目的 通過(guò)對(duì)新生兒藥物不良反應(yīng)（ADE）風(fēng)險(xiǎn)信號(hào)進(jìn)行挖掘，了解新生兒ADE發(fā)生的特點(diǎn)及規(guī)律，為新生兒臨床安全用藥提供參考。方法 對(duì)山東省藥品不良反應(yīng)監(jiān)測(cè)中心2021年1月—2024年12月收到的所有關(guān)于新生兒（出生后≤28 d）報(bào)告進(jìn)行分析。收集患者性別、日齡、給藥途徑、不良反應(yīng)累及系統(tǒng)/器官、臨床表現(xiàn)及轉(zhuǎn)歸情況等信息；采用報(bào)告比值比（ROR）法、比例報(bào)告比值比（PRR）法和英國(guó)藥品和保健品管理局（MHRA）綜合標(biāo)準(zhǔn)法對(duì)與新生兒相關(guān)的ADE風(fēng)險(xiǎn)信號(hào)進(jìn)行挖掘和評(píng)價(jià)。結(jié)果 新生兒ADE報(bào)告病例共1 444份，其中嚴(yán)重不良反應(yīng)310例（21.5%）;108例新報(bào)告例數(shù)；ADE共累及18個(gè)系統(tǒng)/器官，按報(bào)告數(shù)排名前5位的依次為皮膚及皮下組織類疾病[550例（38.1%）]、胃腸系統(tǒng)疾病[538例（37.3%）]、血管與淋巴管類疾病[78例（5.4%）]、精神系統(tǒng)疾病[47例（3.3%）]及心臟器官系統(tǒng)疾病[38例（2.6%）]。551例（38.2%）患者痊愈，844例（58.4%）好轉(zhuǎn)，無(wú)死亡病例。最常與嚴(yán)重ADE相關(guān)的是抗感染藥物、中樞神經(jīng)系統(tǒng)用藥及維生素類/營(yíng)養(yǎng)類藥物。ROR法、PRR法及MHRA綜合標(biāo)準(zhǔn)法共挖掘出風(fēng)險(xiǎn)信號(hào)50個(gè)；50個(gè)風(fēng)險(xiǎn)信號(hào)中，鹽酸多巴胺注射液發(fā)生不良反應(yīng)頻次最多，多種油脂肪乳注射劑-膽汁淤積的信號(hào)強(qiáng)度最大，說(shuō)明書未提及的有多巴胺注射液-瘢痕等。結(jié)論 新生兒發(fā)生新的嚴(yán)重的ADE比例較高，報(bào)告頻次前21位ADE大多數(shù)被藥品說(shuō)明書收載，對(duì)于未被說(shuō)明書收錄的新生兒ADE應(yīng)該引起臨床醫(yī)師的重視，新生兒用藥安全性問(wèn)題仍值得關(guān)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