Safety of omalizumab in the treatment of children with allergic diseases

ZENG Na; LI Jie; SUN Huajun

doi:10.6039/j.issn.1001-0408.2023.24.15

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Safety of omalizumab in the treatment of children with allergic diseases

更新时间：2023-12-22

- Safety of omalizumab in the treatment of children with allergic diseases
- ZHONGGUO YAOFANG Vol. 34, Issue 24, Pages: 3042-3045(2023)
- 作者机构：
  
  上海市儿童医院/上海交通大学医学院附属儿童医院药学部，上海　200062
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.24.15
  CLC： R985;R969.3
- Published：30 December 2023，
  
  Received：07 August 2023，
  
  Revised：26 November 2023，
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曾娜,李捷,孙华君.奥马珠单抗治疗儿童过敏性疾病的安全性分析 ^Δ[J].中国药房,2023,34(24):3042-3045.

ZENG Na,LI Jie,SUN Huajun.Safety of omalizumab in the treatment of children with allergic diseases[J].ZHONGGUO YAOFANG,2023,34(24):3042-3045.
曾娜,李捷,孙华君.奥马珠单抗治疗儿童过敏性疾病的安全性分析 ^Δ[J].中国药房,2023,34(24):3042-3045. DOI： 10.6039/j.issn.1001-0408.2023.24.15.

ZENG Na,LI Jie,SUN Huajun.Safety of omalizumab in the treatment of children with allergic diseases[J].ZHONGGUO YAOFANG,2023,34(24):3042-3045. DOI： 10.6039/j.issn.1001-0408.2023.24.15.

摘要

目的

分析奥马珠单抗治疗儿童过敏性疾病的安全性。

方法

收集2019年2月－2023年7月于我院接受奥马珠单抗治疗的过敏性疾病患儿的临床资料，包括患儿的基本情况、过敏原检测结果、血清总免疫球蛋白E（IgE）水平、奥马珠单抗应用情况和不良事件发生情况；同时针对治疗结束的患儿收集停药后第12个月的电话随访信息；采用Naranjo评估量表评价不良事件与奥马珠单抗的因果关系。

结果

共纳入30例患儿，接受奥马珠单抗皮下注射治疗245次，累计注射473针次。有4例患儿发生了4例次速发型超敏反应（Ⅰ、Ⅱ度各2例次），发生率为13.3%；其中，2例为首次注射后，1例为第3次注射后，1例为第5次注射后；因果关系评价结果显示，2例为“很可能”，2例为“可能”。21例结束治疗的患儿随访结果显示，患儿身体状况良好，未发生恶性肿瘤、蠕虫感染、血清病样反应、动脉血栓栓塞等不良反应。

结论

奥马珠单抗用于儿童过敏性疾病的不良反应发生率较低，多为速发型超敏反应，且以轻度为主，长期用药的安全性较好。

Abstract

OBJECTIVE

To analyze the safety of omalizumab in the treatment of allergic diseases in children.

METHODS

Clinical data of children with allergic diseases who were prescribed omalizumab therapy were collected from our hospital during February 2019 to July 2023， including the children’s basic conditions， allergen test results， serum levels of total immunoglobulin E（IgE）， omalizumab application and the occurrence of adverse events. The information on telephone follow-up was collected among the children who had completed treatment 12th month after drug withdrawal. At the same time， the causal relationship between adverse events and omalizumab was also evaluated by using the Naranjo assessment scale.

RESULTS

A total of 30 children were enrolled and received subcutaneous injections of omalizumab 245 times， accumulating 473 times. Four children suffered from four times of immediate-type hypersensitivity reactions （degree Ⅰ and Ⅱ every two times）， with an incidence of 13.3%； among them， two cases occurred after the first injection， one after the third injection， and one after the fifth injection； the results of the causality evaluation showed that two cases were “very likely” and two cases were “likely”. The telephone follow-up of 21 children showed that the children were in good health and there were no adverse events， such as malignant tumors， worm infections， serum disease-like reactions and arterial thromboembolism.

CONCLUSIONS

Omalizumab in children with allergic diseases is of good safety with a low incidence of adverse reactions， which are mainly mild immediate-type hypersensitivity reactions with a high long-term safety profile.

关键词

奥马珠单抗儿童过敏性疾病不良反应

Keywords

childrenallergic diseasesadverse reaction

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