研究目的:抗血管內皮因子藥物已經被全世界接受是治療糖尿病黃斑部水腫的第一線治療,因為抗血管內皮因子經過protocol S研究,對於糖尿病視網膜病變的病人,眼球內注射可以消除視網膜的新生血管而且可以改善糖尿病視網膜病變的程度。也就是說抗血管內皮因子可以讓糖尿病視網膜病變的期別下降。本研究旨在研究利用向健保局申請的抗血管內皮因子藥物,在有限的藥物之下治療糖尿病視網膜病變及糖尿病黃斑部水腫後病人的表現。 研究方法及資料:本研究為回顧性隊列研究 (retrospective cohort study)。蒐集2014至2020年間彰化基督教醫院申請健保抗血管內皮因子玻璃體注射治療的84隻眼睛於72位病人。本研究資料蒐集完成之後,依治療的藥物不同分為兩組,經鍵入、核對之後,分析資料比較兩組的治療效果。分析方法以SPSS for windows 23.0版套裝軟體(SPSS, Chicago, IL, USA) 進行「t檢定」及「卡方檢定」。 研究結果:送健保局申請抗血管內皮因子眼內注射藥物的病人分有兩組,一組為采視明(Aflibercept, Eylea®),一組為樂舒晴(Ranibizumab, Lucentis®),經2年的治療後兩組視力和黃斑部厚度都比一開始進步,兩組比較視力以及黃斑部厚度的變化沒有顯著的差異。但是在樂舒晴組,需要接受較多次的全視網膜雷射( panretinal photocoagulation, PRP, p=0.04),微脈衝光雷射( Subthreshold micropulse laser, SMPL, p=0.03)治療。 結論與建議:即使健保申請的治療針數有限,但是對於糖尿病視網膜病變黃斑部水腫的病人在兩年內追蹤治療中,兩組治療糖尿病黃斑部水腫都可以維持視力以及黃斑部厚度的穩定。而接受采視明治療的組別,需接受雷射治療的機會較少。
Purpose: To describe and compare the anatomical and functional outcomes of diabetic macular edema (DME) eyes treated with different drug of anti-vascular endothelial growth factor (anti-VEGF) under the policy of National Taiwan Health Insurance Administration. Methods: It’s a retrospective cohort study. We collected 84 eyes in 72 patients who recieved intravitreal Aflibercept or Ranibizumab injections at ChangHua Christian Hospital in November 2014 to March 2020. The patients were received anti-VEGF injection on a treat and extend protocol until the patients ran out the reimbursed anti-VEGF, which is 8 shots for each eye in 5 years. Results: There were no significant differences in the basic characteristics, including age, sex, HbA1C, initial visual acuity (VA) and initial central retinal thickness (CRT). There were also no significant differences in VA and CRT between 2 groups at 2-year followed as swell as VA changes, vitreous hemorrhage rate. However, Ranibizumab group needed more additional laser treatment such as pan-retinal photocoagulation (PRP) and subthreshold micropulse laser (SMPL) to maintain the results. Conclusion: Both ranibizumab and aflibercept were effective in improving visual acuity and reducing CRT in eyes with DME but no difference in the VA outcomes and CRT between the two groups at 2 years. Though the Ranibizumab group needed more additional laser treatment such as PRP and SMPL to keep the same results as Aflibercept group. The less sessions of PRP and SMPL may also lessen the economic burden of Taiwan National Health Insurance Administration for the diabetic retinopathy treatment and also the patients’ discomfort of laser treatment.