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ENGLISH ABSTRACT
单独雷珠单抗玻璃体内注射与联合激光疗法治疗DME疗效和安全性meta分析
纪东晓
靳英辉
任相颖
李绪辉
黄桥
胡馨
赵博
金海鹰
作者及单位信息
·
DOI： 10.3760/cma.j.cn115989-20220622-00291
Efficacy and safety of intravitreal ranibizumab alone and combined laser therapy for the treatment of DME: a meta-analysis
Ji Dongxiao
Jin Yinghui
Ren Xiangying
Li Xuhui
Huang Qiao
Hu Xin
Zhao Bo
Jin Haiying
Authors Info & Affiliations
Ji Dongxiao
Department of Ophthalmology, Huaihe Hospital of Henan University, Kaifeng 475000, China
Jin Yinghui
Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan 430071, China
Ren Xiangying
Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan 430071, China
Li Xuhui
Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan 430071, China
Huang Qiao
Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan 430071, China
Hu Xin
Department of Ophthalmology, Huaihe Hospital of Henan University, Kaifeng 475000, China
Zhao Bo
Department of Ophthalmology, Huaihe Hospital of Henan University, Kaifeng 475000, China
Jin Haiying
Department of Ophthalmology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200040, China
·
DOI： 10.3760/cma.j.cn115989-20220622-00291
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摘要

目的评估玻璃体内注射雷珠单抗联合激光光凝(IVR＋Laser)与单用玻璃体内注射雷珠单抗(IVR)治疗糖尿病性黄斑水肿(DME)的疗效和安全性。

方法采用meta分析方法，检索有关IVR＋Laser疗法与单用IVR治疗DME的随机对照试验(RCT)文献进行二次分析，检索文献范围包括Cochrane Library、PubMed、EMbase、Web of Science、中国生物医学文献数据库、中国知网、维普网、万方数据，检索时间均从建库起至2022年4月。由2位研究员按照纳入和排除标准独立进行文献筛选、资料提取、质量评价并交叉核对后，采用RevMan5.4.1软件进行meta分析，比较不同方法治疗后最佳矫正视力(BCVA)、黄斑中心凹厚度(CMT)、平均注射次数和不良事件的差异。

结果共纳入12篇RCT，共1 695眼。meta分析结果显示，随访结束时，IVR＋Laser组患者BCVA和CMT改善情况优于IVR组，2个组BCVA变化和CMT变化差异均有统计学意义(WMD＝－0.66，95%CI：－1.11~－0.21，P<0.01；WMD＝－5.05，95%CI：－9.21~－0.89，P＝0.02)。随访结束时，IVR＋Laser组平均注射次数明显少于IVR组，差异有统计学意义(WMD＝－1.16，95%CI：－2.07~－0.25，P＝0.01)。2个组不良事件发生率比较，差异均无统计学意义(均P>0.05)。

结论IVR＋Laser联合治疗DME疗效优于单独IVR治疗，安全性与单独IVR治疗相当，且平均注射次数较少。

黄斑水肿;糖尿病并发症;雷珠单抗;激光疗法;血管内皮生长因子;光凝;meta分析
ABSTRACT

ObjectiveTo evaluate the efficacy and safety of intravitreal ranibizumab combined with laser (IVR+ Laser) and the intravitreal ranibizumab (IVR) monotherapy for the treatment of diabetic macular edema (DME).

MethodsA meta-analysis was conducted on randomized controlled trial (RCT) literature related to IVR+ Laser therapy and IVR alone for DME.Databases including Cochrane Library, PubMed, EMbase, Web of Science, SinoMed, CNKI, VIP and WanFang Data were searched from their inception to April 2022.Literature screening, data extraction, quality evaluation and cross-checking were conducted independently by two researchers according to inclusion and exclusion criteria.Then a meta-analysis was conducted using RevMan 5.4.1 software.The two therapies were compared in terms of best corrected visual acuity (BCVA), central macular thickness (CMT), mean number of injections and adverse events.

ResultsTwelve RCTs involving 1 695 eyes were included in the study.Meta-analysis showed that at the end of follow-up, IVR+ Laser demonstrated better improvement in BCVA and CMT than IVR alone, and there were significant differences in the changes in BCVA and CMT between the two groups (weighted mean difference[WMD]=-0.66, 95% confidence interval[CI]: -1.11--0.21, P<0.01; WMD=-5.05, 95%CI: -9.21--0.89, P=0.02).IVR+ Laser required significantly fewer injections than IVR alone (WMD=-1.16, 95%CI: -2.07--0.25, P=0.01).There were no significant differences in the adverse events incidence between the two therapies (all at P>0.05).

ConclusionsThe safety of IVR+ Laser is comparable to IVR alone, and it requires fewer injections for the treatment of DME.

Macular edema;Diabetes complications;Ranibizumab;Laser therapy;Vascular endothelial growth factors;Light coagulation;Meta-analysis
Zhao Bo, Email: mocdef.nabuyilaoboahzih;
Jin Haiying, Email: mocdef.3ab6160271961931
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引用本文

纪东晓,靳英辉,任相颖,等. 单独雷珠单抗玻璃体内注射与联合激光疗法治疗DME疗效和安全性meta分析[J]. 中华实验眼科杂志,2023,41(10)：1004-1010.

DOI:10.3760/cma.j.cn115989-20220622-00291

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根据2021年IDF Diabetes Atlas(第10版)报告[ 1 ]，全球有5.37亿糖尿病患者，我国糖尿病患者人数已达1.4亿。糖尿病视网膜病变(diabetic retinopathy，DR)是人体长期处于高血糖状态引起的一种眼部疾病，是糖尿病患者常见的眼部并发症之一[ 2 ]。糖尿病性黄斑水肿(diabetic macular edema，DME)由于毛细血管渗漏或毛细血管闭塞造成黄斑部视网膜通透性增加或黄斑部缺血，如果未及时治疗，会导致DR患者视力严重受损[ 3 ]。研究发现，DME患者体内血管内皮生长因子(vascular endothelial growth factor，VEGF)水平升高，可以诱导新生血管形成，增加血管通透性，损害患者视力[ 4 ]。激光可以使视网膜形成瘢痕，需氧量减少，刺激新生血管形成的VEGF也相应减少。在过去的几十年中，激光一直是治疗DME的主要方法。然而，激光治疗虽然可以延缓DME患者疾病的进展，但并不能有效改善患者视力，并且传统激光的短时高温效应还会造成永久性视网膜瘢痕，导致DME患者视觉功能受损[ 5 , 6 ]。2020年亚洲人群DME专家小组制订的共识指南中指出，激光已不再被推荐作为DME的一线治疗，抗VEGF治疗已成为新的一线临床治疗方案[ 7 ]。已有纳入多篇随机对照试验(randomized controlled trial，RCT)的高质量系统评价证实玻璃体内注射抗VEGF类药物，如雷珠单抗治疗DME可以获得良好的视觉效果[ 8 ]，但抗VEGF类药物需要反复进行眼内注射，可能发生眼内炎和视网膜脱离等并发症，且治疗周期较长，患者依从性较差，治疗负担较重[ 9 ]。因此，临床上需要一种注射次数更少并可有效改善和维持视力的DME替代疗法。目前在临床上主要使用抗VEGF类药物治疗DME，是否同时使用激光辅助治疗仍存在争议。既往多项大型RCT均表明，玻璃体内注射雷珠单抗联合激光光凝(intravitreal ranibizumab combined with laser，IVR＋Laser)治疗改善DME患者的视觉情况优于单纯激光治疗[ 10 , 11 ]。但尚无系统评价分析IVR＋Laser治疗DME的效果是否优于或至少相当于单独IVR治疗。本研究采用meta分析方法评价IVR＋Laser与单独IVR治疗DME的疗效和安全性，以期为DME临床治疗方法的选择提供参考。
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备注信息
A
赵博，Email：mocdef.nabuyilaoboahzih；
B
金海鹰，Email：mocdef.3ab6160271961931
C

纪东晓：实施研究、采集数据、分析/解释数据、起草文章；靳英辉、赵博：设计试验、审阅及修改文章、定稿；任相颖：采集数据、分析/解释数据、审阅及修改文章；李绪辉：分析/解释数据、统计分析、指导文章；黄桥：统计分析、对文章的知识性内容作批评性审阅；胡馨：采集数据、分析/解释数据；金海鹰：审阅及修改文章、定稿

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