Non-arteritic anterior ischemic optic neuropathy, erectile dysfunction drugs, and amiodarone: is there a relationship?
Non-arteritic anterior ischemic optic neuropathy, erectile dysfunction drugs, and amiodarone: is there a relationship?
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DOI：
10.1097/01.wno.0000205622.45263.ad
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发表时间：
2006-03
期刊：
影响因子：
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通讯作者：
Frederick W. Fraunfelder;T. Shults
中科院分区：
文献类型：
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作者：
Frederick W. Fraunfelder;T. Shults
该杂志最近发表了两篇关于勃起功能障碍药物和非动脉炎性缺血性视神经病变(NAION)的文章(1，2)。第一篇文章(1)报告了7例新的NAION病例，这些患者在发生NAION之前不久曾使用过西地那非(伟哥)。第二份报告(2)代表了Sohan Singh Hayreh医学博士的观点，他是公认的眼血流和NAION专家，他认为有足够的证据支持勃起功能障碍药物的使用和NAION的发展之间存在因果关系。去年发表在本杂志上的另一篇观点文章回顾了胺碘酮和NAION的主题，结论是因果关系似乎不太可能，但不能被排除在外。这些论文概括了临床毒理学家所面临的困境，尤其是在眼科领域。在这个专科中，一旦一种药物被批准用于临床，就很少有足够的资金用于足够的毒理学研究。在大多数情况下，临床眼毒理学包括一系列已发表的病例报告或向国家药物引起的眼部副作用登记处提交的报告。*这一登记处充当自发病例报告库，并试图通过分析数据并在必要时报告结果，为临床医生提供有关药物对视觉系统的不良反应的指导(4，5)。病例报告通常是从治疗眼科医生那里收到的，他们怀疑滴眼液引起的不良药物反应或全身药物引起的眼睛反应。许多报告都是通过电话收到的，并有记录在案。从这些自发报告中获得的数据有时为时过早，质量不佳，不完整，或后续情况不佳。即便如此，来自临床医生的自发报告可能是药物引起的眼部不良反应存在的第一个信号。确定由勃起功能障碍药物或胺碘酮引起的NAION的原因尤其困难，因为NAION是一种相对罕见的事件，分子/分母数据很差，与使用这些药物相关的NAION似乎几乎没有区别于自发发生的NAION的任何表现。临床眼毒学家如何评估药物的使用与使用者出现的疾病之间的潜在因果关系？我们依据七个标准(表1)：1)药物的使用与病情出现之间的密切时间联系；2)与疾病发生的可能性的剂量-反应关系；3)积极的去挑战证据；4)积极的再挑战证据；5)药物合理的因果机制；6)“类别效应”，即也牵涉到其他类似类型和作用的药物的证据；以及
Two articles have appeared recently in this journal on the subject of erectile dysfunction drugs and non-arteritic ischemic optic neuropathy (NAION) (1,2). The first article (1) reported seven new cases of NAION in patients who had used sildenafil (Viagra ) shortly before developing NAION. The second report (2) represented the view of Sohan Singh Hayreh, MD, an acknowledged expert on ocular blood flow and NAION, that there is sufficient evidence to support a cause-and-effect relationship between the use of erectile dysfunction drugs and the development of NAION. Another viewpoint article published last year in this journal (3) reviewed the subject of amiodarone and NAION, concluding that a cause-and-effect relationship seemed unlikely but could not be excluded. These papers epitomize the dilemma confronting clinical toxicologists, especially in ophthalmology. In this subspecialty, sufficient funding is rarely available for adequate toxicological research once a drug has been approved for clinical use. For the most part, clinical ocular toxicology consists of a series of published case reports or reports to The National Registry of Drug-Induced Ocular Side Effects.* This registry acts as a repository of spontaneous case reports and attempts to give the clinician guidance as to drug-related adverse effects on the visual system by analyzing the data and reporting the results when necessary (4,5). The case reports are usually received from treating ophthalmologists who suspect an adverse drug reaction from an eye drop or an ocular reaction from a systemic medication. Many reports are received over the telephone and documented as such. Data garnered from these spontaneous reports are sometimes premature, of poor quality, incomplete, or suffer from poor follow-up. Even so, spontaneous reports from clinicians can be the first signal that an adverse ocular reaction from a medication exists. The problem of determining causation of NAION by erectile dysfunction drugs or amiodarone is made especially difficult because NAION is a relatively rare event with poor numerator/denominator data and the NAION associated with the use of these agents appears to have few if any manifestations that distinguish it from spontaneously-occurring NAION. How does a clinical ocular toxicologist evaluate a potentially causal relationship between the use of a pharmacologic agent and a medical condition that arises in its users? We depend on seven criteria (Table 1): 1) a close temporal association between use of the agent and the appearance of the condition; 2) a dose-response relationship to the likelihood of the occurrence of the condition; 3) positive de-challenge evidence; 4) positive rechallenge evidence; 5) a plausible causal mechanism for the agent; 6) a ‘‘class effect,’’ that is, evidence that other agents of similar type and action have also been implicated; and