不同剂量阿柏西普对雷珠单抗治疗应答不良PCV伴浆液性PED眼疗效及安全性评价  

Effect and safety of aflibercept in the treatment of polypoidal choroidal vasculopathy with ranibizumab-resistant serous pigment epithelial detachment

作　　者：周朋义[1] 杨琳[1] 许友美 潘萌 郭菊 杜利平[1] 金学民[1] Zhou Pengyi;Yang Lin;Xu Youmei;Pan Meng;Guo Ju;Du Liping;Jin Xuemin(Department of Ophthalmology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院眼科,郑州450052

出　　处：《中华实验眼科杂志》2022年第7期632-638,共7页Chinese Journal Of Experimental Ophthalmology

基　　金：国家自然科学基金项目(81800832、81970792、8217040);河南省医学科技攻关项目(201602081)。

摘　　要：目的观察不同剂量阿柏西普玻璃体腔注射对雷珠单抗治疗应答不良的息肉样脉络膜血管病变(PCV)伴浆液性色素上皮脱离(PED)的疗效及安全性。方法采用非随机对照临床研究方法,于2019年1月至2020年12月纳入郑州大学第一附属医院眼科确诊为顽固性PCV伴浆液性PED患者73例73眼。根据患者对治疗方案的选择意愿将患眼分为2 mg阿柏西普组38眼和4 mg阿柏西普组35眼,分别采用2 mg或4 mg阿柏西普进行玻璃体注射,每月注射1次,连续注射3个月后改为按需给药。分别于注射前及首次注射后1、2、3和6个月采用光相干断层扫描(OCT)仪检测各组PED高度和黄斑中心凹视网膜厚度(CMT),采用对数视力表检测最佳矫正视力(BCVA),并转换为LogMAR视力,记录并比较2个组患眼眼压及术后不良反应。结果2 mg阿柏西普组最终33例完成随访,占86.84%,4 mg阿柏西普组最终30例完成随访,占85.71%。2 mg阿柏西普组注射前及末次随访时PED高度分别为(379.24±95.50)和(280.09±120.50)μm,BCVA分别为0.68±0.27和0.51±0.19,CMT分别为(393.96±100.81)和(291.70±44.09)μm,差异均有统计学意义(均P<0.05)。4 mg阿柏西普组注射前及末次随访时PED高度分别为(393.07±93.76)和(278.63±145.07)μm,BCVA分别为0.66±0.31和0.48±0.22,CMT分别为(377.43±79.61)和(284.67±84.88)μm,各自组内注射前后BCVA、PED高度和CMT差异均有统计学意义(均P<0.05)。4 mg阿柏西普组在注射后1个月时CMT显著低于2 mg阿柏西普组,差异有统计学意义(P<0.05)。2个组患眼随访期间均未发生视网膜脱离、眼内炎、白内障及持续性眼压升高等与药物、注射相关的严重眼部和全身不良事件。结论不同剂量阿柏西普均可安全有效地治疗对雷珠单抗治疗应答不良的PCV伴浆液性PED,改善视网膜的解剖学结构,提高视力,4 mg阿柏西普可加快CMT和PED恢复。Objective To evaluate the effectiveness and safety of intravitreal injection of different doses of aflibercept for polypoidal choroidal vasculopathy(PCV)with serous pigment epithelial detachment(PED)resistant to ranibizumab.Methods A non-randomized controlled clinical study was conducted.Seventy-three eyes of 73 patients with PCV and serous PED resistant to ranibizumab were enrolled at the First Affiliated Hospital of Zhengzhou University from January 2019 to December 2020.All patients were treated by intravitreal injection of 2 mg or 4 mg aflibercept according to patients'willingness.2 mg aflibercept or 4 mg aflibercept was intravitreally injected monthly for three consecutive months following pro re nata(PRN)regimen in 2 mg aflibercept group(38 eyes)and 4 mg aflibercept group(35 eyes),respectively.PED height and central macular thickness(CMT)were measured by optical coherence tomography,and the best corrected visual acuity(BCVA)was examined with a visual acuity chart and converted to logarithm of the minimum angle of resolution(LogMAR)unit before injection and 1 month,2,3,6 months from the first injection.Intraocular pressure and treatment-related adverse events were recorded.This study adhered to the Declaration of Helsinki and was approved by an Ethics Committee of The First Affiliated Hospital of Zhengzhou University(No.2021-KY-1252).Written informed consent was obtained from each patient prior to entering study cohort.Results Thirty-three patients(86.84%)in 2 mg aflibercept group and 30 patients(85.71%)in 4 mg aflibercept group finished the treatment and follow-up,respectively.The PED,BCVA and CMT before treatment and at the end of follow-up were(379.24±95.50)and(280.09±120.50)μm,0.68±0.27 and 0.51±0.19,(393.96±100.81)and(291.70±44.09)μm in 2 mg aflibercept group,respectively,showing statistically significant differences(all at P<0.05).The PED,BCVA and CMT before treatment and at the end of follow-up were(393.07±93.76)and(278.63±145.07)μm,0.66±0.31 and 0.48±0.22,(377.43±79.61)and(284.67±84.88

关 键 词：息肉 脉络膜新生血管 色素上皮脱离 浆液性 玻璃体注射 重组融合蛋白/治疗 疗效 视力 

分 类 号：R773.4[医药卫生—眼科]