临床研究
ENGLISH ABSTRACT
康柏西普辅助玻璃体切割术治疗增生性糖尿病视网膜病变的Meta分析
司霞
孙楚枫
陈月
冯婉玉
封宇飞
作者及单位信息
·
DOI: 10.3760/cma.j.cn115989-20200715-00498
A Meta-analysis of the effects of intravitreal conbercept as an adjunct before vitrectomy in proliferative diabetic retinopathy
Si Xia
Sun Chufeng
Chen Yue
Feng Wanyu
Feng Yufei
Authors Info & Affiliations
Si Xia
Department of Pharmacy, Peking University People's Hospital, Beijing 100044, China
Sun Chufeng
Department of Pharmacy, Peking University People's Hospital, Beijing 100044, China
Chen Yue
Department of Pharmacy, Peking University People's Hospital, Beijing 100044, China
Feng Wanyu
Department of Pharmacy, Peking University People's Hospital, Beijing 100044, China
Feng Yufei
Department of Pharmacy, Peking University People's Hospital, Beijing 100044, China
·
DOI: 10.3760/cma.j.cn115989-20200715-00498
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摘要

目的系统评价术前玻璃体腔注射康柏西普(IVC)对玻璃体切割术(PPV)治疗增生性糖尿病视网膜病变(PDR)的疗效及安全性。

方法计算机检索EMbase、PubMed、Cochrane Library、中国期刊全文数据库(CNKI)、万方数据库和维普数据库中已发表的术前IVC联合PPV治疗PDR的随机对照试验(RCT)研究、队列研究及病例对照研究,根据纳入标准和排除标准独立对文献进行筛选及数据提取。采用改良Jadad量表对纳入的随机对照试验研究进行质量评价,采用纽卡斯尔渥太华量表(NOS)对纳入的队列研究或病例对照研究进行质量评价。应用RevMan 5.3软件对数据进行Meta分析。

结果共纳入11个随机对照试验研究、2个队列研究和10个病例对照研究,包含1 625例患者1 844眼。所有RCT文献质量评分均≥3,所有队列研究和病例对照研究的NOS评分均≥5。Meta分析结果显示,术前IVC组总疗效明显优于单纯PPV组,差异有统计学意义( RR=1.31,95% CI:1.21~1.42, P<0.001)。与单纯PPV组相比,术前IVC组可以缩短手术时间(MD=-21.11,95% CI:-26.39~-15.83, P<0.001),降低VEGF水平(MD=-15.33,95% CI:-19.40~-11.26, P<0.001),减少术中出血、医源性视网膜裂孔及术后玻璃体再出血和一过性眼压升高的发生率,差异均有统计学意义(均 P<0.05)。

结论术前IVC辅助PPV治疗PDR的临床疗效优于单用PPV,并发症减少,未见严重不良反应。

康柏西普;增生性糖尿病视网膜病变;玻璃体切割术;血管内皮生长因子;Meta分析
ABSTRACT

ObjectiveTo evaluate the efficacy and safety of preoperative intravitreal conbercept (IVC) as an adjunct to pars plana vitrectomy (PPV) in the treatment of proliferative diabetic retinopathy (PDR).

MethodsA systematic search in EMbase, PubMed, Cochrane Library, Chinese periodical full text database (CNKI), Wanfang database and VIP database were conducted, studies about the effectiveness and safety of IVC combined with PPV in the management of PDR were collected.Two researchers independently screened the studies according to the inclusion criteria and exclusion criteria, and extracted the data.The quality of the randomized controlled trial (RCT) was evaluated by the modified Jadad scale, and the quality of the cohort study or case-control study was evaluated by the Newcastle Ottawa scale (NOS). Rev Man 5.3 was applied for data analysis.

ResultsA total of 11 RCTs, 2 cohort studies and 10 case-control studies involving 1 625 patients and 1 844 eyes were included.The final Jadad score for each RCT was more than 3, and the final NOS score for each cohort study and case-control study was more than 5.The results of Meta-analysis showed that the total effectiveness of treatment was significantly higher in the preoperative IVC group than that in the simple PPV group ( RR=1.31, 95% CI: 1.21-1.42, P<0.001). The average operation duration was significantly shorter in the preoperative IVC group compared with that in the simple PPV group (MD=-21.11, 95% CI: -26.39--15.83, P<0.001). The level of VEGF was significantly lower in the preoperative IVC group than that in the simple PPV group (MD=-15.33, 95% CI: -19.40--11.26, P<0.001). Preoperative IVC could reduce the incidences of intraoperative bleeding, iatrogenic retinal breaks, postoperative recurrent vitreous hemorrhage and temporary increase of intraocular pressure, with statistically significant differences between them (all at P<0.05).

ConclusionsPreoperative intravitreal injection of conbercept shows better effect and safer than vitrectomy alone, and it has no serious side effect.

Conbercept;Proliferative diabetic retinopathy;Vitrectomy;Vascular endothelial growth factor;Meta-analysis
Feng Wanyu, Email: mocdef.aabnisekijoaynimner
引用本文

司霞,孙楚枫,陈月,等. 康柏西普辅助玻璃体切割术治疗增生性糖尿病视网膜病变的Meta分析[J]. 中华实验眼科杂志,2020,38(09):773-780.

DOI:10.3760/cma.j.cn115989-20200715-00498

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增生性糖尿病视网膜病变(proliferative diabetic retinopathy,PDR)是糖尿病的严重并发症之一,是糖尿病中晚期微血管病变的结果,同时患者血液处于高凝状态,加重视网膜血管病变,如不及时防治,可导致患者视力减退,甚至失明 [ 1 ]。玻璃体切割术(pars plana vitrectomy,PPV)可以有效治疗晚期PDR,但随着新生血管增多及原有血管纤维化,剥离纤维新生血管膜时常引起视网膜撕裂或严重出血。血管内皮生长因子(vascular endothelial grow factor,VEGF)是刺激视网膜新生血管形成的重要细胞因子 [ 2 ]。研究发现,糖尿病患者体内VEGF呈高水平表达,促进新生血管形成,严重损伤患者视力。已有大量研究证实术前玻璃体腔注射抗VEGF药物如雷珠单抗和贝伐单抗辅助PPV治疗PDR安全有效 [ 3 , 4 ]。康柏西普是中国自主研发的重组融合蛋白,于2013年底在国内上市,可以同时抑制VEGF-A、VEGF-B和胎盘生长因子(placental growth factor,PlGF),与单抗类抗VEGF药物相比,其具有亲和力强、靶点多、价格适中等优点 [ 5 , 6 ]。目前,康柏西普主要用于治疗湿性年龄相关性黄斑变性,其辅助PPV治疗PDR仍属于超适应证用药。本研究采用循证医学的研究方法,对康柏西普辅助PPV治疗PDR的安全性和有效性进行Meta分析,以期为临床应用提供参考。
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Yan YN , Wei WB , Zhou JQ . The using timing of anti-vascular endothelial growth factor at perioperative period for proliferative diabetic retinopathy[J]Int Rev Ophthalmol 201539(5):333-336. DOI: 10.3760/cma.j.issn.1673-5803.2015.05.008 .
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