Peripheral neuropathy and Guillain-Barre syndrome risks associated with exposure to systemic fluoroquinolones: a pharmacovigilance analysis
Peripheral neuropathy and Guillain-Barre syndrome risks associated with exposure to systemic fluoroquinolones: a pharmacovigilance analysis
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DOI：
10.1016/j.annepidem.2013.12.009
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发表时间：
2014-04-01
影响因子：
5.6
通讯作者：
Ali, Ayad K.
中科院分区：
文献类型：
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作者：
Ali, Ayad K.
目的：周围神经病变（PN）是氟喹诺酮类全身抗菌治疗的已确定风险。风险及其严重程度，包括单个药物之间发生格林-巴利综合征（GBS）的情况尚不确定。本研究探讨了氟喹诺酮类药物与PN和GBS之间的关联，自发报告给FDA不良事件报告系统。方法：1997年至2012年期间报告给FDA不良事件报告系统的病例进行检索。使用国际医学用语词典首选术语定义PN和GBS。通过通用名和给药途径识别个体氟喹诺酮类药物。计算具有95%置信区间（EB 05-EB 95）的经验贝叶斯几何平均值（EBGM）作为重复性指标。EB 05 2或以上的安全信号被认为是一个显着的不成比例的增加，至少两倍以上的事件报告比expected.Results：有539 PN报告的46,257氟喹诺酮类药物的不良事件报告提交。9%的PN报告为GBS。确定了氟喹诺酮类药物的PN（EBGM 2.70; EB 05-EB 95 2.51-2.90）和GBS（EBGM 3.22; EB 05-EB 95 2.55-4.02）的显著不良反应。检测到环丙沙星（EBGM 3.24; EB 05-EB 95 2.87-3.66）和左氧氟沙星（EBGM 3.36; EB 05-EB 95 3.02-3.72）的PN信号。检测到环丙沙星的GBS信号（EBGM 4.15; EB 05-EB 95 2.94-5.74）。GBS和PN，分别排名第6位和第8位的报告neurologicevents.Conclusions：这项研究再次强调氟喹诺酮类药物和PN之间的联系，并显示与更严重的形式的神经损伤，例如，GBS的潜在关联。除非氟喹诺酮治疗的益处（例如，压倒性感染或出现细菌耐药性）超过PN风险，建议使用替代抗菌药物治疗。(C)2014 Elsevier Inc. All rights reserved.
Purpose: Peripheral neuropathy (PN) is an identified risk of systemic antibacterial therapy with fluoroquinolones. The risk and its severity, including the development of Guillain-Barre syndrome (GBS) between individual agents is uncertain. This study examines the association between fluoroquinolones and PN and GBS in cases spontaneously reported to the FDA Adverse Event Reporting System.Methods: Cases reported to FDA Adverse Event Reporting System between 1997 and 2012 were retrieved. The Medical Dictionary for Regulatory Activities Preferred Term was used to define PN and GBS. Individual fluoroquinolones were identified by generic names and route of administration. Empirical Bayes Geometric Mean (EBGM) with 95% confidence interval (EB05-EB95) was calculated as disproportionality measure. Safety signals with EB05 2 or more was considered a significant disproportional increase in the event reporting of at least twice times higher than that expected.Results: There were 539 PN reports out of 46,257 adverse event reports submitted for fluoroquinolones. Nine percent of PN reports were for GBS. Significant disproportionality of PN (EBGM 2.70; EB05-EB95 2.51-2.90) and GBS (EBGM 3.22; EB05-EB95 2.55-4.02) was identified for fluoroquinolones. Signals of PN were detected for ciprofloxacin (EBGM 3.24; EB05-EB95 2.87-3.66) and levofloxacin (EBGM 3.36; EB05-EB95 3.02-3.72). A GBS signal was detected for ciprofloxacin (EBGM 4.15; EB05-EB95 2.94-5.74). GBS and PN, respectively, ranked 6th and 8th among reported neurologic events.Conclusions: This study re-emphasizes the link between fluoroquinolones and PN and shows the potential association with more severe forms of nerve damage, for example, GBS. Unless the benefit of fluoroquinolone therapy (e.g., overwhelming infection or development of bacterial resistance) outweighs PN risk, treatment with alternative antibacterial agents is recommended. (C) 2014 Elsevier Inc. All rights reserved.