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
马瑶 1郝胜利 1黄冠南 1郝维婷 1杨瑞芳 1苏龙1
作者信息
- 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
- 折叠
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%(5/33)],3组间比较差异均无统计学意义(χ2=4.48、2.26,P=0.107、0.324).结论 三种不同治疗方案均能安全有效治疗难治性DME,3+IDI+PRN方案仅需较少注药次数即可使患者获得更好的视力,降低CMT.
Abstract
Objective To compare the clinical efficacy of three different therapeutic regimens in the treatment of refractory diabetic macular edema(DME).Methods This 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.Results Compared 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 and CMT between the 3+IDI+PRN group and the 6+IDI+PRN group(all P>0.05).At the end of the follow-up period,the total number of injections in the 3+IDI+PRN group[(4.75±0.60)times]was significantly less than the(7.33±0.65)times in the 6+IDI+PRN group and the(7.23±1.33)times in the 3+PRN group,and the difference was statistically significant(F=88.28,P<0.001).The incidence of intraocular pressure≥25 mmHg(1 mmHg=0.133 kPa)was 8.57%(3/35),25.00%(9/36),27.27%(9/33),and the incidence of cataract was 5.71%(2/35),16.67%(6/36),15.15%(5/33)in the 3+PRN group,the 3+IDI+PRN group,and the 6+IDI+PRN group,respectively,with no statistical significance among the three groups(χ2=4.48,2.26;P=0.107,0.324).Conclusion All three different treatment regimens can safely and effectively treat refractory DME.The 3+IDI+PRN group regimen only requires fewer injections to achieve better vision and reduce CMT.
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Key words
Diabetic retinopathy/Macular edema/Vascular endothelial growth factors/Intravitreal injections/Dexamethasone/Drug implants引用本文复制引用
出版年
2024
NETL
NSTL
万方数据