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雷珠单抗:新药。黄斑变性:因存在风险而用于二线治疗。

Ranibizumab: new drug. Macular degeneration: second-line use due to risks.

出版信息

Prescrire Int. 2008 Feb;17(93):3-6.

PMID:18354841
Abstract

(1) Due to a lack of any better alternatives, photodynamic therapy is the standard treatment for subfoveal lesions due to neovascular age-related macular degeneration (AMD). It consists of intravenous injection of a photosensitizer, verteporfin, followed by local red laser activation. This treatment, sometimes repeated every 3 months, stabilises the loss of visual acuity for 2 years in about 50% of patients. Adverse effects are generally acceptable. (2) Ranibizumab is an antibody fragment targeting vascular endothelial growth factor (VEGF). VEGF is implicated in the neovascularisation involved in age-related macular degeneration. Ranibizumab is injected into the vitreous in the same way as pegaptanib, the first VEGF antagonist to be approved for an ocular indication. (3) Clinical evaluation of ranibizumab includes 2 placebo-controlled trials (900 patients in total), a trial versus verteporfin (423 patients), and a trial testing ranibizumab in combination with verteporfin (162 patients). More than 90% of patients treated with ranibizumab in these two trials had no tangible loss of vision for one to two years, compared to about 68% of patients treated with verteporfin (statistically significant difference). These trials did not attempt to determine the optimal interval between intravitreal injections. (4) No trials have directly compared ranibizumab with pegaptanib; indirect comparisons suggest that ranibizumab is better than pegaptanib. (5) Intravitreal injection of ranibizumab can have local adverse effects, similar to pegaptanib. These include inflammatory reactions, infections, and elevated intraocular pressure. Arterial thromboses at distant sites, in particular strokes, have been reported with ranibizumab, at a higher frequency with 0.5 mg per infection (about 1%) than with 0.3 mg per injection. (6) When visual acuity continues to deteriorate in patients with age-related macular degeneration despite treatment with verteporfin, ranibizumab provides an effective alternative for patients with no particular risk factors for stroke.

摘要

(1)由于缺乏更好的替代方案,光动力疗法是治疗新生血管性年龄相关性黄斑变性(AMD)所致黄斑中心凹下病变的标准疗法。该疗法包括静脉注射光敏剂维替泊芬,随后进行局部红色激光激活。这种治疗有时每3个月重复一次,约50%的患者在2年内视力丧失情况得到稳定。不良反应一般可以接受。(2)雷珠单抗是一种靶向血管内皮生长因子(VEGF)的抗体片段。VEGF与年龄相关性黄斑变性所涉及的新生血管形成有关。雷珠单抗与首个获批用于眼部适应症的VEGF拮抗剂培加尼布一样,通过玻璃体注射给药。(3)雷珠单抗的临床评估包括2项安慰剂对照试验(共900例患者)、1项与维替泊芬对比的试验(423例患者)以及1项雷珠单抗与维替泊芬联合使用的试验(162例患者)。在这两项试验中,接受雷珠单抗治疗的患者中超过90%在1至2年内没有明显视力丧失,而接受维替泊芬治疗的患者约为68%(具有统计学显著差异)。这些试验并未试图确定玻璃体内注射的最佳间隔时间。(4)尚无试验直接将雷珠单抗与培加尼布进行比较;间接比较表明雷珠单抗优于培加尼布。(5)玻璃体内注射雷珠单抗可能会产生与培加尼布类似的局部不良反应。这些不良反应包括炎症反应

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