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ENGLISH ABSTRACT
两种康柏西普治疗方案治疗息肉样脉络膜血管病变的效果分析
汤然
汤稷旸
韩馨瑶
张琳崎
黎晓新
赵明威
曲进锋
作者及单位信息
·
DOI： 10.3760/cma.j.cn115989-20220117-00023
Comparative study of the efficacy of two intravitreal conbercept regimens in the treatment of polypoidal choroidal vasculopathy
Tang Ran
Tang Jiyang
Han Xinyao
Zhang Linqi
Li Xiaoxin
Zhao Mingwei
Qu Jinfeng
Authors Info & Affiliations
Tang Ran
Department of Ophthalmology, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, College of Optometry, Peking University Health Science Center, Beijing 100044, China
Tang Jiyang
Department of Ophthalmology, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, College of Optometry, Peking University Health Science Center, Beijing 100044, China
Han Xinyao
Department of Ophthalmology, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, College of Optometry, Peking University Health Science Center, Beijing 100044, China
Zhang Linqi
Department of Ophthalmology, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, College of Optometry, Peking University Health Science Center, Beijing 100044, China
Li Xiaoxin
Department of Ophthalmology, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, College of Optometry, Peking University Health Science Center, Beijing 100044, China
Zhao Mingwei
Department of Ophthalmology, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, College of Optometry, Peking University Health Science Center, Beijing 100044, China
Qu Jinfeng
Department of Ophthalmology, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, College of Optometry, Peking University Health Science Center, Beijing 100044, China
·
DOI： 10.3760/cma.j.cn115989-20220117-00023
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摘要

目的比较治疗－延长(TAE)方案与按需治疗(PRN)方案应用于玻璃体内注射康柏西普治疗息肉样脉络膜血管病变(PCV)的疗效和安全性。

方法采用非随机对照研究方法，纳入2016年10月至2019年1月于北京大学人民医院眼科就诊的未经治疗的PCV患者91例91眼。所有患者确诊后均接受康柏西普0.5 mg玻璃体内注射；按照患者意愿决定其抗VEGF治疗方案，根据治疗方案将患者分为按需治疗组(3＋PRN组)和治疗－延长组(3＋TAE组)。随访时间为1年。所有患眼均接受ETDRS视力表、光学相干断层扫描(OCT)、荧光素眼底血管造影(FFA)及吲哚菁绿脉络膜血管造影(ICGA)检查，并记录最佳矫正视力(BCVA)、黄斑中心视网膜厚度(CRT)、最大视网膜厚度(MRT)、色素上皮脱离(PED)高度、脉络膜息肉样病灶数量及面积、视网膜出血面积、分枝状血管网(BVN)面积。比较2个组在治疗后1年内的治疗间隔时间及治疗次数。

结果治疗后1年，3＋PRN组和3＋TAE组的BCVA提升幅度分别为5.0(－2.0，15.0)和6.0(－1.0，14.0)个字母，组间比较差异无统计学意义( Z＝－0.352， P＝0.725)；2个组患眼CRT、MRT、PED高度变化量比较差异均无统计学意义( Z＝－0.145、－0.529、－0.985，均 P>0.05)；2个组患眼息肉数量、息肉面积、不同息肉消退程度眼数、BVN面积和视网膜出血面积比较差异均无统计学意义( Z＝－0.502、－0.300、－0.047、－0.265、－1.243，均 P>0.05)。随访1年时，3＋PRN组患眼平均接受康柏西普玻璃体内注射(7.6±0.9)次，少于3＋TAE组的(8.4±2.0)次，差异有统计学意义( t＝2.432， P＝0.019)。3＋PRN组平均随访次数为(11.3±1.5)次，明显多于3＋TAE组的(10.1±1.7)次，差异有统计学意义( t＝3.403， P＝0.001)。3＋TAE组患眼负荷治疗期后有17.1%(6/35)的患者治疗间隔延长至12周，48.5%(17/35)的患者治疗间隔延长至8周及以上，平均最大延长间隔时间为(9.5±2.0)周。随访期间，3＋PRN组和3＋TAE组分别有10眼和8眼接受光动力治疗。

结论3＋PRN和3＋TAE方案进行康柏西普玻璃体内注射联合光动力补救治疗在改善PCV患者的视力和解剖结果方面疗效接近。其中3＋TAE方案治疗次数增加，患者随访次数减少。

息肉样脉络膜血管病变;抗血管内皮生长因子治疗;康柏西普
ABSTRACT

ObjectiveTo assess the efficacy and safety of the treat-and-extend (TAE) regimen and pro re nata (PRN) regimen of intravitreal conbercept in polypoidal choroidal vasculopathy (PCV) patients.

MethodsA non-randomized controlled study was performed.Ninety-one patients (91 eyes) diagnosed with treatment-naïve PCV from October 2016 to January 2019 at Department of Ophthalmology, Peking University People's Hospital were enrolled.All the patients received the intravitreal injection of 0.5 mg conbercept.After the initial treatment, the patients were divided into 3+ PRN group and 3+ TAE group according to their willingness.The follow-up time was one year.All the eyes underwent visual acuity test with ETDRS chart, optical coherence tomography (OCT) examination, fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA). Best corrected visual acuity (BCVA), central retinal thickness (CRT), maximum retinal thickness (MRT), pigment epithelium detachment (PED) height, the number and area of polypoidal lesions, the area of retinal hemorrhage and the area of branching vascular network (BVN) were recorded.Treatment interval and injection frequencies during the one-year follow-up were compared between the two groups.This study adhered to the Declaration of Helsinki.The study protocol was approved by Peking University People's Hospital (No.2020PHB250-01). Written informed consent was obtained from each patient.

ResultsOne-year after treatment, the BCVA improvement in the 3+ PRN group and 3+ TAE group was 5.0(-2.0, 15.0) and 6.0(-1.0, 14.0) letters, respectively, showing no significant difference ( Z=-0.352, P=0.725). No significant differences were found in CRT, MRT and PED height between the two groups ( Z=-0.145, -0.529, -0.985, all at P>0.05). There was no significant difference in polypoidal lesions number, polypoidal lesions area, the number of eyes with different degrees of polyp regression, BVN area and retinal hemorrhage area between the two groups ( Z=-0.502, -0.300, -0.047, -0.265, -1.243, all at P>0.05). After the one-year follow-up, the mean injection frequency of 3+ PRN group was (7.6±0.9) times, which was lower than (8.4±2.0) times of 3+ TAE group, showing a significant difference ( t=2.432, P=0.019). The mean follow-up frequency was (11.3±1.5) times of 3+ PRN group, which was significantly higher than (10.1±1.7) times of 3+ TAE group ( t=3.403, P=0.001). For the 3+ TAE group, 17.1%(6/35) of patients achieved an extension interval of 12 weeks after the first 3 doses, and 48.5%(17/35) of patients achieved an extension interval of 8 weeks or more, with a mean maximum extension interval of (9.5±2.0) weeks.During the follow-up, 10 patients in 3+ PRN group and 8 patients in 3+ TAE group received photodynamic therapy as a rescue treatment.

ConclusionsThe 3+ PRN and 3+ TAE regimens of intravitreal injection of conbercept combined with photodynamic therapy as a rescue treatment have similar efficacy in visual and anatomical outcomes for PCV patients.3+ TAE regimen has a higher treatment frequency and fewer follow-up visits.

Polypoidal choroidal vasculopathy;Anti-vascular endothelial growth factor;Conbercept
Qu Jinfeng, Email: mocdef.6ab21hpukp_gnefnijuq
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引用本文

汤然,汤稷旸,韩馨瑶,等. 两种康柏西普治疗方案治疗息肉样脉络膜血管病变的效果分析[J]. 中华实验眼科杂志,2024,42(01)：53-59.

DOI:10.3760/cma.j.cn115989-20220117-00023

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息肉样脉络膜血管病变(polypoidal choroidal vasculopathy，PCV)是新生血管性年龄相关性黄斑变性(neovascular age-related macular degeneration，nAMD)的一种亚型，主要表现为视网膜色素上皮(retinal pigment epithelium，RPE)下分枝状血管网(branching vascular network，BVN)息肉样扩张，导致RPE脱离、渗出和视网膜出血 [ 1 , 2 , 3 , 4 ]。PCV在亚洲人群中尤为常见，据估计占亚洲nAMD病例的50% [ 5 , 6 ]。PCV的治疗方式很多，包括局部激光光凝疗法、光动力治疗(photodynamic therapy，PDT)、抗血管内皮生长因子(vascular endothelial growth factor，VEGF)单药治疗以及联合疗法 [ 7 ]。局部激光光凝治疗一般用于中心凹外的息肉。PDT治疗虽然可以在1～2年内稳定甚至改善视力，但长期的视力预后不理想，且有报道可能出现出血、RPE撕裂、脉络膜萎缩等并发症 [ 8 , 9 , 10 , 11 ]。近年来抗VEGF单药治疗已被证明对活动性PCV具有良好的治疗效果 [ 12 , 13 ]。康柏西普是一种新型融合蛋白，可抑制VEGF-A、VEGF-B和胎盘生长因子表达，在我国已被批准用于nAMD的治疗。康柏西普在治疗PCV方面也表现出了良好的临床效果 [ 13 , 14 , 15 ]。AURORA研究中针对PCV患者的亚组分析显示，0.5 mg康柏西普治疗后1年的息肉消退率为82.6%，最佳矫正视力(best corrected visual acuity，BCVA)平均提高14.4个字母，平均视网膜下液(subretinal fluid，SRF)厚度和色素上皮脱离(pigment epithelial detachment，PED)高度分别减少了111.9和79.3 μm [ 16 , 17 ]。Huang等 [ 18 ]的研究表明，康柏西普和雷珠单抗在治疗6个月时对PCV患者的BCVA改善效果相似，康柏西普组息肉完全消退的患者比例更高。目前仍然缺乏针对PCV患者不同给药方案治疗效果的对比研究。本研究拟比较康柏西普玻璃体内注射治疗PCV的不同方案的疗效和安全性，以期为临床上抗VEGF治疗PCV的方法选择提供参考依据。
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汤然：参与研究实施、数据收集和统计分析、论文撰写及修改；汤稷旸：参与研究指标的测量和数据分析、论文修改；韩馨瑶、张琳崎：参与部分研究指标的检查、数据收集整理及分析、论文修改；黎晓新、赵明威：参与选题、研究设计、论文智力性内容的修改；曲进锋：参与选题、研究设计、试验实施、数据分析和论文智力性内容修改和定稿

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