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雷珠单抗(Lucentis)治疗新生血管性年龄相关性黄斑变性:临床试验证据。

Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials.

机构信息

Eye Clinic (B4A), Westmead Hospital, Hawkesbury Road, Westmead, NSW, 2145, Australia.

出版信息

Br J Ophthalmol. 2010 Jan;94(1):2-13. doi: 10.1136/bjo.2009.159160. Epub 2009 May 13.

Abstract

BACKGROUND

Neovascular age-related macular degeneration (AMD) has a poor prognosis if left untreated, frequently resulting in legal blindness. Ranibizumab is approved for treating neovascular AMD. However, further guidance is needed to assist ophthalmologists in clinical practice to optimise treatment outcomes.

METHODS

An international retina expert panel assessed evidence available from prospective, multicentre studies evaluating different ranibizumab treatment schedules (ANCHOR, MARINA, PIER, SAILOR, SUSTAIN and EXCITE) and a literature search to generate evidence-based and consensus recommendations for treatment indication and assessment, retreatment and monitoring.

RESULTS

Ranibizumab is indicated for choroidal neovascular lesions with active disease, the clinical parameters of which are outlined. Treatment initiation with three consecutive monthly injections, followed by continued monthly injections, has provided the best visual-acuity outcomes in pivotal clinical trials. If continued monthly injections are not feasible after initiation, a flexible strategy appears viable, with monthly monitoring of lesion activity recommended. Initiation regimens of fewer than three injections have not been assessed. Continuous careful monitoring with flexible retreatment may help avoid vision loss recurring. Standardised biomarkers need to be determined.

CONCLUSION

Evidence-based guidelines will help to optimise treatment outcomes with ranibizumab in neovascular AMD.

摘要

背景

如果不进行治疗,新生血管性年龄相关性黄斑变性(AMD)预后较差,常导致法定失明。雷珠单抗已获批准用于治疗新生血管性 AMD。然而,需要进一步的指导,以协助眼科医生在临床实践中优化治疗效果。

方法

一个国际视网膜专家小组评估了来自前瞻性、多中心研究的证据,这些研究评估了不同雷珠单抗治疗方案(ANCHOR、MARINA、PIER、SAILOR、SUSTAIN 和 EXCITE),并进行了文献检索,以生成基于证据和共识的治疗适应证和评估、再治疗和监测建议。

结果

雷珠单抗适用于有活动性疾病的脉络膜新生血管病变,其临床参数已概述。在关键临床试验中,连续三个月每月注射三次,然后继续每月注射一次,提供了最佳的视力效果。如果在开始治疗后不能继续每月注射,则似乎可以采用灵活的策略,建议每月监测病变活动。少于三次注射的起始方案尚未得到评估。持续进行仔细监测并灵活进行再治疗可能有助于避免视力再次丧失。需要确定标准化的生物标志物。

结论

基于证据的指南将有助于优化雷珠单抗治疗新生血管性 AMD 的治疗效果。

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