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糖尿病性黄斑水肿的计划治疗方案与实际执行治疗方案:来自太平洋研究的真实世界证据

Planned vs. Performed Treatment Regimens in Diabetic Macular Edema: Real-World Evidence from the PACIFIC Study.

作者信息

Haritoglou Christos, Iwersen Matthias, Müller Bettina, Beeke Erik, Berk Hüsnü, Grüb Matthias, Lorenz Katrin, Scheffler Martin, Ziemssen Focke

机构信息

Augenklinik Herzog Carl Theodor, Nymphenburger Str. 43, 80335 München, Germany.

Novartis Pharma GmbH, Roonstr. 25, 90429 Nürnberg, Germany.

出版信息

J Clin Med. 2025 Apr 30;14(9):3120. doi: 10.3390/jcm14093120.

Abstract

Intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors are standard for diabetic macular edema (DME), yet a gap exists between clinical guidelines and actual practices. This study aimed to investigate the extent of deviation between physician-planned and actually performed treatment regimens. The PACIFIC study (NCT04847895) was a prospective, multicenter, non-interventional study conducted in Germany, the Netherlands, and Switzerland. A total of 910 patients with DME receiving ranibizumab were enrolled. Physicians documented the intended treatment regimen at baseline, and actual treatment patterns were retrospectively derived from the timing of visits and injections over a 24-month observation period. Although most physicians initially planned fixed or pro re nata (PRN) regimens, 77% of pretreated and 73% of treatment-naïve patients ultimately followed a monitor and extend strategy. Treatment discontinuation was frequent (58.8% and 59.4%, respectively), and injection frequencies remained below recommended levels, although central retinal thickness improved over time. The study highlights a consistent and clinically relevant discrepancy between planned and actual treatment delivery in DME care, underscoring the need for better adherence to guideline-informed strategies in routine practice.

摘要

玻璃体内注射血管内皮生长因子(VEGF)抑制剂是治疗糖尿病性黄斑水肿(DME)的标准方法,但临床指南与实际操作之间存在差距。本研究旨在调查医生计划的治疗方案与实际执行的治疗方案之间的偏差程度。PACIFIC研究(NCT04847895)是一项在德国、荷兰和瑞士进行的前瞻性、多中心、非干预性研究。共有910例接受雷珠单抗治疗的DME患者入组。医生在基线时记录了预期的治疗方案,并通过24个月观察期内的就诊和注射时间回顾性得出实际治疗模式。尽管大多数医生最初计划采用固定或按需(PRN)方案,但77%的经治患者和73%的初治患者最终采用了监测并延长治疗策略。治疗中断很常见(分别为58.8%和59.4%),尽管随着时间推移中心视网膜厚度有所改善,但注射频率仍低于推荐水平。该研究突出了DME治疗中计划的治疗与实际治疗之间持续存在的且具有临床相关性的差异,强调在日常实践中需要更好地遵循基于指南的策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bad/12072375/b9ec21523493/jcm-14-03120-g0A1.jpg

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