临床生物样本库信息系统建设与发展

随着转化医学的快速发展, 临床生物样本库的作用日益凸显, 其建设和应用日益受到关注和重视。信息管理系统是样本库的核心部分, 其建设应立足于支撑样本库的运营、管理和服务全过程, 通过建立样本信息数据采集流程、数据集成与交换系统及安全系统, 形成一体化整合数据库和公共门户网站, 实现生物样本、临床资料和分子数据等各种资源的高效管理和全面共享。     

我国生物样本库运营规划现状

  目的  评估我国生物样本库的运营规划现状。   方法  对国内63个主要生物样本库展开问卷调查。问卷内容包括生物样本库基本信息、运营规划、样本利用率、用户/客户群体、市场推广/广告、成本回收和业绩指标等6个类别, 对6个类别的调查数据进行描述性分析。   结果   63个生物样本库中, 96.8%(61/63)属于学术机构或公立医院; 19.0%(12/63)已有运营规划, 39.7%(25/63)正在筹备运营规划, 41.3%(26/63)尚无运营规划; 85.0%(34/40)实际利用率低于20%, 且97.5%(39/40)低于目标利用率; 88.6%(1084/1223)的样本仅用于样本库或所属机构内部使用, 不对外共享。   结论  本次调查结果初步反映, 我国生物样本库运营规划情况不容乐观, 样本实际利用率较低, 且普遍低于其目标利用率, 对外共享不足, 未来应进一步加强国内生物样本库的合作和共享。     

建设特勤人员生物样本库的思考

随着精准医疗和转化医学的发展进步,生物样本库作为链接临床工作和实验室研究的重要环节,在国内外医学研究领域越来越受到重视。本文从生物样本库的国内外发展现状、特勤人员生物样本库建设要点、建设特勤人员生物样本库的意义这三个方面进行阐述,分析探讨建设特勤人员生物样本库的重要性,加强未来对特勤人员的精准化、个性化医疗保障工作。     

临床实验室体液样本库建设

生物样本库是临床医学、基础医学和转化医学研究的基石和重要推动力。临床实验室(检验科)以血液等体液为日常检测对象,拥有丰富的体液标本资源,在体液样本库建设中具有显著优势。临床实验室应推进生物样本库标准操作规程文件撰写,标准化、规范化建设体液样本库,以促进医学检验学科的科研、教学的发展。     

生物样本库知情同意书规范化设计

知情同意书的签署是生物样本库伦理建设的核心, 其结构包括"知情告知"和"自主同意"两部分主体内容。本文依据现阶段生物样本库的特点, 提出生物样本库知情同意书的规范化设计, 具体描述从"生物样本库完备告知"到"捐赠者充分知情"两部分核心内容和要求, 以供生物样本库实践者参考和借鉴。     

综合医院院级平台化样本库各类分库效能的比较

  目的  提出综合医院平台化样本库各分库表现的评价方法, 并对各分库的综合表现进行评估, 以期为从事样本库建设的同仁提供参考。  方法  将北京友谊医院2014年10月1日至2018年3月31日期间建立的所有样本分库纳入本研究。采用样本入库、样本应用以及样本质量3项指标进行分析评价, 并将上述3项指标赋予不同权重进行综合评估(样本入库30%、样本应用30%、样本质量40%)。  结果  77个样本分库中, 项目库22个, 储备库55个。入库评分方面, 项目库和储备库差异无统计学意义(50.7±30.1比47.6±29.9, P=0.1614);应用评分、样本质量评分以及综合评分方面, 项目库均显著高于储备库[应用评分:30.3(0, 84.2)比0(0, 31.6), P=0.0327;质量评分:100.0±0.0比94.5±22.9, P=0.0444;综合评分:62.5±14.8比57.9±17.9, P=0.0077]。  结论  综合医院院级平台化样本库中项目库的综合表现优于储备库。     

精准医疗时代下生物样本库的建设与发展特点

近年来,在"健康中国"大背景下,精准医疗和生物样本库迎来了快速发展的黄金时期.精准医疗时代,生物样本库作为医疗行业的新兴领域,有其自身发展趋势和特点,表现为发展进程需标准化和规范化、高度依赖信息化建设、离不开多中心联盟和资源共享、需多学科融合支撑等.随着精准医学的不断发展,生物样本库已从生物样本和信息资源的整合平台,逐...     

多中心结直肠癌临床研究生物样本库信息系统的建设与管理

近年来,我国结直肠癌的发病率显著升高。随着对结直肠癌复发、转移机制的深入探索,可提供全面生物医学信息的生物样本库信息系统显得尤为重要。本文阐述了采用微服务架构构建包含临床电子数据采集系统、生物样本管理系统和生物信息数据平台三个子系统的多中心结直肠癌临床研究生物样本库信息系统,同时介绍各子系统在多中心临床研究中的管理模式和特色功能;并通过统一化编码规则、结构化临床信息、标准化样本流转信息和规范化数据存储等数据标准化管理方案,保障数据质量和互联互通,从而为推进转化医学研究和精准医疗发展提供全方位生物医学信息。     

生物样本库实习生安全教育和培养

为了满足研究活动中对人类遗传资源的需求,目前国内很多医学类院校和医疗机构陆续开始建设生物样本库和数据平台.生物样本库中储存的临床和科研所需的重要生物样本、生物样本库的人员安全及生物样本信息安全成为生物样本库建设者尤为重视的内容.该文在总结生物样本库管理经验的基础上,对生物样本库实习生的岗前培训、安全教育、应急演练展开讨论.充分对生物样本库实习生进行安全教育,按时展开应急演练有利于培养实习生的科研能力和安全意识,维护生物样本库的生物安全.     

综合护理在鼻咽癌生物样本库管理中的应用

目的探讨综合护理在鼻咽癌患者生物样本库管理中的应用。方法选取2016年5月至2017年5月在广西医科大学第一附属医院门诊进行鼻咽癌筛查患者560例,其中男352例,女208例,确诊病例482例,高危疑似病例78例。确诊患者采用随机数字表分为对照组和试验组,各241例。高危疑似患者同样采用随机数字表法分为对照组和试验组,各39例。分别将鼻咽癌患者及高危患者分为试验组及对照组。对照组患者采用常规护理,试验组患者进行综合护理。对试验组及对照组患者进行档案合格率、患者满意度、复诊率、并发症发生率、戒烟率等对鼻咽癌样本库管理效果进行评价。结果随访1年内,确诊患者中试验组的档案合格率、患者满意度、复诊率、并发症发生率显著优于对照组,高危患者中试验组在档案合格率、患者满意度、复诊率、戒烟率显著高于对照组,差异均有统计学意义(均P<0.05)。结论综合护理对提高鼻咽癌患者生物样本库管理起着重要作用。     

Association Between Personal Activity Intelligence and Mortality: Population-Based China Kadoorie Biobank Study

ObjectiveTo prospectively investigate the association between personal activity intelligence (PAI) — a novel metabolic metric which translates heart rate during physical activity into a simple weekly score — and mortality in relatively healthy participants in China whose levels and patterns of physical activity in addition to other lifestyle factors are different from those in high-income countries.Patients and MethodsFrom the population-based China Kadoorie Biobank study, 443,792 healthy adults were recruited between June 2004 and July 2008. Participant’s weekly PAI score was estimated and divided into four groups (PAI scores of 0, ≤50, 51–99, or ≥100). Using Cox proportional hazard analyses, we calculated adjusted hazard ratios (AHRs) for cardiovascular disease (CVD) and all-cause mortality related to PAI scores.ResultsDuring a median follow-up of 8.2 (interquartile range, 7.3 to 9.1) years, there were 21,901 deaths, including 9466 CVD deaths. Compared with the inactive group (0 PAI score), a baseline weekly PAI score greater than or equal to 100 was associated with a lower risk of CVD mortality, an AHR of 0.87 (95% CI, 0.81 to 0.94) in men, and an AHR of 0.84 (95% CI, 0.78 to 0.92) in women, after adjusting for multiple confounders. Participants with a weekly PAI score greater than or equal to 100 also had a lower risk of all-cause mortality (AHR, 0.93; 95% CI, 0.89 to 0.97 in men, and AHR, 0.93; 95%, 0.88 to 0.98 in women). Moreover, this subgroup gained 2.7 (95% CI, 2.4 to 3.0) years of life, compared with the inactive cohort.ConclusionAmong relatively healthy Chinese adults, the PAI metric was inversely associated with CVD and all-cause mortality, highlighting the generalizability of the score in different races, ethnicities, and socioeconomic strata.     

我国临床输血发展的挑战与思考

国家标委会将输血医学列入临床医学下的二级学科,标志着我国输血医学将进入前所未有的发展时期。在这个特殊的时期如何把握好这种变革机遇,推动学科快速健康发展,笔者提出了自己的见解供同行参考。     

Frequency of Involuntary Admissions and Its Associations With Demographic and Clinical Characteristics in China

Involuntary admissions (IA) continue to be a controversial topic in psychiatry. There have been very few studies investigating the pattern of IA and contributing factors in Chinese psychiatric patients. This study examined the prevalence of IA and its relationships with demographic and clinical characteristics in a large psychiatric institution in Hunan province, China. A consecutively collected sample of 161 psychiatric inpatients was collected. The patients' basic socio-demographic and clinical data including admission types were collected. The frequency of IA was 53.1% in the whole sample. In multiple logistic regression analysis, IA was independently associated with female sex, more recent aggression prior to admission and poorer social function and insight into illness. IA was common in clinical practice in China, and its demographic and clinical correlates are similar to the findings reported from western settings.     

Clinical and Molecular Characteristics of Emerging Hypervirulent Klebsiella pneumoniae Bloodstream Infections in Mainland China

Recently, the newly emerged hypervirulent Klebsiella pneumoniae strain (hvKP) has caused great concern globally, but the clinical features and molecular characteristics of bacteremia caused by hvKP are rarely reported in mainland China. Seventy patients with K. pneumoniae bacteremia were investigated to study the clinical features of hvKP infection from 2008 till 2012 in Beijing Chao-Yang Hospital. The molecular characteristics of the hvKP strains were also studied using PCR, multilocus sequence typing, and pulsed-field gel electrophoresis (PFGE) methods. hvKP was identified in 31.4% of the patients with K. pneumoniae bacteremia, which displayed 4 serotypes (K1, K2, K20, and K57). Patients with hvKP infection tended to have no underlying diseases compared to those with classic K. pneumoniae (cKP). More hvKP-positive patients (95.5%) had community-acquired infection than did cKP-infected patients (35.4%) (P < 0.001). The 30-day mortality rate was lower in hvKP-infected patients than in cKP-infected patients (4.5% compared to 16.7%). Resistance to tested antimicrobials was significantly greater in cKP- than in hvKP-infected patients. Two extended-spectrum-beta-lactamase (ESBL)-producing hvKP strains were found. Seven novel sequence types (STs) and 4 new alleles of K. pneumoniae were revealed. A strong correlation was found between two STs (ST23, ST1265) and the K1 serotype. The hvKP isolates (n = 22) had 14 different PFGE patterns, and among them 10 K1 isolates shared similar PFGE patterns. The emerging hvKP strain was prevalent in patients with severe community-acquired infections in healthy individuals in China. Identification of ESBL-producing hvKP strains in hvKP-infected patients will facilitate clinical management of hvKP infection.     

基于IT技术平台的中国疾病监测

随着IT技术的发展,我国已逐步建立起连接乡镇、县(区)、地(市)、省、国家五级卫生行政部门和医疗卫生机构的双向信息传输网络[1]。并通过合理利用虚拟专用网络(VPN)技术和Internet资源建立“公网专用”的网络系统,将信息采集功能延伸到基层,服务于广大的医疗机构和基层CDC人员,大幅度提升了全国疾病和公共卫生监测的覆盖率、准确性和时效性。1中国传染病监测的发展历程1950年建立传染病报告系统,要求报告的病种为13类;到60年代已经开始形成较为完善的传染病报告系统。1980年代以来,很多单病监测系统开始发展,一般都包括实验室监测的内容…