三种不同给药方案治疗难治性糖尿病性黄斑水肿的效果比较  

Comparison of the efficacy of three different treatment methods for the treatment of refractory diabetic macular edema

作　　者：马瑶 郝胜利 黄冠南[1] 郝维婷 杨瑞芳 苏龙[1] Ma Yao;Hao Shengli;Huang Guannan;Hao Weiting;Yang Ruifang;Su Long(Department of Ophthalmology,the Second Hospital of Tianjin Medical University,Tianjin Institute of Orbital Diseases,Tianjin 300211,China)

机构地区：[1]天津医科大学第二医院眼科、天津市眼眶病研究所,天津300211

出　　处：《中华眼外伤职业眼病杂志》2024年第5期321-327,共7页Chinese Journal of Ocular Trauma and Occupational Eye Disease

摘　　要：目的对比三种不同给药方案治疗难治性糖尿病性黄斑水肿(DME)的临床效果。方法回顾性病例对照研究。收集天津医科大学第二医院眼科2020年2月至2023年2月难治性DME患者74例(104只眼)的临床资料。患眼均接受起始每月玻璃体内注射抗血管内皮生长因子(VEGF)药物1次,连续3个月或6个月,其后根据患者最佳矫正视力(BCVA,logMAR)和OCT检查结果进行按需治疗(PRN)或联合地塞米松玻璃体内植入剂(IDI),即3+PRN、3+IDI+PRN或6+IDI+PRN。按照治疗方案将患者分为单纯玻璃体内注射抗VEGF治疗组(3+PRN组)23例(35只眼)、3+IDI+PRN组27例(36只眼)、6+IDI+PRN组24例(33只眼)。随访时间为治疗后12个月。分析比较3组在随访期各时间点的BCVA、黄斑中心区视网膜厚度(CMT)、玻璃体内注药次数及并发症的发生情况。结果与基线相比,治疗后各时间点3组BCVA均提高,CMT均降低(均P<0.05)。治疗后3个月,3组间BCVA及CMT差异均无统计学意义(均P>0.05);治疗后6个月,3+IDI+PRN组BCVA为0.39±0.19,CMT为(326.25±57.33)μm,与3+PRN组[BCVA为0.53±0.21,CMT为(430.49±95.92)μm]和6+IDI+PRN组[BCVA为0.52±0.17,CMT为(428.76±81.28)μm]比较,差异均有统计学意义(均P<0.05)。治疗后9个月和12个月,3+IDI+PRN组和6+IDI+PRN组的BCVA及CMT分别与3+PRN组[治疗后9个月:BCVA为0.51±0.18,CMT为(444.57±83.15)μm;治疗后12个月:BCVA为0.56±0.18,CMT为(454.63±100.54)μm]相比均改善,差异有统计学意义(均P<0.05);且3+IDI+PRN组和6+IDI+PRN组患者BCVA、CMT相比差异均无统计学意义(均P>0.05)。随访期末,3+IDI+PRN组的玻璃体内注药次数为(4.75±0.60)次,明显少于6+IDI+PRN组的注射次数(7.33±0.65)次和3+PRN组的注射次数(7.23±1.33)次,总体差异有统计学意义(F=88.28,P<0.001)。3+PRN组、3+IDI+PRN组、6+IDI+PRN组患者治疗后眼压≥25 mmHg(1 mmHg=0.133 kPa)的发生率[8.57%(3/35)、25.00%(9/36)、27.27%(9/33)]和白内障的发生率[5.71%(2/35)、16.67%(6/36)、15.15%(5/33ObjectiveTo compare the clinical efficacy of three different therapeutic regimens in the treatment of refractory diabetic macular edema(DME).MethodsThis was a retrospective case control study.A total of 104 eyes of 74 patients with refractory DME in the Second Hospital of Tianjin Medical University from Feb.2020 to Feb.2023 were included.All diseased eyes received intravitreal injections of anti-vascular endothelial growth factor(VEGF)once a month for 3 or 6 months,followed with pro re nata(PRN)treatment or intravitreal dexamethasone implant(IDI),according to the best corrected visual acuity(BCVA,logMAR)and OCT examination results,namely 3+PRN,3+IDI+PRN or 6+IDI+PRN treatment plan.They were divided into three groups based on different treatment methods,i.e.,the 3+PRN group(35 eyes of 23 patients),the 3+IDI+PRN group(36 eyes of 27 patients),and the 6+IDI+PRN group(33 eyes of 24 patients).The follow-up period was 12 months after treatment.BCVA,central macular thickness(CMT),number of intravitreal injections,and occurrence of complications were analyzed and compared among the three groups at different time points in the follow-up period.ResultsCompared with baseline,BCVA increased and CMT decreased in the three groups at all time points after treatment(all P<0.05).At 3 months after treatment,there were no significant differences in BCVA and CMT among the three groups(all P>0.05).At 6 months after treatment,BCVA(0.39±0.19)and CMT(326.25±57.33)μm in the 3+IDI+PRN group were better than those in the 3+PRN group[BCVA(0.53±0.21),CMT(430.49±95.92)μm]and in the 6+IDI+PRN group[BCVA(0.52±0.17),CMT(428.76±81.28)μm],the differences were statistically significant(all P<0.05).At 9 and 12 months after treatment,the BCVA and CMT in the 3+IDI+PRN group and 6+IDI+PRN group were better than those in the 3+PRN group[at 9 months:BCVA 0.51±0.18,CMT(444.57±83.15)μm;at 12 months:BCVA 0.56±0.18,CMT(454.63±100.54)μm]and the differences were statistically significant(all P<0.05),but there was no significant difference in BCVA

关 键 词：糖尿病视网膜病变 黄斑水肿 血管内皮生长因子类 玻璃体内注射 地塞米松 药物植入物 

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