玻璃体腔注射康柏西普治疗糖尿病黄斑水肿的疗效观察

Clinical observation of intravitreal injection of Conbercept treating diabetic macular edema

目的:观察玻璃体腔注射康柏西普治疗糖尿病黄斑水肿(diabetic macular edema,DME)的有效性及安全性。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。

AIM： To observe the clinical efficiency of intravitreal conbercept on diabetic macular edema（DME）. 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 for6 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±167.921Jm, range from 337 to 987pm. The mean BCVA showed significant improvement during 1, 3, 6too 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 1too after treatment were different compared with the changes （P〈0.01）. During the latest between before and at 6too follow up, the mean BCVAwas 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±166.9μ m respectively （ P〈0. 001 ）. The CMT at 1 mo 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.