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玻璃体腔内注射治疗糖尿病性黄斑水肿的临床疗效和药物费用:意大利撒丁岛的一项回顾性研究

Clinical Outcome and Drug Expenses of Intravitreal Therapy for Diabetic Macular Edema: A Retrospective Study in Sardinia, Italy.

作者信息

Altana Chiara, Donadu Matthew Gavino, Dore Stefano, Boscia Giacomo, Carmelita Gabriella, Zanetti Stefania, Boscia Francesco, Pinna Antonio

机构信息

Hospital Pharmacy, Azienda Ospedaliero Universitaria di Sassari, 07100 Sassari, Italy.

Department of Biomedical Sciences, University of Sassari, 07100 Sassari, Italy.

出版信息

J Clin Med. 2021 Nov 16;10(22):5342. doi: 10.3390/jcm10225342.

Abstract

BACKGROUND

Diabetic macular edema (DME) is a leading cause of visual loss in working-age adults. The purpose of this retrospective study was to perform an epidemiological analysis on DME patients treated with intravitreal drugs in a tertiary hospital. The clinical outcome, adverse drug reactions (ADRs), and intravitreal drug expenses were assessed.

METHODS

All DME patients treated with Ranibizumab, Aflibercept, Dexamethasone implant, and Fluocinolone Acetonide implant at the Sassari University Hospital, Italy, between January 2017 and June 2020 were included. Central macular thickness (CMT) and best corrected visual acuity (BCVA) were measured. ADRs and drug expenses were analyzed.

RESULTS

Two-hundred thirty-one DME patients (mean age: 65 years) received intravitreal agents. Mean CMT and BCVA were 380 μm and 0.5 LogMAR at baseline, 298 μm and 0.44 logMAR after one year ( = 0.04), and 295 μm and 0.4 logMAR at the end of the follow-up period. A total of 1501 intravitreal injections were given; no major ADRs were reported. Treatment cost was €915,000 (€261,429/year). Twenty non-responders to Ranibizumab or Aflibercept were switched to a Dexamethasone implant. In these patients, mean CMT and BCVA were 468 µm and 0.5 LogMar at the time of switching and 362 µm and 0.3 LogMar at the end of the follow-up ( = 0.00014 and = 0.08, respectively).

CONCLUSION

Results confirm that Ranibizumab, Aflibercept, and Dexamethasone implant are effective and safe in DME treatment. A switch to Dexamethasone implant for patients receiving Aflibercept or Ranibizumab with minimal/no clinical benefit should be considered.

摘要

背景

糖尿病性黄斑水肿(DME)是导致工作年龄成年人视力丧失的主要原因。这项回顾性研究的目的是对一家三级医院接受玻璃体内注射药物治疗的DME患者进行流行病学分析。评估了临床结局、药物不良反应(ADR)和玻璃体内药物费用。

方法

纳入2017年1月至2020年6月期间在意大利萨萨里大学医院接受雷珠单抗、阿柏西普、地塞米松植入剂和氟轻松丙酮化物植入剂治疗的所有DME患者。测量中心黄斑厚度(CMT)和最佳矫正视力(BCVA)。分析ADR和药物费用。

结果

231例DME患者(平均年龄:65岁)接受了玻璃体内注射药物。基线时平均CMT和BCVA分别为380μm和0.5 LogMAR,1年后分别为298μm和0.44 logMAR(P = 0.04),随访期末分别为295μm和0.4 logMAR。共进行了1501次玻璃体内注射;未报告重大ADR。治疗费用为915,000欧元(261,429欧元/年)。20例对雷珠单抗或阿柏西普无反应的患者改用了地塞米松植入剂。在这些患者中,改用药物时平均CMT和BCVA分别为468µm和0.5 LogMar,随访期末分别为362µm和0.3 LogMar(分别为P = 0.00014和P = 0.08)。

结论

结果证实雷珠单抗、阿柏西普和地塞米松植入剂在DME治疗中有效且安全。对于接受阿柏西普或雷珠单抗但临床获益极少/无临床获益的患者,应考虑改用 地塞米松植入剂。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a56/8619487/03b1b8788af0/jcm-10-05342-g001.jpg

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