评估与使用抗肿瘤药物相关的肿瘤溶解综合征风险:基于美国食品药物管理局不良事件报告系统数据库的真实世界药物警戒研究。

IF 3.4 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Therapeutic Advances in Drug Safety Pub Date : 2024-09-06 eCollection Date: 2024-01-01 DOI:10.1177/20420986241274909
Dongxuan Li, Chunmeng Qin, Hongli Wang, Dan Du, Yalan Wang, Qian Du, Songqing Liu
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引用次数: 0

摘要

背景:使用抗肿瘤药物是诱发肿瘤溶解综合征(TLS)的重要因素之一,但目前对可能诱发TLS的抗肿瘤药物以及不同抗肿瘤药物的TLS风险差异仍缺乏全面的认识:本研究旨在调查不同抗肿瘤药物的 TLS 风险,为临床实践提供参考信息:设计:以FDA不良事件报告系统(FAERS)数据库中的真实不良事件数据为基础,进行比例失调分析:我们回顾了2004年至2022年FAERS数据库中的TLS报告,总结出了一份被报告引发TLS的抗肿瘤药物清单,并在此基础上进行了比例失调分析,以评估每种抗肿瘤药物的TLS风险:结果:据报道,共有 164 种抗肿瘤药物可引发 TLS。总体而言,利妥昔单抗是TLS报告中最多的抗肿瘤药物,其次是环磷酰胺、韦尼妥昔单抗、多柔比星和依托泊苷;而在药物不良反应(ADR)信号强度检测中,他克莫司普是信号强度最高的抗肿瘤药物,其次是氟尿嘧啶、喷司他丁、替本他普和韦尼妥昔单抗。综合 ADR 信号检测结果,164 种抗肿瘤药物中有 129 种出现了至少一个阳性 ADR 信号,其中 6 种抗肿瘤药物(贝伐珠单抗、卡铂、顺铂、氟尿嘧啶、来伐替尼和紫杉醇)的阳性信号总数最多。进一步将 164 种抗肿瘤药物分为 46 个化学亚类进行 ADR 信号检测,氮芥类似物是报告最多的抗肿瘤药物亚类,其次是分化 20 抑制剂簇和嘧啶类似物,而分化 22 抑制剂簇是 ADR 信号强度最高的抗肿瘤药物亚类,其次是豆荚毒素衍生物和放线菌素:我们的研究通过检测和整合 ADR 信号显示了 164 种抗肿瘤药物的 TLS 风险特征,这可能有助于优化临床实践。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Assessing the risk of tumor lysis syndrome associated with the use of antineoplastic agents: a real-world pharmacovigilance study based on the FDA Adverse Event Reporting System database.

Background: The use of antineoplastic agents is one of the important triggers of tumor lysis syndrome (TLS), but there is still a lack of comprehensive understanding of antineoplastic agents that may trigger TLS and the TLS risk differences between different antineoplastic agents.

Objectives: This study aims to investigate the TLS risk of different antineoplastic agents and provide reference information for clinical practice.

Design: Real-world adverse events data in the FDA Adverse Event Reporting System (FAERS) database were used as the basis for the disproportionality analysis.

Methods: We reviewed the TLS reports in the FAERS database from 2004 to 2022 to summarize an antineoplastic agent list that was reported to trigger TLS, based on which we conducted disproportionality analysis to assess the TLS risk of each antineoplastic agent.

Results: In all, 164 antineoplastic agents were reported to trigger TLS. On the whole, rituximab was the most reported antineoplastic agent in TLS reports, followed by cyclophosphamide, venetoclax, doxorubicin, and etoposide, while tagraxofusp was the antineoplastic agent with the highest adverse drug reaction (ADR) signal strength in signal detection, followed by floxuridine, pentostatin, tebentafusp, and venetoclax. Integrating ADR signal detection results, 129 of 164 antineoplastic agents showed at least one positive ADR signal, and six antineoplastic agents (bevacizumab, carboplatin, cisplatin, fluorouracil, lenvatinib, and paclitaxel) have the highest total number of positive signals. Further classifying the 164 antineoplastic agents into 46 chemical subgroups to conduct ADR signal detection, nitrogen mustard analogs were the most reported antineoplastic agent subclasses, followed by clusters of differentiation 20 inhibitors, and pyrimidine analogs, while clusters of differentiation 22 inhibitors were the antineoplastic agent subclass with the highest ADR signal strength, followed by podophyllotoxin derivatives and actinomycines.

Conclusion: Our study showed the TLS risk characteristics of 164 antineoplastic agents by detecting and integrating ADR signals, which may help to optimize clinical practice.

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来源期刊
Therapeutic Advances in Drug Safety
Therapeutic Advances in Drug Safety Medicine-Pharmacology (medical)
CiteScore
6.70
自引率
4.50%
发文量
31
审稿时长
9 weeks
期刊介绍: Therapeutic Advances in Drug Safety delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies pertaining to the safe use of drugs in patients. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in drug safety, providing a forum in print and online for publishing the highest quality articles in this area. The editors welcome articles of current interest on research across all areas of drug safety, including therapeutic drug monitoring, pharmacoepidemiology, adverse drug reactions, drug interactions, pharmacokinetics, pharmacovigilance, medication/prescribing errors, risk management, ethics and regulation.
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