初治疗新生血管性的年龄相关性黄斑变性:复习一下。
文章的细节
-
引用
复制到剪贴板 -
Kourlas H,艾布拉姆斯P
初治疗新生血管性的年龄相关性黄斑变性:复习一下。
其他。2007年9月,29 (9):1850 - 61。
- PubMed ID
-
18035187 (在PubMed]
- 文摘
-
背景:脉络膜新生血管性(湿)老年性视网膜黄斑性病变(ARMD)变得越来越盛行全球随着平均寿命不断增加。初为intravitreal注入是一个人类血管内皮生长因子抑制剂经美国食品和药物管理局批准用于治疗老年性视网膜黄斑性病变2006年6月。之初的行为导致减少细胞增殖,减少新血管的形成,和最小化的血管渗漏。目的:本文综述了药理学和药代动力学特性,临床疗效、安全性之初,和pharmacoeconomic和其使用相关联的因素。方法:MEDLINE(1966 - 2006年12月)和国际制药摘要(1970 - 2007年12月)寻找原始研究(I, II, III期和希望),摘要和评论文章之初。搜索词脉络膜新生血管形成,黄斑变性,Lucentis,之初,视网膜变性,血管内皮生长因子。偏好IlfllI阶段研究。从生产之初选择信息也包括在内。结果:初的功效研究3大型临床试验疗效相同,病人的比例失去< 15基线在12个月的来信(糖尿病视网膜病变的早期治疗研究图表)。III期多中心,随机、双盲、假对照,24个月的临床试验评估之初716年0.3和0.5 mg患者最低限度经典或神秘的脉络膜新生血管(CNV)与老年性视网膜黄斑性病变有关。 The results for the primary efficacy end point were 94.5% and 94.6% in the ranibizumab 0.3- and 0.5-mg groups, respectively, compared with 62.2% in the sham-injection group (P < 0.001, both ranibizumab groups vs sham injection); at 24 months, the corresponding proportions were 92.0%, 90.0%, and 52.9% (P < 0.001, both ranibizumab groups vs sham injection). A 2-year, Phase I/II, single-masked (masked patient and visual acuity examiner, unmasked investigator), multicenter trial evaluated the tolerability and efficacy of the combination of ranibizumab 0.5 mg and verteporfin photodynamic therapy (PDT) compared with verteporfin PDT alone in 162 patients with predominantly classic CNV. For the primary efficacy end point, the results were 90.5% for ranibizumab + PDT and 67.9% for PDT alone (P < 0.001). Receipt of ranibizumab + PDT was also associated with improved visual acuity, with 23.8% of patients gaining >15 letters from baseline, compared with 5.4% of those who received PDT alone (P = 0.003). Finally, an international Phase III, double-blind, active-controlled study compared ranibizumab 0.3 and 0.5 mg with verteporfin PDT in 423 patients with predominantly classic lesions associated with CNV secondary to ARMD. For the primary efficacy end point, the results were 35.7% for ranibizumab 0.3 mg, 40.3% for ranibizumab 0.5 mg, and 5.6% for verteporfin PDT (P < 0.001). Serious adverse ocular events, which occurred in association with < 0.1% of intravitreal injections in these trials, included retinal detachment and endophthalmitis. Less serious adverse ocular reactions occurring in < 2% of patients included intraocular inflammation and increased intraocular pressure. CONCLUSION: The findings of these 3 large clinical trials suggest that ranibizumab was effective and well tolerated in patient.