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首页> 外文期刊>Transactions of the American Ophthalmological Society. >Ocular safety of Viagra, (sildenafil citrate).
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Ocular safety of Viagra, (sildenafil citrate).

机译：伟哥的眼安全性（枸sil酸西地那非）。

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摘要

To date, sildenafil citrate (Viagra) gives every evidence of being a safe drug for the eye despite a series of expressed concerns. A review of how its ocular safety profile has been identified offers insights into the strengths and weaknesses of present systems and resources for judging the ocular safety of Viagra or, for that matter, of any new drug. Such insights include: The great value of careful, informed assessment of preclinical information gleaned from laboratory experiments. By and large, such assessments point the way toward appropriate clinical evaluation. For Viagra, early in its development it was noted that besides exerting a major inhibitory effect on the intended target, the vascular-associated enzyme phosphodiesterase 5 (PDE5), the drug also exerts a lesser but definite inhibitory effect on the closely related PDE6, located in the retina. For this reason, preclinical evaluation of the drug included electroretinography plus postmortem histology. In addition, an extended eye examination was incorporated into clinical protocols. The often chaotic but invaluable information stream that becomes available once marketing approval has been gained and large populations begin to use a drug. False alarms, misattribution, and erroneous information are the order of the day. Nevertheless, as information accumulates, patterns of response clarify and the true nature of special susceptibility for subpopulations, if any, becomes apparent. A role for the astute clinician remains: Subtle changes or unusual risks for subpopulations can be missed entirely for long periods of time. A manifest need for improvement in evaluation of postmarketing side-effects. This need has led to the establishment of a new discipline: pharmacoepidemiology. In ophthalmology, the National Registry of Drug Induced Ocular Side-Effects maintains a constant and invaluable surveillance. Examples are supplied to illustrate each of these major points: Our presentation will include data gleaned from clinical trials plus postmarketing information on the incidence, duration, and type of color vision defects observed at different doses of Viagra.
机译：迄今为止，尽管存在一系列明确的担忧，但枸den酸西地那非（Viagra）仍提供了对眼睛安全的所有证据。对如何确定其眼部安全性的综述提供了对现有系统和资源的优缺点的见解，这些系统和资源可用于判断伟哥或任何新药的眼部安全性。这些见解包括：从实验室实验中收集的对临床前信息进行仔细，知情评估的巨大价值。总体而言，此类评估为正确的临床评估指明了方向。对于伟哥，在其研发的早期，人们注意到，除了对预定靶标产生重大抑制作用外，与血管相关的酶磷酸二酯酶5（PDE5）还对该药物产生了较弱但确定的抑制作用，该密切相关的PDE6位于在视网膜上。因此，该药物的临床前评估包括视网膜电图和验尸组织学。此外，将扩展的眼部检查纳入了临床方案。一旦获得市场批准并且大量人群开始使用药物，通常会出现混乱但无价的信息流。错误的警报，错误的归因和错误的信息已成为日常工作。然而，随着信息的积累，应对方式得以澄清，对亚种群（如果有）的特殊易感性的真实性质也变得显而易见。精明的临床医生仍然扮演着这样的角色：细微的变化或亚群的异常风险可能会在很长一段时间内完全消失。显然需要改进上市后副作用的评估。这种需求导致建立了一个新学科：药物流行病学。在眼科方面，国家药物诱发的眼部副作用注册管理机构保持持续且宝贵的监督。提供的示例说明了这些主要方面：我们的演示将包括从临床试验中收集的数据，以及有关在不同剂量的伟哥中观察到的色觉缺陷的发生率，持续时间和类型的上市后信息。

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