| Abstract: | 摘要 Fenofibrate是一種PPAR-α agonist的降血脂藥物，在 ACCORD-Eye 和FIELD 研究中，已被證明可減少糖尿病視網膜病變的進展以及雷射治療的需求。然於次族群分析收案前沒有糖尿病視網膜病變患者，fenofibrate組與安慰劑組之間的糖尿病視網膜病變發展無顯著差異。本研究為以台灣人口為基礎的回溯性世代研究，探討第二型糖尿病患者服用fenofibrate是否可以降低發生糖尿病視網膜病變與雷射治療的風險。在2001-2002年間共有892,419名患者，從中篩選出32,253名收案前沒有視網膜病變的第2型糖尿病患者，然後根據是否服用fenofibrate將其分為兩組，並追蹤患者是否被診斷出糖尿病視網膜病變直到2008年底為止。對於2,500名fenofibrate使用者和29,753名非使用者，其平均追蹤時間分別為6.8±1.5年和5.4±2.6年，Cox比例風險回歸分析顯示新發糖尿病視網膜病變的風險比(HR)為0.57 (95% CI 0.57–0.62, p <0.001)。在調整高血壓、查爾森合併症指數(CCI)、以及藥物，例如血管收縮素轉換?抑製劑(ACE-I)、血管收縮素受體阻斷劑(ARB)、抗凝血劑、Gemfibrozil、Statin藥物和降血糖藥，調整後的HR值為0.75 (95% CI 0.68–0.82, p <0.001)。需要雷射治療的HR和調整後的HR分別為0.59 (95% CI 0.49-0.71, p <0.001)和0.67 (95% CI 0.56-0.81, p <0.001)。本研究發現，長期且規律使用fenofibrate會降低第二型糖尿病患者發生視網膜病變的風險和雷射治療的需要。
AbstractFenofibrate is a PPAR-α agonist drug. The ACCORD-Eye and the FIELD study proven to reduce demand progress and laser treatment of diabetic retinopathy (DR). However, the patients without pre-existing DR in the subgroup of the FIELD study, between the fenofibrate treatment group and the placebo group there was no significant difference in the progression of DR. In this study we analyze type 2 diabetes (T2DM) patients in a retrospective cohort study based on the Taiwanese population whether fenofibrate can reduce the risk of a DR incident. From 2001 to 2002, a total of 32,253 patients with T2DM who had no pre-existing DR were enrolled from 892,419 patients. Then it was divided into two groups, one with fenofibrate and the other without using. The patients were followed up whether they were diagnosed with DR until the end of 2008. The follow-up periods for 2,500 users of fenofibrate group were 6.8 ± 1.5 years and 29,753 non-users were 5.4 ± 2.6 years. The hazard ratio (HR) for new-onset DR was 0.57 (95 % CI 0.57–0.62, p <0.001) as shown by Cox proportional hazard regression analysis. After adjusting for hypertension; the Charlson comorbidity index (CCI); and medications like angiotensin-converting enzyme inhibitors (ACE-I), angiotensin receptor blockers (ARB), anticoagulants, gemfibrozil, hypoglycemic agents, and Statins, the adjusted HR was 0.75 (95 % CI 0.68–0.82, p < 0.001). The HR of the need for laser treatment were 0.59 (95 % CI 0.49-0.71, p <0.001) and after adjusting HR were 0.67 (95 % CI 0.56-0.81, p <0.001). Our research shows that long-term and regular fenofibrate treatment can reduce the risk of DR and the laser treatment requirement of patients with T2DM. |
