方法：前瞻性研究。选取2015-12/2016-12在深圳市人民医院眼科就诊，经荧光素眼底血管造影(fluorescein fundus angiography，FFA)及光学相干断层扫描(optical coherence tomography，OCT)检查确诊的DME患者20例20眼纳入本研究。采用糖尿病视网膜病变早期治疗研究视力表(ETDRS)检查最佳矫正视力(best corrected visual acuity，BCVA)，OCT检查测量黄斑中心厚度(central macular thickness，CMT)。所有患眼玻璃体腔注射10mg/mL康柏西普0.05mL(含康柏西普0.5mg)，每1mo注射1次，连续3次为核心治疗，之后根据病情需要决定是否重复治疗。每1mo随访1次，平均随访时间8.55±1.96mo。对比分析治疗前后患眼BCVA、CMT及黄斑水肿渗漏的变化，同时观察随访期间眼部与全身不良反应的发生情况。

结果：治疗前，患眼平均BCVA为43.35±17.45个字母，平均CMT为576.30±167.92μm。患眼平均注射次数3.20±0.52次。治疗后1、3、6mo及末次随访时，患眼平均BCVA均较治疗前分别提高11.2±5.9、13.8±7.9、15.7±6.8、14.7±8.6个字母，差异均有显著统计学意义(均P<0.01)。治疗后1mo平均BCVA提高的字母数与术后6mo及末次随访相比，差异均有显著统计学意义(P<0.01)； 末次随访时，视力显著提高者10眼(50%)； 提高者7眼(35%)； 稳定者3眼(15%)。治疗后1、3、6mo及末次随访时，患眼平均CMT较治疗前分别降低了183.8±159.5、292.9±169.0、271.4±167.2、286.4±166.9μm，差异均有显著统计学意义(P<0.01)，治疗后1mo平均CMT与术后3、6mo及末次随访相比，差异均有显著统计学意义(P<0.01)。末次随访时FFA检查发现，黄斑水肿消失者6眼(30%)； 水肿减轻者12眼(60%)； 水肿范围扩大者2眼(10%)。随访期间均未见视网膜脱离、眼压持续升高、眼内炎等与治疗相关的严重眼部及全身并发症。

结论：玻璃体腔注射康柏西普治疗DME可提高患眼视力，降低患眼CMT，安全性好。

METHODS: This was a single arm, open-babel prospective study. Twenty eyes from 20 patients(12 males and 8 females)with DME diagnosed by fundus fluorescein angiography(FFA)and optical coherence tomography(OCT)were enrolled. Before the injection, best-corrected visual acuity(BCVA)of early treatment of diabetic retinopathy study(ETDRS), non-contact tonometer, ophthalmoscope, fundus photography, fundus fluoresein angiograph(FFA), and OCT were examined. All affected eyes were treated with intravitreal conbercept 0.05mL(10mg/mL). Patients were followed up for 6 to 11mo, with a mean duration of 8.55±1.96mo. Post-treatment BCVA, CMT, leakage of macular edema and complications were compared with baseline using repeat analysis.

RESULTS: The initial average visual acuity(ETDRS letters)were 43.35±17.45, range from 9 to 70. The initial average central macular thickness(CMT)was 576.30±167.92μm, range from 337 to 987μm. The mean BCVA showed significant improvement during 1, 3, 6mo post-treatment and the latest follow up, with a mean increase of 11.2±5.9, 13.8±7.9, 15.7±6.8 and 14.7±8.6, respectively(P<0.01). The changes of BCVA between before and at 1mo after treatment were different compared with the changes between before and at 6mo(P<0.01). During the latest follow up, the mean BCVA was obviously improved in 10 eyes(50%), improved in 7 eyes(35%), stable in 3 eyes(15%). Likewise, the mean CMT significantly decreased during the follow-up period with a mean CMT reduction of 183.8±159.5, 292.9±169.0, 271.4±167.2 and 286.4±166.9μm respectively(P<0.001). The CMT at 1mo were different with that 3, 6mo and final follow-up(P<0.01). During the latest follow up, macula lutea leakage disappeared in 6 eyes(30%), decreased in 12 eyes(60%)and increased in 2 eyes(10%). No adverse events such as secondary retinal detachment or endophthalmitis were found during the follow-up.

CONCLUSION: Intravitreal conbercept significantly improve visual acuity and macular edema exudation.