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雷珠单抗治疗新生血管性年龄相关性黄斑变性的治疗方案:来自PACIFIC研究的真实世界结果

Treatment Regimens with Ranibizumab in Neovascular Age-Related Macular Degeneration: Real-World Results from the PACIFIC Study.

作者信息

Lorenz Katrin, Haritoglou Christos, Barthelmes Daniel, Sefat Armin Mir Mohi, Berk Hüsnü, Beeke Erik, Scheffler Martin, Iwersen Matthias, Müller Bettina, Ziemssen Focke

机构信息

Augenklinik und Poliklinik, Universitätsmedizin Mainz, Mainz, Germany.

Herzog Carl Theodor Eye Hospital, Munich, Germany.

出版信息

Clin Ophthalmol. 2025 Aug 24;19:2927-2937. doi: 10.2147/OPTH.S512630. eCollection 2025.

Abstract

INTRODUCTION

Intravitreal anti-VEGF is the gold standard for treating neovascular age-related macular degeneration (nAMD). The treatment success depends not only on drug efficacy but also on regimen feasibility for physicians and patients. The implementation of different regimen might lead to varying outcomes. "Treat-and-extend" aims to minimize undertreatment with injections at each visit and tailored intervals. This study investigates the utilization and effectiveness of ranibizumab in nAMD, focusing on different treatment regimens in real-world settings.

MATERIALS AND METHODS

The PACIFIC study, a non-interventional, prospective, multicenter study, included nAMD patients treated with ranibizumab at 185 sites across Germany, the Netherlands and Switzerland. Over 24 months, functional and morphological outcomes were documented for 3051 patients over 24 months, highlighting the practiced treatment regimens.

RESULTS

A pattern of an observational approach with nevertheless increasing interval extension prevailed (70.4%, 1028 pre-treated; 68.6%, 1090 treatment-naïve patients), emerging as the preferred strategy within the first 3 months. Across all regimens, the average number of injections was comparable (mean ± SD: 7.34 ± 5.30 in pre-treated; 7.26 ± 4.70 in treatment-naïve patients). The treat and extend regimen, however, demonstrated superior effectiveness in improving visual acuity, particularly among treatment-naïve patients (number of injections: 7.89 ± 5.54 pre-treated; 9.54 ± 5.42 treatment-naïve patients).

CONCLUSION

Over 2-year observational period, the treat and extend regimen emerged as a highly effective approach, particularly for those newly diagnosed, with a low risk of undertreatment. Despite its benefits, an unconscious shift to a observe-and-extend or "monitor-and-extend" approach occurred early in treatment, highlighting the need for tailored approaches to optimize patient outcomes in clinical practice.

摘要

引言

玻璃体内注射抗血管内皮生长因子(VEGF)是治疗新生血管性年龄相关性黄斑变性(nAMD)的金标准。治疗的成功不仅取决于药物疗效,还取决于医生和患者的治疗方案可行性。不同治疗方案的实施可能导致不同的结果。“治疗并延长”旨在尽量减少每次就诊时的注射不足,并根据具体情况调整注射间隔。本研究调查了雷珠单抗在nAMD中的应用情况和有效性,重点关注真实世界环境中的不同治疗方案。

材料与方法

太平洋研究是一项非干预性、前瞻性、多中心研究,纳入了在德国、荷兰和瑞士185个地点接受雷珠单抗治疗的nAMD患者。在24个月的时间里,记录了3051例患者的功能和形态学结果,突出了实际采用的治疗方案。

结果

一种观察性方法且注射间隔不断延长的模式占主导(70.4%,1028例既往治疗患者;68.6%,1090例初治患者),在前3个月内成为首选策略。在所有治疗方案中,平均注射次数相当(平均值±标准差:既往治疗患者为7.34±5.30次;初治患者为7.26±4.70次)。然而,“治疗并延长”方案在提高视力方面显示出更好的效果,尤其是在初治患者中(注射次数:既往治疗患者为7.89±5.54次;初治患者为9.54±5.42次)。

结论

在2年的观察期内,“治疗并延长”方案成为一种高效的治疗方法,尤其是对新诊断患者,治疗不足风险较低。尽管有这些益处,但在治疗早期仍出现了不自觉地转向“观察并延长”或“监测并延长”方法的情况,这突出表明在临床实践中需要采用针对性方法来优化患者治疗效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9732/12394746/ecd8c5b7dbfc/OPTH-19-2927-g0001.jpg

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