18岁以下患者使用头孢他啶阿维巴坦的安全性文献分析

Safety Literature Analysis of Ceftazidime Avibactam in Children Less than 18 Years Old

目的:文献分析18岁以下患者使用头孢他啶阿维巴坦(ceftazidime avibactam,CAZ/AVI)的安全性。方法:中文以药品名“头孢他啶阿维巴坦”,再以“儿童”“婴幼儿”“早产儿”“新生儿”为范围,检索中国知网(CNKI)、万方数据库和维普数据库(VIP);英文以药品名“ceftazidime avibactam”,再以“children”“newborn”“premature infant”为范围检索PubMed、ScienceDirect、Embase、Wiley Online Library数据库,均从建库检索至2022年3月。筛选出18岁以下患者使用CAZ/AVI的临床病例,从患者的性别、年龄、诊断、病原菌类型、用药方法、合并用药、药品不良反应(adverse drug reaction,ADR)/不良事件(adverse event,AE)发生情况等方面分析用药安全性。结果:共检出有效文献9篇,纳入病例176例。统计病例中出现CAZ/AVI引起的ADR/AE总发生率为11.93%(21/176),以一般的为主,无需停药,治疗结束后可自行好转;严重的ADR/AE较少[0.57%(1/176)],停药后恢复正常,无新的、致死的ADR/AE的发生,但新生儿的ADR发生率稍高[45.45%(5/11)]。结论:18岁以下儿童使用CAZ/AVI的安全性与成人相似,新生儿未发生特殊ADR,但目前研究数据较少,仍需更多临床研究来证实。

Objective:The safety of ceftazidime avibactam(CAZ/AVI)in patients under 18 years old was analyzed in the literature.Methods:In Chinese,the drug name"ceftazidime avibactam",and then"children""infant""premature"and"newborn"as the range were searched in China National Knowledge Network(CNKI),Wanfang database and VIP database;in English,the drug name"ceftazidime avibactam"and then PubMed,ScienceDirect,Embase,and Wiley Online Library databases were retrieved in the range of"children""newborn"and"premature infant".The retrieval time was from the database establishment to March 2022.Clinical cases of CAZ/AVI in patients less than 18 years old were screened.The gender,age,diagnosis,pathogen type,medication method,combined medication,and adverse drug reaction(ADR)/adverse event(AE)of the patients were analyzed to abserve the safety of medication.Results:A total of 9valid literatures were detected,and 176 cases were included.The total incidence of adverse drug reaction/adverse event was 11.93%(21/176),which was mainly general.There was no need to stop medication,and the patients could improve spontaneously after treatment.Serious adverse reactions/adverse events were less(0.57%1/176),and returned to normal after drug withdrawal.No new fatal ADR/AE occurred,but the incidence was slightly higher in neonates,which was 45.45%(5/11).Conclusion:The safety of CAZ/AVI in children less than 18 years old is similar to that in adults,and there are no special adverse reactions in neonates.However,there are few research data at present,and more clinical studies are needed to confirm it.