为新生儿临床安全用药提供参考。方法 对山东省药品不良反应监测中心2021年1月—2024年12月收到的所有关于新生儿（出生后≤28 d）报告进行分析。收集患者性别、日龄、给药途径、不良反应累及系统/器官、临床表现及转归情况等信息；采用报告比值比（ROR）法、比例报告比值比（PRR）法和英国药品和保健品管理局（MHRA）综合标准法对与新生儿相关的ADE风险信号进行挖掘和评价。结果 新生儿ADE报告病例共1 444份，其中严重不良反应310例（21.5%）;108例新报告例数；ADE共累及18个系统/器官，按报告数排名前5位的依次为皮肤及皮下组织类疾病[550例（38.1%）]、胃肠系统疾病[538例（37.3%）]、血管与淋巴管类疾病[78例（5.4%）]、精神系统疾病[47例（3.3%）]及心脏器官系统疾病[38例（2.6%）]。551例（38.2%）患者痊愈，844例（58.4%）好转，无死亡病例。最常与严重ADE相关的是抗感染药物、中枢神经系统用药及维生素类/营养类药物。ROR法、PRR法及MHRA综合标准法共挖掘出风险信号50个；50个风险信号中，盐酸多巴胺注射液发生不良反应频次最多，多种油脂肪乳注射剂-胆汁淤积的信号强度最大，说明书未提及的有多巴胺注射液-瘢痕等。结论 新生儿发生新的严重的ADE比例较高，报告频次前21位ADE大多数被药品说明书收载，对于未被说明书收录的新生儿ADE应该引起临床医师的重视，新生儿用药安全性问题仍值得关注。

Objective To explore the characteristics and patterns of adverse drug reactions（ADEs） in neonates by mining risk signals, providing references for the safe clinical use of drugs. Methods All reports related to neonates（≤ 28 d after birth） received by the Shandong Provincial Center for Adverse Drug Reaction Monitoring from January 2021 to December 2024 were studied. Information such as patient gender, age in days, route of administration, systems/organs involved in ADEs, clinical manifestations, and outcomes was collected. The risk signals of ADEs related to neonates were mined and evaluated using the reporting odds ratio（ROR） method, the proportional reporting ratio（PRR） method, and the comprehensive standard of the Medicines and Healthcare Products Regulatory Agency（MHRA） of the United Kingdom. Results A total of 1 444 reports of ADEs in neonates were collected, among which 310 cases（21.5%） were severe ADEs; 108 cases were new reports. ADEs involved 18 systems/organs, with the top five being skin and subcutaneous tissue diseases [550 cases（38.1%）], gastrointestinal system diseases [538 cases（37.3%）], vascular and lymphatic system diseases [78 cases（5.4%）], nervous system diseases [47 cases（3.3%）], and heart organ system [38 cases（2.6%）]. 551 cases（38.2%） recovered, 844 cases（58.4%） improved, and there were no deaths. The most common drugs associated with severe ADEs were anti-infective drugs, central nervous system drugs, and vitamin/nutritional drugs. A total of 50 risk signals were mined using the ROR method, the PRR method, and the MHRA comprehensive standard method. Among the 50 risk signals, the most frequent ADEs were associated with Dopamine Hydrochloride Injection, and the signal strength of multiple oil fat emulsion injection-cholestasis was the largest. Unmentioned in the instructions were dopamine injection-scar, etc. Conclusion The proportion of new and severe ADEs in neonates is relatively high. Most of the top 21 ADEs in terms of reporting frequency are included in the drug instructions. For ADEs in neonates not mentioned in the instructions, clinicians should pay attention. The safety of drugs in neonates still needs to be addressed.

R985