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贝伐单抗治疗渗出性年龄相关性黄斑变性疗效的系统评价

A systematic review on the effect of bevacizumab in exudative age-related macular degeneration.

作者信息

Schouten Jan S A G, La Heij Ellen C, Webers Carroll A B, Lundqvist Igor J, Hendrikse Fred

机构信息

Department of Ophthalmology, Maastricht University Hospital, P.O. box 5800, 6202 AZ, Maastricht, The Netherlands.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2009 Jan;247(1):1-11. doi: 10.1007/s00417-008-0952-y. Epub 2008 Oct 9.

Abstract

AIM

To provide evidence for the effect of bevacizumab on visual acuity (VA) and central retinal thickness (CRT) in exudative age-related macular degeneration

METHODS

A systematic review of all articles of bevacizumab for exudative AMD was conducted. Articles published up to March 2008 were identified in Medline, Embase, the Cochrane Controlled Trials Register and references from included articles. Search terms were "Bevacizumab or Avastin" and "Macula* or ARMD or AMD or intra(-)vitreal or intra(-)vitreous". Three observers participated in the data retrieval and assignment of the quality scores.

RESULTS

A total of 561 articles were retrieved. Three randomised controlled trials (RCT) and 23 before-and-after studies of patients (n = 1,435) who had received bevacizumab were published. Inclusion criteria varied. Lack of masking was the main methodological shortcoming. These RCTs showed that bevacizumab is more effective than PDT. Bevacizumab was given intravenously or as intravitreal injection. The latter was given once, or repeatedly every 4 weeks, and with or without additional injection when a recurrence occurred, mostly based on visual acuity and/or findings from optical coherence tomography. After intravenous administration, the weighted mean change in VA was +12.8 ETDRS letters (range +11 to +14) and the weighted mean change for CRT was -129 microm (range -100 to -202). For the 23 studies with intravitreal injections, the change in VA was +8.6 letters (range +2 to +26) and the change in CRT was -90 microm (range -46 to -190). The incidence of adverse events was low. The change in VA was 2.7 letters higher for studies with a higher quality vs lower quality.

CONCLUSION

Visual acuity improves and central retinal thickness decreases in patients with exudative AMD after bevacizumab. There is no reasonable doubt that this is caused by bevacizumab. It is likely that a randomised controlled trial will show that bevacizumab is equivalent in effect to ranibizumab, which showed a change in ETDRS of +5.9 letters for occult or minimally classic CNV and +9.8 letters for classic CNV after three monthly injections in two large RCTs.

摘要

目的

为贝伐单抗治疗渗出性年龄相关性黄斑变性对视力(VA)和视网膜中央厚度(CRT)的影响提供证据。

方法

对所有关于贝伐单抗治疗渗出性年龄相关性黄斑变性的文章进行系统评价。通过检索Medline、Embase、Cochrane对照试验注册库以及纳入文章的参考文献,找出截至2008年3月发表的文章。检索词为“贝伐单抗或阿瓦斯汀”以及“黄斑*或年龄相关性黄斑变性或年龄相关性黄斑病变或玻璃体内或玻璃体内注射”。三名观察者参与了数据检索和质量评分的赋值。

结果

共检索到561篇文章。发表了三项随机对照试验(RCT)以及23项对接受贝伐单抗治疗患者(n = 1435)的前后对照研究。纳入标准各不相同。缺乏盲法是主要的方法学缺陷。这些随机对照试验表明,贝伐单抗比光动力疗法(PDT)更有效。贝伐单抗通过静脉注射或玻璃体内注射给药。玻璃体内注射给药方式为单次注射,或每4周重复注射,复发时根据视力和/或光学相干断层扫描结果决定是否额外注射。静脉给药后,视力的加权平均变化为+12.8个ETDRS字母(范围为+11至+14),视网膜中央厚度的加权平均变化为 -129微米(范围为 -100至 -202)。对于23项玻璃体内注射研究,视力变化为+8.6个字母(范围为+2至+26),视网膜中央厚度变化为 -90微米(范围为 -46至 -190)。不良事件发生率较低。质量较高的研究与质量较低的研究相比,视力变化高2.7个字母。

结论

贝伐单抗治疗后,渗出性年龄相关性黄斑变性患者的视力提高,视网膜中央厚度降低。毫无疑问这是由贝伐单抗引起的。一项随机对照试验可能会表明,贝伐单抗的疗效与雷珠单抗相当,在两项大型随机对照试验中,雷珠单抗在每月注射三次后,对隐匿性或微小经典性脉络膜新生血管(CNV)的ETDRS变化为+5.9个字母,对经典性CNV的变化为+9.8个字母。

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