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奥沙利铂相关休克在III期结直肠癌患者中的情况:台湾地区的真实世界证据

Oxaliplatin-associated shock in stage III colorectal cancer patients: real-world evidence in Taiwan.

作者信息

Wang Ling-Yi, Hsieh Hui-Hsia, Chu Sung-Chao, Chang Wei-Chuan, Kuo Yi-Ting, Wu Tien-Yuan

机构信息

Graduate Institute of Clinical Pharmacy, Tzu Chi University, Hualien, Taiwan.

Department of Pharmacy, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.

出版信息

Ther Adv Drug Saf. 2024 Jul 30;15:20420986241266439. doi: 10.1177/20420986241266439. eCollection 2024.

Abstract

BACKGROUND

Oxaliplatin-associated shock (referred to as shock) is a rare but life-threatening adverse event.

OBJECTIVES

This pioneering cohort study aimed to quantitatively investigate the association between oxaliplatin use and shock in patients with stage III colorectal cancer (CRC), identify potential independent risk factors for shock, and assess the cycle-to-shock during oxaliplatin treatment.

DESIGN

The study utilized a nested case-control (NCC) design to assess the association between oxaliplatin and shock and employed a case-crossover approach to address unmeasured confounders.

METHODS

All newly diagnosed stage III CRC patients were identified from the CRC Health Database (2012-2016). Conditional logistic regression was used to calculate odds ratios (OR) and 95% confidence intervals (CIs) for oxaliplatin's link to shock incidence.

RESULTS

Among 6932 oxaliplatin recipients, 331 suffered shock. In all, 3309 controls were selected risk-set sampling for the shock cases. Oxaliplatin use is associated with a doubled risk of shock (adjusted OR: 2.08, 95% CI: 1.23-3.52). Two independent risk factors were male sex (adjusted OR: 1.33, 95% CI: 1.05-1.69) and heart diseases (adjusted OR: 1.65, 95% CI: 1.17-2.32). The case-crossover analysis revealed a more than fourfold risk (OR: 4.4, 95% CI: 1.67-11.62). In total, 22 of 331 shock cases were exposed to oxaliplatin within 2 days of shock onset, with a median cycle-to-shock time at the seventh cycle.

CONCLUSION

Oxaliplatin use significantly increased shock risk in stage III CRC patients. Male sex and heart disease are two independent risk factors.

摘要

背景

奥沙利铂相关休克(以下简称休克)是一种罕见但危及生命的不良事件。

目的

这项开创性的队列研究旨在定量调查奥沙利铂使用与III期结直肠癌(CRC)患者休克之间的关联,确定休克的潜在独立危险因素,并评估奥沙利铂治疗期间至休克发生的周期。

设计

该研究采用巢式病例对照(NCC)设计评估奥沙利铂与休克之间的关联,并采用病例交叉方法处理未测量的混杂因素。

方法

从CRC健康数据库(2012 - 2016年)中识别出所有新诊断的III期CRC患者。使用条件逻辑回归计算奥沙利铂与休克发生率之间的比值比(OR)和95%置信区间(CI)。

结果

在6932名接受奥沙利铂治疗的患者中,331人发生休克。总共为休克病例通过风险集抽样选择了3309名对照。使用奥沙利铂会使休克风险增加一倍(调整后的OR:2.08,95%CI:1.23 - 3.52)。两个独立危险因素为男性(调整后的OR:1.33,95%CI:1.05 - 1.69)和心脏病(调整后的OR:1.65,95%CI:1.17 - 2.32)。病例交叉分析显示风险增加了四倍多(OR:4.4,95%CI:1.67 - 11.62)。在331例休克病例中,共有22例在休克发作后2天内接受了奥沙利铂治疗,至休克发生的中位周期为第七个周期。

结论

使用奥沙利铂显著增加了III期CRC患者的休克风险。男性和心脏病是两个独立危险因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3290/11289823/bcd9a029ef43/10.1177_20420986241266439-fig1.jpg

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