中国神经再生研究(英文版)

中国神经再生研究(英文版) ›› 2019, Vol. 14 ›› Issue (8): 1445-1448.doi: 10.4103/1673-5374.253528

• 原著:视神经损伤修复保护与再生 • 上一篇    下一篇

糖尿病性视网膜病变和与年龄相关的黄斑变性：意大利卡拉布里亚地区药物使用与成本调查

  

  • 出版日期:2019-08-15 发布日期:2019-08-15

Diabetic retinopathy and age-related macular degeneration: a survey of pharmacoutilization and cost in Calabria, Italy

Damiana Scuteri 1 , Ada Vero 2 , Mariacristina Zito 2 , Maria Diana Naturale 3 , Giacinto Bagetta 1 , Carlo Nucci 4 , Paolo Tonin 5 , Maria Tiziana Corasaniti 3   

  1. 1 Preclinical and Translational Pharmacology, Department of Pharmacy, Health Science and Nutrition, University of Calabria, Rende (Cosenza), Italy
    2 Pharmacy Unit, “Mater Domini” University Hospital, Catanzaro, Italy
    3 Department of Health Sciences, University “Magna Graecia” of Catanzaro, Catanzaro, Italy
    4 Ophtalmology Unit, Department of Experimental Medicine, University of Rome “Tor Vergata”, Rome, Italy
    5 S. Anna Institute, Regional Center for Serious Brain Injuries, Crotone, Italy
  • Online:2019-08-15 Published:2019-08-15
  • Contact: Giacinto Bagetta, MD, giacinto.bagetta@unical.it.

PDF

95

摘要：

糖尿病性视网膜病变伴随年龄相关性黄斑变性与新血管的增殖有关，因此其药物治疗包括玻璃体内注射抗血管内皮生长因子药物。人源化抗血管内皮生长因子单克隆抗体雷珠单抗已获得美国食品和药物管理局批准用于糖尿病性视网膜病变的治疗，但尚缺乏其在意大利卡拉布里亚地区应用的流行病学和药物经济学评估，此次回顾性观察研究重点关注了2014年1月至2017年6月在意大利卡拉布里亚地区“Mater Domini”大学医院眼科870例患者的数据，调查其糖尿病性视网膜病变和年龄相关性黄斑变性患病率，以及雷珠单抗治疗的应用和治疗费用。结果显示，最常见的视网膜疾病是年龄相关性黄斑变性和糖尿病性视网膜病变，并且雷珠单抗的使用和费用逐年降低，并且用于治疗这两种疾病的雷珠单抗费用相近。因此，需要评估意大利卡拉布里亚地区应用雷珠单抗以外药物治疗的适当性，并且必须深入监测视网膜疾病药物治疗，以防止或延迟视力下降和完全视力丧失。

orcid: 0000-0001-8540-6218 (Giacinto Bagetta)

关键词: 年龄相关性黄斑变性, 抗VEGF, 糖尿病性视网膜病变, 药物警戒, 雷珠单抗, 回顾性研究

Abstract:

The aged population is constantly growing, thus fostering an increase in age-dependent diseases. Among these, diabetic retinopathy (DR) along with age-related macular degeneration entails progressive vision loss. Since such conditions are associated with the proliferation of novel vessels, their pharmacotherapeutic management consists of the intravitreal injection of anti-vascular endothelial growth factor drugs, able to hinder the driving of vascular proliferation prompted by vascular endothelial growth factor. The humanized anti-vascular endothelial growth factor monoclonal antibody ranibizumab provided evidence for efficacy in several trials, hence earning approval by the US Food and Drug Administration for therapeutic use in all the stages of DR. Due to the lack of epidemiologic and pharmacoeconomic evaluation in the local Calabria Region context, the present retrospective observational study focused on prevalence of DR and age-related macular degeneration, treatment and cost of therapy with ranibizumab in 870 patients arriving to clinical observation at the “Mater Domini” University Hospital in Calabria, Italy from January 2014 to June 2017. Data were extracted from the database of ophthalmology ward and subjected to statistical analysis. The results suggest that the most frequent retinal diseases are age-related macular degeneration and DR and that the use of ranibizumab has been decreasing over the 4-year study period together with the associated cost per patient which was similar for both disorders. Therefore, appropriateness of treatment with drugs other than ranibizumab needs to be assessed in this setting and deep monitoring of pharmacologic treatment for retinal diseases is necessary to prevent or delay visual acuity decrease and complete vision loss. Study procedures were performed in accordance with the “Mater Domini” University Hospital ethical standards of the responsible committee on human experimentation

Key words: age-related macular degeneration, diabetic retinopathy, pharmacovigilance, ranibizumab, anti-VEGFs, retrospective study