COVID-19相关研究的文献计量学分析

目的 探索新型冠状病毒肺炎(corona virus disease 2019,COVID-19)研究领域最新进展和研究趋势.方法 从Web of Science数据库检索2019年12月1日至2020年11月15日COVID-19相关文献,应用CiteSpace软件对数据进行可视化分析.结果 截至2020年11月15...     

我国男性不育症临床试验注册现状分析

目的 探讨我国男性不育症临床试验注册现状。方法 检索ChiCTR和ClinicleTrials.gov自建库至2022年10月,我国男性不育症所有注册临床试验,按照纳入及排除标准筛选注册研究,提取临床试验的注册时间、注册地点、干预措施、结局指标、研究设计等信息,采用描述性统计学方法进行分析。结果 共检索到96项研究,最终纳入研究31项,总样本量37 507例,2018年开始注册量逐年增长,研究方法以干预性研究为主（21项,67.74%）,研究设计以随机平行对照最多（18项,58.06%）;申办方单位地域分布以郑州、北京、南京、广州、上海为主,申办单位性质以医院和生殖中心最多;经费资助主要来源于医院自筹（18项,58.06%）;干预措施主要包括药物类和非药物类,其中药物类以中成药为主（7项,33.33%）,非药物类包括辅助生殖和手术,结局指标以精液质量、性激素水平、妊娠率为主。结论 纳入研究中医药干预措施占比较高且特色显著,以补肾益精功效的中成药为主,该领域临床试验注册仍存在注册较少、地域分布不均,注册信息未及时更新等问题。     

COVID-19临床诊疗及防控进展

新型冠状病毒肺炎(coronavirus disease 2019,COVID-19)由于感染新型冠状病毒(2019 novel coronavirus,2019-nCoV)所致。由于2019-nCoV为此前未知种类,疫情早期对其知之甚少,诊疗有一定难度。随着研究的推进,目前涌现大量基于COVID-19临床诊疗和疫情走势的相关文献报道,对科研和临床工作者具有重要参考价值。现对近期基于COVID-19发表的相关文章进行归纳,对2019-nCoV致病机制和COVID-19临床特征、CT表现、药物治疗进展及疫情防控的结果予以综述。     

COVID-19中相关炎症因子的临床价值探讨

新型冠状病毒肺炎目前在全球广泛传播,具有感染力强、进展快、病死率高等特点.研究发现COVID-19患者的病情严重程度与机体炎症反应的强度相关.细胞因子风暴是指机体感染微生物后引起体液中多种细胞因子如TNF-α、IL-1、IL-6、IFN-β、IFN-γ、MCP-1和IL-8等迅速大量产生的现象,大量的细胞因子可引起炎症...     

COVID-19相关低钠血症的治疗策略

新型冠状病毒疾病(novel coronavirus disease,COVID-19)是一种传染性较强的感染性疾病,对人类的健康、经济造成了沉重的负担。COVID-19常合并低钠血症,低钠血症明显加重了COVID-19的病情进展,并延长住院时间、明显增加重症肺炎的发生率及病死率。早期识别COVID-19合并低钠血症非常重要。COVID-19患者合并低钠血症的机制包括抗利尿激素分泌不当综合征、钠离子经消化道丢失及摄入减少、急性肾损伤等,及时的发现并纠正低钠血症可明显改善COVID-19的不良结局。     

中国临床试验注册和发表机制及实施说明

2006年4月16-17日在成都召开第四届亚太地区循证医学研讨会期间，中国48家医（药）学期刊和中国临床试验注册中心（Chinese Clinical Trial Register。ChiCTR）、卫生部中国循证医学中心、循证医学教育部网上合作研究中心和Chinese Cochrane Centre的代表经过充分讨论达成共识，决定共同发起创建中国临床试验注册和发表机制，并成立“中国临床试验注册和发表协作网（Chinese Clinical Trial Registration and Publishin gCollaboration，ChiCTRPC）”。这种临床医学研究管理新模式的创建和应用，将对提高中国临床试验信息透明度和质量、提高医学研究公信度发挥极其重要的作用。本文介绍其结构特点和运作方式。     

国内癌因性疲劳中医药相关临床试验注册现状分析

目的 通过分析中国临床试验注册中心(Chinese clinical trial registry，ChiCTR)注册的与中医药干预癌因性疲劳(cancer-related fatigue，CRF)相关的临床试验，探讨其试验注册现状。方法 检索ChiCTR数据库收录的从建库至2022年6月2日与中医药相关的CRF临床研究注册试验，对检索结果进行筛选并提取所需数据信息，运用WPS Office软件的表格功能对纳入研究数据进行统计分析，并归纳临床试验特征。结果 最终纳入36项CRF中医药相关临床试验，覆盖全国6个省、3个直辖市，其中包括干预性研究34项，观察性研究2项，招募样本量5 327例，干预措施包括内服药物疗法、中药注射液、外治法和中医传统功法。结论 目前有关CRF中医药临床试验注册数量总体呈上升趋势，试验以随机对照试验(randomized controlled trial, RCT)研究居多，干预性研究为主，其空间分布欠均衡，且注册信息的严谨性与结局指标的规范性待进一步提高。     

基于WHO国际临床试验注册平台重症哮喘临床试验注册现状分析

背景　重症哮喘临床控制较差,且欠缺有效的治疗方法,故亟需更多相关临床研究;临床注册试验可为临床防治工作奠定基础,而目前重症哮喘临床注册现状尚不清楚,尚不能为临床试验提供新视角。目的　基于WHO国际临床试验注册平台（ICTRP）数据,了解重症哮喘临床试验注册特点。方法　计算机检索WHO ICTRP数据库,搜集建库起至2019-12-15注册的重症哮喘相关临床试验资料。由2名研究者独立筛选文献、提取资料后,对纳入试验进行描述性分析。结果　共检索到重症哮喘相关临床试验235个,临床试验注册数量自建库起逐年上升,近4年有下降趋势。试验申请国家分布不均,重症哮喘患病率较高国家试验申请极少。各注册中心试验大多来自本国家。资金主要来源于单位和企业。研究病种以重症哮喘为主（89.36%）,涉及年龄以成人为主（90.64%）。试验类型以干预性为主（65.96%）,干预性试验中随机试验占67.10%,仅9个试验描述其采用的随机方法;观察性研究中以队列研究居多（38.75%）;44.26%的试验未注明盲法情况,其余试验双盲占据较多（25.53%）;试验分期以N/A（32.77%）、Ⅲ期试验（20.00%）最多。干预措施以药物干预为主（77.42%）。结局指标以肺功能、哮喘加重情况、生存质量评价为主。结论　重症哮喘临床试验近几年呈下降趋势,试验申请国家分布不均,研究病种以重症哮喘为主,研究类型以干预性为主,干预措施多为西药干预。     

Ethical issues arising from human genetics.

Advances in understanding genetic disorders have been rapid in the last few years and with them the need and desire for genetic counselling have grown. Almost simultaneously, particularly in the USA, several large screening programmes have been initiated to screen large numbers of people who may be carriers of such deleterious genes as those of Tay-Sachs disease and sickle cell anaemia. The authors of this paper, clinical medical students at University College Hospital, London, spent some time studying the ethical issues raised. The first part of their study, which is not published here, relates to the biochemistry of certain genetic disorders, so leading up to the aspect of the subject which must concern readers of this journal, genetic counselling. At present genetic counselling is generally the province of the medical practitioner working with clinical biochemists, and in this paper their function is described and how programmes of screening for carriers are designed. Whether the subjects of the screening tests are found to be 'innocent' or 'guilty' psychological problems confront them, and of these the genetic counsellor must be aware. In fact the range of ethical problems raised by such counselling is wide and can only be sketched in this article.     

COVID-19 trial graph: a linked graph for COVID-19 clinical trials

ObjectiveClinical trials are an essential part of the effort to find safe and effective prevention and treatment for COVID-19. Given the rapid growth of COVID-19 clinical trials, there is an urgent need for a better clinical trial information retrieval tool that supports searching by specifying criteria, including both eligibility criteria and structured trial information.Materials and MethodsWe built a linked graph for registered COVID-19 clinical trials: the COVID-19 Trial Graph, to facilitate retrieval of clinical trials. Natural language processing tools were leveraged to extract and normalize the clinical trial information from both their eligibility criteria free texts and structured information from ClinicalTrials.gov. We linked the extracted data using the COVID-19 Trial Graph and imported it to a graph database, which supports both querying and visualization. We evaluated trial graph using case queries and graph embedding.ResultsThe graph currently (as of October 5, 2020) contains 3392 registered COVID-19 clinical trials, with 17 480 nodes and 65 236 relationships. Manual evaluation of case queries found high precision and recall scores on retrieving relevant clinical trials searching from both eligibility criteria and trial-structured information. We observed clustering in clinical trials via graph embedding, which also showed superiority over the baseline (0.870 vs 0.820) in evaluating whether a trial can complete its recruitment successfully.ConclusionsThe COVID-19 Trial Graph is a novel representation of clinical trials that allows diverse search queries and provides a graph-based visualization of COVID-19 clinical trials. High-dimensional vectors mapped by graph embedding for clinical trials would be potentially beneficial for many downstream applications, such as trial end recruitment status prediction and trial similarity comparison. Our methodology also is generalizable to other clinical trials.     

Towards clinical data-driven eligibility criteria optimization for interventional COVID-19 clinical trials

ObjectiveThis research aims to evaluate the impact of eligibility criteria on recruitment and observable clinical outcomes of COVID-19 clinical trials using electronic health record (EHR) data.Materials and MethodsOn June 18, 2020, we identified frequently used eligibility criteria from all the interventional COVID-19 trials in ClinicalTrials.gov (n = 288), including age, pregnancy, oxygen saturation, alanine/aspartate aminotransferase, platelets, and estimated glomerular filtration rate. We applied the frequently used criteria to the EHR data of COVID-19 patients in Columbia University Irving Medical Center (CUIMC) (March 2020–June 2020) and evaluated their impact on patient accrual and the occurrence of a composite endpoint of mechanical ventilation, tracheostomy, and in-hospital death.ResultsThere were 3251 patients diagnosed with COVID-19 from the CUIMC EHR included in the analysis. The median follow-up period was 10 days (interquartile range 4–28 days). The composite events occurred in 18.1% (n = 587) of the COVID-19 cohort during the follow-up. In a hypothetical trial with common eligibility criteria, 33.6% (690/2051) were eligible among patients with evaluable data and 22.2% (153/690) had the composite event.DiscussionBy adjusting the thresholds of common eligibility criteria based on the characteristics of COVID-19 patients, we could observe more composite events from fewer patients.ConclusionsThis research demonstrated the potential of using the EHR data of COVID-19 patients to inform the selection of eligibility criteria and their thresholds, supporting data-driven optimization of participant selection towards improved statistical power of COVID-19 trials.     

Issues in the registration of clinical trials

Deborah A. Zarin, MD; Nicholas C. Ide, MS; Tony Tse, PhD; William R. Harlan, MD; Joyce C. West, PhD; Donald A. B. Lindberg, MD

JAMA. 2007;297:2112-2120.

Public concerns about the perils associated with incomplete or delayed reporting of results from clinical trials has heightened interest in trial registries and results databases. Here we review the current status of trial registration efforts and the challenges in developing a comprehensive system of trial registration and reporting of results. ClinicalTrials.gov, the largest trial registry with 36 249 trials from approximately 140 countries, has procedures in place to help ensure that records are valid and informative. Key challenges include the need to minimize inadvertent duplicate registrations, to ensure that interventions have unambiguous names, and to have a search engine that identifies all trials that meet a user's specifications. Recent policy initiatives have called for the development of a database of trial results. Several issues confound the implementation of such a database, including the lack of an accepted format or process for providing summaries of trial results to the public and concerns about disseminating data in the absence of independent scientific review.

     

Ethical issues arising from the requirement to sign a consent form in palliative care

French healthcare networks aim to help healthcare workers to take care of patients by improving cooperation, coordination and the continuity of care. When applied to palliative care in the home, they facilitate overall care including medical, social and psychological aspects. French legislation in 2002 required that an information document explaining the functioning of the network should be given to patients when they enter a healthcare network. The law requires that this document be signed. Ethical issues arise from this legislation with regard to the validity of the signature of dying patients. Signature of the consent form by a guardian or trustee, a designated person--the Person of Trust--transforms the doctor-patient relationship into a triangular doctor-patient-third-party relationship.     

55例新型冠状病毒肺炎患者临床特征

目的 探讨新型冠状病毒肺炎（COVID-19）患者的临床和流行病学特征,为疫情的防控提供参考。方法 以2020年1月23日—2月16日在某院确诊并收治的COVID-19患者55例为研究对象,收集患者近期是否到湖北出行,是否接触过来自湖北的人员,近期是否接触呼吸道疾病患者等流行病学资料,临床症状资料包括发热、乏力、干咳、肌肉疼痛、咳痰等,收集相关的实验室检测和影像学检查指标,分析COVID-19患者临床和流行病学特征。结果 55例患者中男性27例,女性28例,平均年龄（43.11±17.91）岁。临床分型：轻型3例,普通型48例,重型3例,危重型1例,以普通型为主（87.27%）。家庭聚集性病例29例（52.73%）,输入性病例19例（34.55%）,近期接触到过湖北的人员27例（49.09%）。临床症状为干咳34例（61.82%）,发热30例（54.55%）,咳痰19例（34.55%）,乏力18例（32.73%）,无症状者6例（10.91%）。首次住院检测白细胞总数正常或降低者52例（94.55%）,淋巴细胞计数减少12例（21.82%）。出现症状后5 d CT双肺毛玻璃样变46例（83.64%）。结论 COVID-19患者以普通型为主,主要为输入性和家庭聚集性病例,同时也存在着无症状感染者。对COVID-19防控要严防输入性病例和人员的聚集,加强体温的监测。加强对确诊患者密切接触者的COVID-19核酸检测,及时发现无症状病例并进行隔离和治疗。