枸橼酸西地那非的使用与非动脉性前部缺血性视神经病变的发生率
Sildenafil citrate use and the incidence of nonarteritic anterior ischemic optic neuropathy.
作者信息
Gorkin L, Hvidsten K, Sobel R E, Siegel R
机构信息
World Wide Outcomes Research, Global Epidemiology, US Medical Research, Pfizer Inc, NY, USA.
出版信息
Int J Clin Pract. 2006 Apr;60(4):500-3. doi: 10.1111/j.1368-5031.2006.00904.x.
Abstract
Nonarteritic anterior ischemic optic neuropathy (NAION) has been reported rarely in men after taking sildenafil or other phosphodiesterase 5 inhibitors for erectile dysfunction (ED). The incidence of NAION in men receiving sildenafil treatment for ED was estimated using pooled safety data from global clinical trials and European observational studies. Based on clinical trial data in more than 13,000 men and on more than 35,000 patient-years of observation in epidemiologic studies, we estimated an incidence of 2.8 cases of NAION per 100,000 patient-years of sildenafil exposure. This is similar to estimates reported in general US population samples (2.52 and 11.8 cases per 100,000 men aged >or=50 years). The data cited herein do not suggest an increased incidence of NAION in men who took sildenafil for ED.
摘要
非动脉炎性前部缺血性视神经病变（NAION）在男性服用西地那非或其他用于治疗勃起功能障碍（ED）的5型磷酸二酯酶抑制剂后鲜有报道。利用全球临床试验和欧洲观察性研究的汇总安全性数据，估算了接受西地那非治疗ED的男性中NAION的发病率。基于超过13000名男性的临床试验数据以及流行病学研究中超过35000患者年的观察，我们估算出每100000患者年西地那非暴露的NAION发病率为2.8例。这与美国一般人群样本中的估算值相似（每100000名年龄≥50岁的男性中分别为2.52例和11.8例）。本文引用的数据并未表明服用西地那非治疗ED的男性中NAION发病率增加。
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