阿柏西普和地塞米松玻璃体内植入剂治疗糖尿病黄斑水肿的对比研究  

A comparison study of Aflibercept and Dexamethasone intravitreal implant in the treatment of diabetes macular edema

作　　者：陈珊娜 陈松[2] 苏少平 吴企煌 何广辉[2] 黄磊 吴晓东 杨鹏飞 陈闽敏 Chen Shanna;Chen Song;Su Shaoping;Wu Qihuang;He Guanghui;Huang Lei;Wu Xiaodong;Yang Pengfei;Chen Minmin(Xiamen Kehong Eye Hospital,Xiamen 361006,China;Tianjin Eye Hospital,Tianjin 300020,China)

机构地区：[1]厦门科宏眼科医院,361006 [2]天津市眼科医院,300020

出　　处：《临床眼科杂志》2024年第6期500-505,共6页Journal of Clinical Ophthalmology

基　　金：2022年厦门市医疗卫生指导项目(3502Z20224ZD1365)。

摘　　要：目的对比研究阿柏西普单独或转换或联合地塞米松玻璃体内植入剂(DEX)治疗糖尿病黄斑水肿(DME)的短期疗效与安全性。方法前瞻性对照研究。DME患者59例(59只眼)纳入本研究,单纯组20只眼、转换组19只眼、联合组20只眼,第1、2次三组均注射阿柏西普,第3次单纯组注射阿柏西普、转换组植入DEX、联合组注射阿柏西普和DEX,注射间隔1个月,共随访5个月。所有患者均进行最佳矫正视力(BCVA)、裂隙灯、检眼镜、眼压(IOP)、相干光层析成像术(OCT)、荧光素眼底血管造影(FFA)。记录各相关数据及并发症、观察黄斑形态变化,进行治疗前后组间和组内对比分析。结果治疗前组间基线资料差异均无统计学意义(均P>0.05),三组治疗后每个月logMAR BCVA、黄斑中心凹厚度(CMT)、黄斑总体积(TMV)较治疗前显著变小,差异均有统计学意义(均P<0.01)。治疗后每个月logMAR BCVA组间差异均无统计学意义(均P>0.05),4、5个月转换组和联合组CMT均显著低于单纯组(P_(转换组)=0.003、0.010,P_(联合组)=0.002、0.001)。治疗后4个月转换组和联合组TMV均显著低于单纯组(P=0.008、0.007),5个月联合组显著低于单纯组(P=0.015)。治疗后5个月,CMT降幅(%)和TMV降幅(%)在联合组和单纯组间差异均有统计学意义(Uc=7.377、8.473,P=0.025、0.014),CMT(μm)、TMV(mm^(3))降幅组间差异均无统计学意义(Uc=1.604、5.398,P=0.448、0.067)。治疗后4个月联合组IOP大于治疗前(Z=2.013,P=0.044)。3只眼DEX注射后局部结膜下出血,2只眼阿柏西普注射后轻度刺痛不适。结论阿柏西普单独或转换或联合DEX均能有效地降低DME的高度和范围、提高视力且安全,联合组解剖效果最好,采用CMT、TMV降幅百分比衡量水肿消退程度更有意义。Objective To compare the short-term efficacy and safety of Aflibercept alone or switched or combined with Dexamethasone intravitreal implant(DEX)in patients with diabetes macular edema(DME).Methods A prospective comparison study.DME patients(59 cases,59 eyes)were randomly divided into simple group(20 eyes),switched group(19 eyes)and combined group(20 eyes).Each group received two monthly intravitreal injections of Aflibercept.For the third time,the simple group was injected with Aflibercept,the switched group was DEX,and the combined group was Aflibercept and DEX.The interval was 1 month,and the patients were followed up for 5 months from the first injection.All patients underwent best corrected visual acuity(BCVA),slit lamp,ophthalmoscopy,intraocular pressure(IOP),optical coherence tomography(OCT)and fluorescein fundus angiography(FFA)examination.The relevant data and complications were recorded,and the morphological changes of the macula were observed.They were compared and analyzed within and among the groups.Results There was no statistically significant difference in baseline data among the groups(P>0.05).logMAR BCVA,central macular thickness(CMT)and total macular volume(TMV)of the three groups every month after treatment were smaller than those before treatment,the difference was statistically significant(P<0.01).And there was no significant difference in logMAR BCVA among groups every month(P>0.05).The CMT of the switched and combined group was significantly lower than that of the simple group at 4 and 5 months after treatment(P_(switched)=0.003,0.010,P_(combined)=0.002,0.001).The TMV of the switched and combined group was significantly lower than that of the simple group at the 4-month(P=0.008,0.007),and the combined group was significantly lower than that of the simple group at the 5-month(P=0.015).Five months after the treatment,there was a significantly difference in CMT decrease(%)and TMV decrease(%)between the combined and simple group(Uc=7.377,8.473,P=0.025,0.014)and there was no significant differe

关 键 词：糖尿病视网膜病变 黄斑水肿 血管生成抑制剂 地塞米松玻璃体内植入剂 

分 类 号：S43[农业科学—农业昆虫与害虫防治]