Risk of gastrointestinal perforation in patients taking oral fluoroquinolone therapy

An analysis of nationally representative cohort

Shou Chien Hsu, Shy Shin Chang, Meng Tse Gabriel Lee, Si Huei Lee, Yi Wen Tsai, Shen Che Lin, Szu Ta Chen, Yi Chieh Weng, Lorenzo Porta, Jiunn Yih Wu, Chien Chang Lee

研究成果: 雜誌貢獻文章

4 引文 (Scopus)

摘要

Background: Fluoroquinolone is a commonly prescribed antimicrobial agent, and up to 20% of its users registers adverse gastroenterological symptoms. We aimed to evaluate the association between use of fluoroquinolone and gastrointestinal tract perforation. Methods: We conducted a nested case-control study on a national health insurance claims database between 1998 and 2011. The use of fluoroquinolones was classified into current (< 60 days), past (61–365 days prior to the index date) and any prior year use of fluoroquinolones. We used the conditional logistic regression model to estimate rate ratios (RRs), adjusting or matching by a disease risk score (DRS). Results: We identified a cohort of 17,510 individuals diagnosed with gastrointestinal perforation and matched them to 1,751,000 controls. Current use of fluoroquinolone was associated with the greatest increase in risk of gastrointestinal perforations after DRS score adjustment (RR, 1.90; 95% CI, 1.62–2.22). The risk of gastrointestinal perforation was attenuated for past (RR, 1.33; 95% CI, 1.20–1.47) and any prior year use (RR, 1.46; 95% CI, 1.34–1.59). To gain insights into whether the observed association can be explained by unmeasured confounder, we compared the risk of gastrointestinal perforation between fluoroquinolone and macrolide. Use of macrolide, an active comparator, was not associated with a significant increased risk of gastrointestinal perforation (RR, 1.11, 95%CI, 0.15–7.99). Sensitivity analysis focusing on perforation requiring in-hospital procedures also demonstrated an increased risk associated with current use. To mitigate selection bias, we have also excluded people who have never used fluoroquinolone before or people with infectious colitis, enteritis or gastroenteritis. In both of the analysis, a higher risk of gastrointestinal perforation was still associated with the use of fluoroquinolone. Conclusions: We found that use of fluoroquinolones was associated with a non-negligible increased risk of gastrointestinal perforation, and physicians should be aware of this possible association.

原文英語
文章編號e0183813
期刊PLoS One
12
發行號9
DOIs
出版狀態已發佈 - 九月 1 2017

指紋

fluoroquinolones
Fluoroquinolones
mouth
therapeutics
macrolides
Therapeutics
Macrolides
Logistic Models
Health insurance
health insurance
Enteritis
Selection Bias
gastroenteritis
colitis
Gastroenteritis
National Health Programs
enteritis
Colitis
Anti-Infective Agents
case-control studies

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

引用此文

Risk of gastrointestinal perforation in patients taking oral fluoroquinolone therapy : An analysis of nationally representative cohort. / Hsu, Shou Chien; Chang, Shy Shin; Lee, Meng Tse Gabriel; Lee, Si Huei; Tsai, Yi Wen; Lin, Shen Che; Chen, Szu Ta; Weng, Yi Chieh; Porta, Lorenzo; Wu, Jiunn Yih; Lee, Chien Chang.

於: PLoS One, 卷 12, 編號 9, e0183813, 01.09.2017.

研究成果: 雜誌貢獻文章

Hsu, SC, Chang, SS, Lee, MTG, Lee, SH, Tsai, YW, Lin, SC, Chen, ST, Weng, YC, Porta, L, Wu, JY & Lee, CC 2017, 'Risk of gastrointestinal perforation in patients taking oral fluoroquinolone therapy: An analysis of nationally representative cohort', PLoS One, 卷 12, 編號 9, e0183813. https://doi.org/10.1371/journal.pone.0183813
Hsu, Shou Chien ; Chang, Shy Shin ; Lee, Meng Tse Gabriel ; Lee, Si Huei ; Tsai, Yi Wen ; Lin, Shen Che ; Chen, Szu Ta ; Weng, Yi Chieh ; Porta, Lorenzo ; Wu, Jiunn Yih ; Lee, Chien Chang. / Risk of gastrointestinal perforation in patients taking oral fluoroquinolone therapy : An analysis of nationally representative cohort. 於: PLoS One. 2017 ; 卷 12, 編號 9.
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abstract = "Background: Fluoroquinolone is a commonly prescribed antimicrobial agent, and up to 20{\%} of its users registers adverse gastroenterological symptoms. We aimed to evaluate the association between use of fluoroquinolone and gastrointestinal tract perforation. Methods: We conducted a nested case-control study on a national health insurance claims database between 1998 and 2011. The use of fluoroquinolones was classified into current (< 60 days), past (61–365 days prior to the index date) and any prior year use of fluoroquinolones. We used the conditional logistic regression model to estimate rate ratios (RRs), adjusting or matching by a disease risk score (DRS). Results: We identified a cohort of 17,510 individuals diagnosed with gastrointestinal perforation and matched them to 1,751,000 controls. Current use of fluoroquinolone was associated with the greatest increase in risk of gastrointestinal perforations after DRS score adjustment (RR, 1.90; 95{\%} CI, 1.62–2.22). The risk of gastrointestinal perforation was attenuated for past (RR, 1.33; 95{\%} CI, 1.20–1.47) and any prior year use (RR, 1.46; 95{\%} CI, 1.34–1.59). To gain insights into whether the observed association can be explained by unmeasured confounder, we compared the risk of gastrointestinal perforation between fluoroquinolone and macrolide. Use of macrolide, an active comparator, was not associated with a significant increased risk of gastrointestinal perforation (RR, 1.11, 95{\%}CI, 0.15–7.99). Sensitivity analysis focusing on perforation requiring in-hospital procedures also demonstrated an increased risk associated with current use. To mitigate selection bias, we have also excluded people who have never used fluoroquinolone before or people with infectious colitis, enteritis or gastroenteritis. In both of the analysis, a higher risk of gastrointestinal perforation was still associated with the use of fluoroquinolone. Conclusions: We found that use of fluoroquinolones was associated with a non-negligible increased risk of gastrointestinal perforation, and physicians should be aware of this possible association.",
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AU - Hsu, Shou Chien

AU - Chang, Shy Shin

AU - Lee, Meng Tse Gabriel

AU - Lee, Si Huei

AU - Tsai, Yi Wen

AU - Lin, Shen Che

AU - Chen, Szu Ta

AU - Weng, Yi Chieh

AU - Porta, Lorenzo

AU - Wu, Jiunn Yih

AU - Lee, Chien Chang

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N2 - Background: Fluoroquinolone is a commonly prescribed antimicrobial agent, and up to 20% of its users registers adverse gastroenterological symptoms. We aimed to evaluate the association between use of fluoroquinolone and gastrointestinal tract perforation. Methods: We conducted a nested case-control study on a national health insurance claims database between 1998 and 2011. The use of fluoroquinolones was classified into current (< 60 days), past (61–365 days prior to the index date) and any prior year use of fluoroquinolones. We used the conditional logistic regression model to estimate rate ratios (RRs), adjusting or matching by a disease risk score (DRS). Results: We identified a cohort of 17,510 individuals diagnosed with gastrointestinal perforation and matched them to 1,751,000 controls. Current use of fluoroquinolone was associated with the greatest increase in risk of gastrointestinal perforations after DRS score adjustment (RR, 1.90; 95% CI, 1.62–2.22). The risk of gastrointestinal perforation was attenuated for past (RR, 1.33; 95% CI, 1.20–1.47) and any prior year use (RR, 1.46; 95% CI, 1.34–1.59). To gain insights into whether the observed association can be explained by unmeasured confounder, we compared the risk of gastrointestinal perforation between fluoroquinolone and macrolide. Use of macrolide, an active comparator, was not associated with a significant increased risk of gastrointestinal perforation (RR, 1.11, 95%CI, 0.15–7.99). Sensitivity analysis focusing on perforation requiring in-hospital procedures also demonstrated an increased risk associated with current use. To mitigate selection bias, we have also excluded people who have never used fluoroquinolone before or people with infectious colitis, enteritis or gastroenteritis. In both of the analysis, a higher risk of gastrointestinal perforation was still associated with the use of fluoroquinolone. Conclusions: We found that use of fluoroquinolones was associated with a non-negligible increased risk of gastrointestinal perforation, and physicians should be aware of this possible association.

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