DEX-I联合雷珠单抗治疗视网膜血管性疾病继发黄斑水肿的疗效观察

doi:10.11958/20260079

天津医药 ›› 2026, Vol. 54 ›› Issue (6): 647-652.doi: 10.11958/20260079

DEX-I联合雷珠单抗治疗视网膜血管性疾病继发黄斑水肿的疗效观察

许正杰(), 李田, 畅立斌^△()

北京京煤集团总医院眼科（邮编102300）

收稿日期:2026-01-06 修回日期:2026-04-09 出版日期:2026-06-15 发布日期:2026-06-15
通讯作者: ^△E-mail：mdchang@yeah.net
作者简介:许正杰（1988），男，主治医师，主要从事眼底病、白内障方面研究。E-mail：13522737169@163.com
基金资助:
北京市卫生健康委科研课题计划项目(202101103)

Clinical efficacy of DEX-I combined with ranibizumab for macular edema secondary to retinal vascular diseases

XU Zhengjie(), LI Tian, CHANG Libin^△()

Department of Ophthalmology, Beijing Jingmei Group General Hospital, Beijing 102300, China

Received:2026-01-06 Revised:2026-04-09 Published:2026-06-15 Online:2026-06-15
Contact: ^△E-mail：mdchang@yeah.net

许正杰, 李田, 畅立斌. DEX-I联合雷珠单抗治疗视网膜血管性疾病继发黄斑水肿的疗效观察[J]. 天津医药, 2026, 54(6): 647-652.

XU Zhengjie, LI Tian, CHANG Libin. Clinical efficacy of DEX-I combined with ranibizumab for macular edema secondary to retinal vascular diseases[J]. Tianjin Medical Journal, 2026, 54(6): 647-652.

摘要/Abstract

摘要：

目的探讨地塞米松玻璃体内植入剂（DEX-I）联合雷珠单抗治疗视网膜血管性疾病继发黄斑水肿（ME）的临床疗效。方法回顾性分析116例糖尿病性视网膜病变（DR）或视网膜静脉阻塞（RVO）继发ME患者的资料，按治疗方法不同分为DEX-I组（39例，玻璃体腔注入DEX-I 0.7 mg，单次治疗后按需给药）、雷珠单抗组（37例，玻璃体腔注入雷珠单抗0.05 mL，每月1次，连续3个月后按需给药）和联合组（40例，玻璃体腔注射雷珠单抗0.05 mL，1周后玻璃体腔注入DEX-I 0.7 mg，单次治疗后按需给药），比较3组黄斑中心凹视网膜厚度（CMT）、最佳矫正视力（BCVA）、眼压（IOP）及房水微小RNA（miR）-146a、miR-377-3p、血管内皮生长因子（VEGF）水平，并统计不良事件发生情况及注射次数。结果联合组治疗1、2、3、6个月CMT均低于DEX-I组和雷珠单抗组（P<0.05），DEX-I组治疗1、2个月CMT均低于雷珠单抗组（P<0.05）。联合组治疗1、2、3、6个月BCVA[最小分辨角对数（LogMAR）]均低于DEX-I组和雷珠单抗组（P<0.05），3组治疗1、2、3、6个月IOP比较差异无统计学意义（P>0.05）。联合组治疗6个月后的房水miR-146a、miR-377-3p水平均高于DEX-I组和雷珠单抗组，VEGF水平低于DEX-I组和雷珠单抗组（P<0.05），3组不良事件发生率比较差异无统计学意义（P>0.05）。联合组、雷珠单抗组注射次数均多于DEX-I组（P<0.05）。结论 DEX-I联合雷珠单抗可减少视网膜血管性疾病继发ME患者CMT，提高视力及房水miR-146a、miR-377-3p水平，抑制VEGF水平，且安全性可控。

关键词: 黄斑水肿, 糖尿病视网膜病变, 视网膜静脉闭塞, 地塞米松, 地塞米松玻璃体内植入剂, 雷珠单抗

Abstract:

Objective To explore the clinical efficacy of dexamethasone intravitreal implant (DEX-I) combined with ranibizumab in the treatment of macular edema (ME) secondary to retinal vascular diseases. Methods The data of 116 patients with ME secondary to diabetic retinopathy (DR) or retinal vein occlusion (RVO) were retrospectively analyzed. Based on different treatment methods, patients were assigned to the DEX-I group (n=39, 0.7 mg of DEX-I was injected into the vitreous cavity, with subsequent dosing as needed after a single treatment), the ranibizumab group (n=37, 0.05 mL of ranibizumab was injected into the vitreous cavity, once a month for 3 consecutive months, followed by dosing as needed), and the combined group (n=40, 0.05 mL of ranibizumab was injected into the vitreous cavity, followed by 0.7 mg of DEX-I injected into the vitreous cavity 1 week later, with subsequent dosing as needed after a single treatment). The central macular thickness (CMT), best corrected visual acuity (BCVA), intraocular pressure (IOP), and the levels of miR-146a, miR-377-3p and vascular endothelial growth factor (VEGF) in aqueous humor were compared between the three groups. Adverse events and the number of injections were recorded. Results After 1, 2, 3 and 6 months of treatment, CMT was lower in the combined group than that in the DEX-I group and the ranibizumab groups (P<0.05)，and CMT of the DEX-I group was smaller than that of the ranibizumab group after 1 and 2 months of treatment (P<0.05). After 1, 2, 3 and 6 months of treatment, the BCVA was lower in the combined group than that of the DEX-I group and the ranibizumab group (P<0.05), and there was no significant difference in IOP between the three groups (P>0.05). After 6 months of treatment, the combined group exhibited higher levels of miR-146a and miR-377-3p and lower VEGF level in aqueous humor compared to those of the DEX-I group and the ranibizumab group (P<0.05). There was no significant difference in incidence of adverse events between the three groups (P>0.05). The number of injections was higher in the combined group and the ranibizumab group than that in the DEX-I group (P<0.05). Conclusion DEX-I combined with ranibizumab can reduce CMT in patients with ME secondary to retinal vascular diseases, improve visual acuity and levels of miR-146a and miR-377-3p in the aqueous humor, inhibit VEGF levels, and the safety is controllable.

Key words: macular edema, diabetic retinopathy, retinal vein occlusion, dexamethasone, dexamethasone intravitreal implant, ranibizumab

中图分类号:

R774.5

图/表 5

参考文献 24

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组别		n	性别（男/女）		年龄/岁	病程/月
DEX-I组		39	21（53.85）/18（46.15）		61.23±7.14	4.46±0.64
雷珠单抗组		37	21（56.76）/16（43.24）		60.57±6.42	4.62±0.68
联合组		40	23（57.50）/17（42.50）		61.55±7.18	4.83±0.71
χ²或F			0.119		0.199	2.841
组别	眼别（左眼/右眼）			视网膜血管性疾病（DR/RVO）
DEX-I组	23（58.97）/16（41.03）			26（66.67）/13（33.33）
雷珠单抗组	20（54.05）/17（45.95）			24（64.86）/13（35.14）
联合组	21（52.50）/19（47.50）			28（70.00）/12（30.00）
χ²	0.362			0.239

组别		n	性别（男/女）		年龄/岁	病程/月
DEX-I组		39	21（53.85）/18（46.15）		61.23±7.14	4.46±0.64
雷珠单抗组		37	21（56.76）/16（43.24）		60.57±6.42	4.62±0.68
联合组		40	23（57.50）/17（42.50）		61.55±7.18	4.83±0.71
χ²或F			0.119		0.199	2.841
组别	眼别（左眼/右眼）			视网膜血管性疾病（DR/RVO）
DEX-I组	23（58.97）/16（41.03）			26（66.67）/13（33.33）
雷珠单抗组	20（54.05）/17（45.95）			24（64.86）/13（35.14）
联合组	21（52.50）/19（47.50）			28（70.00）/12（30.00）
χ²	0.362			0.239

组别	n	治疗前	治疗1个月	治疗2个月	治疗3个月	治疗6个月
DEX-I组	39	451.62±33.46	325.21±24.74^A	298.13±22.25^AB	310.26±19.18^ABC	315.79±21.62^ABC
雷珠单抗组	37	453.08±33.81	340.19±27.13^Aa	315.05±24.18^ABa	318.65±21.45^AB	320.46±22.59^AB
联合组	40	452.10±33.39	306.05±20.55^Aab	275.63±18.22^ABab	285.50±16.60^ABCab	270.53±14.80^ABDab
F_组间/F_时间/F_交互		92.272^＊＊/842.68^＊＊/7.040^＊＊

组别	n	治疗前	治疗1个月	治疗2个月	治疗3个月	治疗6个月
DEX-I组	39	451.62±33.46	325.21±24.74^A	298.13±22.25^AB	310.26±19.18^ABC	315.79±21.62^ABC
雷珠单抗组	37	453.08±33.81	340.19±27.13^Aa	315.05±24.18^ABa	318.65±21.45^AB	320.46±22.59^AB
联合组	40	452.10±33.39	306.05±20.55^Aab	275.63±18.22^ABab	285.50±16.60^ABCab	270.53±14.80^ABDab
F_组间/F_时间/F_交互		92.272^＊＊/842.68^＊＊/7.040^＊＊

组别	n	治疗前	治疗1个月	治疗2个月	治疗3个月	治疗6个月
DEX-I组	39	0.77±0.23	0.51±0.15^A	0.53±0.15^A	0.48±0.12^A	0.41±0.10^ABCD
雷珠单抗组	37	0.81±0.26	0.54±0.17^A	0.56±0.18^A	0.53±0.16^A	0.44±0.13^ABCD
联合组	40	0.78±0.24	0.43±0.11^Aab	0.37±0.10^ABab	0.32±0.07^ABCab	0.26±0.04^ABCDab
F_组间/F_时间/F_交互		32.142^＊＊/131.794^＊＊/4.414^＊＊

DEX-I联合雷珠单抗治疗视网膜血管性疾病继发黄斑水肿的疗效观察

Clinical efficacy of DEX-I combined with ranibizumab for macular edema secondary to retinal vascular diseases

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组别	n	治疗前	治疗1个月	治疗2个月	治疗3个月	治疗6个月
DEX-I组	39	15.41±3.36	17.02±3.55^A	16.87±3.44	16.70±3.34	16.50±3.35
雷珠单抗组	37	15.22±3.28	15.83±3.36	15.87±3.35	15.50±3.31	15.38±3.26
联合组	40	14.91±3.15	16.03±3.35	16.22±3.39	15.95±3.33	15.95±3.28
F_组间/F_时间/F_交互		2.104/2.904^＊/0.254

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组别	n	miR-146a			miR-377-3p			VEGF/（ng/L）
组别	n	治疗前	治疗6个月	t	治疗前	治疗6个月	t	治疗前	治疗6个月	t
DEX-I组	39	1.00±0.24	2.81±0.58	20.158^＊＊	1.00±0.13	1.39±0.52	5.301^＊＊	418.69±35.41	135.58±16.79	45.593^＊＊
雷珠单抗组	37	0.97±0.22	2.65±0.53	17.013^＊＊	0.97±0.11	1.33±0.43	3.787^＊＊	421.50±36.04	129.77±14.75	46.371^＊＊
联合组	40	1.03±0.27	3.99±0.83^ab	25.396^＊＊	0.94±0.16	2.17±0.76^ab	12.874^＊＊	422.01±36.23	103.90±10.23^ab	50.355^＊＊
F		0.579	47.429^＊＊		0.934	25.341^＊＊		0.097	56.122^＊＊

组别	n	miR-146a			miR-377-3p			VEGF/（ng/L）
组别	n	治疗前	治疗6个月	t	治疗前	治疗6个月	t	治疗前	治疗6个月	t
DEX-I组	39	1.00±0.24	2.81±0.58	20.158^＊＊	1.00±0.13	1.39±0.52	5.301^＊＊	418.69±35.41	135.58±16.79	45.593^＊＊
雷珠单抗组	37	0.97±0.22	2.65±0.53	17.013^＊＊	0.97±0.11	1.33±0.43	3.787^＊＊	421.50±36.04	129.77±14.75	46.371^＊＊
联合组	40	1.03±0.27	3.99±0.83^ab	25.396^＊＊	0.94±0.16	2.17±0.76^ab	12.874^＊＊	422.01±36.23	103.90±10.23^ab	50.355^＊＊
F		0.579	47.429^＊＊		0.934	25.341^＊＊		0.097	56.122^＊＊