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[早产儿视网膜病变临床试验综述:现状与未来展望]

[Review of clinical trials in retinopathy of prematurity : Current state and future perspectives].

作者信息

Stahl Andreas

机构信息

Klinik für Augenheilkunde, Universitätsklinikum Freiburg, Medizinische Fakultät, Albert-Ludwigs-Universität Freiburg, Killianstraße 5, 79106, Freiburg, Deutschland.

出版信息

Ophthalmologe. 2018 Jun;115(6):456-463. doi: 10.1007/s00347-018-0720-2.

DOI:10.1007/s00347-018-0720-2
PMID:29789899
Abstract

BACKGROUND

The treatment of retinopathy of prematurity (ROP) has gained a new dynamic since the introduction of anti-vascular endothelial growth factor (VEGF) therapy. This review summarizes clinical trial data in order to aid informed decision-making.

METHODS

In this article, pivotal clinical trials are summarized and discussed with regard to their implications for ROP therapy.

RESULTS

The longest follow-up phase exists for children treated in the CRYO-ROP study, which used retinal cryocoagulation to treat ROP. Based on results of the ETROP study and others, retinal laser therapy has replaced cryotherapy as standard of care. For anti-VEGF treatment, three controlled clinical trials exist to date: BEAT-ROP, CARE-ROP, and the PEDIG study. Combined, these studies demonstrate efficacy of anti-VEGF in treating acute ROP. However, they also emphasize the risk of (late) recurrences and the largely unsolved questions regarding choice of drug and dose as well as long-term safety.

CONCLUSION

Treatment of ROP remains a highly individual decision in which many variables need to be considered. The data discussed in this article can help in decision-making and emphasize the unique characteristics of the available therapeutic approaches, in particular regarding postoperative follow-up.

摘要

背景

自从引入抗血管内皮生长因子(VEGF)治疗以来,早产儿视网膜病变(ROP)的治疗有了新的动态。本综述总结临床试验数据,以帮助做出明智的决策。

方法

在本文中,对关键临床试验进行了总结,并讨论了其对ROP治疗的意义。

结果

接受视网膜冷冻凝固术治疗ROP的儿童在CRYO-ROP研究中的随访期最长。基于ETROP研究及其他研究结果,视网膜激光治疗已取代冷冻疗法成为标准治疗方法。对于抗VEGF治疗,迄今为止有三项对照临床试验:BEAT-ROP、CARE-ROP和PEDIG研究。综合这些研究表明,抗VEGF在治疗急性ROP方面有效。然而,它们也强调了(晚期)复发的风险以及关于药物选择、剂量和长期安全性等基本未解决的问题。

结论

ROP的治疗仍然是一个高度个体化的决策,需要考虑许多变量。本文讨论的数据有助于决策,并强调了现有治疗方法的独特特点,特别是关于术后随访方面。

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本文引用的文献

1
Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity: A Randomized Clinical Trial.比较不同雷珠单抗剂量治疗早产儿视网膜病变的安全性和有效性:一项随机临床试验。
JAMA Pediatr. 2018 Mar 1;172(3):278-286. doi: 10.1001/jamapediatrics.2017.4838.
2
Assessment of Lower Doses of Intravitreous Bevacizumab for Retinopathy of Prematurity: A Phase 1 Dosing Study.低剂量玻璃体内注射贝伐单抗治疗早产儿视网膜病变的评估:一项1期剂量研究。
JAMA Ophthalmol. 2017 Jun 1;135(6):654-656. doi: 10.1001/jamaophthalmol.2017.1055.
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Reactivation of Retinopathy of Prematurity Three Years After Treatment With Bevacizumab.
Br J Pharmacol. 2019 Jan;176(1):93-109. doi: 10.1111/bph.14507. Epub 2018 Nov 19.
贝伐单抗治疗三年后早产儿视网膜病变复发
Ophthalmic Surg Lasers Imaging Retina. 2017 Mar 1;48(3):255-259. doi: 10.3928/23258160-20170301-10.
4
Treatment of type I ROP with intravitreal bevacizumab or laser photocoagulation according to retinal zone.根据视网膜区域,采用玻璃体内注射贝伐单抗或激光光凝治疗I型视网膜病变。
Br J Ophthalmol. 2017 Mar;101(3):365-370. doi: 10.1136/bjophthalmol-2016-308375. Epub 2016 Jun 14.
5
Neurodevelopmental Outcomes Following Bevacizumab Injections for Retinopathy of Prematurity.贝伐单抗注射治疗早产儿视网膜病变后的神经发育结局
Pediatrics. 2016 Apr;137(4). doi: 10.1542/peds.2015-3218. Epub 2016 Mar 17.
6
The German ROP Registry: data from 90 infants treated for retinopathy of prematurity.德国 ROP 登记处:90 名早产儿视网膜病变患儿的治疗数据。
Acta Ophthalmol. 2016 Dec;94(8):e744-e752. doi: 10.1111/aos.13069. Epub 2016 May 20.
7
Current Practice Patterns for Treatment of Retinopathy of Prematurity.早产儿视网膜病变的当前治疗实践模式
Ophthalmic Surg Lasers Imaging Retina. 2016 May 1;47(5):491-5. doi: 10.3928/23258160-20160419-16.
8
Regression Rates Following the Treatment of Aggressive Posterior Retinopathy of Prematurity with Bevacizumab Versus Laser: 8-Year Retrospective Analysis.贝伐单抗与激光治疗侵袭性早产儿视网膜病变后的消退率:8年回顾性分析
Med Sci Monit. 2016 Apr 10;22:1192-209. doi: 10.12659/msm.897095.
9
Very Late Reactivation of Retinopathy of Prematurity After Monotherapy With Intravitreal Bevacizumab.玻璃体内注射贝伐单抗单药治疗后早产儿视网膜病变的极晚期复发
Ophthalmic Surg Lasers Imaging Retina. 2016 Mar;47(3):280-3. doi: 10.3928/23258160-20160229-12.
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Neurodevelopmental Outcomes in Infants with Retinopathy of Prematurity and Bevacizumab Treatment.早产儿视网膜病变及贝伐单抗治疗婴儿的神经发育结局
PLoS One. 2016 Jan 27;11(1):e0148019. doi: 10.1371/journal.pone.0148019. eCollection 2016.