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非布司他对台湾痛风不良事件和死亡率的影响:一项中断时间序列分析。

Effect of febuxostat on adverse events and mortality in gout in Taiwan: An interrupted time series analysis.

机构信息

Division of Rheumatology, Allergy and Immunology, Department of Internal Medicine, New Taipei Municipal Tucheng Hospital, New Taipei City, Taiwan.

Division of Rheumatology, Allergy and Immunology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou, Taoyuan City, Taiwan.

出版信息

Int J Rheum Dis. 2023 Mar;26(3):471-479. doi: 10.1111/1756-185X.14558. Epub 2023 Jan 6.

DOI:10.1111/1756-185X.14558
PMID:36608705
Abstract

OBJECTIVES

To evaluate the influence of febuxostat on adverse events and mortality in gout.

METHODS

We retrospectively enrolled patients with newly diagnosed gout and prescribed urate-lowering therapy between 2006 and 2017 from the Taiwan National Health Insurance Database. These patients were divided into 2 groups: with and without comorbidities (n = 294 847 and 194 539). An interrupted time series analysis with adjustments for demographics, comorbidities, and comedication by propensity score-based stabilized weights was used to compare the trend of adverse events and mortality before vs after febuxostat was introduced in 2012.

RESULTS

The proportion of febuxostat use gradually increased from 0% in 2012 to 30% in those with comorbidities and 10% in those without comorbidities in 2017. Allopurinol use decreased from 30% in 2012 to 10% in 2017. The slope of the 1-year incidence rate of Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) (per 10 000 patients) significantly reduced after 2012 in those with and without comorbidities (-0.375 per quarter, P = .015 and -.253 per quarter, P = .049). The slope of the 3-year incidence rate of acute myocardial infarction (AMI) (per 1000 patients), percutaneous coronary intervention (PCI) (per 1000 patients), and all-cause mortality (per 100 patients) significantly increased after 2012 in those with comorbidities (+0.207 per quarter, P = .013; +.389 per quarter, P = .002; +.103 per quarter, P = .001).

CONCLUSIONS

Febuxostat may reduce SJS and TEN in all gout patients but increase AMI, PCI, and all-cause mortality in gout patients with comorbidities.

摘要

目的

评估非布司他对痛风患者不良事件和死亡率的影响。

方法

我们从台湾全民健康保险数据库中回顾性招募了 2006 年至 2017 年期间新诊断为痛风并接受尿酸降低治疗的患者。这些患者分为两组:有合并症组(n=294847 人)和无合并症组(n=194539 人)。采用倾向评分稳定加权的中断时间序列分析,调整了人口统计学、合并症和合并用药因素,比较了 2012 年引入非布司他前后不良事件和死亡率的趋势。

结果

有合并症组和无合并症组中,非布司他的使用率从 2012 年的 0%逐渐增加到 2017 年的 30%和 10%。别嘌醇的使用率从 2012 年的 30%下降到 2017 年的 10%。有合并症和无合并症患者中,史蒂文斯-约翰逊综合征(SJS)或中毒性表皮坏死松解症(TEN)的 1 年发生率斜率(每 10000 例患者)在 2012 年后显著降低(每季度分别减少 0.375 和 0.253,P 值均为.015 和.049)。有合并症患者中,急性心肌梗死(AMI)(每 1000 例患者)、经皮冠状动脉介入治疗(PCI)(每 1000 例患者)和全因死亡率(每 100 例患者)的 3 年发生率斜率在 2012 年后显著增加(每季度分别增加 0.207、0.389 和 0.103,P 值均为.013、.002 和.001)。

结论

非布司他可能会降低所有痛风患者的 SJS 和 TEN,但会增加有合并症的痛风患者的 AMI、PCI 和全因死亡率。

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