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本帖最后由 蓝鱼o_0 于 2011-5-4 12:37 编辑
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http://ophthalmology.dxy.cn/bbs/topic/20015652
阿瓦斯丁对比Lucentis裁决书已出来了, 新英格兰医学杂志的临床论文显示效果相仿,价格差40倍.
结果明摆着, 全球眼科医生所做的努力没有白花,
期待FDA将给与阿瓦斯丁新的标记, 罗氏要是再想阻扰医生使用标签外用于AMD,将会成为徒劳.
我们国家的卫生管理部门应该有所行动, 让罗氏让步,允许医生使用阿瓦斯丁用于AMD患者,
即使罗氏不主动推销阿瓦斯丁这一用途, 政府也应该采购阿瓦斯丁, 用规范而专业的药品分装机构进行分装和分销,尤其要做好冷链管理, 确保质量和安全.
我们的医生尤其是院士院长们应该积极争取为病人的利益,获得阿瓦斯丁德新适应症, 不要因为药厂的利益而站错立场.
我们应该为上海第一医院眼药门事件,有澄清事实, 恢复舆论强加的不实指控. 对医生的利益和声誉要有保护.
我们的记者也应该更多了解实情,用更专业和客观的态度和立场去报到日常中发生的医疗事故和事件.
我们的药政管理部门, 应该学习美国FDA和NIH的严谨态度, 支持老药新用, 更经济实用地推广阿瓦斯丁德AMD用途.
最后希望罗氏不要再玩以前的游戏, 正视临床试验的结果, 不要为了商业利润而不顾市场和患者的利益.
详细报道, 请见新英格兰医学杂志, 4月28日头篇报道及随刊发表的编辑部评论文章,
CATT Results Released: Avastin and Lucentis Equivalent for AMD 29 04 2011
Well, it’s the big news today. The one-year results of the NIH sponsored CATT trial, comparing Avastin (bevacizumab) and Lucentis (ranibizumab) in a head-to-head comparison for the treatment of AMD were released early. The results at one year show equal efficacy in terms of visual acuity. Interestingly, the study also show that prn dosing results in equal visual acuities when compared to monthly dosing.
Here are the key paragraphs from the NIH press release. The full article is available online at the NEJM site, if you have access to that site.
“NEI launched CATT in 2008 to compare Lucentis and Avastin for treatment of wet AMD. The study has now reported results for 1,185 patients treated at 43 clinical centers in the United States. Patients were randomly assigned and treated with one of four regimens for a year. They received Lucentis monthly or PRN, or Avastin monthly or PRN. Enrollment criteria required that study participants had active disease.
“Patients in the monthly dosing groups received an initial treatment and then had an injection every 28 days. Patients in the PRN groups received an initial treatment and were then examined every 28 days to determine medical need for additional treatment. PRN groups received subsequent treatment when there were signs of disease activity, such as fluid in the retina. Ophthalmologists involved in patient care did not know which study drug a patient was getting, to make sure that the data was not affected by how anyone felt about the treatment.
“Change in visual acuity served as the primary outcome measure for CATT. Thus far, visual acuity improvement was virtually identical (within one letter difference on an eye chart) for either drug when given monthly. In addition, no difference was found in the percentage of patients who had an important gain or loss in visual function. Also, when each drug was given on a PRN schedule, there also was no difference (within one letter) between drugs. PRN dosing required four to five fewer injections per year than monthly treatment. Visual gains were about two letters less with PRN than with monthly treatment but overall visual results were still excellent.
“‘In addition to the primary finding of equivalence between Lucentis and Avastin for visual acuity, CATT also demonstrates that PRN dosing is a viable treatment option for either of these drugs,’ said Daniel F. Martin M.D., study chair for CATT and chairman of the Cole Eye Institute at the Cleveland Clinic. ‘Substantial visual acuity gains may be accomplished with a lower treatment burden.’
“Adverse events indicate development or worsening of a medical condition. They may or may not be causally associated with the clinical trial treatment, but they are always monitored and reported in any clinical trial. The median age of patients in CATT was over 80 years, and a high rate of hospitalizations might be anticipated as a result of chronic or acute medical conditions more common to older populations.
“Serious adverse events (primarily hospitalizations) occurred at a 24 percent rate for patients receiving Avastin and a 19 percent rate for patients receiving Lucentis. These events were distributed across many different conditions, most of which were not associated with Avastin in cancer clinical trials where the drug was administered at 500 times the dose used for AMD. The number of deaths, heart attacks, and strokes were low and similar for both drugs during the study. CATT was not capable of determining whether there is an association between a particular adverse event and treatment. Differences in serious adverse event rates require further study.
“Investigators in the CATT study will continue to follow patients through a second year of treatment. These additional data will provide information on longer-term effects of the drugs on vision and safety.
Lucentis vs Avastin: Who will win the race?
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David Khorram, MD, Editor
David Khorram, MD is the co-founder of Marianas Eye Institute, and the medical director of the Center for Advanced Diabetic Eye Care. A US-trained Board Certified ophthalmologist, he is listed in "Guide to America's Top Ophthalmologists." Dr. Khorram is an investigator for the Diabetic Retinopathy Clinical Research Network (DRCR.net) and an international member of the American Society of Retina Specialists.
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发表于 2011-5-4 12:35
