胸腔镜下心包厚壁囊肿切除术1例报告

面对来势汹汹的新型冠状病毒肺炎(COVID-19),如何能够正确、快速诊断和筛检出确诊病例显得尤为重要,国内诸多科技工作者都在积极开展相关的诊断试验研究。本文回顾了目前正在开展的十余项诊断试验的注册信息,针对其中存在的共性问题进行了讨论,重点阐述了如何使用PICOS原则构造COVID-19诊断试验的研究问题,还对金标准的设置、受试者的代表性、样本量计算和同步、独立、盲法的测定等诊断试验的设计要点进行了详细说明。旨在为广大研究者提供开展COVID-19诊断试验的设计建议,帮助研究者在顶层设计阶段减少、避免偏倚,完成高质量的临床研究,为临床诊疗提供循证医学证据。     

新型冠状病毒肺炎诊断的相关实验室检测技术应用

2019年底暴发的新型冠状病毒肺炎(COVID-19)已成全球蔓延态势,对世界公共卫生安全造成了重大威胁。实验室检测在COVID-19诊治全过程都具有重要价值。目前,严重急性呼吸综合征冠状病毒2(SARSCoV-2)核酸检测仍是诊断COVID-19的金标准。文章对COVID-19的确诊、鉴别诊断及辅助诊断相关实验室检测技术的原理、优缺点、现有研究情况、结果判读等问题进行综述,以期为临床医生及检验工作者提供参考。     

新型冠状病毒肺炎诊疗:从方案更新到临床实践

2019年年末新型冠状病毒肺炎(COVID-19)疫情出现,全国上下同心进行了全民防疫阻击战。全国军队、地方医疗队分批驰援湖北,其他省市地区强化防控管理、对确诊及疑似病例进行集中收治。该文对国家卫生健康委员会COVID-19诊疗方案更新、诊断流程图、治疗实践体会进行了解读述评,以期为COVID-19的进一步临床诊断治疗提供参考。     

SAA联合CRP、血常规检测在新型冠状病毒肺炎中的诊断价值

目的探讨血清淀粉样蛋白A(SAA)联合血常规、C反应蛋白(CRP)检测在新型冠状病毒肺炎(COVID-19)诊断中的价值。方法选取襄阳市中心医院30例COVID-19住院患者(COVID-19组),以33名体检健康者作为对照组,收集并分析所有研究对象的血常规、CRP、SAA检测数据以及临床资料。结果与对照组比较,COVID-19组体温、中性粒细胞百分比(NEUT%)、CRP、SAA显著升高,淋巴细胞百分比(LYMPH%)显著降低(P0.01),但白细胞(WBC)计数差异无统计学意义(P0.05)。COVID-19组5个血液学指标中SAA的阳性率最高(93.3%)。受试者工作特征(ROC)曲线分析结果显示,SAA诊断COVID-19的曲线下面积(AUC)为0.994,最佳临界值为6.43 mg/L,敏感性和特异性分别为100%和91.9%。不同电子计算机断层扫描(CT)分期患者比较,SAA的差异有统计学意义(P0.01),SAA判断CT分期的AUC为0.851,敏感性和特异性分别为82.4%和76.9%。结论血液学指标,尤其是SAA,可快速、准确地辅助诊断COVID-19,为临床及时诊治提供参考。     

北京某综合三甲医院对COVID-19疑似和非疑似患者进行SARS-CoV-2核酸筛查结果分析

目的 以北京综合三甲医院为例,对新型冠状病毒肺炎(COVID-19)疑似患者和非疑似患者的新型冠状病毒(SARS-CoV-2)核酸筛查结果进行分析,为COVID-19的实验室诊断提供实验依据.方法 SARS-CoV-2核酸检测的咽拭子标本来自2595例患者,COVID-19疑似患者81例,非疑似患者2514例.咽拭子标...     

SARS-CoV-2抗体检测在新型冠状病毒肺炎诊断中的应用价值

目的探讨血清严重急性呼吸综合征冠状病毒(SARS-CoV-2)IgM和IgG抗体检测在新型冠状病毒肺炎(COVID-19)诊断中的价值。方法选取COVID-19患者173例(COVID-19组),其中140例SARSCoV-2首次核酸检测阳性,33例多次检测后呈阳性。以101例排除COVID-19的患者作为对照组。采用胶体金免疫层析法(CGIA)检测SARS-CoV-2 IgM和IgG抗体,采用荧光定量聚合酶链反应(PCR)检测SARS-CoV-2核酸。以临床诊断为金标准,分析SARS-CoV-2 IgM和IgG抗体诊断COVID-19的效能。结果 SARS-CoV-2 IgM和IgG抗体的敏感性分别为76.9%、74.6%,特异性分别为94.0%、95.1%,临床总符合率分别为83.2%、82.1%,与临床诊断的一致性均较好(kappa值分别为0.663、0.644)。受试者工作特征(ROC)曲线分析结果显示,SARS-CoV-2 IgM和IgG抗体诊断COVID-19的曲线下面积(AUC)均为0.85。结论 SARS-CoV-2抗体检测具有较高的敏感性、特异性和临床总符合率,可用于COVID-19的辅助诊断。     

2例新型冠状病毒肺炎粪便SARS-CoV-2核酸阳性临床启示

目前中国新型冠状病毒肺炎(COVID-19)疫情仍十分严峻,及时、早期地识别COVID-19患者是控制疫情的关键步骤。而新型冠状病毒(SARS-CoV-2)核酸检测作为诊断COVID-19的金标准,不但对检测技术提出更高的要求,同时对不同病程患者如何选择标本类型也是一个挑战。本文报道2例COVID-19确诊病例的诊疗经过,并分析采用不同类型标本检测SARS-CoV-2核酸的检出情况,为临床诊断COVID-19时如何选择标本类型和如何提高核酸检出率提供参考。     

基于文献计量学的中国新型冠状病毒感染影像学研究分析

目的 通过文献计量学的方法分析我国新型冠状病毒感染（coronavirus disease 2019, COVID-19影像研究者发表于国内外的论文,探讨COVID-19影像学研究热点,为应对长期COVID-19带来的挑战提供参考和指引。方法 在Web of Science和中国科学引文数据库检索2020年1月1日-2022年12月31日中国作者发表的COVID-19影像相关文献。应用CiteSpace软件进行文献计量及可视化分析。结果 共纳入文献2 229篇（Web of Science数据库1 771篇,中国科学引文数据库458篇）。月度发文量呈显著增长再缓慢下降,而后维持在稳定水平的趋势。关键词及共被引聚类分析显示COVID-19影像领域的研究热点是COVID-19临床特征、影像鉴别诊断以及人工智能的应用。关键词突现分析显示爆发强度最强的关键词是“deep learning”（深度学习）,爆发时长最长的关键词是“attention mechanism”（注意力机制）。结论 近年来COVID-19影像领域研究稳中有进,医学影像人工智能领域最受关注。研究者们的关注重点是COVID-1...     

COVID-19疫情下临床检验面对的挑战与对策

新型冠状病毒肺炎(COVID-19)的暴发和流行给临床检验带来了巨大的挑战,检验科承担了疑似和确诊患者标本的相关实验室指标的检测,而患者的标本都具有较强的传染性。核酸检测为诊断COVID-19的主要方法,但假阴性率较高。因此,在COVID-19疫情下临床检验需要在做好防护的同时提高COVID-19的诊断效率。     

新型冠状病毒肺炎的鉴别诊断:从初筛到确诊

根据《中华人民共和国传染病防治法》,新型冠状病毒肺炎(COVID-19)作为乙类传染病,按照甲类传染病进行管理。医院发热门诊在此次疫情防控中作为第一道防线,对呼吸道常见感染性疾病的鉴别诊断极为重要。《新型冠状病毒肺炎诊疗方案(试行第七版)》中明确指出,COVID-19应与4种呼吸道常见感染性疾病相鉴别。本文综述了COVID-19的鉴别要点,以期为工作在发热门诊一线的检验同行提供参考。     

新型冠状病毒肺炎(COVID-19)临床研究的启示与国家临床试验网络构想

新型冠状病毒肺炎(COVID-19)疫情爆发以来,从2020年1月23日至2020年3月5日由中国临床研究人员在中国临床试验注册中心(www.chictr.org.cn)和美国临床试验注册网站(www.clinicaltrials.gov)两个平台上登记注册并已经或将要在中国境内进行的针对新型冠状病毒肺炎的干预性临床试验项目总数已超过200个。这一现象引起了社会各界的关注。本文在对已登记注册的249个在中国开展的COVID-19临床试验项目的主要特征作描述性分析的基础上,借鉴美国国家卫生研究院(National Institutes of Health)组建的专项疾病领域国家临床试验网络的实践,思考在突发流行病情况下提高临床试验质量与效率的对策。     

Data monitoring committees for clinical trials evaluating treatments of COVID-19

The first cases of coronavirus disease 2019 (COVID-19) were reported in December 2019 and the outbreak of SARS-CoV-2 was declared a pandemic in March 2020 by the World Health Organization. This sparked a plethora of investigations into diagnostics and vaccination for SARS-CoV-2, as well as treatments for COVID-19. Since COVID-19 is a severe disease associated with a high mortality, clinical trials in this disease should be monitored by a data monitoring committee (DMC), also known as data safety monitoring board (DSMB). DMCs in this indication face a number of challenges including fast recruitment requiring an unusually high frequency of safety reviews, more frequent use of complex designs and virtually no prior experience with the disease. In this paper, we provide a perspective on the work of DMCs for clinical trials of treatments for COVID-19. More specifically, we discuss organizational aspects of setting up and running DMCs for COVID-19 trials, in particular for trials with more complex designs such as platform trials or adaptive designs. Furthermore, statistical aspects of monitoring clinical trials of treatments for COVID-19 are considered. Some recommendations are made regarding the presentation of the data, stopping rules for safety monitoring and the use of external data. The proposed stopping boundaries are assessed in a simulation study motivated by clinical trials in COVID-19.     

Ethical Challenges in COVID-19 Biospecimen Research: Perspectives From Institutional Review Board Members and Bioethicists

Biospecimen research is a prominent investigative strategy that aims to provide novel insights into coronavirus disease 2019 (COVID-19), inform clinical trials, and develop effective, life-saving treatments. However, COVID-19 biospecimen research raises accompanying ethical concerns and practical challenges for investigators and participants. In this special article, we discuss the ethical issues that are associated with autonomy, beneficence, and justice in COVID-19 biospecimen research and describe strategies to manage the practical challenges, with an emphasis on protecting the rights and welfare of human research participants during a pandemic response. Appropriate institutional review board oversight and bioethics guidance for COVID-19 biospecimen research must maintain their focus on protecting the rights and welfare of research participants, despite the urgent need for more knowledge about the virus and the threat it poses to communities and nations.     

A Framework for Systematic Assessment of Clinical Trial Population Representativeness Using Electronic Health Records Data

Background  Clinical trials are the gold standard for generating robust medical evidence, but clinical trial results often raise generalizability concerns, which can be attributed to the lack of population representativeness. The electronic health records (EHRs) data are useful for estimating the population representativeness of clinical trial study population. Objectives  This research aims to estimate the population representativeness of clinical trials systematically using EHR data during the early design stage. Methods  We present an end-to-end analytical framework for transforming free-text clinical trial eligibility criteria into executable database queries conformant with the Observational Medical Outcomes Partnership Common Data Model and for systematically quantifying the population representativeness for each clinical trial. Results  We calculated the population representativeness of 782 novel coronavirus disease 2019 (COVID-19) trials and 3,827 type 2 diabetes mellitus (T2DM) trials in the United States respectively using this framework. With the use of overly restrictive eligibility criteria, 85.7% of the COVID-19 trials and 30.1% of T2DM trials had poor population representativeness. Conclusion  This research demonstrates the potential of using the EHR data to assess the clinical trials population representativeness, providing data-driven metrics to inform the selection and optimization of eligibility criteria.     

基于CT影像的COVID-19智能辅助诊断方法

目的结合COVID-19患者肺部CT影像学特征,探讨深度学习技术在COVID-19辅助诊断上的价值。方法搜集武汉大学中南医院和华中科技大学同济医学院确诊为COVID-19患者的部分CT影像资料构建小样本COVID-19数据集,将VGG-16具有提取高层抽象特征部分与设计的全连接层共同构成初步的基于迁移学习的COVID-19智能辅助诊断模型,使用COVID-19训练集迭代训练诊断模型,不断优化全连接层网络参数,最后训练出一个基于VGG-16卷积神经网络迁移学习的COVID-19智能辅助诊断模型。结果在COVID-19测试集中早期、进展期和重症期3个类别的样本上,COVID-19智能辅助诊断模型测试的敏感度分别为0.95、0.93和0.96,F1 Score分别为0.98、0.95和0.92,综合的诊断准确率达到94.59%。结论小样本数据集上采用迁移学习技术训练的COVID-19辅助诊断模型具有较高的可靠性,在防控疫情的关键时期,能快速地为医生提供诊断的参考意见,提高医生的工作效率。     

One year of SARS-CoV-2 and lung ultrasound: what has been learned and future perspectives

A first screening by ultrasound can be relevant to set a specific diagnostic and therapeutic route for a patient with a COVID-19 infection. The finding of bilateral B-lines and white lung areas with patchy peripheral distribution and sparing areas is the most suggestive ultrasound picture of COVID-19 pneumonia. Failure to detect bilateral interstitial syndrome (A pattern) on ultrasound excludes COVID-19 pneumonia with good diagnostic accuracy, but does not exclude current infection. The use of shared semiotic and reporting schemes allows the comparison and monitoring of the COVID-19 pulmonary involvement over time. This review aims to summarise the main data on pulmonary ultrasound and COVID-19 to provide accurate and relevant information for clinical practice.     

Coronavirus Disease 2019 Strategies,Examination Details,and Safety Procedures for Diagnostic Radiology Facilities: An Extensive Multicenter Experience in Istanbul,Turkey

This study aimed to share our experiences during the coronavirus disease 2019 (COVID-19) pandemic obtained in diagnostic radiology facilities of 5 training research hospitals in the Asian part of Istanbul (North Hospitals). Accordingly, we reported the used examination details, allocation of radiology staff and actions, and safety procedures for patients and radiology staff. As the corporate radiology team serving in these designated pandemic hospitals, examination details and safety procedures of some diagnostic radiology facilities among 5 training research hospitals have been identified in the current study. Our guidelines and preparedness protocol aimed to reduce patient morbidity and infection-related mortality through quick and proper diagnosis to prevent the spread of COVID-19 to our employees, patients, and the general public during the COVID-19 pandemic. Results showed that teamwork is a key factor while providing medical services. In addition, continuous communication efforts and individual responsibilities of radiology staff were remarkable during the COVID-19 pandemic. The recent situation also showed that co-operation of radiology facilities with device manufacturers and applicators is quite significant especially for development of special protocols in the frame of As Low As Reasonably Achievable. The COVID-19 pandemic has tackled several challenges in radiology among radiology departments. Therefore, continuous co-operation plans and motivational actions are highly recommended not only between radiology staff but also between radiology stakeholders and service providers in the future. Technical details of recent investigation can provide useful information about the management of diagnostic radiology departments during the fight with the COVID-19 pandemic in cities with high population density such as Istanbul.     

Frontiers of COVID-19-related myocarditis as assessed by cardiovascular magnetic resonance

Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In some patients, COVID-19 is complicated with myocarditis. Early detection of myocardial injury and timely intervention can significantly improve the clinical outcomes of COVID-19 patients. Although endomyocardial biopsy (EMB) is currently recognized as the ‘gold standard’ for the diagnosis of myocarditis, there are large sampling errors, many complications and a lack of unified diagnostic criteria. In addition, the clinical methods of treating acute and chronic COVID-19-related myocarditis are different. Cardiac magnetic resonance (CMR) can evaluate the morphology of the heart, left and right ventricular functions, myocardial perfusion, capillary leakage and myocardial interstitial fibrosis to provide a noninvasive and radiation-free diagnostic basis for the clinical detection, efficacy and risk assessment, and follow-up observation of COVID-19-related myocarditis. However, for the diagnosis of COVID-19-related myocarditis, the Lake Louise Consensus Criteria may not be fully applicable. COVID-19-related myocarditis is different from myocarditis related to other viral infections in terms of signal intensity and lesion location as assessed by CMR, which is used to visualize myocardial damage, locate lesions and quantify pathological changes based on various sequences. Therefore, the standardized application of CMR to timely and accurately evaluate heart injury in COVID-19-related myocarditis and develop rational treatment strategies could be quite effective in improving the prognosis of patients and preventing potential late-onset effects in convalescent patients with COVID-19.     

Convalescent plasma as a treatment modality for coronavirus disease 2019 in Sudan

Coronavirus disease 2019 (COVID-19) is a disease spreading rapidly in Sudan, the rest of the African continent and the world with no known definitive treatment or vaccines. However, among many treatment interventions being tested globally, beneficial effects and clinical improvements have been reported when convalescent plasma is used for treating COVID-19 patients. We prepared a guiding protocol for treating early to moderate COVID-19 patients with plasma transfusion from convalescent COVID-19 patients. This protocol was deduced based on previously published reports and studies that evaluated and tested convalescent plasma as a prospective therapy for COVID-19 patients. The protocol covers instructions on patient and donor selection criteria, plasma harvesting, plasma product specifications, dosage and precautions for convalescent plasma collection and transfusion process. Altogether, we prepared a treatment protocol that is tailored to the context of Sudan to be adopted by Sudan's health authority. Moreover, it will also provide reference for researchers to design open label clinical trials for convalescent plasma transfusion.