Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Silver Spring, MD, USA.
CMAJ. 2013 Jul 9;185(10):E475-82. doi: 10.1503/cmaj.121730. Epub 2013 Jun 3.
Case reports indicate that the use of fluoroquinolones may lead to acute kidney injury. We studied the association between the use of oral fluoroquinolones and acute kidney injury, and we examined interaction with renin-angiotensin-system blockers.
We formed a nested cohort of men aged 40-85 enrolled in the United States IMS LifeLink Health Plan Claims Database between 2001 and 2011. We defined cases as men admitted to hospital for acute kidney injury, and controls were admitted to hospital with a different presenting diagnosis. Using risk-set sampling, we matched 10 controls to each case based on hospital admission, calendar time (within 6 wk), cohort entrance (within 6 wk) and age (within 5 yr). We used conditional logistic regression to assess the rate ratio (RR) for acute kidney injury with current, recent and past use of fluoroquinolones, adjusted by potential confounding variables. We repeated this analysis with amoxicillin and azithromycin as controls. We used a case-time-control design for our secondary analysis.
We identified 1292 cases and 12 651 matched controls. Current fluoroquinolone use had a 2.18-fold (95% confidence interval [CI] 1.74-2.73) higher adjusted RR of acute kidney injury compared with no use. There was no association between acute kidney injury and recent (adjusted RR 0.87, 95% CI 0.66-1.16) or past (RR 0.86, 95% CI 0.66-1.12) use. The absolute increase in acute kidney injury was 6.5 events per 10 000 person-years. We observed 1 additional case per 1529 patients given fluoroquinolones or per 3287 prescriptions dispensed. The dual use of fluoroquinolones and renin-angiotensin-system blockers had an RR of 4.46 (95% CI 2.84-6.99) for acute kidney injury. Our case-time-control analysis confirmed an increased risk of acute kidney injury with fluoroquinolone use (RR 2.16, 95% CI 1.52-3.18). The use of amoxicillin or azithromycin was not associated with acute kidney injury.
We found a small, but significant, increased risk of acute kidney injury among men with the use of oral fluoroquinolones, as well as a significant interaction between the concomitant use of fluoroquinolones and renin-angiotensin-system blockers.
病例报告表明,氟喹诺酮类药物的使用可能导致急性肾损伤。我们研究了口服氟喹诺酮类药物的使用与急性肾损伤之间的关系,并检查了与肾素-血管紧张素系统阻滞剂的相互作用。
我们在美国 IMS LifeLink 健康计划索赔数据库中组建了一个嵌套队列,纳入 2001 年至 2011 年间年龄在 40-85 岁的男性。我们将因急性肾损伤住院的男性定义为病例,将因其他疾病住院的男性定义为对照。使用风险集抽样,我们根据住院时间、日历时间(6 周内)、队列入组时间(6 周内)和年龄(5 年内),为每个病例匹配 10 个对照。我们使用条件逻辑回归来评估当前、近期和过去使用氟喹诺酮类药物与急性肾损伤的比值比(RR),并调整了潜在混杂变量。我们使用阿莫西林和阿奇霉素作为对照进行了重复分析。我们使用病例时间对照设计进行了二次分析。
我们确定了 1292 例病例和 12651 例匹配对照。与未使用者相比,当前氟喹诺酮类药物使用者发生急性肾损伤的调整 RR 为 2.18(95%置信区间[CI] 1.74-2.73)。近期(调整 RR 0.87,95%CI 0.66-1.16)或过去(RR 0.86,95%CI 0.66-1.12)使用氟喹诺酮类药物与急性肾损伤无关。每 10000 人年有 6.5 例急性肾损伤的绝对增加。我们观察到每 1529 例接受氟喹诺酮类药物治疗的患者或每 3287 例开具氟喹诺酮类药物处方就会增加 1 例急性肾损伤。氟喹诺酮类药物和肾素-血管紧张素系统阻滞剂的双重使用与急性肾损伤的 RR 为 4.46(95%CI 2.84-6.99)。我们的病例时间对照分析证实了氟喹诺酮类药物使用与急性肾损伤风险增加(RR 2.16,95%CI 1.52-3.18)。阿莫西林或阿奇霉素的使用与急性肾损伤无关。
我们发现,男性使用口服氟喹诺酮类药物会导致急性肾损伤的风险略有增加,但具有统计学意义,同时还发现氟喹诺酮类药物与肾素-血管紧张素系统阻滞剂的同时使用存在显著的相互作用。