Regenstrief Institute Inc., Indiana University School of Medicine, Indianapolis, Indiana 46202, USA.
Retina. 2010 Feb;30(2):271-4. doi: 10.1097/IAE.0b013e3181b7740f.
The purpose of this study was to determine if there is an increased risk of central serous chorioretinopathy (CSC) associated with prescription exposure to phosphodiesterase-5 (PDE-5) inhibitors.
A case-control study linking 2 National Veterans Health Administration databases (clinical and pharmacy) for fiscal years 2004 to 2005. The likelihood of past exposure to PDE-5 inhibitors among newly diagnosed patients with CSC, identified through International Classification of Diseases, 9th Edition, Clinical Modification codes, was compared with 2 age-matched control groups after excluding subjects with risk factors for CSC.
Among 577 men, aged 59 years and younger with newly diagnosed CSC during the study year, 111 were prescribed a PDE-5 inhibitor (19.2%). The proportions of age-matched controls prescribed a PDE-5 inhibitor in the 2 groups were 18.5% and 21.5%. The odds ratio of exposure was 1.05 (95% confidence limit: 0.74-1.22) and 0.87 (95% confidence limit: 0.68-1.12).
Patients with CSC had no increase in prescription exposure to PDE-5 inhibitors than did age-matched control subjects. Although the findings in this study do not support an association between CSC and PDE-5 inhibitors, postmarketing surveillance methods for drug-related side effects have acknowledged limitations.
本研究旨在确定与磷酸二酯酶-5(PDE-5)抑制剂的处方暴露相关,是否会增加中心性浆液性脉络膜视网膜病变(CSC)的风险。
这是一项病例对照研究,将 2004 年至 2005 年期间国家退伍军人健康管理局的(临床和药房)2 个数据库进行了链接。通过国际疾病分类第 9 版临床修正码(International Classification of Diseases, 9th Edition, Clinical Modification codes),确定新诊断为 CSC 的患者(通过这些代码识别)中,过去接触 PDE-5 抑制剂的可能性,并在排除 CSC 风险因素的患者后,将其与 2 个年龄匹配的对照组进行比较。
在研究年内,年龄在 59 岁及以下的 577 名新诊断为 CSC 的男性患者中,有 111 人被处方了 PDE-5 抑制剂(19.2%)。在这 2 个组中,年龄匹配的对照组被处方 PDE-5 抑制剂的比例分别为 18.5%和 21.5%。暴露的比值比为 1.05(95%置信区间:0.74-1.22)和 0.87(95%置信区间:0.68-1.12)。
与年龄匹配的对照组相比,CSC 患者的 PDE-5 抑制剂处方暴露没有增加。尽管本研究的结果不支持 CSC 与 PDE-5 抑制剂之间存在关联,但药物相关副作用的上市后监测方法存在局限性。