糖尿病黄斑的口服拉米武丁:一个随机,双盲,安慰剂控制的临床试验
Felipe Pereira1, Joseph Magagnoli2, Meenakshi Ambati3
1Departamento de Oftalmologia e Ciências Visuais, Universidade Federal de São Paulo, São Paulo, Brazil.
Med (New York, N.Y.)
|May 28, 2025
概括
口服拉米武丁显著改善了中心参与糖尿病黄斑胀 (CI-DME) 的患者的视力. 这种廉价的治疗方法为DME的标准疗法提供了一个有希望的替代方案.
科学领域:
- 眼科医生 眼科 眼科
- 药理学 药理学是指药理学的学科.
- 炎症研究 炎症研究
背景情况:
- 糖尿病黄斑 (DME) 影响全球数百万人,目前的治疗方法如抗血管内皮生长因子 (VEGF) 抑制剂是昂贵的,并具有潜在的并发症.
- 拉米武丁是一种可获得的口服药物,通过抑制炎症酶激活,这是DME病变的一个关键因素,显示出潜在的潜力.
研究的目的:
- 评估与安慰剂相比,口服拉米武丁在改善中心参与DME (CI-DME) 的视力敏度方面的疗效.
主要方法:
- 这是一项随机,双盲,安慰剂对照试验,涉及24名患有CI-DME的成人.
- 参与者接受口服 lamivudine (150 毫克每天两次) 或安慰剂 8 周,所有参与者都在第 4 周接受静脉内贝瓦西祖马布.
- 同一初级结局包括在第4周和第8周最佳校正的视敏度 (BCVA) 变化,并与合成对照的抗VEGF药物进行比较.
主要成果:
- 在4周后,拉米武丁显示了9.8个字母的BCVA显著改善,而安慰剂的1.8个字母减少 (p < 0.001).
- 在8周后,拉米武丁与贝瓦齐祖马布结合,导致BCVA增长16.9个字母,显著优于安慰剂和贝瓦齐祖马布 (p < 0.001).
- 与贝瓦齐祖马布和拉尼比祖马布相比,拉米武丁显示出优异的BCVA改善,与阿弗利塞普特的结果相似,视网膜厚度或不良事件没有显著差异.
结论:
- 口服拉米武丁在被诊断患有中心涉及的糖尿病黄斑 (CI-DME) 的患者中有效提高视力.
- 作为口服炎症酶抑制剂,拉米武丁为CI-DME提供了可行的和有效的治疗选择.
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