治疗制品

静注人免疫球蛋白(pH4)皮下渗出不良反应的原因分析及其处理建议

  • 邹玲玲 杜志如
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  • 成都蓉生药业有限责任公司质量保证部 610041

网络出版日期: 2025-08-16

The cause analysis and treatment suggestions of adverse reactions after human intravenous immunoglobulin (pH4) subcutaneous exudation

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  • Quality Assurance Department, Chengdu Rongsheng Pharmaceuticals Co., Ltd., Chengdu 610041, China

Online published: 2025-08-16

摘要

 目的  探讨静注人免疫球蛋白(human intravenous immunoglobulinIVIG)(pH4外渗不良反应发生的影响因素方法  临床收集1例儿童IVIG皮下渗出的不良反应个案资料,并采用回顾性研究分析方法,对截至202010月国内外报道的37例IVIG皮下外渗病例,分别基础用药信息、肿胀部位、不良反应处理及转归进行统计分析。结果  37例病例中男20例、女16例、不详1例,年龄为1日龄至26月龄,主要为新生儿所有病例均在IVIG皮下渗出后发生不良反应。IVIG皮下渗出后肿胀部位主要位于手背(29.73%)和脚踝(29.73%),其他部位依次为肘部(18.92%)、足背(13.51%)、腘窝(5.41%)、头皮(2.70%)。对肿胀部位应急局部封闭处理后,肿胀消除效果明显,湿性敷料和外用药物有明显效果。结论  IVIG皮下渗出后不良反应与患者年龄、输注部位等因素存在一定的关系。当儿童使用IVIG发生皮下渗出时,采用文献中提到的方法对相应部位进行处理,可有效缓解和治疗对皮肤组织的损伤。

本文引用格式

邹玲玲 杜志如 . 静注人免疫球蛋白(pH4)皮下渗出不良反应的原因分析及其处理建议[J]. 国际生物制品学杂志, 2021 , 44(4) : 202 -205 . DOI: 10.3760/cma.j.cn311962-20201120-00112

Abstract

Objective  To investigate the influencing factors for adverse reactions after the extravasation of human intravenous immunoglobulin (IVIG) (pH4). Methods  One clinical IVIG subcutaneous extravasation case and 37 cases reported in medical academic journals worldwide as of October 2020 were retrospectively analyzed from the aspects of basic medication information, swelling site, adverse reaction treatment and outcome. Results  In 37 cases, there were 20 males, 16 females and 1 unknown case aged from 1 day to 26 months, mainly newborns. All cases had adverse reactions after IVIG subcutaneous exudation. The swelling mainly occurred in the dorsum of hand (29.73%) and ankle (29.73%). Other swelling parts were elbow (18.92%), dorsum of foot (13.51%), popliteal fossa (5.41%), and scalp (2.70%). After emergency local closure of the swelling part, the swelling was obviously eliminated. Wet dressing and topical drugs had significant effect. Conclusion  The adverse reactions after IVIG subcutaneous exudation have relationship with the age of patients, the place of infusion, etc. When subcutaneous exudation occurs, especially in infants, the method mentioned in literature can effectively alleviate and treat the damage to skin tissue.

 

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