目的 分析布瓦西坦致兒童不良反應(yīng)(ADR)的一般規(guī)律及特點(diǎn),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(yīng)"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(duì)中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫(kù)(CNKI)、萬(wàn)方數(shù)據(jù)庫(kù)(Wanfang Data)、維普生物醫(yī)學(xué)數(shù)據(jù)庫(kù)(VIP)、PubMed、Web of Sciene和Embase等數(shù)據(jù)庫(kù)進(jìn)行文獻(xiàn)檢索,檢索時(shí)限均為數(shù)據(jù)庫(kù)建庫(kù)起至2024年1月31日。對(duì)納入研究患者性別、年齡、用藥情況、聯(lián)合用藥、ADR臨床表現(xiàn)等進(jìn)行統(tǒng)計(jì)分析。結(jié)果 共納入文獻(xiàn)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(gè)系統(tǒng)/器官,以神經(jīng)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(yùn)動(dòng)機(jī)能亢進(jìn)、行為問(wèn)題等。大多數(shù)ADR是可逆且預(yù)后良好的,但仍有部分患者在進(jìn)行干預(yù)治療后產(chǎn)生了不良結(jié)局,甚至死亡。結(jié)論 布瓦西坦可致兒童嚴(yán)重ADR的發(fā)生,臨床應(yīng)關(guān)注該藥的合理使用,加強(qiáng)用藥監(jiān)護(hù)和隨訪,以確保患者臨床用藥安全。

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(jié)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(diǎn)培養(yǎng)項(xiàng)目(tjd-szxyy20210023)