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硼替佐米、卡非佐米和伊沙佐米感染相关不良事件的比较:一项基于美国食品药品监督管理局不良事件报告系统的药物警戒研究

Infection-related adverse events comparison of bortezomib, carfilzomib and ixazomib: a pharmacovigilance study based on FAERS.

作者信息

Xiang Chenhuan, Guo Rongrong, Ti Juanjuan, Zhang Shaoli, Wang Tao

机构信息

Department of Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Third Hospital of Shanxi Medical University, Tongji Shanxi Hospital, Taiyuan, China.

出版信息

Expert Opin Drug Saf. 2025 Apr 23:1-10. doi: 10.1080/14740338.2025.2494692.

Abstract

BACKGROUND

Bortezomib, carfilzomib and ixazomib are the most common proteasome inhibitors (PIs) used to treat Multiple Myeloma (MM). We conducted a pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS), aiming to offer a reference for safe and reasonable clinical use.

RESEARCH DESIGN AND METHODS

Adverse drug reaction (ADR) signals of bortezomib, carfilzomib and ixazomib were analyzed by statistical methods including Reporting Odds Ratio (ROR), Proportional Reporting Ratios (PRR), and Multi-item Gamma-Poisson Shrinker (MGPS).

RESULTS

A total of 13,977, 8263 and 13296 ADRs of bortezomib, carfilzomib and ixazomib were analyzed respectively from the FAERS database. The most frequent adverse reaction signal for bortezomib was peripheral neuropathy; for carfilzomib, it was acute kidney injury; for ixazomib, it was vomiting. Then, a total of 43, 23 and 10 infection-related adverse events of bortezomib, carfilzomib and ixazomib were analyzed. The most common infection-related adverse event for bortezomib was cytomegalovirus infection; for carfilzomib, it was bacteremia; and for ixazomib, it was conjunctivitis.

CONCLUSIONS

In real-world pharmacovigilance studies, PIs are associated with infection-related adverse events, which is crucial for the safe use of PIs in the treatment of MM. However, further research is needed to validate the hypotheses generated in this study.

摘要

背景

硼替佐米、卡非佐米和伊沙佐米是用于治疗多发性骨髓瘤(MM)最常用的蛋白酶体抑制剂(PIs)。我们使用美国食品药品监督管理局不良事件报告系统(FAERS)进行了药物警戒分析,旨在为安全合理的临床使用提供参考。

研究设计与方法

采用报告比值比(ROR)、比例报告比(PRR)和多项目伽马-泊松收缩器(MGPS)等统计方法分析硼替佐米、卡非佐米和伊沙佐米的药物不良反应(ADR)信号。

结果

分别从FAERS数据库中分析了硼替佐米、卡非佐米和伊沙佐米的13977例、8263例和13296例ADR。硼替佐米最常见的不良反应信号是周围神经病变;卡非佐米是急性肾损伤;伊沙佐米是呕吐。然后,分别分析了硼替佐米、卡非佐米和伊沙佐米的43例、23例和10例与感染相关的不良事件。硼替佐米最常见的与感染相关的不良事件是巨细胞病毒感染;卡非佐米是菌血症;伊沙佐米是结膜炎。

结论

在真实世界的药物警戒研究中,蛋白酶体抑制剂与感染相关的不良事件有关,这对蛋白酶体抑制剂在MM治疗中的安全使用至关重要。然而,需要进一步研究来验证本研究中产生的假设。

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