Abstract：
BACKGROUND: Recent studies suggest that 5α-reductase inhibitors (5ARIs) for benign prostate hyperplasia (BPH) result in abnormal retinal anatomical alteration.
OBJECTIVE: To compare age-related macular degeneration (AMD) incidence in BPH patients receiving 5ARIs or tamsulosin.
METHODS: Retrospective, population-based cohort study using new-user and active-comparator design.
METHODS: General population.
METHODS: Males with BPH, newly receiving 5ARIs or tamsulosin from 2010 to 2018.
METHODS: Data were extracted from Taiwan\'s National Health Insurance Research Database. We used Cox proportional hazards model with 1:4 propensity score (PS) matching, based on intention-to-treat analysis to determine the risk of incident AMD. Sensitivity analyses included an as-treated approach and weighting-based PS methods. We also separately reported the risks of incident AMD in patients receiving finasteride and dutasteride to determine risk differences among different 5ARIs.
RESULTS: We included 13 586 5ARIs users (mean age: 69 years) and 54 344 tamsulosin users (mean age: 68.37 years). After a mean follow-up of 3.7 years, no differences were observed in the risk of incident AMD between 5ARIs and tamsulosin users [hazard ratio (HR): 1.06; 95% confidence intervals (95% CI): 0.98-1.15], with similar results from sensitivity analyses. However, increased risk of incident age-related macular degeneration was observed in patients receiving dutasteride [HR: 1.13; 95% CI: 1.02-1.25], but not in those receiving finasteride [HR: 0.99; 95% CI: 0.87-1.12], in the subgroup analyses.
CONCLUSIONS: We found no difference between 5ARIs and tamsulosin regarding the incidence of AMD in BPH patients. However, the risk profiles for AMD differed slightly between dutasteride and finasteride, suggesting that the potency of androgen inhibition is a factor related to AMD incidence.
OBJECTIVE: To compare age-related macular degeneration (AMD) incidence in BPH patients receiving 5ARIs or tamsulosin.
METHODS: Retrospective, population-based cohort study using new-user and active-comparator design.
METHODS: General population.
METHODS: Males with BPH, newly receiving 5ARIs or tamsulosin from 2010 to 2018.
METHODS: Data were extracted from Taiwan\'s National Health Insurance Research Database. We used Cox proportional hazards model with 1:4 propensity score (PS) matching, based on intention-to-treat analysis to determine the risk of incident AMD. Sensitivity analyses included an as-treated approach and weighting-based PS methods. We also separately reported the risks of incident AMD in patients receiving finasteride and dutasteride to determine risk differences among different 5ARIs.
RESULTS: We included 13 586 5ARIs users (mean age: 69 years) and 54 344 tamsulosin users (mean age: 68.37 years). After a mean follow-up of 3.7 years, no differences were observed in the risk of incident AMD between 5ARIs and tamsulosin users [hazard ratio (HR): 1.06; 95% confidence intervals (95% CI): 0.98-1.15], with similar results from sensitivity analyses. However, increased risk of incident age-related macular degeneration was observed in patients receiving dutasteride [HR: 1.13; 95% CI: 1.02-1.25], but not in those receiving finasteride [HR: 0.99; 95% CI: 0.87-1.12], in the subgroup analyses.
CONCLUSIONS: We found no difference between 5ARIs and tamsulosin regarding the incidence of AMD in BPH patients. However, the risk profiles for AMD differed slightly between dutasteride and finasteride, suggesting that the potency of androgen inhibition is a factor related to AMD incidence.
摘要：
背景：最近的研究表明，5α-还原酶抑制剂（5ARIs）治疗良性前列腺增生（BPH）会导致视网膜解剖结构异常改变。
目的：比较接受5ARIs或坦索罗辛治疗的BPH患者年龄相关性黄斑变性（AMD）的发生率。
方法：回顾性，使用新用户和主动比较器设计的基于人群的队列研究。
方法：一般人群。
方法：患有BPH的男性，2010年至2018年新接受5ARIs或坦索罗辛。
方法：数据来自台湾国家健康保险研究数据库。我们使用Cox比例风险模型，倾向评分(PS)匹配，基于意向治疗分析来确定事件AMD的风险。敏感性分析包括处理后的方法和基于加权的PS方法。我们还分别报告了接受非那雄胺和度他雄胺的患者发生AMD的风险，以确定不同5ARI之间的风险差异。
结果：我们包括13.5865ARIs使用者（平均年龄：69岁）和54.344坦索罗辛使用者（平均年龄：68.37岁）。经过3.7年的平均随访，5ARIs和坦索罗辛使用者发生AMD的风险无差异[风险比(HR):1.06;95%置信区间(95%CI):0.98-1.15],敏感性分析结果相似。然而,接受度他雄胺治疗的患者发生年龄相关性黄斑变性的风险增加[HR:1.13;95%CI:1.02-1.25],但不是那些接受非那雄胺[HR：0.99；95%CI：0.87-1.12]，在亚组分析中。
结论：我们发现在BPH患者中，5ARIs和坦索罗辛的AMD发病率没有差异。然而,AMD的风险状况在度他雄胺和非那雄胺之间略有不同，表明雄激素抑制的效力是与AMD发病相关的因素。
目的：比较接受5ARIs或坦索罗辛治疗的BPH患者年龄相关性黄斑变性（AMD）的发生率。
方法：回顾性，使用新用户和主动比较器设计的基于人群的队列研究。
方法：一般人群。
方法：患有BPH的男性，2010年至2018年新接受5ARIs或坦索罗辛。
方法：数据来自台湾国家健康保险研究数据库。我们使用Cox比例风险模型，倾向评分(PS)匹配，基于意向治疗分析来确定事件AMD的风险。敏感性分析包括处理后的方法和基于加权的PS方法。我们还分别报告了接受非那雄胺和度他雄胺的患者发生AMD的风险，以确定不同5ARI之间的风险差异。
结果：我们包括13.5865ARIs使用者（平均年龄：69岁）和54.344坦索罗辛使用者（平均年龄：68.37岁）。经过3.7年的平均随访，5ARIs和坦索罗辛使用者发生AMD的风险无差异[风险比(HR):1.06;95%置信区间(95%CI):0.98-1.15],敏感性分析结果相似。然而,接受度他雄胺治疗的患者发生年龄相关性黄斑变性的风险增加[HR:1.13;95%CI:1.02-1.25],但不是那些接受非那雄胺[HR：0.99；95%CI：0.87-1.12]，在亚组分析中。
结论：我们发现在BPH患者中，5ARIs和坦索罗辛的AMD发病率没有差异。然而,AMD的风险状况在度他雄胺和非那雄胺之间略有不同，表明雄激素抑制的效力是与AMD发病相关的因素。
