出版空间以及编辑关注度的竞争异常激烈。将原稿投送给杂志编辑，附上一封信“原稿请见附件”是远远不够的。投稿信是你与拟投杂志直接交流的机会。除了写明你的研究与众不同外，还应直接向总编辑说明为什么你的发现很重要及其应该在此杂志上发表的理由。 投稿信应含有几个重要内容。具体内容可通过www.liwenbianji.cn/coverletter 链接下载。大家可根据批注中的建议起草你自己的投稿信，选择提出的句子类型替代括号中的句子。投稿信的格式几乎适用于所有投稿；当然，某些类别的论文需要加入额外的内容。例如，关于临床试验数据的存储信息通常需要附上一份临床试验报告，提供你的序列数据进入公共数据库的信息。 查阅目标杂志的《稿约》是每篇稿件的既定程序，其中很可能含有投稿信必须写入的内容。另外一个信息来源是杂志的投稿网页。尽管以下列出的内容以及关于“Edanz投稿信模版”中描述的内容不一定完全都是这些目标杂志所要求的，但所有这些都是投稿信中必不可少的，因为这样做可引起编辑对你的关注。以下方法适用于投稿信的撰写： • 一些杂志根据其刊出文章领域的不同进行编辑分工，你可以根据不同的领域，有时也可根据编辑的专业背景选择最合适的编辑。直接称呼收信编辑，如：“Dear Dr. Smith”。如果不能找到合适的编辑，可将投稿信写给总编辑。 • 信的开头应写出文章题目，希望文章在杂志的哪一个栏目或作为哪一个文章类别发表，以及投稿杂志的名称。 • 之后简单叙述研究背景与理论基础，说明研究目的以及开展的工作。然后简单描述研究成果。 • 接下来的段落很重要。你需要向研究界解释你的发现的意义，特别是对杂志读者的意义。如果你不能解释为什么该杂志读者会对你的发现感兴趣，你需要选择另一家更合适的刊物，因为编辑只将他们认为会引起读者兴趣的文章送同行评议。研究一下你准备投稿杂志的“目标与刊出范围”会对你有帮助。 • 投稿信的最后一段应包含杂志所要求的声明或说明。这些通常包括关于利益冲突、基金资助与资助来源的声明，以及所有作者已阅读过并同意文章的内容以及未一稿多投的声明。每个作者的作者资格确认也是需要的。 • 最后，留下详细的通讯方式以及礼貌的结束语。 示例： 英文原文 The cover letter: your sales pitch Competition for publication space and for editors’ attention is now very high, and it is no longer sufficient to send a manuscript to a journal editor along with a letter saying little more than “please find my manuscript attached”. The cover letter is your opportunity to directly address the editor of your target journal. It can be used to set your study apart from others and directly explain to the editor why your findings are important and why they should be published in their journal. There are a number of important components of a cover letter, all of which should be included. These components are described in detail in Edanz Cover Letter Template, which is shown on the following page and can be downloaded from: www.liwenbianji.cn/coverletter. This template can be used to develop your own cover letters by following the suggestions in the comments and replacing the bracketed sentences with the types of sentences explained. The format of this letter is applicable for most if not all submissions, although additional sections may be required for some types of paper; for example, information about deposition of clinical trial data would most likely need to accompany a report of a clinical trial, and information about the deposition of sequence data into public databases would possibly need to be provided where such data has been obtained. As always, the target journal’s instructions to authors should be consulted; these will most likely outline the information that absolutely must be included in the cover letter. Another source of this information is the journal’s submission webpages. Although not all of the components listed below and described in the cover letter template will be described as required on the target journal’s webpages, all should be included in your letter, because to do so will increase your chances of grabbing the editor’s attention. The following principles apply to cover letter development: • Some journals have different editors for the different areas of research the journal covers and you can choose the most appropriate one based on area and occasionally also editor profiles. Address your letter personally to the appropriate editor, e.g., “Dear Dr. Smith”. If one cannot be readily identified, address your letter to the editor-in-chief. • Begin by providing the title of your manuscript, the section/publication type you would like to see it published as, and the name of the journal you are submitting it to. • You then need to provide a very brief background and rationale for your study, explaining why you did what you did. This can be followed by a brief description of the results. • The following paragraph is very important. You will need to explain the significance of your findings to the research community, and specifically to the readers of your target journal. If you find it difficult to explain why the readers of that journal would be interested in your findings, then you may need to select a more appropriate journal. Editors will only send papers to review that they think will be of interest to their readers. Studying the ‘aims and scope’ of your chosen journal might help with this. • The last paragraph of the letter should contain any statements or declarations required by the target journal. These usually include declarations of any conflicts of interest, grant support or other sources of funding, a statement that all authors have read and approved the manuscript and a statement that the same manuscript has not been submitted elsewhere. Confirmation of each author’s qualification for authorship may also be required. • Finally, include details for correspondence and a polite farewell. Example: Dr Daniel McGowan 分子神经学博士 理文编辑学术总监
本研究的亮点：采用随机、双盲、安慰剂对照，观察了氢气水对患者线粒体和炎症肌病（肌肉营养不良）的治疗效果。 分子氢气具有许多神奇的效应，超过 30 多种动物疾病模型中发现氢气具有治疗氧化应激相关疾病的作用。更重要的是，在临床研究中，人们发现氢气对人类二型糖尿病、血液透析、代谢综合征、肝癌放射治疗的损伤、脑干中风具有显著治疗效果。氢气治疗疾病的细胞学机制被认为是通过清除羟基自由基、过氧亚硝酸根这样具有强大氧化作用的自由基（不影响温和的过氧化氢等），而且氢气也可以影响细胞内信号系统。但是目前人们对氢气生物效应的分子细节仍不清楚（这里确实是一个非常令人值得期待的研究方向）。氢气是一个具有生物安全性的分子，人体内不停产生，到目前几乎没有任何明显不良作用被发现。因此氢气相关药物可能成为一类令人神往的临床应用药物。本文是第一个氢气医学领域的双盲随机对照研究。 先开展的开放性试验（试探性研究）中让进行性肌肉营养不良（ 进行性肌萎缩 ） 患者每天饮 1 升富氢气水，连续 12 周。其中， 4 例患者为 多发性肌炎 - 皮肌炎（似乎是自身免疫性疾病）， 5 例患者为线粒体病。每四周检测 18 类血清学指标和尿的人 8- 异前列腺素 F2a （ 8-isoprostane 是可以说明氧化损伤程度的指标）。在随后的随机、双盲、安慰剂试验中，有 10 例 DM( 肌病 ) 和 12 例 线粒体病患者，给患者连续 8 周（怎么没有用 12 周） 0.5 升富氢水（为什么不是 1 升）或普通水（安慰剂），每 4 周检测 18 类血清指标。 研究结果：在该开放性研究（患者和医生了解治疗情况的研究）中，没有发现临床症状的加重或减轻。但是，发现氢气在肌肉病患者中乳糖 / 丙酮酸比例，餐后血糖，血清 MMP3 和血清甘油三脂具有显著影响。在双盲试验中，也没有发现明显的临床效果，但 DM 患者的乳糖 / 丙酮酸比例，和 MM 患者的血清 MMP3 仍明显改变，尽管没有统计学差异。没有在糖尿病患者中发现任何不良效应。 结论：氢气水 MM 患者的对线粒体功能和 PM/DM 患者的炎症反应过程具有治疗效果，但双盲试验中效果较差的原因可能是剂量比较小和观察时间比较短（为什么不增加剂量，延长观察时间？）。但也说明氢气的效果存在一个最低有效剂量（意思是说不能喝太少，至少要 1 升，有广告嫌疑），而且有剂量效应（更确认效果的可靠性）。 Research Open-label trial and randomized, double-blind, placebo-controlled, crossover trial of hydrogen-enriched water for mitochondrial and inflammatory myopathies Mikako Ito , Tohru Ibi , Ko Sahashi , Masatoshi Ichihara , Masafumi Ito and Kinji Ohno For all author emails, please log on . Medical Gas Research 2011, 1 :24doi:10.1186/2045-9912-1-24 Published: 3 October 2011 Abstract (provisional) Background Molecular hydrogen has prominent effects on more than 30 animal models especially of oxidative stress-mediated diseases and inflammatory diseases. In addition, hydrogen effects on humans have been reported in diabetes mellitus type 2, hemodialysis, metabolic syndrome, radiotherapy for liver cancer, and brain stem infarction. Hydrogen effects are ascribed to specific radical-scavenging activities that eliminate hydroxyl radical and peroxynitrite, and also to signal-modulating activities, but the detailed molecular mechanisms still remain elusive. Hydrogen is a safe molecule that is largely produced by intestinal bacteria in rodents and humans, and no adverse effects have been documented. Methods We performed open-label trial of drinking 1.0 liter per day of hydrogen-enriched water for 12 weeks in five patients with progressive muscular dystrophy (PMD), four patients with polymyositis/dermatomyositis (PM/DM), and five patients with mitochondrial myopathies (MM), and measured 18 serum parameters as well as urinary 8-isoprostane every 4 weeks. We next conducted randomized, double-blind, placebo-controlled, crossover trial of 0.5 liter per day of hydrogen-enriched water or placebo water for 8 weeks in 10 patients with DM and 12 patients with MM, and measured 18 serum parameters every 4 weeks. Results In the open-label trial, no objective improvement or worsening of clinical symptoms was observed. We, however, observed significant effects in lactate-to-pyruvate ratios in PMD and MM, fasting blood glucose in PMD, serum matrix metalloproteinase-3 (MMP3) in PM/DM, and serum triglycerides in PM/DM. In the double-blind trial, no objective clinical effects were observed, but a significant improvement was detected in lactate in MM. Lactate-to-pyruvate ratios in MM and MMP3 in DM also exhibited favorable responses but without statistical significance. No adverse effect was observed in either trial except for hypoglycemic episodes in an insulin-treated MELAS patient, which subsided by reducing the insulin dose. Conclusions Hydrogen-enriched water improves mitochondrial dysfunction in MM and inflammatory processes in PM/DM. Less prominent effects with the double-blind trial compared to the open-label trial were likely due to a lower amount of administered hydrogen and a shorter observation period, which implies a threshold effect or a dose-response effect of hydrogen. The complete article is available as a provisional PDF . The fully formatted PDF and HTML versions are in production.
标签: 临床试验
