视网膜下注射阿柏西普治疗难治性息肉样脉络膜血管病变疗效的初步研究

Preliminary study on the efficacy of subretinal injection of Aflibercept in the treatment of refractory polypoidal choroidal vasculopathy

目的观察视网膜下注射阿柏西普治疗难治性息肉样脉络膜血管病变(PCV)的安全性及有效性。方法前瞻性临床研究。2022年1~6月于南昌大学附属眼科医院检查确诊的PCV患者18例18只眼纳入研究。患眼均行最佳矫正视力(BCVA)、吲哚青绿血管造影、光相干断层扫描(OCT)检查。采用国际标准视力表行BCVA检查,统计时换算为最小分辨角对数(logMAR)视力。采用OCT仪的增强深度成像技术测量脉络膜大血管层厚度(LVCT)、中心凹视网膜厚度(CRT)、中心凹下脉络膜厚度(SFCT)、视网膜色素上皮脱离(PED)高度;计算脉络膜血管指数(CVI)。18例18只眼中,男性11例11只眼,女性7例7只眼;年龄(64.22±3.86)岁;病程(5.22±1.80)年。既往接受玻璃体腔注射抗血管内皮生长因子(VEGF)药物治疗(7.72±1.36)次。患眼logMAR BCVA为1.28±0.25;SFCT、CRT、LVCT及PED高度分别为(436.56±9.80)、(432.44±44.29)、(283.78±27.10)、(342.44±50.18)μm,CVI为0.65±0.01。所有患眼均给予1次视网膜下注射40 mg/ml阿柏西普0.05 ml(含阿柏西普2.0 mg)治疗。根据治疗后OCT、BCVA结果将病变分为活动型及静止型。活动型病变给予玻璃体腔注射阿柏西普治疗,剂量同前;静止型病变,随访观察。治疗后1~3、6、9、12个月采用治疗前相同设备和方法行相关检查。观察BCVA、LVCT、CRT、SFCT、PED高度、CVI、视网膜层间积液或视网膜下液、病灶消退率以及注药次数、治疗中和治疗后并发症发生情况。治疗前后BCVA、SFCT、CRT、LVCT、PED高度、CVI比较采用重复测量方差分析。结果18只眼共接受视网膜下和(或)玻璃体腔注射阿柏西普(1.61±0.85)(1~4)次。末次随访时,息肉样病灶消退4只眼;PED消失1只眼。与治疗前比较,治疗后BCVA(F=50.298)逐渐提高,CRT(F=25.220)、PED高度(F=144.16)、SFCT(F=69.77)、LVCT(F=136.69)、CVI(F=72.70)逐渐降低,差异均有统计学意义(P<0.001)。治疗后发生黄斑裂孔1只眼,治疗后3个月裂孔自行闭合。治疗中及治疗后所有患眼均未发生视网膜撕裂、视网膜脱离、眼内炎、玻璃体积血等严重并发症。结论视网膜下注射阿柏西普治疗难治性PCV安全、有效。

Objective To observe the efficacy and safety of subretinal injection of Aflibercept for the treatment of refractory or recurrent polypoidal choroidal vasculopathy(PCV).Methods A prospective clinical research.From January to June 2022,18 patients of 18 eyes with PCV diagnosed in The Affiliated Eye Hospital of Nanchang University were included in the study.All patients underwent best corrected visual acuity(BCVA),indocyanine green angiography and optical coherence tomography(OCT).The BCVA examination was performed using the international standard visual acuity chart,which was converted to logarithm of the minimum angle of resolution(logMAR)visual acuity during statistics.The large choroidal vessel thickness(LVCT),central retinal thickness(CRT),sub-foveal choroidal thickness(SFCT)and retinal pigment epithelium detachment(PED)height were measured by enhanced depth imaging technique of OCT.The choroidal vascular index(CVI)was calculated.There were 18 patients of 18 eyes,11 males of 11 eyes and 7 females of 7 eyes.The age was(64.22±3.86)years old.The disease duration was(5.22±1.80)years.The patient had received intravitreal injection of anti-vascular endothelial growth factor(VEGF)drugs for(7.72±1.36)times.The logMAR BCVA of the affected eyes was 1.28±0.25.The SFCT,CRT,LVCT,PED height were(436.56±9.80),(432.44±44.29),(283.78±27.10),(342.44±50.18)μm,respectively,and CVI was 0.65±0.01.All eyes were treated with a single subretinal injection of 40 mg/ml Aflibercept 0.05 ml(including Aflibercept 2.0 mg).According to the results of OCT and BCVA after treatment,the lesions were divided into active type and static type.The active lesions were treated with intravitreal injection of Aflibercept at the same dose as before.Quiescent lesions were followed up.Examinations were performed 1-3,6,9 and 12 months after treatment using the same equipment and methods before treatment.The BCVA,LVCT,CRT,SFCT,PED height,CVI,interretinal or subretinal fluid,lesion regression rate,injection times,and complications during and after treatment were observed.The BCVA,SFCT,CRT,LVCT,PED height and CVI before and after treatment were compared by repeated measures analysis of variance.Results Eighteen eyes received subretinal and/or intravitreal injection of Aflibercept(1.61±0.85)times(1-4 times).At the last follow-up,the polypoid lesions regressed in 4 eyes and PED disappeared in 1 eye.Compared with before treatment,BCVA(F=50.298)gradually increased,CRT(F=25.220),PED height(F=144.16),SFCT(F=69.77),LVCT(F=136.69),CVI(F=72.70)gradually decreased after treatment.The differences were statistically significant(P<0.001).Macular hole occurred in 1 eye after treatment,and the hole closed spontaneously 3 months after treatment.No serious complications such as retinal tear,retinal detachment,endophthalmitis and vitreous hemorrhage occurred during and after treatment.Conclusion Subretinal injection of Aflibercept is safe and effective in the treatment of refractory PCV.