基于CHPS评价儿科人群使用万古霉素的安全性及风险因素  

Safety and risk factors of vancomycin use in pediatric population based on CHPS

作　　者：施丹妮 蔡璨 陈蔚达 万隽 黄志杰 潘秀铭 SHI Dan-ni;CAI Can;CHEN Wei-da(Research Innovation Center of Women and Children's Hospital Affiliated to Xiamen University,Xiamen 361003,China)

机构地区：[1]厦门大学附属妇女儿童医院科研创新中心,361003 [2]厦门大学附属妇女儿童医院药学部,361003

出　　处：《中国现代药物应用》2024年第4期147-153,共7页Chinese Journal of Modern Drug Application

摘　　要：目的基于中国医院药物警戒系统(CHPS)回顾性分析儿科人群使用万古霉素的安全性情况,并进一步探索不良反应发生的潜在危险因素,为临床安全使用万古霉素提供参考。方法利用CHPS,选取2013年7月~2023年6月在本院住院且需使用万古霉素抗感染治疗的患儿作为研究对象,分析儿科人群使用万古霉的不良反应数据并做安全性评价,利用Logistic等统计学方法分析不良反应发生的危险因素。结果本研究纳入使用万古霉素的儿科人群980例次,常见的不良反应依次排序为γ-谷氨酰转肽酶升高(7.96%)、血红蛋白减少(6.43%)、嗜酸性粒细胞升高(5.61%)等;发现新的不良反应有低钾血症(0.82%)、尿酸增加(0.10%)和腹胀(0.29%);多因素分析中发现新生儿发生嗜酸性粒细胞升高的风险大于婴幼儿;女孩发生低钾血症的风险高于男孩;随着体重的升高。发生低钾血症的风险升高;合并苯巴比妥是γ-谷氨酰转肽酶升高的独立高危因素;合并左卡尼汀是天冬氨酸氨基转移酶升高和丙氨酸氨基转移酶升高的独立高危因素。结论万古霉素不良反应在儿科人群中发生率均较高。对于各方面机能不太健全的儿童,尤其是新生儿,应定期监护。监护的指标应包括γ-谷氨酰转肽酶、嗜酸性粒细胞、天冬氨酸氨基转移酶、丙氨酸氨基转移酶、血钾等。而在此后增设研究结果的危险因素至CHPS规则中,将利用触发器的功能,给予临床医生预警信息,以期减少不良反应的发生,提高儿科人群使用万古霉素的安全性。Objective To retrospectively analyze the safety of vancomycin in the pediatric population based on the China Hospital Pharmacovigilance System(CHPS),and further explore potential risk factors for adverse reactions,in order to provide reference for the safe use of vancomycin in clinical practice.Methods Using CHPS,pediatric patients who were hospitalized in our hospital and needed to use vancomycin for antiinfections from July 2013 to June 2023 were selected as the study subjects.The data of adverse reactions of the pediatric population using vancomycin were analyzed and the safety was evaluated,and the risk factors for adverse reactions were analyzed by Logistic and other statistical methods.Results This study included 980 pediatric patients who used vancomycin,and the common adverse reactions were ranked as followsγ-An increase in glutamyltranspeptidase(7.96%),a decrease in hemoglobin(6.43%),and an increase in eosinophils(5.61%);Discovered new adverse reactions include hypokalemia(0.82%),increased uric acid(0.10%),and abdominal distension(0.29%);In multivariate analysis,it was found that the risk of eosinophil elevation in newborns is higher than that in infants and young children;Girls have a higher risk of developing hypokalemia than boys;As weight increases.An increased risk of developing hypokalemia;Merging phenobarbital isγ-Independent high-risk factors for elevated glutamyltranspeptidase;The combination of L-carnitine is an independent high-risk factor for elevated aspartate aminotransferase and elevated alanine aminotransferase.Conclusion The incidence of adverse reactions of vancomycin in pediatric patients has increased.Children who are not functioning well in all aspects,especially newborns,should be monitored regularly.The indicators of guardianship should includeγ-glutamyl transpeptidase,eosinophilic granulocyte,aspartate aminotransferase,alanine aminotransferase,blood potassium,etc.In the future,the risk factors of the research results will be added to the CHPS rule,and the function of triggers w

关 键 词：万古霉素 儿科人群 安全性 中国医院药物警戒系统 

分 类 号：R95[医药卫生—药学]