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雷珠单抗治疗新生血管性年龄相关性黄斑变性的初步临床经验。

Initial clinical experience of ranibizumab therapy for neovascular age-related macular degeneration.

作者信息

Rotsos Tryfon, Patel Praveen J, Chen Fred K, Tufail Adnan

机构信息

Medical Retina Service, Moorfields Eye Hospital, London, UK.

出版信息

Clin Ophthalmol. 2010 Nov 10;4:1271-5. doi: 10.2147/OPTH.S14684.

Abstract

PURPOSE

To describe the visual acuity and safety outcomes for the first 50 patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab at Moorfields Eye Hospital.

METHODS

A retrospective analysis of case notes from the first 50 consecutive patients with Primary Care Trust funding for ranibizumab therapy for nAMD. Visual acuity outcomes and adverse events were noted, as were service delivery-related indicators.

RESULTS

The mean (±standard deviation) age of the 50 patients was 81 ± 17 years. The mean follow-up of patients was 13.6 ± 2 (range 7.7-18) months. The mean change in visual acuity ± standard error was +4.6 ± 2.2 letters at the end of follow-up, with 26% gaining 15 letters or more. The mean (median) number of injections was 4.7 (4.5) per 12-month period. The mean (median) delay in Primary Care Trust funding approval was 35 days (32 days) prior to the final appraisal document from the National Institute of Health and Clinical Excellence.

CONCLUSIONS

The real-world outcomes of ranibizumab therapy in this initial cohort of patients with nAMD are comparable with those reported in the pivotal, randomized, controlled trials using fewer injections and a prn strategy of retreatment to achieve the gain in visual acuity.

摘要

目的

描述在摩尔菲尔兹眼科医院接受雷珠单抗治疗的首批50例新生血管性年龄相关性黄斑变性(nAMD)患者的视力和安全性结果。

方法

对首批连续50例由初级医疗信托基金资助接受雷珠单抗治疗nAMD的患者病历进行回顾性分析。记录视力结果、不良事件以及与服务提供相关的指标。

结果

50例患者的平均(±标准差)年龄为81±17岁。患者的平均随访时间为13.6±2(范围7.7 - 18)个月。随访结束时视力的平均变化±标准误为+4.6±2.2个字母,26%的患者视力提高了15个字母或更多。每12个月的平均(中位数)注射次数为4.7(4.5)次。在国家卫生与临床优化研究所的最终评估文件之前,初级医疗信托基金资助批准的平均(中位数)延迟时间为35天(32天)。

结论

在这一初始队列的nAMD患者中,雷珠单抗治疗的实际效果与在关键的随机对照试验中报告的效果相当,使用的注射次数更少,采用按需再治疗策略来实现视力提高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6055/2993128/b41180933d54/opth-4-1271f1.jpg

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