目的 分析布瓦西坦致兒童不良反應(ADR)的一般規(guī)律及特點,為臨床安全用藥提供參考。方法 以"布瓦西坦" "布立西坦" "不良反應"和"副作用"等為中文檢索詞,以"Brivaracetam" "adverse reaction" "adverseeffects""ADR "和" side effect"等為英文檢索詞,對中國學術期刊全文數據庫(CNKI)、萬方數據庫(Wanfang Data)、維普生物醫(yī)學數據庫(VIP)、PubMed、Web of Sciene和Embase等數據庫進行文獻檢索,檢索時限均為數據庫建庫起至2024年1月31日。對納入研究患者性別、年齡、用藥情況、聯合用藥、ADR臨床表現等進行統(tǒng)計分析。結果 共納入文獻13篇,納入病例849例,其中男性458例(53.9 %)、女性391例(46.1 %),ADR共累及6個系統(tǒng)/器官,以神經系統(tǒng)(39.22 %)和精神疾病(31.86 %)為主,包括嗜睡、癲癇發(fā)作惡化、抽搐、易怒、攻擊性、精神運動機能亢進、行為問題等。大多數ADR是可逆且預后良好的,但仍有部分患者在進行干預治療后產生了不良結局,甚至死亡。結論 布瓦西坦可致兒童嚴重ADR的發(fā)生,臨床應關注該藥的合理使用,加強用藥監(jiān)護和隨訪,以確?；颊吲R床用藥安全。

Objective To analyze the general rules and characteristics of adverse drug reactions caused by brivaracetam in children, and to provide reference for clinical safety of drug use. Methods Clinical trial studies and case reports of adverse drug reactions caused by brivaracetam in children were searched from PubMed, CNKI, WanFang Data and VIP. The time limit for the search was from the establishment of the databases to January 31, 2024. The gender, age, usage and dosage of brivaracetam, combined drug use and ADR clinical manifestations of patients were statistically analyzed. Results A total of 13 literatures were included, with a total of 849 patients, including 458 males (53.9 %) and 391 females (46.1 %). ADR involved 6 systems/organs, which were mainly nervous system (39.22 %) and mental diseases (31.86 %), such as somnolence, seizure worsening, convulsion, irritability, aggression, psychomotor hyperactivity, behavioral problems. The most of ADR are reversible and have a good prognosis, but some patients still have adverse outcomes or even death after active treatment. Conclusion Brivaracetam can cause serious ADR in children. Clinical attention should be paid to the rational use of brivaracetam, and the monitoring and follow-up should be strengthened to ensure the safety ofpatients.

R287.5

天津市衛(wèi)生健康委中醫(yī)中西醫(yī)結合科研課題(2023219);天津市第四中心醫(yī)院2021年度優(yōu)秀青年人才重點培養(yǎng)項目(tjd-szxyy20210023)