Department of Biomedical and Biotechnological Sciences, Section of Pharmacology, University of Catania, Catania, Italy; Center for Research in Ocular Pharmacology, CERFO University of Catania, Catania, Italy.
Regional Pharmacovigilance Centre of Catania, A.O.U. Policlinico-Vittorio Emanuele, Catania, Italy.
J Pharmacol Sci. 2018 Dec;138(4):219-232. doi: 10.1016/j.jphs.2018.11.001. Epub 2018 Nov 20.
Systematic review of real-world studies about repeated dexamethasone intravitreal implant (DEXi) 0.7 mg in diabetic macular edema management, in order to identify the effective window of time occurring between injections, the critical evaluation of efficacy of the treatment, and the relative long-term safety in the real life setting.
Literature databases such as PubMed, SCOPUS, and EMBASE were used to identify reports including DEX implant injections.
Twenty-one peer-reviewed publications were identified. DEX implants retreatment was considered on a pro re nata (PRN) basis at any time or starting from month three or four. About 1/3 of the eyes were retreated before six months from first injection (range 0-86.7%). Mean retreatment average time was 5.3 ± 0.9 months, with an estimated average of 1.3 injections each six months. There was no statistical correlation between average retreatment time and incidence of adverse events or other variables investigated. Limited safety issues related to implants number have been found, suggesting an overall good tolerance of long-term DEXi.
Comprehensive evaluation of real-world data suggests an average DEXi duration close to five months, following a PRN treatment strategy, including about 1/3 of patients. Repeated DEXi administration revealed an acceptable long-term efficacy/safety ratio.
对关于糖尿病黄斑水肿管理中重复使用 0.7mg 地塞米松玻璃体内植入剂(DEXi)的真实世界研究进行系统评价,以确定注射之间的有效时间窗口,评估治疗效果的关键,并在真实环境下评估其长期安全性。
使用 PubMed、SCOPUS 和 EMBASE 等文献数据库,确定包括 DEX 植入物注射的报告。
确定了 21 篇同行评审的出版物。DEX 植入物的重复治疗被认为是根据需要(PRN)随时进行,或者从第三个或第四个月开始。大约有 1/3 的眼睛在第一次注射后的六个月内(范围 0-86.7%)进行了再次治疗。平均再治疗平均时间为 5.3±0.9 个月,估计每六个月平均进行 1.3 次注射。平均再治疗时间与不良事件发生率或其他调查变量之间没有统计学相关性。发现与植入物数量相关的安全性问题有限,表明长期使用 DEXi 的总体耐受性良好。
对真实世界数据的综合评估表明,采用 PRN 治疗策略,大约有 1/3 的患者的 DEXi 平均持续时间接近五个月。重复使用 DEXi 显示出可接受的长期疗效/安全性比。