临床研究
ENGLISH ABSTRACT
递法明片对糖尿病视网膜病变全视网膜光凝后视网膜功能恢复的促进作用
张茉莉
魏文斌
田蓓
作者及单位信息
·
DOI: 10.3760/cma.j.cn115989-20210325-00205
Promoting effects of Difrarel ® on retinal function following panretinal photocoagulation in diabetic retinopathy
Zhang Moli
Wei Wenbin
Tian Bei
Authors Info & Affiliations
Zhang Moli
Department of Ophthalmology, Beijing Daxing District People's Hospital, Beijing 102600, China
Wei Wenbin
Beijing Tongren Eye Center, Beijing Key Laboratory of Intraocular Tumor Diagnosis and Treatment, Beijing Ophthalmology & Visual Sciences Key Lab, Medical Artificial Intelligence Research and Verification Key Laboratory of the Ministry of Industry and Information Technology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
Tian Bei
Beijing Tongren Eye Center, Beijing Key Laboratory of Intraocular Tumor Diagnosis and Treatment, Beijing Ophthalmology & Visual Sciences Key Lab, Medical Artificial Intelligence Research and Verification Key Laboratory of the Ministry of Industry and Information Technology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
·
DOI: 10.3760/cma.j.cn115989-20210325-00205
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摘要

目的评估递法明片对全视网膜光凝(PRP)术后视网膜功能损伤修复的促进作用。

方法采用非随机对照研究方法,于2014年12月至2020年2月在北京同仁眼科中心和北京市大兴区人民医院纳入非增生性糖尿病视网膜病变(NPDR)患者108例108眼。根据患者自愿原则将患者分为2个组,其中PRP+递法明组患者56例56眼,于PRP后口服递法明片;PRP组患者52例52眼,未服用递法明片。于PRP治疗前及治疗后1 d及1、3、6、12个月对患者进行随访,采用国际视力表检查患眼视力;采用Humphrey视野计检查30°~60°环形视野并采用RETLscan系统记录多焦视网膜电图;采用光相干断层扫描仪检测黄斑中心凹厚度(CMT);分别于PRP后6个月、12个月采用荧光素眼底血管造影观察眼底新生血管情况。

结果PRP+递法明组末次随访时视力治疗有效率为57.14%(32/56),明显高于PRP组的32.69%(17/52),差异有统计学意义( χ 2=3.56, P<0.05)。2个组治疗前后各时间点视野平均阈值敏感度总体比较差异均有统计学意义( F 分组=4.77, P<0.05; F 时间=6.51, P<0.05),2个组治疗后视野平均阈值敏感度均较治疗前降低,差异均有统计学意义(均 P<0.05);PRP+递法明组治疗后3、6、12个月视野平均阈值敏感度值均高于PRP组,差异均有统计学意义(均 P<0.05)。PRP+递法明组第3、4、5环的P1波振幅密度高于PRP组,差异均有统计学意义(均 P<0.05)。2个组治疗前后不同时间点CMT总体比较差异均无统计学意义( F 分组=3.57, P>0.05; F 时间=1.23, P>0.05)。治疗后12个月,所有患眼均未出现视网膜新生血管及无灌注区。

结论口服递法明片可促进NPDR患眼PRP术后视网膜功能的恢复。

糖尿病视网膜病变/治疗;激光光凝术;术后并发症;视网膜/生理功能;花青素
ABSTRACT

ObjectiveTo investigate the promoting effect of Difrarel ® on retinal function following panretinal photocoagulation (PRP) in the eyes with diabetic retinopathy.

MethodsA non-randomized controlled study was performed.A total of 108 eyes of 108 patients with non-proliferative diabetic retinopathy (NPDR) were enrolled in Tongren Ophthalmology Center and Beijing Daxing District People's Hospital from December 2014 to February 2020.The patients were divided into PRP group and PRP+ Difrarel ® group according to different therapies under patients' selection.Difrarel ® was orally administered after PRP in 56 patients of PRP+ Difrarel ® group, and only PRP was given in 52 patients of PRP group.The visual acuity, 30°~60° circular visual field and multifocal electroretinogram were examined before and 1 day, 1 month, 3 months, 6 months, 12 months after PRP.The central macular thickness (CMT) was measured by optical coherence tomography, and fundus neovascularization was observed by fluorescein fundus angiography at 6 and 12 months after PRP.The study protocol was approved by an Ethics Committee of Beijing Daxing District People's Hospital (No.2021-F4).

ResultsVisual improvement rate was 57.14% (32/56) and 32.69% (17/52) in PRP+ Difrarel ® group and PRP group at the end of following-up, respectively, showing a significant difference between two groups ( χ 2=3.56, P<0.05). The visual field mean sensitivity was significantly different at different time points in two groups ( F group=4.77, P<0.05; F time=6.51, P<0.05), and was lower after PRP than those before treatment in both groups (both at P<0.05), and was significantly higher in PRP+ Difrarel ® group than PRP group at 3, 6, 12 months after PRP (all at P<0.05). The P1 amplitude density in 3 to 5 rings in PRP+ Difrarel ® group were higher than those in PRP group, and the differences were statistically significant (all at P<0.05). There was no significant difference in CMT between the two groups at different time points ( F group=3.57, P>0.05; F time=1.23, P>0.05). No new blood vessels and non-perfusion area were found in both groups.

ConclusionsOral Difrarel ® can improve retinal function after PRP in the eyes with NPDR.

Diabetic retinopathy/therapy;Laser photocoagulation;Postoperative complications;Retina/physiological function;Anthocyanin
Wei Wenbin, Email: mocdef.3ab61rtnibnewiew
引用本文

张茉莉,魏文斌,田蓓. 递法明片对糖尿病视网膜病变全视网膜光凝后视网膜功能恢复的促进作用[J]. 中华实验眼科杂志,2022,40(03):247-252.

DOI:10.3760/cma.j.cn115989-20210325-00205

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递法明片的主要成分为花青素,其具有强大的抗氧化作用,能清除体内、体外多种氧自由基,包括超氧阴离子、羟自由基等,具有维护毛细血管正常的通透性、抑制醛糖还原酶、提高视紫红质的再生速率等药理作用,对视网膜微循环及淋巴系统有明确的灌注作用 [ 1 , 2 , 3 ]。递法明片被广泛用于改善糖尿病视网膜病变(diabetic retinopathy,DR)患者的视功能、青少年近视、视网膜色素变性、视网膜光损伤的修复等眼部疾病的临床治疗,并已取得良好的效果 [ 4 , 5 , 6 , 7 , 8 ]。DR是一种慢性进展性微血管病变,高血糖可导致视网膜色素上皮屏障损害、外层视网膜缺血和炎症反应,缺血、缺氧导致慢性视网膜炎症和血管内皮生长因子(vascular endothelial growth factor,VEGF)的高表达,促进DR的发生和发展。以新生血管为标志,可将DR分为非增生性糖尿病视网膜病变(nonproliferative diabetic retinopathy,NPDR)和增生性糖尿病视网膜病变(proliferative diabetic retinopathy,PDR)。PDR是糖尿病严重并发症之一,亦是主要致盲眼病之一,其主要治疗方法是玻璃体切割术,但术后视力的恢复非常有限。目前对于DR治疗的共识是在NPDR期进行积极治疗,预防PDR发生,全视网膜光凝(panretinal photocoagulation,PRP)是防止NPDR向PDR发展的主要方法,可有效减少缺血、缺氧诱导的血管生成因子的合成和释放,延缓疾病的发展,降低视力严重损害的风险 [ 9 , 10 ]。然而,PRP治疗的同时可引发黄斑水肿、脉络膜渗漏、视野缺损及暗适应下降等并发症 [ 11 ]。本研究拟观察递法明片对视网膜激光光凝所致视网膜损伤的影响,以期建立减少PRP不良反应的治疗方案。
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备注信息
A
魏文斌,Email: mocdef.3ab61rtnibnewiew
B

张茉莉:参与试验设计、研究实施、数据采集及文章撰写;魏文斌:参与选题和研究设计、研究实施、数据分析、论文智力性内容修改和定稿;田蓓:参与试验设计,研究实施及对文章修改

C
所有作者均声明不存在利益冲突
D
首都卫生发展科研专项项目 (首发2020-1-2052)
北京市科委科技计划项目 (Z201100005520045、Z181100001818003)
北京市医院管理局"登峰"人才培养计划项目 (DFL20150201)
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