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玻璃体腔内注射贝伐单抗治疗早产儿视网膜病变的神经发育结局的 Meta 分析。

A Meta-Analysis of Neurodevelopmental Outcomes following Intravitreal Bevacizumab for the Treatment of Retinopathy of Prematurity.

机构信息

Faculty of Medicine and Health Sciences, McGill University, Montreal, Québec, Canada,

Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.

出版信息

Neonatology. 2023;120(5):577-588. doi: 10.1159/000531541. Epub 2023 Jul 24.

Abstract

BACKGROUND

Retinopathy of prematurity (ROP) is the most common cause of preventable blindness in preterm infants. First-line treatments include intravitreal bevacizumab (IVB) or laser photocoagulation (LPC).

OBJECTIVES

The aim of the study was to evaluate neurodevelopmental safety of IVB compared to LPC for ROP.

METHODS

MEDLINE, Embase, and Cochrane library were searched up to September 2022. Studies were included with at least 12-month follow-up of primary outcomes such as severe neurodevelopmental impairment (sNDI), cerebral palsy (CP), and hearing impairment (HI). Secondary outcomes were moderate-to-severe neurodevelopmental impairment (msNDI), Bayley Scores of Infant Development (BSID-III), and visual impairment.

RESULTS

1,231 patients from 11 comparative studies were included. Quality of evidence was rated low for all outcomes. IVB was associated with a higher risk for sNDI (risk ratio [RR] = 1.25, 95% confidence interval [CI]: [1.01, 1.53], p = 0.04); and CP (RR = 1.40, CI: [1.08, 1.81], p = 0.01) compared to LPC. There was no significant difference between IVB and LPC for msNDI (RR = 1.15, CI: [0.98, 1.35], p = 0.08) and HI (RR = 1.43, CI: [0.86, 2.39], p = 0.17). BSID-III percentile scores were similar between IVB and LPC, with weighted mean differences of 1.51 [CI = -1.25, 4.27], 2.43 [CI = -1.36, 6.22], and 1.97 [CI = -1.06, 5.01] for cognitive, language, and motor domains, respectively (p > 0.05).

CONCLUSION

To our knowledge, this is the largest meta-analysis on neurodevelopmental outcomes and the first to rigorously examine IVB monotherapy in ROP treatment. Compared to LPC, there was a marginally increased risk for sNDI and CP with IVB but little or no difference in the risk of msNDI and HI. Further randomized studies are needed to strengthen these findings.

摘要

背景

早产儿视网膜病变(ROP)是早产儿致盲的最常见原因。一线治疗包括玻璃体内注射贝伐单抗(IVB)或激光光凝(LPC)。

目的

本研究旨在评估 IVB 治疗 ROP 的神经发育安全性与 LPC 相比。

方法

检索 MEDLINE、Embase 和 Cochrane 图书馆,截至 2022 年 9 月。纳入至少有 12 个月主要结局(如严重神经发育障碍 [sNDI]、脑瘫 [CP] 和听力障碍 [HI])随访的研究。次要结局为中重度神经发育障碍(msNDI)、贝利婴幼儿发展量表第三版(BSID-III)和视力障碍。

结果

纳入 11 项比较研究的 1231 名患者。所有结局的证据质量均评定为低级别。与 LPC 相比,IVB 与 sNDI (风险比 [RR] = 1.25,95%置信区间 [CI]:[1.01,1.53],p = 0.04)和 CP (RR = 1.40,CI:[1.08,1.81],p = 0.01)风险更高。IVB 与 LPC 比较,msNDI (RR = 1.15,CI:[0.98,1.35],p = 0.08)和 HI (RR = 1.43,CI:[0.86,2.39],p = 0.17)无显著差异。IVB 和 LPC 之间的 BSID-III 百分位数评分相似,认知、语言和运动领域的加权均数差值分别为 1.51 [CI = -1.25,4.27]、2.43 [CI = -1.36,6.22]和 1.97 [CI = -1.06,5.01](p > 0.05)。

结论

据我们所知,这是关于神经发育结局的最大荟萃分析,也是第一个严格检查 IVB 单药治疗 ROP 的研究。与 LPC 相比,IVB 治疗的 sNDI 和 CP 风险略有增加,但 msNDI 和 HI 的风险差异较小或无差异。需要进一步的随机研究来加强这些发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26f4/10777715/38e75fd2064e/neo-0120-0577-g01.jpg

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