Augustin Albert J, Becker Matthias D, Hatz Katja, Kaymak Hakan, Shirlaw Andrew
Eye Care Clinic, Karlsruhe, Germany.
Department of Ophthalmology, Zurich City Hospital, Zurich, Switzerland.
Clin Ophthalmol. 2021 Sep 29;15:3957-3967. doi: 10.2147/OPTH.S315548. eCollection 2021.
The purpose was to assess the number and intervals of dexamethasone intravitreal implant (DEX) reinjections in a real-world setting for the treatment of diabetic macular edema (DME) and to determine the relationship with effectiveness and safety.
Data were abstracted from medical records of DME patients in Germany and Switzerland for this retrospective, multicenter, drug utilization study. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) changes 7-12 weeks post-injection(s) measured effectiveness. Adverse events (AEs) of special interest were reported.
A total of 141 patients, 108 from Germany and 33 from Switzerland, were assessed. Mean (SD) reinjection interval was 5.7 (4.2) months. Mean baseline BCVA was 61.6 letters, and mean baseline CRT was 413.3 µm. The mean BCVA and CRT changes at 7-12 weeks after baseline, reinjection 1, 2, and 3 were +3.4, +3.7, +3.2, and -1.4 letters and -88.3, -81.6, -102.4, and -124.1 μm, respectively. The Spearman correlation between change in BCVA and CRT and DEX reinjection interval was r=0.03 (=0.66) and r=0.07 (=0.38), respectively. Only 18% of patients experienced at least 1 AE.
There was no statistically significant correlation between drug effectiveness and reinjection intervals in either country. Although these results are preliminary, they indicate that DEX improves BCVA and CRT in real-world clinical practice.
本研究旨在评估在现实环境中玻璃体内注射地塞米松植入物(DEX)治疗糖尿病性黄斑水肿(DME)的再注射次数和间隔时间,并确定其与有效性和安全性的关系。
本回顾性、多中心药物利用研究的数据来自德国和瑞士DME患者的医疗记录。通过注射后7 - 12周最佳矫正视力(BCVA)和中心视网膜厚度(CRT)的变化来衡量有效性。报告了特别关注的不良事件(AE)。
共评估了141例患者,其中108例来自德国,33例来自瑞士。平均(标准差)再注射间隔时间为5.7(4.2)个月。平均基线BCVA为61.6字母,平均基线CRT为413.3µm。基线、首次注射、第二次注射和第三次注射后7 - 12周时,BCVA的平均变化分别为+3.4、+3.7、+3.2和 - 1.4字母,CRT的平均变化分别为 - 88.3、 - 81.6、 - 102.4和 - 124.1µm。BCVA和CRT变化与DEX再注射间隔之间的Spearman相关性分别为r = 0.03(P = 0.66)和r = 0.07(P = 0.38)。只有18%的患者经历了至少1次不良事件。
在这两个国家中,药物有效性与再注射间隔之间均无统计学显著相关性。尽管这些结果是初步的,但它们表明在现实临床实践中DEX可改善BCVA和CRT。