摘要目的 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.

abstractsObjective 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.