Fever with Thrombocytopenia Associated with a Novel Bunyavirus in China （新英格兰医学杂志，影响因子51.29） 转眼便六月，QQ、校内，到处充满了毕业的气息。 反思研究生三年， 对科学的爱和失望充斥着头脑。 三年的研究生，我最珍贵的东西，莫过于能够理解“仰视常识、俯视理论、重视假设”这十二个字的深远与厚重。对此，时而高兴，时而沮丧。高兴的是自己的想法与别人不同，能理解科学最本质的东西；沮丧的是科学的本质和中国文化相差太远，周边的人均无法理解自己。科学在这片土地上，有点像小三，或者青楼女子，随着兴子，大家玩玩罢了。 诸多的不确定性，或者说人生的迷茫，我还是选择了先工作。 前几天在网上看到一篇文章，《 谁先发现重要吗？ 》，里面讲述了中国科研界的一件大事。中国科学家发现了一个全新的流行病毒，文章发表在新英格兰医学杂志（ Fever with Thrombocytopenia Associated with a Novel Bunyavirus in Chi na ），而文章的作者之一，据说是主要的一线科学家之一Shou-Yin Zhang（张守印），他的名字后面却打了个星号，标示为：Deceased（已故）。 经过查询，才知原来张守印已 跳楼自杀 。 这篇文章讲的就是2009年湖北、河南地区所传言的蜱螨叮咬之后，传播怪病的故事。死者大多发高烧，血小板急剧减少。这种致死的病症被称为发热伴血小板减少综合征（severe fever with thrombocytopenia syndrome (SFTS)）。 SFTS致死率高达30%，病因被风传为 蜱螨叮咬后，感染人粒细胞无形体（anaplasma phagocytophilum）。经过中国疾控中心调研发现 后不是 人粒细胞无形体 ，而是一种全新的传染病毒，新亚型布尼亚病毒。 新亚型布尼亚病毒形态解剖图 A. 细胞病变图B.萤光染色图C.背景染色图 D. 电镜扫描图 遗传系谱图 文章结果分为两部分，一是 新亚型布尼亚病毒 形态解剖图，二是分子系谱图。形态解剖是发现新物种现的经典手段，通过形态特征鉴定新的物种，而新的手段则依据物种的遗传信息，通过分析遗传结构（DNA或RNA）确定新的物种。两种方法都被科学界认可。 按说，这应该是中国科学界的荣耀。中国的科学界发现了在国内的致死传染性疾病的治病病毒。这是医学家、科学界的义务，但也足以给作者带来荣耀和名誉。但 张守印 之死给新发现蒙上了一层厚厚的阴影。在张的悼词里这样写道： 2009年，张守印通过对湖北疫情的分析和研究，首次分离出“新型布尼亚病毒”，成为华人史上发现病毒的第一人，是中国乃至世界 病毒史上一次跨越性的飞跃，为人类做出了巨大贡献。 据说，张守印研究组首先通过形态解剖，发现了新病毒。文章投到柳叶刀之后，另一位研究人员于学杰给编辑写信说他们是第一个发现新病毒的。由于归属不清，柳叶刀杂志将文章退了回来。 据说 ，直道卫生部部长出面才平息了此事，成果大家共享，于是有了新英格兰医学杂志的文章 Fever with Thrombocytopenia Associated with a Novel Bunyavirus in Chi na ，和两种方法鉴别新病毒的图表。 看了这个有些心酸的故事。第一反应是，科学不应该是这样的。 本来，研究本身就应该关注国家最需要，最迫切和最基础的问题，比如疾病、政治体制、环境、卫生、建筑、交通，经济、贫困等等，这些是中国科学家的责任。而现状是，不少地方有怪病了，没人在意；有问题了，也没有研究。更有甚者，SARS、甲流，这些本身又是科研上极好的资源，中国很多科学家都不给外人研究，自己蒙头搞。最后，于国家，于个人都没有意义。 更可怕的是，自己搞不出来，还不让别人搞，到最后苦了老百姓。 说到这里，不禁想起北宋哲学家张载的那句话。“为天地立心，为生民立命， 为往圣继绝学，为万世开太平。” 什么时候，我们的科学能有如此立意？ 只期望别走得太远，太远。
体会：言必称希腊，与一切从循证出发，都是本本主义的表现。 NEJM公布阿瓦斯丁对比Lucentis裁决书, 效果相仿,价格差40倍 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? Notify me of follow-up comments via email. Subscribe to this site by email David Khorram, MD, Editor http://1.gravatar.com/avatar/917c493f63651ef7db1a6a40fdb2b60f?s=128d=identiconr=G 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 Americaapos;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. 阿瓦斯丁与Lucentis对比结果裁决 http://www.dxyer.cn/jinwsapa/2011/05/02/33_1565/
标签: 新英格兰
