阿弗利塞普特8毫克在多性冠状血管病:对PULSAR随机临床试验的后期分析
Won Ki Lee1, Tien Y Wong2,3, Shih-Jen Chen4
1Nune Eye Hospital, Seoul, Republic of Korea.
JAMA ophthalmology
|December 18, 2025
概括
高剂量aflibercept (8毫克) 与标准剂量aflibercept (2毫克) 相比,在患有多性冠状血管病变 (PCV) 的患者中显示出类似的视力增长和解剖改善. 这支持8毫克aflibercept作为PCV的有效单疗法.
科学领域:
- 眼科医生 眼科 眼科
- 视网膜疾病 视网膜疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 神经血管与年龄相关的黄斑变性 (nAMD) 导致由于异常的血管生长导致视力丧失.
- 多性冠状血管病变 (PCV) 是nAMD的一个亚型.
- 在PULSAR试验中,研究了高剂量aflibercept (8 mg) 与标准剂量 (2 mg) 的nAMD.
研究的目的:
- 为了比较8毫克和2毫克aflibercept单一治疗在PCV患者的疗效和安全性.
- 在PULSAR试验中评估PCV患者的视力敏度和解剖结果.
主要方法:
- 随机PULSAR临床试验的特异分组后期分析.
- 包括139名参与者与ICGA确认的PCV.
- 在初始剂量后,阿弗利塞普特8mg (12或16周间隔) 与2mg (8周间隔) 的比较.
主要成果:
- 在48周,最小平方平均BCVA变化为+9.5个字母 (8 mg q12w),+8.4个字母 (8 mg q16w) 和+9.1个字母 (2 mg q8w).
- 在第48周,在37% (8 mg q12w),47% (8 mg q16w) 和38% (2 mg q8w) 的参与者中观察到没有多形病变.
- 在接受8毫克阿弗利伯塞普的参与者中,87%的参与者保持了12周或更长的剂量间隔.
结论:
- 在PCV患者中,aflibercept 8 mg显示出与aflibercept 2 mg可比的视觉和解剖结果.
- 支持使用aflibercept 8 mg作为PCV的有效单疗选择.
- 更高的剂量允许更少的注射频率,同时保持有效性.
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