儿童患者应用静注人免疫球蛋白的情况及合理性评价

Evaluation of the clinical use of intravenous immunoglobulin in pediatric patients

目的:考察我院儿童患者应用静注人免疫球蛋白的情况,并评价其合理性。方法:回顾2014年9月–2016年4月我院儿童患者应用静注人免疫球蛋白的情况,评价临床诊断与我国说明书和《临床用药须知》适应证的相符性,同时根据相关指南对超说明书应用静注人免疫球蛋白的获益情况进行评分,根据平均分确定获益等级,并评价给药方案的合理性。结果:160例应用静注人免疫球蛋白的儿童患者的主要诊断为重症感染、肝移植和新生儿ABO溶血等,其中有53.74%的病例存在超说明书用药。在超说明书用法中,肝移植、新生儿ABO溶血病、噬血细胞综合征、造血干细胞移植、急性移植物抗宿主病和新生儿溶血性贫血可能获益。仅68例患儿应用静注人免疫球蛋白的给药方案符合说明书或指南推荐。结论:部分儿童患者应用静注人免疫球蛋白的合理性还有待进一步验证,且给药方案仍需进一步优化。

Objective:To review and evaluate the clinical application of intravenous immunoglobulin in pediatric patients.Methods:The data of intravenous immunoglobulin used in pediatric patients were collected from September2014to April2016retrospectively.The consistency between the primary diagnoses and the label information or pharmacopoeia was evaluated.Thebenefits of the off-label use of intravenous immunoglobulin were scored and graded based on the guidelines.The rationality of dosingregimen was evaluated according to the label information,pharmacopoeia and guidelines.Results:A total of160pediatric patientswere included,and the primary diagnoses of the patients were severe infections,liver transplantation and ABO hemolytic disease ofthe newborn,53.74%of which were off-label use.Among the off-label use,intravenous immunoglobulin was probably beneficial forthe patients with liver transplantation,ABO hemolytic disease of the newborn,hemophagocytic lymphohistiocytosis,hematopoieticstem cell transplantation,acute graft-versus-host disease and hemolytic anemia of the newborn.Only68patients'dosing regimenswere judged as rational according to the label information or guidelines.Conclusion:The rationality of the clinical use ofintravenous immunoglobulin in pediatric patients demands to be further verified,and the dosing regimen needs to be standardized.