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雷珠单抗与激光治疗早产儿视网膜病变的疗效比较
作者:小柯机器人 发布时间:2019/9/18 14:04:09

英国伦敦学院大学Neil Marlow研究团队取得一项新突破。他们比较了雷珠单抗与激光治疗早产儿视网膜病变(ROP)的疗效。 该研究于2019年9月12日在线发表于《柳叶刀》。

这项随机、开放标签、优势多中心、三臂、平行组试验在26个国家的87个新生儿和眼科中心进行。2015年12月31日至2017年6月29日,研究团队招募了225名符合视网膜病变治疗标准的出生体重低于1500克的婴儿,并按1:1:1随机分组,其中74名接受单次双侧玻璃体内注射雷珠单抗0.2 mg,77名接受注射雷珠单抗0.1 mg,74名接受激光治疗。

对资料完整的214名婴儿进行评估,治疗24周后,70名接受雷珠单抗0.2 mg的婴儿中有56名(80%)获得成功,76名接受雷珠单抗0.1 mg的婴儿中有57名(75%)获得成功,接受激光治疗的68名婴儿中有45名(66%)获得成功。与激光治疗相比,雷珠单抗0.2 mg治疗成功率的优势比为2.19,雷珠单抗0.1 mg为1.57。接受雷珠单抗0.2 mg的婴儿中有一名发生视网膜不良结构性改变,雷珠单抗0.1 mg中有5例,激光治疗有7例。三组间婴儿死亡、严重或不严重系统性不良反应以及眼部不良事件的发生率无显著性差异。

综上,在ROP治疗中,雷珠单抗0.2 mg可能优于激光治疗,视力不良发生率较低,且24周内相对安全。

研究人员表示,尽管抗血管内皮生长因子治疗ROP的应用越来越多,但关于其眼部疗效,合适的药物和剂量,复治的必要性,以及长期全身效应概率的数据很少。

附:英文原文

Title: Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial

Author: Andreas Stahl, Domenico Lepore, Alistair Fielder, Brian Fleck, James D Reynolds, Michael F Chiang, Jun Li, Melissa Liew, Rainer Maier, Qi Zhu, Neil Marlow

Issue&Volume: 12 September 2019

Summary: 

Background

Despite increasing worldwide use of anti-vascular endothelial growth factor agents for treatment of retinopathy of prematurity (ROP), there are few data on their ocular efficacy, the appropriate drug and dose, the need for retreatment, and the possibility of long-term systemic effects. We evaluated the efficacy and safety of intravitreal ranibizumab compared with laser therapy in treatment of ROP.

Methods

This randomised, open-label, superiority multicentre, three-arm, parallel group trial was done in 87 neonatal and ophthalmic centres in 26 countries. We screened infants with birthweight less than 1500 g who met criteria for treatment for retinopathy, and randomised patients equally (1:1:1) to receive a single bilateral intravitreal dose of ranibizumab 0·2 mg or ranibizumab 0·1 mg, or laser therapy. Individuals were stratified by disease zone and geographical region using computer interactive response technology. The primary outcome was survival with no active retinopathy, no unfavourable structural outcomes, or need for a different treatment modality at or before 24 weeks (two-sided α=0·05 for superiority of ranibizumab 0·2 mg against laser therapy). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02375971.

Interpretation

Between Dec 31, 2015, and June 29, 2017, 225 participants (ranibizumab 0·2 mg n=74, ranibizumab 0·1 mg n=77, laser therapy n=74) were randomly assigned. Seven were withdrawn before treatment (n=1, n=1, n=5, respectively) and 17 did not complete follow-up to 24 weeks, including four deaths in each group. 214 infants were assessed for the primary outcome (n=70, n=76, n=68, respectively). Treatment success occurred in 56 (80%) of 70 infants receiving ranibizumab 0·2 mg compared with 57 (75%) of 76 infants receiving ranibizumab 0·1 mg and 45 (66%) of 68 infants after laser therapy. Using a hierarchical testing strategy, compared with laser therapy the odds ratio (OR) of treatment success following ranibizumab 0·2 mg was 2·19 (95% Cl 0·99–4·82, p=0·051), and following ranibizumab 0·1 mg was 1·57 (95% Cl 0·76–3·26); for ranibizumab 0·2 mg compared with 0·1 mg the OR was 1·35 (95% Cl 0·61–2·98). One infant had an unfavourable structural outcome following ranibizumab 0·2 mg, compared with five following ranibizumab 0·1 mg and seven after laser therapy. Death, serious and non-serious systemic adverse events, and ocular adverse events were evenly distributed between the three groups.

Findings

In the treatment of ROP, ranibizumab 0·2 mg might be superior to laser therapy, with fewer unfavourable ocular outcomes than laser therapy and with an acceptable 24-week safety profile.

DOI: 10.1016/S0140-6736(19)31344-3

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31344-3/fulltext

期刊信息

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:59.102
官方网址:http://www.thelancet.com/
投稿链接:http://ees.elsevier.com/thelancet