A case of febrile neutropenia caused by meropenem in an infant after congenital heart surgery and data mining analysis

WU Fan; LI Shisi; MENG Fang; XU Wenxiu

doi:10.6039/j.issn.1001-0408.2024.18.20

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A case of febrile neutropenia caused by meropenem in an infant after congenital heart surgery and data mining analysis

更新时间：2024-09-25

- A case of febrile neutropenia caused by meropenem in an infant after congenital heart surgery and data mining analysis
- ZHONGGUO YAOFANG Vol. 35, Issue 18, Pages: 2304-2309(2024)
- 作者机构：
  
  1.云南省阜外心血管病医院药剂科，昆明　650032
  2.云南省阜外心血管病医院心外科，昆明　650032
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.18.20
  CLC： R969.3;R978.1
- Published：30 September 2024，
  
  Received：20 December 2023，
  
  Revised：16 August 2024，
- 稿件说明：
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吴凡,李世思,孟方等.美罗培南致婴儿先天性心脏病术后发热性中性粒细胞减少症 1例及文献挖掘分析 ^Δ[J].中国药房,2024,35(18):2304-2309.

WU Fan,LI Shisi,MENG Fang,et al.A case of febrile neutropenia caused by meropenem in an infant after congenital heart surgery and data mining analysis[J].ZHONGGUO YAOFANG,2024,35(18):2304-2309.
吴凡,李世思,孟方等.美罗培南致婴儿先天性心脏病术后发热性中性粒细胞减少症 1例及文献挖掘分析 ^Δ[J].中国药房,2024,35(18):2304-2309. DOI： 10.6039/j.issn.1001-0408.2024.18.20.

WU Fan,LI Shisi,MENG Fang,et al.A case of febrile neutropenia caused by meropenem in an infant after congenital heart surgery and data mining analysis[J].ZHONGGUO YAOFANG,2024,35(18):2304-2309. DOI： 10.6039/j.issn.1001-0408.2024.18.20.

摘要

目的

为临床安全使用美罗培南提供参考。

方法

临床药师基于1例婴儿先天性心脏病术后使用美罗培南发生发热性中性粒细胞减少症的病例进行不良反应关联性分析；检索中英文数据库，对美罗培南诱发血液系统不良反应的个案报道进行归纳分析；再对美国FDA不良事件报告系统中相关不良事件风险信号进行挖掘分析，总结美罗培南致血液系统不良反应的特点。

结果

临床药师采用Naranjo’s评估量表对该患儿发热性中性粒细胞减少症与美罗培南的关联性进行评价，结果为“很可能”。文献分析共纳入16例患者，其中有1例为发热性中性粒细胞减少症；有13例患者的不良反应是危及生命、需要紧急治疗的4级严重不良反应；所有患者均在停药后好转。数据挖掘结果显示，美罗培南致血液系统不良事件的中位发生时间是6 d；新生儿血小板减少、血管内溶血、粒细胞计数降低是不良事件风险强度排前3位的信号。

结论

临床使用美罗培南抗感染初期可能诱发严重危及生命的血液系统不良反应，尤其对于婴幼儿和老人、使用较高剂量美罗培南、既往抗菌药物过敏、基础疾病复杂、联用较多抗菌药物、用药后出现高热和出血的患者，临床应予以密切监护。

Abstract

OBJECTIVE

To provide a reference for the safe clinical use of meropenem.

METHODS

The relationship of adverse reactions was analyzed based on a case of febrile neutropenia after using meropenem in an infant after congenital heart surgery by clinical pharmacists. By retrieving Chinese and English databases， case reports of adverse reactions induced by meropenem in blood system were summarized and analyzed. Relevant risk signals of adverse events were excavated from the FDA Adverse Event Reporting System， and the characteristics of meropenem-induced hematologic adverse reactions were summarized.

RESULTS

This case was assessed as “very likely” according to the Naranjo’s assessment scale by clinical pharmacists. A total of 16 patients were included in the literature analysis， of which one was febrile neutropenia， 13 patients had grade 4 serious adverse reactions that were life-threatening or required urgent treatment. All adverse reactions improved after drug withdrawal. Data mining revealed that the median occurrence time of hematologic adverse events induced by meropenem was 6 d； neonatal thrombocytopenia， intravascular hemolysis and neutrophil count decrease were the top 3 signals of risk intensity for adverse events.

CONCLUSIONS

Early use of meropenem may induce serious life-threatening hematological adverse reactions， especially in infants and elderly， those who use higher doses of meropenem， those who have previous antibiotic allergies， those with complex underlying diseases， those who use multiple antibiotics in combination， and those who experience high fever and bleeding after medication. Close monitoring should be provided in clinical practice.

关键词

美罗培南发热性中性粒细胞减少症血液系统不良事件药学监护FDA不良事件报告系统数据挖掘

Keywords

febrile neutropeniahematologic systemadverse eventpharmaceutical monitoringFAERSdata mining

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