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FDA于2013年8月15日发布药物安全信息通报,要求更新氟喹诺酮类抗菌药物的说明书和相关用药指导,以便更好地提醒这类药物可能导致严重外周神经炎的副作用。氟喹诺酮类抗菌药物导致的这种严重的神经损害可以出现在用药后不久,这种损害可能是永久性的,而且目前证据仅支持口服或注射给药有此风险眼睛和耳朵等局部应用尚不清楚是否会导致外周神经炎。外周神经炎是一种累及胳膊或腿的神经功能障碍,症状包括疼痛、烧灼感、针刺感、麻木感、虚弱,或者对温、痛、脓觉以及本体感觉的改变。氟喹诺酮类药物导致的外周神经炎可能出现在治疗中的任何时间,即使停药,症状也可以持续数月到数年,甚至是永久性的。FDA早在2004年已经将口服和注射用氟喹诺酮类药物可能引起外周神经病变的风险列入说明书中。FDA宣布,最近一个针对FDA不良事件报告系统
The FDA released the Drug Safety Information Bulletin on August 15, 2013, which requires updated instructions and guidance on the use of fluoroquinolone antibiotics in order to better remind them that these drugs may cause side effects of severe peripheral neuritis. This serious neurological damage caused by fluoroquinolones may occur shortly after treatment, and the damage may be permanent, and current evidence only supports this risk for oral or injectable administration. Topical applications such as the eye and the ears are not yet Clearly lead to peripheral neuritis. Peripheral neuritis is a neurological dysfunction involving the arm or leg. Symptoms include pain, burning, acupuncture, numbness, weakness, or changes in temperature, pain, pus, and ontological sensations. Peripheral neuritis caused by fluoroquinolones may occur at any time during treatment, and the symptoms may persist for months to years or even be permanent, even with withdrawal. FDA included as early as 2004 the risk that oral and injectable fluoroquinolones may cause peripheral neuropathy. FDA recently announced a system for reporting adverse event in the FDA