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
Department of Emergency Medicine, Chang Gung Memorial Hospital, Keelung, Taiwan and Chang Gung University College of Medicine, Taoyuan, Taiwan.
Department of Family Medicine, Taipei Medical University Hospital and School of Medicine, Taipei Medical University, Taipei, Taiwan.
PLoS One. 2017 Sep 5;12(9):e0183813. doi: 10.1371/journal.pone.0183813. eCollection 2017.
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.
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).
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.
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.
氟喹诺酮是一种常用的抗菌药物，高达20%的使用者会出现不良胃肠道症状。我们旨在评估氟喹诺酮的使用与胃肠道穿孔之间的关联。
我们在1998年至2011年的全国医疗保险索赔数据库上进行了一项巢式病例对照研究。氟喹诺酮的使用被分为当前使用（<60天）、过去使用（索引日期前61 - 365天）以及任何前一年使用氟喹诺酮的情况。我们使用条件逻辑回归模型来估计率比（RRs），并通过疾病风险评分（DRS）进行调整或匹配。
我们确定了一组17510名被诊断为胃肠道穿孔的个体，并将他们与1751000名对照进行匹配。在DRS评分调整后，当前使用氟喹诺酮与胃肠道穿孔风险的最大增加相关（RR，1.90；95%CI，1.62 - 2.22）。过去使用（RR，1.33；95%CI，1.20 - 1.47）和任何前一年使用（RR，1.46；95%CI，1.34 - 1.59）时，胃肠道穿孔的风险有所降低。为了深入了解观察到的关联是否可以由未测量的混杂因素解释，我们比较了氟喹诺酮和大环内酯类药物使用者之间胃肠道穿孔的风险。作为活性对照的大环内酯类药物的使用与胃肠道穿孔风险的显著增加无关（RR，1.11，95%CI，0.15 - 7.99）。针对需要住院治疗的穿孔进行的敏感性分析也表明当前使用与风险增加有关。为了减轻选择偏倚，我们还排除了以前从未使用过氟喹诺酮的人或患有感染性结肠炎、肠炎或肠胃炎的人。在这两项分析中，使用氟喹诺酮仍然与较高的胃肠道穿孔风险相关。
我们发现使用氟喹诺酮与胃肠道穿孔风险的增加存在不可忽视的关联，医生应意识到这种可能的关联。
