康柏西普与地塞米松玻璃体缓释植入物对糖尿病性黄斑水肿的疗效比较  

Comparison of the efficacy of conbercept and intravitreal dexamethasone implant Ozurdex in the treatment of diabetic macular edema

作　　者：高荣玉 刘建东 朱方兴 杨娟娟 徐恩沛 徐鑫彦 Gao Rongyu;Liu Jiandong;Zhu Fangxing;Yang Juanjuan;Xu Enpei;Xu Xinyan(Weifang Eye Hospital,Weifang 261000,China)

机构地区：[1]潍坊眼科医院,潍坊261000

出　　处：《中华实验眼科杂志》2022年第7期658-663,共6页Chinese Journal Of Experimental Ophthalmology

基　　金：潍坊市科技发展计划项目(2018YX044)。

摘　　要：目的比较玻璃体腔注射抗血管内皮生长因子(VEGF)药物康柏西普与地塞米松玻璃体缓释植入物(Ozurdex)治疗糖尿病性黄斑水肿(DME)的有效性及安全性。方法采用随机对照临床研究方法,纳入2018年3月至2019年6月在潍坊眼科医院诊断为DME的患者36例36眼。采用随机数字表法将患者随机分为Ozurdex组及康柏西普组,每组18眼。Ozurdex组患者玻璃体腔注射Ozurdex 1次,维持6个月;康柏西普组患者玻璃体腔注射康柏西普3次,每月给药1次。采用国际标准视力表检测患眼最佳矫正视力(BCVA)并换算为LogMAR视力;采用非接触式眼压计测量患眼眼压;采用光相干断层扫描(OCT)测量患眼中央视网膜厚度(CRT)。结果所有患者均完成6个月的随访。Ozurdex组患者在注射前及首次注射后1、3、4和6个月BCVA分别为0.59±0.22、0.53±0.20、0.41±0.16、0.38±0.19和0.56±0.19,其中首次注射后1、3和4个月BCVA均优于注射前,差异均有统计学意义(均P<0.05)。康柏西普组患者注射前及首次注射后1、3、4和6个月BCVA分别为0.60±0.23、0.51±0.17、0.29±0.13、0.56±0.18和0.60±0.18,其中首次注射后1个月和3个月BCVA明显优于注射前,差异均有统计学意义(均P<0.05)。2个组首次注射后1、3、4个月的CRT均低于注射前,差异均有统计学意义(均P<0.05);Ozurdex组首次注射后6个月CRT为(462.17±48.74)μm,显著低于注射前的(498.61±77.14)μm,差异有统计学意义(P<0.05),康柏西普组首次注射后6个月CRT为(491.89±43.00)μm,与注射前的(502.94±69.65)μm比较,差异无统计学意义(P>0.05)。Ozurdex组中6眼出现高眼压,占33.3%,康柏西普组1眼出现高眼压,占5.56%,2个组间高眼压发生率比较差异有统计学意义(χ^(2)=4.433,P=0.035)。各组随访期内均未出现白内障加重、晶状体损伤、眼内炎、玻璃体积血、视网膜脱离等不良反应。结论在DME的治疗中,康柏西普与Ozurdex均能改善BCVA、减小CRT。Ozurdex具有�Objective To compare the efficacy and safety of intravitreal injection of anti-vascular endothelial growth factor drug conbercept and intravitreal dexamethasone implant Ozurdex in the treatment of diabetic macular edema(DME).Methods A randomized controlled clinical study was performed.Thirty-six DME patients(36 eyes)were enrolled in Weifang Eye Hospital from March 2018 to June 2019.The patients were randomized into Ozurdex group and conbercept group via a random number table,with 18 eyes in each group.Patients received Ozurdex injection once,which was maintained for 6 months,or conbercept injection once a month for 3 times according to grouping.Before and after treatment,the best corrected visual acuity(BCVA)was examined with the International Standard Visual acuity chart and converted to logarithm of minimal angle resolution unit.The intraocular pressure(IOP)was measured using a non-contact tonometer.The central retinal thickness(CRT)was detected by optical coherence tomography(OCT).This study followed the Declaration of Helsinki and was approved by the Ethics Committee of Weifang Eye Hospital.Results All patients were followed up for 6 months.In Ozurdex group,the BCVA pre-injection and at 1 month,3,4,6 months after the first injection was 0.59±0.22,0.53±0.20,0.41±0.16,0.38±0.19 and 0.56±0.19,respectively.The BCVA at 1 month,3 and 4 months after the first injection were better than that before injection,and the differences were statistically significant(all at P<0.05).In conbercept group,the BCVA pre-injection and at 1 month,3,4,6 months after the first injection were 0.60±0.23,0.51±0.17,0.29±0.13,0.56±0.18 and 0.60±0.18,respectively.The BCVA at 1 month and 3 months after the first injection were better than that before injection,showing statistically significant differences(all at P<0.05).The CRT at 1 month,3 and 4 months after the first injection were significantly lower than that before treatment in both the two groups(all at P<0.05).The CRT pre-injection was(498.61±77.14)μm in Ozurdex group,which

关 键 词：康柏西普 地塞米松 药物植入物 糖尿病性黄斑水肿 最佳矫正视力 中央视网膜厚度 

分 类 号：R587.2[医药卫生—内分泌] R774.5[医药卫生—内科学]