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| 1 | 报告随机对照试验的CONSORT声明修订版:说明与详述(一)显示文摘有充分的证据表明目前随机对照试验(RCT)的报告质量不尽如人意。最近的方法学调查表明,不恰当的报告及试验设计将使治疗措施的效果产生偏倚。这种系统偏差正严重损害RCT本可摒弃系统偏差的特征。RCT中的系统偏差反映出了科学性差,而科学性差会严重影响正确的伦理标准。科学家和编辑们共同制定了CONSORT(试验报告统一标准,ConsolidatedStandardsofReportingTrials,)声明以提高RCT报告质量。CONSORT声明由清单和流程图组成,作者可用来报告RCT。许多优秀期刊和重要国际性编辑组织已经采用CONSORT声明。CONSORT声明为作者提高临床试验报告质量提供指南,使得评价和解释RCT结果更方便。此文旨在增强大家对CONSORT声明的理解、应用和传播,并对每个清单项目的意义和原理进行了说明。很多项目都列出优秀报告的示例,并尽可能参考相关的经验性研究,还列出几个流程图的示例。CONSORT声明的说明和详述文件在以下网址可找到:http://www.consort-statement.org,这是提高随机对照试验报告质量的有益资源。 | Douglas G.Altman Kenneth F.Schulz David Moher Matthias Egger Frank Davidoff Diana Elbourne Peter C.Gφtzsch Thomas Lang the CONSORT Group 刘雪梅 | 2005 | 中国循证医学杂志2005，5，9： | 19 |
| 2 | 报告随机对照试验的CONSORT声明修订版:说明与详述(三)显示文摘 | Douglas G.Altman Kenneth F.Schulz David Moher Matthias Egger Frank Davidoff Diana Elbourne Peter C.GФtzsch Thomas Lang 刘雪梅 | 2005 | 中国循证医学杂志2005，5，11： | 8 |
| 3 | 报告随机对照试验的CONSORT声明修订版:说明与详述(六)显示文摘 | Douglas G.Altman Kenneth F.Schulz David Moher Matthias Egger Frank Davidoff Diana Elbourne Peter C.Gφtzsche Thomas Lang 姚巡 | 2006 | 中国循证医学杂志2006，6，2： | 7 |
| 4 | 报告随机对照试验的CONSORT声明修订版:说明与详述(七)显示文摘第18条通过报告所有所做的分析,探讨各种可能影响结果的因素,包括亚组分析和校正分析,并指出哪些分析是既定的,哪些是临时增加的举例 另一个有趣的发现是,是否使用维生素A治疗与随之表现出的疾病严重程度有一定联系。使用维生素A治疗的住院患者的转归较未使用维生素A的门诊患者稍好。虽然该结果来自研究方案既定的亚组分析,但两组差异无统计学意义(α=0.05) | Douglas G.Altman Kenneth F.Schulz David Moher Matthias Egger Frank Davidoff Diana Elbourne Peter C.Gotzsche Thomas Lang 孙丁 | 2006 | 中国循证医学杂志2006，6，3： | 5 |
| 5 | Low serum neutralizing anti-SARS-CoV-2 S antibody levels in mildly affected COVID-19 convalescent patients revealed by two different detection methods显示文摘Neutralizing antibodies targeting the receptor-binding domain(RBD)of the SARS-CoV-2 spike(S)block severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)entry into cells via surface-expressed angiotensin-converting enzyme 2(ACE2).We used a surrogate virus neutralization test(sVNT)and SARS-CoV-2 S protein-pseudotyped vesicular stomatitis virus(VSV)vector-based neutralization assay(pVNT)to assess the degree to which serum antibodies from coronavirus disease 2019(COVID-19)convalescent patients interfere with the binding of SARS-CoV-2 S to ACE2.Both tests revealed neutralizing anti-SARS-CoV-2 S antibodies in the sera of ~90% of mildly and 100% of severely affected COVID-19 convalescent patients.Importantly,sVNT and pVNT results correlated strongly with each other and to the levels of anti-SARS-CoV-2 S1 IgG and IgA antibodies.Moreover,levels of neutralizing antibodies correlated with the duration and severity of clinical symptoms but not with patient age.Compared to pVNT,sVNT is less sophisticated and does not require any biosafety labs.Since this assay is also much faster and cheaper,sVNT will not only be important for evaluating the prevalence of neutralizing antibodies in a population but also for identifying promising plasma donors for successful passive antibody therapy. | Berislav Bosnjak Saskia Catherina Stein Stefanie Willenzon Anne Katrin Cordes Wolfram Puppe Gunter Bernhardt Inga Ravens Christiane Ritter Christian R.Schultze-Florey Nina Godecke Jorg Martens Hannah Kleine-Weber Markus Hoffmann Anne Cossmann Mustafa Yilmaz Isabelle Pink Marius M.Hoeper Georg M.N.Behrens Stefan Pohlm ann Rainer Blasczyk Thomas F.Schulz Reinhold Forster | 2021 | Cellular & Molecular Immunology2021，18，4： | 2 |
| 6 | Endothelial dysfunction contributes to severe COVID-19 in combination with dysregulated lymphocyte responses and cytokine networks显示文摘The systemic processes involved in the manifestation of life・threatening COVID-19 and in disease recovery are still incompletely understood,despite investigations focusing on the dysregulation of immune responses after SARS-CoV-2 infection.To define hallmarks of severe COVID-19 in acute disease(n=58)and in disease recovery in con valesce nt patie nts(n=28)from Han nover Medical School,we used flow cytometry and proteomics data with unsupervised clustering analyses.In our observational study,we combined analyses of immune cells and cytokine/chemokine networks with endothelial activation and injury.ICU patients displayed an altered immune signature with prolonged lymphopenia but the expansion of granulocytes and plasmablasts along with activated and terminally differentiated T and NK cells and high levels of SARS-CoV-2-specific antibodies.The core signature of seven plasma proteins revealed a highly inflammatory microenvironment in addition to endothelial injury in severe COVID-19.Changes within this sign ature were associated with either disease progression or recovery.In summary,our data suggest that besides a strong inflammatory response,severe COVID-19 is driven by endothelial activation and barrier disruption,whereby recovery depends on the regeneration of the endothelial integrity. | Louisa Ruhl Isabell Pink Jenny F.Kiihne Kerstin Beushausen Jana Keil Stella Christoph Andrea Sauer Lennart Boblitz Julius Schmidt Sascha David Hans-Martin Jack Edith Roth Markus Cornberg Thomas F.Schulz Tobias Welte Marius M.Hoper Christine S.Falk | 2022 | Signal Transduction and Targeted Therapy2022，7，1： | 1 |
| 7 | 报告随机对照试验的CONSORT声明修订版:说明与详述(二)显示文摘 | Douglas G.Altman Kenneth F.Schulz David Moher Matthias Egger Frank Davidoff Diana Elbourne Peter C.Gtzsch Thomas Lang 8刘雪梅 | 2006 | 中国实用内科杂志:临床前沿版2006，26，3： | 1 |
| 8 | 报告随机对照试验的CONSORT声明修订版:说明与详述(八)显示文摘 | Douglas G.Altman Kenneth F.Schulz David Moher Matthias Egger Frank Davidoff Diana Elbourne Peter C.Gφtzsch Thomas Lang 杜亮 黄楷森 何顶秀 张小利 秦文霞 袁文明 | 2006 | 中国实用内科杂志:临床前沿版2006，26，10： | 1 |
| 9 | 随机对照试验的CONSORT声明修订版:说明与详述(六)显示文摘 | Douglas G.Altman Kenneth F.Schulz David Moher Matthias Egger Frank Davidoff Diana Elbourne Peter C.Gφtzsch Thomas Lang 姚巡 秦莉 | 2006 | 中国实用内科杂志:临床前沿版2006，26，7： | 0 |
| 10 | 随机对照试验的CONSORT声明修订版:说明与详述(七)显示文摘 | Douglas G.Altman Kenneth F.Schulz David Moher Matthias Egger Frank Davidoff Diana Elbourne Peter C.Gφtzsch Thomas Lang 孙丁 | 2006 | 中国实用内科杂志:临床前沿版2006，26，9： | 0 |
| 11 | 随机对照试验的CONSORT声明修订版:说明与详述(五)显示文摘 | Douglas G.Altman Kenneth F.Schulz David Moher Matthias Egger Frank Davidoff Diana Elbourne Peter C.Gφtzsch Thomas Lang 孙丁 廖家群 秦莉 李幼平 | 2006 | 中国实用内科杂志:临床前沿版2006，26，6： | 0 |
| 12 | 随机对照试验的CONSORT声明修订版:说明与详述(四)显示文摘 | Douglas G.Altman Kenneth F.Schulz David Moher Matthias Egger Frank Davidoff Diana Elbourne Peter C.Gφtzsch Thomas Lang 刘雪梅 | 2006 | 中国实用内科杂志:临床前沿版2006，26，5： | 0 |
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