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Advances in Clinical Medicine
Vol. 10  No. 10 ( 2020 ), Article ID: 38339 , 8 pages
10.12677/ACM.2020.1010361

玻璃体腔注射康柏西普联合曲安奈德与单用康柏西普治疗青年CRVO的临床疗效比较

翟改霞*，刘娜*，王少鹏#，王怀华，王作芬

淄博市中心医院眼科，山东 淄博

收稿日期：2020年10月6日；录用日期：2020年10月21日；发布日期：2020年10月28日

摘要

背景：视网膜中央静脉阻塞(central retinal vein occlusion CRVO)继发黄斑水肿治疗的理论基础是降低VEGF (vascular endothelial growth factor)的作用，中青年CRVO的发病机制与炎症密切相关，康柏西普联合曲安奈德(triamcinolone acetonide, TA)在青年CRVO治疗方面的研究较少。目的：比较康柏西普(Conbercept)联合曲安奈与单用康柏西普治疗青年CRVO的临床疗效及安全性。方法：采用回顾性研究，选择2015.06~2019.04于淄博市中心医院眼科行康柏西普联合1 mg TA玻璃体腔注射治疗的20例(20眼)青年CRVO患者，作为观察组，同时间行0.5 mg (0.05 ml)康柏西普玻璃体腔注射治疗的20例(20眼)青年CRVO患者作为对照组。观察两组的视力、眼压、裂隙灯、眼底检查、眼底荧光血管造影和光学相干断层扫描等指标变化情况及有无全身不良反应，并比较治疗前及治疗后1个月、3个月、6个月的最佳矫正视力(best-correct visual acuity, BCVA) EDTRS字母数、黄斑中心视网膜厚度(central retina thickness, CRT)、眼压及两组的注射次数。结果：两组人口基线特征相比无差异(P > 0.05)，观察组治疗前BCVA为65.35 ± 6.11，治疗后1、3、6个月的BCVA分别为75.40 ± 4.47、76.05 ± 3.71、75.85 ± 3.88，较治疗前均有提高；对照组治疗前BCVA为67.30 ± 5.99，治疗后1、3、6个月的BCVA分别为73.00 ± 3.84、73.00 ± 5.53、76.40 ± 3.25，较治疗前均有提高，观察组治疗3个月BCVA高于对照组(P < 0.05)，治疗6个月两组BCVA组间比较无差异(P > 0.05)，对照组较治疗前提高>10个字母8例，提高5~10个字母12例，观察组较治疗前提高>10个字母11例，提高5~10个字母7例，提高<5个字母2例。观察组治疗前基线CRT为(518.85 ± 30.67) μm，治疗后1、3、6个月的CRT分别为(271.65 ± 75.31)、(260.20 ± 68.15)、(271.35 ± 80.82) μm，均低于治疗前；对照组治疗前CRT为(519.45 ± 39.54) μm，治疗后1、3、6个月的CRT分别为(312.05 ± 93.55)、(317.35 ± 97.27)、(276.30 ± 73.09) μm，均低于治疗前，观察组治疗3个月CRT低于对照组(P < 0.05)。对照组治疗前眼压为(13.90 ± 2.75) mmHg，治疗后1个月、3个月、6个月眼压为(15.05 ± 2.31)、(15.25 ± 2.51)、(15.95 ± 2.42) mmHg，与治疗前相比，差异无统计学意义(P > 0.05)，观察组治疗前眼压为(14.65 ± 1.93) mmHg，治疗后1个月、3个月、6个月眼压为(15.50 ± 2.01)、(15.10 ± 2.73)、(15.05 ± 2.70) mmHg，与治疗前相比，差异无统计学意义(P > 0.05)，观察组与对照组治疗后各时间点眼压相比，差异无统计学意义。对照组注射2~4 (3.00 ± 0.65)次，观察组注射1~2 (1.25 ± 0.44)次，两组有统计学差异(P < 0.05)。两组均未发生青光眼、白内障、眼内炎等眼部并发症及全身不良反应。结论：康柏西普联合曲安奈德与单用康柏西普玻璃体腔注射均能减轻青年型CRVO患者的黄斑水肿，提高矫正视力。与单用康柏西普相比，康柏西普联合曲安奈德能减少注射次数。

关键词

康柏西普，曲安奈德，视网膜中央静脉阻塞，青年，有效性

Comparison of Clinical Efficacy of Intravitreal Injection of Conbercept Combined with Triamcinolone Acetonide and Conbercept Alone on the Treatment of CRVO in Young Adults

Gaixia Zhai*, Na Liu*, Shaopeng Wang#, Huaihua Wang, Zuofen Wang

Department of Ophthalmology, Zibo Central Hospital, Zibo Shandong

Received: Oct. 6th, 2020; accepted: Oct. 21st, 2020; published: Oct. 28th, 2020

ABSTRACT

Background: The theoretical basis for treating macular edema secondary to central retinal vein occlusion is to reduce the effect of vascular endothelial growth factor. The pathogenesis of central retinal vein occlusion in young and middle-aged people is closely related to inflammation. The research of the treatment of CRVO in young adults with intravitreal injection of conbercept combined with triamcinolone acetonide is rather little. Objective: To compare the clinical efficacy and safety of intravitreal injection of conbercept combined with triamcinolone acetonide and conbercept alone in the treatment of CRVO in young adults. Methods: A retrospective study was designed. Twenty cases (20 eyes) of young patients with central retinal vein occlusion who received intravitreal injection of conbercept combined with 1 mg triamcinolone acetonide in Ophthalmology Department of Zibo Central Hospital from June 2015 to April 2019 were selected as the observation group, and 20 cases (20 eyes) of young patients with central retinal vein occlusion who received intravitreal injection of 0.5 mg (0.05 ml) conbercep at the same time were selected as the control group. We will observe the changes of visual acuity, intraocular pressure, slit lamp, fundus examination, fundus fluorescence angiography and optical coherence tomography and the presence of systemic adverse reactions in the two groups and compare the best corrected visual acuity, central retina thickness, intraocular pressure and the number of injections in both groups before and after treatment 1 month, 3 months, 6 months. Results: There was no difference in baseline population characteristics between the two groups (P > 0.05). The best corrected visual acuity of the observation group before treatment was 65.35 ± 6.11, and the best corrected visual acuity at 1, 3 and 6 months after treatment was (75.40 ± 4.47), (76.05 ± 3.71), (75.85 ± 3.88), which were all higher than those before treatment. The best corrected visual acuity of the control group before treatment was (67.30 ± 5.99), and the best corrected visual acuity at 1, 3 and 6 months after treatment was (73.00 ± 3.84), (73.00 ± 5.53), (76.40 ± 3.25), which were all higher than those before treatment. The best corrected visual acuity in the observation group was higher than that in the control group when the treatment time is three months (P < 0.05). There was no difference in the best corrected visual acuity between the two groups when the treatment time is six months (P > 0.05). Compared with before treatment, 8 patients in the control group increased by more than 10 letters, and 12 patients increased by 5 - 10 letters and in the observation group, 11 patients improved by more than 10 letters, 7 patients improved by 5 - 10 letters, and 2 patients improved by less than 5 letters. The central retina thickness of the observation group before treatment was (518.85 ± 30.67) μm, and the central retina thickness of the observation group at 1, 3 and 6 months after treatment was (271.65 ± 75.31), (260.20 ± 68.15), (271.35 ± 80.82) μm, which were all lower than those before treatment. The central retina thickness of the control group before treatment was (519.45 ± 39.54) μm, and the central retina thickness of the control group at 1, 3 and 6 months after treatment was 312.05 ± 93.55, 317.35 ± 97.27, and 276.30 ± 73.09 μm, which were all lower than those before treatment. The central retina thickness in the observation group was lower than that in the control group when the treatment time is 3 months (P < 0.05). The intraocular pressure of the control group before treatment was (13.90 ± 2.75) mmHg, and the intraocular pressure at 1, 3 and 6 months after treatment was (15.05 ± 2.31), (15.25 ± 2.51), (15.95 ± 2.42) mmHg. Compared with before treatment, the difference was not statistically significant (P > 0.05). The intraocular pressure of the observation group before treatment was (14.65 ± 1.93) mmHg, and the intraocular pressure of the control group at 1, 3 and 6 months after treatment was (15.50 ± 2.01), (15.10 ± 2.73), (15.05 ± 2.70) mmHg. Compared with before treatment, the difference was not statistically significant (P > 0.05). There was no significant difference in intraocular pressure between the two groups after treatment (P > 0.05). The number of injections in the control group was 2 - 4 times (3.00 ± 0.65), and the number of injections in the observation group was 1 - 2 times (1.25 ± 0.44). There was a statistical difference between the two groups (P < 0.05). There is no glaucoma, cataract, endophthalmitis and other ocular complications and systemic adverse reactions occurred in the control group and the observation group. Conclusion: The treatment of intravitreal conbercept with triamcinolone acetonide and conbercept alone all can relieve the macular edema, improve the best corrected visual acuity of central retinal vein occlusion in young adults. Compared with intravitreal conbercept alone, intravitreal conbercept with triamcinolone acetonide can reduce the number of injections.

Keywords:Conbercept, Triamcinolone Acetonide, Central Retinal Vein Occlusion, Young Adults, Efficacy

Copyright © 2020 by author(s) and Hans Publishers Inc.

This work is licensed under the Creative Commons Attribution International License (CC BY 4.0).

http://creativecommons.org/licenses/by/4.0/

1. 引言

老年人视网膜中央静脉阻塞(central retinal vein occlusion CRVO)一般与高血糖、高血压、高血脂、血液流变学改变、动脉硬化等血管性疾病相关 [1]。中青年CRVO的发病机制与炎症密切相关 [2]。炎症的原因主要包括中毒、外伤、感染、眼部自身免疫性特发性视网膜血管炎症及全身免疫性疾病等 [3]。曲安奈德(triamcinolone acetonide, TA)作为一种长效糖皮质激素，在临床上被应用于多种原因引起的黄斑水肿。Penfold等 [4] 研究报道TA不仅能抑制多种炎症因子的生成，还能使细胞间的通透性降低，稳定血–视网膜屏障，具有抗新生血管及抗炎的作用。研究报道 [5] RVO患者眼内(vascular endothelial growth factor, VEGF)水平高表达。中国自主研发的抗VEGF制剂康柏西普(Conbercept)，具有亲和力强、靶点多、眼内作用时间长等特点 [6]。康柏西普对黄斑水肿的治疗短期效果明显，考虑到青年CRVO发病与炎症有关，联合TA治疗可能会起到更好的治疗效果。有研究 [7] 回顾性观察了康柏西普联合TA球内注射对青年CRVO的临床治疗效果，并指出1 mg TA球内注射的安全性优于4 mg TA球内注射，但未与单用康柏西普相比较。本研究对康柏西普组及康柏西普联合TA组在青年CRVO治疗中的临床资料进行回顾性分析，为临床上青年CRVO的治疗提供指导。

2. 资料与方法

2.1. 一般资料

采用回顾性对照研究，选择2015.06~2019.04于淄博市中心医院眼科行康柏西普联合1 mg TA玻璃体腔注射治疗的20例(20眼)青年CRVO患者，作为观察组，其中男11例(11眼)，女9例(9眼)，年龄21~36岁，平均29.40岁，病程3~14 d，平均7.75 d。选择同时间行0.5 mg (0.05 ml)康柏西普玻璃体腔注射治疗的20例(20眼)青年CRVO患者作为对照组，男10例(10眼)，女10例(10眼)，年龄22~38岁，平均30.90岁，病程3~18 d，平均8.50 d。青年CRVO诊断依据：(1) 年龄在40岁以下；(2) 视网膜4个象限出血；(3) 4个象限的静脉迂曲、扩张；(4) 弥漫性黄斑水肿，视盘水肿、棉絮斑；(5) 毛细血管无灌注等。入选标准：(1) 年龄18~40岁，从发病到我院就诊的时间为3~60天；(2) 无其他眼部疾病及手术史；(3) 术前行血压、血糖、血脂、血常规、血生化、血沉、感染四项、Torch四项等检查；(4) 缺血的黄斑水肿；(5) ETDRS BCVA超过35个字母。排除标准：(1) 青光眼、白内障、眼部炎症等眼部病史；(2) 哺乳或妊娠期妇女；(3) 使用雷珠单抗、阿柏西普等其他试验药物；(4) 患有不适宜玻璃体腔药物治疗的脑梗死、心肌梗死等全身疾病；(5) 缺血性CRVO。眼科检查包括视力、眼压、裂隙灯、眼底检查、光学相干断层扫描(optical coherence tomography, OCT)、眼底荧光血管造影(fundus fluorescein angiograph, FFA)。本研究获得淄博市中心医院伦理委员批准，所有患者均签署知情同意书。

2.2. 方法

两组患者收入院，在无菌手术室内行玻璃体腔注射。眼内注药前向患者及家属讲明术中及注药后可能出现的并发症及不良反应，并签署手术知情同意书。注药前3 d 0.5%左氧氟沙星眼水4次/天点双眼，以预防眼内感染。术前用5 g∙L−1盐酸丙美卡因滴眼点术眼，并以5 g∙L−1碘伏溶液冲洗结膜囊。对照组：于距角巩膜缘3.5~4.0 mm颞下方睫状体平坦部垂直进针入玻璃体内，注入康柏西普0.05 mL (0.5 mg；成都康弘生物科技有限公司)，无菌棉签压迫穿刺点，指测眼压正常，结膜下注射阿米卡星20 mg、地塞米松2.5 mg，无菌敷料包扎。观察组：康柏西普0.05 mL (0.5 mg) + 曲安奈德1 mg (0.025 ml)玻璃体内注射。手术中弃除TA上清液，减少了赋形剂对视网膜功能和形态的影响。

术后第二天观察眼部无感染征、眼压正常出院，出院后给予0.5%左氧氟沙星滴眼液一天四次点眼。第一次随访时间是术后1周，以后每月随访一次，所有患者均完成6个月的随访时间。每次复查均行最佳矫正视力、眼底、眼压、OCT、眼部及全身不良反应发生情况。必要时复查FFA，若复查发现黄斑水肿，则按需玻璃体腔再次注入药物。

2.3. 观察指标

治疗前后的最佳矫正视力、黄斑中心视网膜厚度、眼压，末次随访时注射次数及并发症发生情况。

2.4. 统计学分析

采用SPSS17.0统计学软件分析，所有数据以均数 ± 标准差( x ¯ ± s)表示，同组治疗前后的BCVA、CRT、眼压应用单因素方差分析，两组各随访时间点的BCVA、CRT、眼压、末次随访时的注射次数等组间比较用独立样本t检验，P < 0.05为差异有统计学意义。

3. 结果

3.1. 两组患者人口基线特征

两组患者基线年龄、病程、眼压、BCVA及CRT比较，差异均无统计学意义。见表1。

Table 1. Comparison of population baseline characteristics between the two groups

表1. 两组人口基线特征组间比较( x ¯ ± s, n = 20)

3.2. 最佳矫正视力

两组治疗后各时间点BCVA均较同组治疗前基线提高(F对照 = 12.41，P对照 = 0.00，F观察 = 25.29，P观察 = 0.00)；同组治疗后各时间点BCVA差异均无统计学意义(P对照 = 0.07，P观察 = 0.90)；观察组治疗3个月BCVA高于对照组(P < 0.05)，观察组治疗1个月、6个月BCVA与对照组比较差异无统计学意义(P > 0.05)；6个月时，对照组较基线提高>10个字母8例，提高5~10个字母12例，观察组较基线提高>10个字母11例，提高5~10个字母7例，提高<5个字母2例。不同随访时间组间BCVA比较结果见表2。

Table 2. comparison of BCVA at different time points between the two groups after treatment

表2. 两组治疗后不同时间点BCVA比较( x ¯ ± s 字母数)

3.3. 黄斑中心视网膜厚度

两组治疗后各时间点CRT均较同组治疗前基线变薄(F对照 = 38.74，P对照 = 0.00，F观察 = 71.02，P观察 = 0.00)，但同组治疗后各时间点差异无统计学意义(P对照 = 0.24，P观察 = 0.85)；观察组治疗3个月CRT低于对照组(P < 0.05)，观察组治疗1个月、6个月CRT与对照组比较差异无统计学意义(P > 0.05)。不同随访时间组间CRT比较结果见表3。

Table 3. Comparison of CRT at different time points between the two groups after treatment

表3. 两组治疗后不同时间点CRT比较( x ¯ ± s μm)

3.4. 眼压

对照组2例，观察组4例，术后一过性眼压升高，最高达26 mmHg，未用药物，术后3天正常；观察组1例，第一次玻璃体腔注药后眼压达30 mmHg，给予降眼压药物，术后1周降至正常；但同组治疗后1个月、3个月、6个月眼压与基线相比，差异均无统计学意义(F对照 = 2.31，P对照 = 0.08，F观察 = 0.43，P观察 = 0.73)；观察组与对照组各时间点眼压相比，差异均无统计学意义，(P > 0.05)。不同随访时间组间眼压比较结果见表4。

Table 4. Comparison of intraocular pressure at different time points between the two groups after treatment

表4. 两组治疗后不同时间点眼压比较( x ¯ ± s mmHg)

3.5. 注射次数

对照组注射2~4 (3.00 ± 0.65)次，观察组注射1~2 (1.25 ± 0.44)次，与对照组比较，注射次数减少，有统计学差异(t = 9.95, P = 0.00)。

3.6. 并发症

对照组与观察组均未发生青光眼、白内障、眼内炎等眼部并发症及全身不良反应。

4. 讨论

CRVO患者视力损害的主要因素是黄斑水肿。研究报道 [5] RVO患者眼内VEGF水平高表达。CRVO继发黄斑水肿治疗的理论基础是降低VEGF的作用。近年来，抗VEGF药物被广泛应用于治疗视网膜静脉阻塞、湿性年龄相关性黄斑变性、糖尿病性视网膜病变等血管性疾病。抗VEGF药物玻璃体腔注射短期临床疗效明显、并发症少，但黄斑水肿易复发，需要重复注射 [8]。康柏西普是一种融合蛋白，通过多靶点对VEGF与受体的结合起阻断作用，从而抑制内皮细胞增殖和新生血管的生长 [9]。康柏西普玻璃体腔注射治疗继发性黄斑水肿短期效果明显 [10]。

近年来中青年CRVO发病明显增加，除高血压、高血糖等危险因素以外，更多原因受到重视，如高同型半胱氨酸血症、抗磷脂抗体等，曾报道三型混合型冷球蛋白血症与年轻CRVO相关 [11]。中青年CRVO的发病机制与炎症密切相关 [2]。一般认为，青年型CRVO导致视力损害的主要原因是视网膜血管炎症所致黄斑水肿。TA不仅能抑制多种炎症因子的生成，还能使细胞间的通透性降低，稳定血-视网膜屏障，具有抗新生血管及抗炎的作用 [4]。高眼压是玻璃体腔注射TA常见并发症，此外还有眼内炎、并发性白内障、视网膜脱离等 [12]。TA小剂量玻璃体腔注射，对黄斑水肿的治疗安全性较高 [13]。研究报道 [14] 康柏西普与TA相比，在对CRVO继发黄斑水肿的治疗上更加安全可靠。

联合治疗在临床上逐渐被广泛应用。本研究比较了康柏西普(Conbercept)联合曲安奈与单用康柏西普治疗青年CRVO的临床疗效及安全性。结果显示：两组治疗后各时间点BCVA及CRT与治疗前基线相比，有显著统计学差异，与研究 [15] 报道的康柏西普可减轻RVO继发的黄斑水肿，提高矫正视力相一致。观察组治疗3个月BCVA高于对照组，察组治疗3个月CRT低于对照组(P < 0.05)，这可能与对照组黄斑水肿复发有关。TA被用来治疗多种原因引起的黄斑水肿，已有多年，但仍有一些争议，主要是青光眼及白内障等。但本研究中两组治疗后的眼压与治疗前相比无差异，仅发现对照组2例，观察组4例，术后一过性眼压升高，最高达26 mmHg，未用药物，术后3天正常；观察组1例，第一次玻璃体腔注药后眼压达30 mmHg，给予降眼压药物，术后1周降至正常，可能与本研究联合采用TA剂量小有关。手术中弃除TA上清液，减少了赋形剂对视网膜功能和形态的影响。本研究对照组与观察组经过6个月随访期，均未发生青光眼、白内障、眼内炎等眼部并发症及全身不良反应。末次随访时，观察组与对照组比较，注射次数显著减少(P < 0.05)，可能的原因是，康柏西普的主要作用是抗VEGF，TA的主要作用是抗炎，联合治疗对青年CRVO有互补作用；另一方面，可能与曲安奈德眼内持续作用时间长有关。但6个月时，组间BCVA及CRT比较并未发现统计学差异。Fan等 [16] 前瞻性比较了雷珠单抗联合1 mg TA与单用雷珠单抗治疗CRVO继发黄斑水肿的疗效，研究结束组间BCVA及CRT无统计学差异，本研究结果与此一致。本研究显示：青年CRVO的发病越来越年轻化，部分视力损伤较轻，无全身性疾病，各种实验室检查无异常。

5. 结论

综上，本研究结果表明，康柏西普联合1 mg TA玻璃体腔注射能缓解青年型CRVO患者的黄斑水肿，提高矫正视力，与单用抗VEGF药物康柏西普相比，减少注射次数，缓解患者经济压力。本研究的局限性主要有样本量少，观察时间短，采用回顾性研究。因此长期疗效和并发症尚需要长期、大样本前瞻研究。

文章引用

翟改霞,刘 娜,王少鹏,王怀华,王作芬. 玻璃体腔注射康柏西普联合曲安奈德与单用康柏西普治疗青年CRVO的临床疗效比较
Comparison of Clinical Efficacy of Intravitreal Injection of Conbercept Combined with Triamcinolone Acetonide and Conbercept Alone on the Treatment of CRVO in Young Adults[J]. 临床医学进展, 2020, 10(10): 2393-2400. https://doi.org/10.12677/ACM.2020.1010361

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    17. NOTES

    *第一作者。

    #通讯作者。

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