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【drug-news】Lucentis可以有效地治疗AMD

CORRECTION: Lucentis effective for common cause of blindness


Reuters Health

Thursday, October 5, 2006

[Corrects story posted Oct 4, 2006. A portion of the first sentence was deleted in earlier version.]

NEW YORK (Reuters Health) - Monthly eye injections with Lucentis (ranibizumab), an antibody designed to bind to and inhibit a protein that plays a role in the formation of new blood vessels, can help prevent vision loss from "wet" age-related macular degeneration (AMD), a common cause of blindness in older adults. Moreover, this treatment appears to be superior to verteporfin therapy, which combines drug and light therapy.

The findings stem from two studies appearing in The New England Journal of Medicine.

AMD is the number one cause of blindness among adults over 50 years of age in the US. However, 90 percent of the cases are due to a "dry" form of the disease. Wet AMD, which accounts for the remaining cases, involves abnormal blood vessel formation, which results in fluid leakage that damages the vision cells in the eye.

Lucentis was approved by the US Food and Drug Administration in June as a treatment for wet AMD, also known as neovascular AMD.

In the MARINA study, Dr. Philip J. Rosenfeld, from the University of Miami, and colleagues assessed the vision of 716 patients who had been randomly assigned to monthly injections of Lucentis (at a high or low dose) or placebo injections for 2 years. All of the patients had relatively early-stage disease.

At 1 year, roughly 95 percent of patients treated with either dose of Lucentis had no loss of vision compared with 62 percent of comparison subjects. Moreover, 25 percent of patients treated with low-dose Lucentis and 34 percent treated with the high dose experienced an improvement in vision, compared with just 5 percent of comparison subjects.

These benefits were still apparent after 2 years.

Inner eye inflammation, which can signal a serious infection, developed in about 1 percent of patients treated with Lucentis compared with 0 percent of comparison subjects.

Meanwhile, in the ANCHOR study, Dr. David M. Brown, from the Methodist Hospital in Houston, and colleagues compared the outcomes of 423 patients who were treated with Lucentis or with verteporfin therapy for 1 year.

About 95 percent of Lucentis-treated subjects lost no vision compared with 64 percent of verteporfin-treated patients at 1-year follow-up. In addition, vision improved in 36 to 40 percent of Lucentis-treated patients compared with 6 percent of those given verteporfin.

Once again, inner eye inflammation developed in about 1 percent of patients treated with Lucentis.

Both MARINA and ANCHOR were supported by Lucentis-maker Genentech and Novartis Pharma.

In a related editorial, Dr. Edwin M. Stone, from University of Iowa in Iowa City, comments that before Lucentis became available, many doctors were using bevacizumab, an antibody therapy originally approved for advanced colon cancer. Early reports suggested that this agent, which is much less expensive than Lucentis, is safe and effective for wet AMD.

"A head-to-head study of Lucentis and bevacizumab and a careful evaluation of an 'induction and follow-up' strategy with either drug are probably the next most useful steps in this field," Stone concludes.

SOURCE: The New England Journal of Medicine, October 5, 2006. 认领了 不好意思,这么久才回帖。
订正:Lucentis对致盲常见原因的作用
路透社 健康
星期四, 2006年10月5日

[对2006年10月4的文章的订正。早期版本中第一句话的一部分被删除了]

纽约(路透社健康)--Lucentis (ranibizumab)是一种抗体,将它每月进行眼内注射旨在绑定和抑制新生血管生成中起作用的一种蛋白,这样就能够帮助阻止老年患者常见致盲原因—“湿型”与年龄相关的黄斑退行性改变(AMD)所致的视觉丧失。而且,这种治疗似乎优于联合药物与光线的verteporfin疗法。

结果源于发表在新英格兰医学杂志中的两篇研究。

AMD是美国50对岁以上人们致盲的头号原因。然而,90%的病例是由于此疾病所形成的“干燥”形式。而在剩下病例中湿型的AMD涉及到异常的血管生成,导致眼液溢出,损伤视觉细胞。

六月美国食品与药品管理局批准Lucentis作为湿型AMD、也叫做年龄相关性黄斑变性的治疗。

在MARINA研究中,来自迈阿密大学的Philip J. Rosenfeld博士及其同事对随机分配716名患者接受2年的Lucentis(每月注射较高或较低的剂量)或安慰剂,并对他们进行评估。其中所有的患者均处在相对较早的疾病阶段。

在第1年,接受了Lucentis(两种剂量中的任一种)的患者中有大约95%的视力没有丧失,而对照受试者中的比例为62%。而且,接受低剂量的Lucentis中25%的患者和接受高剂量的Lucentis34%的患者的视力出现提高,而对照组的比例仅为5%。

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作者:admin@医学,生命科学    2010-12-03 05:11
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