静注人免疫球蛋白不同制剂对儿童川崎病治疗有效性和安全性的比较分析  

Comparison of Efficacy and Safety of Different Preparations of Intravenous Human Immunoglobulin for Kawasaki Disease Treatment in Children

作　　者：赵华伟[1,2] 沈月芳 周武孝[3] 倪映华 李彦红[1] 孙洋洋 缪静 ZHAO Huawei;SHEN Yuefang;ZHOU Wuxiao;NI Yinghua;LI Yanhong;SUN Yangyang;MIAO Jing(National Clinical Research Center for Child Health,Department of Pharmacy,Children's Hospital of Zhejiang University School of Medicine,Hangzhou 310052,China;Research Center for Clinical Pharmacy,Zhejiang University,Hangzhou 310058,China;Department of Pharmacy,Wuyi Maternal and Child Care Hospital,Jinhua 321200,China)

机构地区：[1]浙江大学医学院附属儿童医院药剂科,国家儿童健康与疾病临床医学研究中心,杭州310052 [2]浙江大学临床药学研究中心,杭州310058 [3]武义县妇幼保健院药剂科,浙江金华321200

出　　处：《中国药学杂志》2024年第16期1545-1550,共6页Chinese Pharmaceutical Journal

基　　金：国家自然科学基金青年基金项目资助(82003720);浙江省基础公益研究计划项目资助(LYY22H310002);浙江省新一轮卫生高层次人才培养工程资助(2022年度医坛新秀);浙江大学医学院附属儿童医院青年临床科学家培育专项基金资助(CHZJU2023YS006)。

摘　　要：目的 比较分析不同静注人免疫球蛋白(intravenous immunoglobulin,IVIG)制剂对儿童川崎病治疗的有效性和安全性。方法 回顾性分析我院近3年的川崎病患儿的病历,使用2种IVIG制剂,分别定义为制剂A和制剂B。纳入患儿均在确诊川崎病后给予IVIG(2g·kg^(-1))联合阿司匹林治疗,进而对比2种IVIG制剂治疗前后的体温变化、白细胞计数、血小板计数、C-反应蛋白及IVIG单药费用、住院时间和不良事件的情况。结果 根据药品说明书,制剂A和制剂B的药品相关信息存在一定的差异。制剂B退热所需时间比制剂A更短,两者之间存在显著性差异(P<0.005),在输注结束后第一次体温检测中,制剂B组患者体温值显著低于制剂A组(P<0.05),并且与制剂A相比,制剂B治疗后患者白细胞下降更为显著(P=0.010)。在住院时间和IVIG单药费用方面,制剂B显著缩短住院时间(P<0.05),单位体质量的IVIG费用更低(P<0.001)。在不良事件方面,包括皮疹、高热中断输液、肝损伤和冠脉扩张的发生,2组之间没有显著差异。结论 静注人免疫球蛋白不同制剂对儿童川崎病治疗的临床有效性存在差异,但治疗安全性相当。OBJECTIVE To investigate the efficacy and safety of different preparations of intravenous immunoglobulin(IVIG) for Kawasaki disease treatment in children.METHODS A retrospective analysis of medical records of pediatric Kawasaki disease patients at our institution in recent three years was conducted.Patients were divided into preparation A group and preparation B group based on the type of IVIG preparations used.Both groups received IVIG(2 g·kg~(-1)) in conjunction with aspirin therapy following Kawasaki disease diagnosis.Changes in body temperature,white blood cell count,platelet count,C-reactive protein levels,IVIG cost,length of hospital stay,and adverse events were compared.RESULTS According to the drug labeling,there are certain differences between preparation A and preparation B.Preparation B exhibited a significantly shorter duration of fever resolution compared with preparation A(P<0.005),and at the first temperature test after infusion,the body temperature of preparation B group was significantly lower than that of preparation A group(P<0.05).Furthermore,preparation B demonstrated a more significant reduction in white blood cell count following treatment(P=0.010).In terms of hospital stay duration and IVIG monotherapy costs,preparation B had significantly shorter hospital stay(P<0.05) and lower per-unit IVIG expense(P<0.001).No significant differences were observed between the two groups in terms of adverse events,including rashes,infusion interruptions due to high fever,liver injury,and coronary dilation.CONCLUSION There is significant difference in efficacy between different preparations of intravenous immunoglobulin in the treatment of Kawasaki disease in children,but the safety is similar.

关 键 词：静注人免疫球蛋白 川崎病 制剂 退热时间 不良事件 

分 类 号：R979.5[医药卫生—药品]