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阿柏西普治疗对雷珠单抗耐药的渗出性年龄相关性黄斑变性

Aflibercept in exudative age related macular degeneration refractory to ranibizumab.

作者信息

Ruiz Ramos J, Pascual-Camps I, Cuéllar-Monreal M J, Dolz-Marco R, Fenoll M A, Font-Noguera I, Poveda-Andrés J L, Gallego-Pinazo R

机构信息

Servicio de Farmacia, Hospital Universitario y Politécnico La Fe, Valencia, España.

Servicio de Oftalmología, Hospital Universitario y Politécnico La Fe, Valencia, España.

出版信息

Arch Soc Esp Oftalmol. 2015 Dec;90(12):566-71. doi: 10.1016/j.oftal.2015.07.018. Epub 2015 Oct 26.

Abstract

PURPOSE

The aim of this study is to determine the effectiveness, safety and cost of aflibercept in the treatment of wet age-related macular degeneration (ARMD) refractory to ranibizumab.

METHODS

Retrospective observational study was conducted on patients diagnosed with wet ARMD, and previously treated with ranibizumab. Efficacy variables assessed were changes in visual acuity (BCVA) and anatomical improvements in the most affected eye. Factors associated with improvement of BCVA with aflibercept were also studied. Adverse events related to the aflibercept administration were recorded. Cost analysis data were collected from the hospital perspective, and only taking the direct medical costs into account. Cost-effectiveness analysis was calculated using the aflibercept treatment cost, and effectiveness calculated as BCVA gained.

RESULTS

A total of 50 eyes corresponding to 46 patients were included. The median follow-up period was 4.6 months (range: 1.0-6.0). Improvement in visual acuity after the first 2 doses and at the end of the follow-up period was observed in 32.0 and 28.0% of treated eyes, respectively. None of the variables studied was associated with an improvement in the BCVA after treatment. No significant differences were found in the average monthly cost between treatments.

CONCLUSIONS

Aflibercept is shown to be an effective treatment in a significant number of patients resistant to treatment with ranibizumab, presenting a cost similar to that generated during the final stages of treatment with ranibizumab.

摘要

目的

本研究旨在确定阿柏西普治疗对雷珠单抗耐药的湿性年龄相关性黄斑变性(ARMD)的有效性、安全性和成本。

方法

对诊断为湿性ARMD且先前接受过雷珠单抗治疗的患者进行回顾性观察研究。评估的疗效变量为视力(最佳矫正视力,BCVA)变化以及最患眼的解剖学改善情况。还研究了与阿柏西普治疗后BCVA改善相关的因素。记录与阿柏西普给药相关的不良事件。从医院角度收集成本分析数据,仅考虑直接医疗成本。使用阿柏西普治疗成本计算成本效益分析,并将获得的BCVA作为有效性计算指标。

结果

共纳入46例患者的50只眼。中位随访期为4.6个月(范围:1.0 - 6.0个月)。分别有32.0%和28.0%的治疗眼在首次2剂治疗后及随访期末视力得到改善。所研究的变量均与治疗后BCVA的改善无关。各治疗组间平均每月成本无显著差异。

结论

阿柏西普对大量对雷珠单抗治疗耐药的患者显示出有效,其成本与雷珠单抗治疗最后阶段产生的成本相似。

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