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抗血管内皮生长因子药物与激光光凝术治疗糖尿病性视网膜病变的比较:一项系统评价和荟萃分析。

Anti-VEGF drugs compared with laser photocoagulation for the treatment of diabetic retinopathy: a systematic review and meta-analysis.

作者信息

Simmonds Mark, Llewellyn Alexis, Walker Ruth, Fulbright Helen, Walton Matthew, Hodgson Rob, Bojke Laura, Stewart Lesley, Dias Sofia, Rush Thomas, Lawrenson John G, Peto Tunde, Steel David

机构信息

Centre for Reviews and Dissemination, University of York, York, UK.

Centre for Health Economics, University of York, York, UK.

出版信息

Health Technol Assess. 2024 Dec 11:1-71. doi: 10.3310/PCGV5709.

DOI:10.3310/PCGV5709
PMID:39673354
Abstract

BACKGROUND

Diabetic retinopathy is a major cause of sight loss in people with diabetes. The most severe form, proliferative diabetic retinopathy, carries a high risk of vision loss, vitreous haemorrhage, macular oedema and other harms. Panretinal photocoagulation is the primary treatment for proliferative diabetic retinopathy. Anti-vascular endothelial growth factor drugs are used to treat various eye conditions and may be beneficial for people with diabetic retinopathy.

OBJECTIVE

To investigate the efficacy and safety of anti-vascular endothelial growth factor therapy for the treatment of diabetic retinopathy when compared to panretinal photocoagulation.

METHODS

A systematic review and network meta-analysis of all published randomised controlled trials comparing anti-vascular endothelial growth factor (alone or in combination with panretinal photocoagulation) to panretinal photocoagulation in people with diabetic retinopathy. The database searches were updated in May 2023. Trials where the primary focus was treatment of macular oedema or vitreous haemorrhage were excluded.

RESULTS

A total of 14 trials were included: 3 of aflibercept, 5 of bevacizumab and 6 of ranibizumab. Two trials were of patients with non-proliferative diabetic retinopathy; all others were in proliferative diabetic retinopathy. Overall, anti-vascular endothelial growth factor was slightly better than panretinal photocoagulation at preventing vision loss, measured as best corrected visual acuity, at up to 2 years follow-up [mean difference in the logarithm of the minimum angle of resolution -0.089 (or 3.6 Early Treatment Diabetic Retinopathy Study letters), 95% confidence interval -0.180 to -0.019]. There was no clear evidence of any difference between the anti-vascular endothelial growth factors, but the potential for bias complicated the comparison. One trial found no benefit of anti-vascular endothelial growth factor over panretinal photocoagulation after 5 years. Anti-vascular endothelial growth factor was superior to panretinal photocoagulation at preventing macular oedema (relative risk 0.29, 95% confidence interval 0.18 to 0.49) and vitreous haemorrhage (relative risk 0.77, 95% confidence interval 0.61 to 0.99). There was no clear evidence that the effectiveness of anti-vascular endothelial growth factor varied over time.

CONCLUSIONS

Anti-vascular endothelial growth factor injections reduce vision loss when compared to panretinal photocoagulation, but the benefit is small and unlikely to be clinically meaningful. Anti-vascular endothelial growth factor may have greater benefits for preventing complications such as macular oedema. Observational studies extending follow-up beyond the 1-year duration of most trials are needed to investigate the longer-term effects of repeated anti-vascular endothelial growth factor injections.

FUNDING

This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR132948.

摘要

背景

糖尿病视网膜病变是糖尿病患者视力丧失的主要原因。最严重的形式,增殖性糖尿病视网膜病变,具有视力丧失、玻璃体积血、黄斑水肿和其他危害的高风险。全视网膜光凝是增殖性糖尿病视网膜病变的主要治疗方法。抗血管内皮生长因子药物用于治疗各种眼部疾病,可能对糖尿病视网膜病变患者有益。

目的

与全视网膜光凝相比,研究抗血管内皮生长因子疗法治疗糖尿病视网膜病变的疗效和安全性。

方法

对所有已发表的随机对照试验进行系统评价和网络荟萃分析,这些试验比较了抗血管内皮生长因子(单独或与全视网膜光凝联合使用)与全视网膜光凝治疗糖尿病视网膜病变患者的效果。数据库检索于2023年5月更新。主要关注黄斑水肿或玻璃体积血治疗的试验被排除。

结果

共纳入14项试验:3项关于阿柏西普,5项关于贝伐单抗,6项关于雷珠单抗。2项试验的患者为非增殖性糖尿病视网膜病变;其他所有试验的患者均为增殖性糖尿病视网膜病变。总体而言,在长达2年的随访中,以最佳矫正视力衡量,抗血管内皮生长因子在预防视力丧失方面略优于全视网膜光凝[最小分辨角对数的平均差异为-0.089(或3.6个早期糖尿病视网膜病变研究字母),95%置信区间为-0.180至-0.019]。没有明确证据表明抗血管内皮生长因子之间存在任何差异,但偏倚的可能性使比较变得复杂。一项试验发现,5年后抗血管内皮生长因子相比全视网膜光凝并无益处。在预防黄斑水肿(相对风险0.29,95%置信区间0.18至0.49)和玻璃体积血(相对风险0.77,95%置信区间0.61至0.99)方面,抗血管内皮生长因子优于全视网膜光凝。没有明确证据表明抗血管内皮生长因子的有效性随时间变化。

结论

与全视网膜光凝相比,抗血管内皮生长因子注射可减少视力丧失,但益处较小且不太可能具有临床意义。抗血管内皮生长因子在预防黄斑水肿等并发症方面可能具有更大益处。需要进行观察性研究,将随访时间延长至超过大多数试验的1年时长,以调查重复注射抗血管内皮生长因子的长期效果。

资助

本文介绍了由英国国家卫生与保健研究院(NIHR)卫生技术评估计划资助的独立研究,资助编号为NIHR132948。

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