摘要
目的探讨法瑞西单抗对于抗血管内皮生长因子(VEGF)药物治疗应答不佳的新生血管性年龄相关性黄斑变性(nAMD)患者的转换治疗价值,并初步评估其临床效果。方法回顾性临床研究。2024年3月至2025年1月于中国人民解放军中部战区总医院检查确诊的nAMD患者25例32只眼纳入研究。所有患眼均因既往抗VEGF药物治疗应答不佳而转为接受法瑞西单抗治疗。治疗方案为首次注射后,根据随访情况按需治疗。通过最佳矫正视力(BCVA)、扫频源光相干断层扫描血管成像(SS-OCTA)进行评估。BCVA检查采用Snellen视力表进行,并转换为最小分辨角对数(logMAR)视力进行统计分析;SS-OCTA系统自动测算中央视网膜厚度(CRT)、脉络膜新生血管表面积(CSA)及脉络膜新生血管流量面积(CFA)等指标。主要观察治疗后1、3、6个月的BCVA、CSA、CFA、CRT变化及不良反应。采用混合线性模型比较各指标与基线的差异。结果25例患者中,男性20例(80.0%,20/25),女性5例(20.0%,5/25);年龄(66.6±11.2)岁;病程(41.2±36.4)个月。既往接受抗VEGF药物治疗(20.5±21.6)次,涉及药物平均2.2种。32只眼中,存在视网膜下液、视网膜内液及两者并存者分别为16(50.0%)、11(34.4%)、7(21.9%)只眼。基线时,患眼logMAR BCVA为0.67±0.41,CSA、CFA分别为(7.46±6.27)、(3.26±2.59)mm^(2),CRT为(380.75±147.56)µm。转换为法瑞西单抗治疗后1、3、6个月,logMAR BCVA分别改善至0.57±0.42、0.55±0.41、0.50±0.35;CSA相应为(6.36±6.10)、(6.44±6.12)、(6.44±5.96)mm^(2);CFA相应为(2.79±2.50)、(2.35±2.25)、(2.59±2.35)mm^(2);CRT相应为(330.64±147.56)、(329.44±130.73)、(340.05±144.56)μm。与基线相比,治疗后各时间点BCVA显著改善,CSA与CFA显著减小,差异均有统计学意义(P<0.05);治疗后1、3个月,CRT较基线显著降低,差异有统计学意义(P=0.005、0.025)。所有患眼在随访期间眼压均维持正常,未发生眼内感染等严重不良事件。结论对于抗VEGF药物治疗应答不佳的nAMD患者,转换为法瑞西单抗治疗可有效改善患眼BCVA与解剖结构(包括CSA、CFA及CRT),且安全性良好。
ObjectiveTo explore the conversion treatment value of Faricimab in patients with neovascular age-related macular degeneration(nAMD)who had sub-optimal response to anti-vascular endothelial growth factor(VEGF)drug therapy,and to preliminarily evaluate its clinical effect.MethodsA retrospective clinical study.From March 2024 to January 2025,25 patients(32 eyes)diagnosed with nAMD at Department of Ophthalmology of General Hospital of Central Theater Command were included in the study.All affected eyes were converted to receive Faricimab treatment due to sub-optimal response to previous anti-VEGF drug therapy.The treatment plan is to provide treatment as needed after the first injection based on the follow-up results.The best corrected visual acuity(BCVA)and swept-source optical coherence tomography angiography(SS-OCTA)were evaluated.BCVA examination was conducted using the Snellen visual acuity chart and converted to the logarithm of the minimum angle of resolutionn(logMAR)visual acuity for statistical analysis.The SS-OCTA system automatically calculates indicators such as central retinal thickness(CRT),choroidal neovascularization surface area(CSA),and choroidal neovascularization flow area(CFA).The main observations were made on the changes of BCVA,CSA,CFA,CRT and adverse reactions at 1,3 and 6 months after treatment.A mixed linear model was adopted to compare the differences between each index and the baseline.ResultsAmong the 25 patients,20 were male(80.0%,20/25)and 5 were female(20.0%,5/25).Age was(66.6±11.2)years old.The disease course was(41.2±36.4)months.Previously received anti-VEGF drug treatment(20.5±21.6)times,involving 2.2 types of drugs.Among the 32 eyes,16(50.0%),11(34.4%),and 7(21.9%)eyes had subretinal fluid,intraretinal fluid,and both coexisting,respectively.At baseline,the logMAR BCVA of the affected eye was 0.67±0.41,the CSA and CFA were(7.46±6.27)and(3.26±2.59)mm^(2),respectively,and the CRT was(380.75±147.56)µm.At 1,3,and 6 months after switching to Faricimab treatment,logMAR BCVA improved to 0.57±0.42,0.55±0.41,and 0.50±0.35,respectively.The corresponding CSA were(6.36±6.10),(6.44±6.12),and(6.44±5.96)mm^(2).The corresponding CFA values were(2.79±2.50),(2.35±2.25),and(2.59±2.35)mm^(2).The corresponding CRT were(330.64±147.56),(329.44±130.73),(340.05±144.56)μm.Compared with the baseline,BCVA significantly improved at each time point after treatment,and CSA and CFA significantly decreased.The differences were statistically significant(P<0.05).At 1 and 3 months after treatment,CRT was significantly lower than the baseline,and the difference was statistically significant(P=0.005,0.025).During the follow-up period,the intraocular pressure of all affected eyes remained normal,and no serious adverse events such as intraocular infection occurred.ConclusionFor nAMD patients with poor response to anti-VEGF drug treatment,switching to Faricimab treatment can effectively improve the BCVA and anatomical structure(including CSA,CFA and CRT)of the affected eyes,and has good safety.
作者
张文婧
闫明
陈丛
叶娅
黄珍
邓玉梦
宋艳萍
Zhang Wenjing;Yan Ming;Chen Cong;Ye Ya;Huang Zhen;Deng Yumeng;Song Yanping(Department of Ophthalmology,General Hospital of Central Theater Command,Wuhan 430070,China)
出处
《中华眼底病杂志》
北大核心
2025年第12期922-929,共8页
Chinese Journal of Ocular Fundus Diseases
基金
国家重点研发计划"常见多发病防治研究"重点专项(2022YFC2502800)
国家自然科学基金(82471110)
中部战区总医院博士后科研启动基金(20210517KY04)。
