静脉注射人免疫球蛋白临床应用的不良反应之三年回顾性研究（英文）

Adverse events of intravenous immunoglobulin infusions:a three-year retrospective study in China

本文主要描述静脉注射人免疫球蛋白在儿童临床应用中常见的不良反应。收集浙东地区最大的儿童医院宁波市妇女儿童医院2015年至2017年所有应用IVIG的情况,并对发生不良反应的患儿的临床数据进行记录、归纳及总结。结果发现,三年间共有2100名患儿应用了静脉注射人免疫球蛋白,其中共计10名儿童发生药物不良反应,且1至3岁患儿的发生率最高(40%),其中7名患儿的用药指征为川崎病及重症肺炎(70%)。另外,其中8名患儿出现皮疹,5名患儿存在胸痛,4名患儿伴有面色发绀。不良反应最常发生于注射开始的30min内,且于大剂量应用时更容易发生。鉴于2015–2016年该药不良反应发生率高于往年,医院2017年更改不同品牌的IVIG,该药的不良反应发生率从1.39%降至0.13%。在我们的研究中,0.48%的应用IVIG的患儿产生不良反应,过敏样反应是发生率最高的不良反应,且症状通常出现在开始滴注的30 min内,且受用药剂量、患儿的免疫状态、用药的指征、以及药品品牌所影响。

Intravenous immunoglobulin(IVIG) is biological product, which is extensively used in pediatric patients, with high adverse effects on children among different brand preparations. In the present study, we aimed to describe the adverse events of pediatric patients given IVIG infusions in China. Data were collected from all patients receiving IVIG infusion at the largest children’s hospital in Ningbo of China form January 2015 to December 2017. Descriptive statistics was used. A total of 2100 patients received IVIG infusion. All the patients who experienced adverse reactions were children(0.48%), with the highest frequency of infusion among those age 1 to 3 years old(40%). Among 10 infusions with adverse reactions, the most common indication was Kawasaki disease(40%) followed by severe pneumonia(30%). Rash was the most common adverse event(80%), followed by chest pain & cough(50%) and cyanosis(40%). Adverse events were observed to occur most frequently within 30 min from onset of infusion. Most of the reactions occurred with the large dose and the indications of used for. Since the hospital changed the brand, the incidence of adverse reactions was decreased from 1.39% to 0.13%. In this study, 0.48% of pediatric patients given IVIG infusions experienced adverse events. Anaphylactoid reaction was the most common manifestation. Symptoms occurred within 30 min from onset of infusion, which were affected by the dose, the value of lgE, the indications and the different brands.