Scuteri Damiana, Vero Ada, Zito Mariacristina, Naturale Maria Diana, Bagetta Giacinto, Nucci Carlo, Tonin Paolo, Corasaniti Maria Tiziana
Preclinical and Translational Pharmacology, Department of Pharmacy, Health Science and Nutrition, University of Calabria, Rende (Cosenza), Italy.
Pharmacy Unit, "Mater Domini" University Hospital, Catanzaro, Italy.
Neural Regen Res. 2019 Aug;14(8):1445-1448. doi: 10.4103/1673-5374.253528.
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.
老年人口持续增长,从而导致与年龄相关疾病的增加。其中,糖尿病性视网膜病变(DR)以及年龄相关性黄斑变性会导致视力逐渐丧失。由于这些病症与新生血管的增殖有关,其药物治疗包括玻璃体内注射抗血管内皮生长因子药物,这种药物能够抑制血管内皮生长因子引发的血管增殖。人源化抗血管内皮生长因子单克隆抗体雷珠单抗在多项试验中证明了其有效性,因此获得了美国食品药品监督管理局的批准,可用于DR各个阶段的治疗。由于在意大利南部卡拉布里亚地区缺乏流行病学和药物经济学评估,本回顾性观察研究聚焦于2014年1月至2017年6月期间在意大利卡拉布里亚“Domini圣母”大学医院接受临床观察的870例患者中DR和年龄相关性黄斑变性的患病率、雷珠单抗治疗及治疗费用。数据从眼科病房数据库中提取并进行统计分析。结果表明,最常见的视网膜疾病是年龄相关性黄斑变性和DR,在4年的研究期内,雷珠单抗的使用量及其相关的每位患者成本均在下降,这两种疾病的成本相似。因此,在这种情况下需要评估使用雷珠单抗以外的药物进行治疗的适宜性,并且有必要对视网膜疾病的药物治疗进行深入监测,以预防或延缓视力下降和完全失明。研究程序是按照“Domini圣母”大学医院人类实验负责委员会的伦理标准进行的。