Talany G, Guo M, Etminan M
Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Department of Pharmacology and Therapeutics, University of British Columbia, Vancouver, BC, Canada.
Eye (Lond). 2017 Apr;31(4):628-631. doi: 10.1038/eye.2016.265. Epub 2016 Dec 23.
PurposeTo assess the risk of intraocular hemorrhage with warfarin and new oral anticoagulants (NOACs).MethodsWe ascertained all reported cases of intraocular hemorrhage (vitreous, choroidal, or retinal) with warfarin and NOACs (including dabigatran, rivaroxaban, apixaban) from the World Health Organizations's Vigibase database from 1968-2015. We used a disproportionality analysis to compute reported odds ratios (RORs) and corresponding 95% confidence by comparing the number of events with the study outcomes and study drugs compared with all other drugs reported to Vigibase. A harmful signal was deemed for a lower limit of the 95% confidence interval above 1.ResultsWe identified 80 cases of intraocular hemorrhage (vitreous, choroidal, or retinal) with warfarin in the World Health Organizations's Vigibase database from 1968-2015. A total of 156 cases of intraocular hemorrhage with NOACs (82 with rivaroxaban, 65 with dabigatran, 9 with apixaban). Warfarin had the highest signal of association with choroidal hemorrhage (ROR= 65.40 (33.86-126.30)). Rivaroxaban had the highest signal of association with both retinal and vitreous hemorrhage (ROR=7.41 (5.73-9.59) and ROR= 11.14 (7.37-16.86), respectively). Dabigatran was also significantly associated with retinal and vitreous hemorrhage (ROR= 3.78 (2.82-5.08) and ROR= 5.83 (3.66-9.30), respectively). The number of reports of retinal and vitreous hemorrhage were also significantly higher with apixaban, but the number of cases may be too little to make a meaningful evaluation.ConclusionA signal for risk of intraocular hemorrhage was detected for warfarin, dabigatran, and rivaroxaban. Large epidemiologic studies are needed to further confirm these findings.
目的
评估华法林和新型口服抗凝剂（NOACs）导致眼内出血的风险。
方法
我们从世界卫生组织的药物不良反应数据库（Vigibase）中确定了1968年至2015年间所有报告的使用华法林和NOACs（包括达比加群、利伐沙班、阿哌沙班）后发生眼内出血（玻璃体、脉络膜或视网膜出血）的病例。我们采用不成比例分析，通过将事件数量与研究结果和研究药物进行比较，并与报告给Vigibase的所有其他药物进行比较，来计算报告比值比（RORs）和相应的95%置信区间。当95%置信区间的下限高于1时，则判定存在有害信号。
结果
在世界卫生组织的Vigibase数据库中，我们确定了1968年至2015年间80例使用华法林后发生眼内出血（玻璃体、脉络膜或视网膜出血）的病例。共有156例使用NOACs后发生眼内出血的病例（82例使用利伐沙班，65例使用达比加群，9例使用阿哌沙班）。华法林与脉络膜出血的关联信号最强（ROR = 65.40（33.86 - 126.30））。利伐沙班与视网膜和玻璃体出血的关联信号最强（分别为ROR = 7.41（5.73 - 9.59）和ROR = 11.14（7.37 - 16.86））。达比加群也与视网膜和玻璃体出血显著相关（分别为ROR = 3.78（2.82 - 5.08）和ROR = 5.83（3.66 - 9.30））。阿哌沙班导致视网膜和玻璃体出血的报告数量也显著更高，但病例数量可能太少，无法进行有意义的评估。
结论
检测到华法林、达比加群和利伐沙班存在眼内出血风险信号。需要进行大型流行病学研究以进一步证实这些发现。
