CAJ | 학술논문

目的观察玻璃体腔单次注射抗血管内皮生长因子单克隆抗体Bevacizumab治疗糖尿病性黄斑水肿(DME)的临床疗效和安全性. 方法前瞻性非随机对照临床研究,共18例眼科常规检查以及荧光素眼底血管造影(FFA)和光相干断层扫描(OCT)检查确诊的DME患者的18只患眼纳入观察.患者年龄34～75岁,平均年龄(54±11)岁,无全身及局部手术禁忌症.治疗前平均logMAR最佳矫正视力(BCVA)为1.023±0.45,黄斑中心凹视网膜厚度486 μm.患眼玻璃体腔注射Bevacizumab 1.5 mg(0.06ml),治疗后随访观察12～20周,平均随访观察时间(16±4)周.对比观察治疗前后视力、眼压、OCT及FFA改变. 结果 18例患者治疗后1、4、12周的平均logMAR BCVA分别提高至0.864±0.48(P=0.001)、0.739±0.51(P=0.003)、0.792±0.50(P=0.015),与治疗前比较,差异均有统计意义.治疗后12周,16只眼视力稳定或提高,占88.9%.其中,10只眼logMAR视力提高2行或以上,占55.6%;2只眼视力下降.OCT检查黄斑中心凹视网膜厚度,治疗后4周下降至413μm,治疗后12周下降到383 μm,与治疗前比较,差异均有统计学意义(P=0.002,P=0.001).治疗后12周,黄斑水肿改善者13只眼,占72.2%.所有患者均未出现眼内或全身不良反应.结论玻璃体腔注射Bevacizumab治疗DME能明显改善患者视功能,减轻黄斑水肿,副作用少;但尚需进一步大样本、多中心的临床随机对照研究.
목적 관찰파리체강단차주사항혈관내피생장인자단극륭항체Bevacizumab치료당뇨병성황반수종(DME)적림상료효화안전성. 방법전첨성비수궤대조림상연구,공18례안과상규검사이급형광소안저혈관조영(FFA)화광상간단층소묘(OCT)검사학진적DME환자적18지환안납입관찰.환자년령34～75세,평균년령(54±11)세,무전신급국부수술금기증.치료전평균logMAR최가교정시력(BCVA)위1.023±0.45,황반중심요시망막후도486 μm.환안파리체강주사Bevacizumab 1.5 mg(0.06ml),치료후수방관찰12～20주,평균수방관찰시간(16±4)주.대비관찰치료전후시력、안압、OCT급FFA개변. 결과 18례환자치료후1、4、12주적평균logMAR BCVA분별제고지0.864±0.48(P=0.001)、0.739±0.51(P=0.003)、0.792±0.50(P=0.015),여치료전비교,차이균유통계의의.치료후12주,16지안시력은정혹제고,점88.9%.기중,10지안logMAR시력제고2행혹이상,점55.6%;2지안시력하강.OCT검사황반중심요시망막후도,치료후4주하강지413μm,치료후12주하강도383 μm,여치료전비교,차이균유통계학의의(P=0.002,P=0.001).치료후12주,황반수종개선자13지안,점72.2%.소유환자균미출현안내혹전신불량반응.결론 파리체강주사Bevacizumab치료DME능명현개선환자시공능,감경황반수종,부작용소;단상수진일보대양본、다중심적림상수궤대조연구.
Objective To observe the efficiency and safety of a single intravitreal injection of Bevacizumab(Avastin)in patients with diabetic macular edema. Methods Prospective,open-label study of 18 eyes of 18 patients with diabetic macular edema which was diagnosed by examination of regular inspection,fundus fluorescein angiography(FFA)and optic coherence tomography(OCT).The patients without general or partial surgery contraindications,aged from 34-75 years with a mean age of 54±11years.The best corrected visual acuity of logMAR was 1.023±0.45 and the retinal thickness of macular foveal was 486 pm before the treatment.The eyes have intravitrealjnjection with Bevacizumab at dose 1.5mg(0.06 ml).After the treatment,the follow-up period ranging from 12 to 20 weeks(mean 16±4weeks).The changes of visual acuity.intraocular pressure.OCT and FFA before and after the treatment were observed and analyzed. Results All 18 patients had a mean IogMAR BCVA of 1.023±0.45 at baseline and at the follow-up weeks 1,4,12,the mean IogMAR BCVA was significantly improved as 0.864±0.48(P=0.001),0.739±0.51(P=0.003),0.792±0.50(P=0.015)respectively,and thedifferences are statistically significant compared with before.Sixteen eyes(88.9%)had a improved orstable visual acuity,the BCVA increased 2 lines(0.2 logMAR vision)or better in 10 eyes(55.6%)anddecreased in 2 eyes at 1 2 weeks after injection.OCT demonstrated that retinal thickness of macular foveal decreased from 486 pm to 413 μm at 4 weeks,decreased to 383μm at 12 weeks(P=0.002,P=0.001),and the differences are statistically significant compared with before.There are remarkable resolution of central retinal edema in 13 eyes(72.2 %)at 12 weeks after the injection.No local or systemic adverse events were observed in any patients. Conclusions The preliminary result in our observation showed that intravitreal injection of Bevacizumab therapy was well tolerated with a significant improvement in BCVA and decrease in macular edema for patients with diabetic macular edema. A randomly controlled muhicenter clinical trial is necessary.