Thrombosis and thromboembolism: Brighton collaboration case definition and guidelines for data collection,analysis, and presentation of immunization safety data

This is a Brighton Collaboration case definition of thrombosis and thromboembolism to be used in the evaluation of adverse events following immunization, and for epidemiologic studies for the assessment of background incidence or hypothesis testing. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of SARS-CoV-2 vaccines. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected expert reviewers prior to submission.     

Endoscopy-Related Bleeding and Thromboembolic Events in Patients on Direct Oral Anticoagulants or Vitamin K Antagonists

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99Tcm标记人源化抗人血小板膜糖蛋白Ⅲ a单克隆抗体SZ21F(ab)2血栓栓塞显像

目的用动物血栓栓塞模型显像评估99^Tc^m标记人源化抗人血小板膜糖蛋白（GP）Ⅲa单克隆抗体（简称单抗）F（ab）2片段SZ21F（ab）2的应用价值。方法通过体外抑制二磷酸腺苷（ADP）诱导的犬血小板聚集实验，评估SZ21F（ab）2与血小板结合的亲和性和特异性。以2-亚氨基噻吩盐酸盐（IT）法修饰SZ21F（ab）2分子的亚氨基，以99^Tc^m-葡庚糖酸钠（GH）转换络合法进行标记。分别用快速薄层层析（ITLC）法和ELISA测定标记物的放化纯及生物活性。对3条肺动脉血栓和8条（包括上述3条）后肢深静脉血栓栓塞比格犬模型进行显像研究。结果SZ21F（ab）2抑制ADP诱导的犬富含血小板血浆（PRP）聚集实验的半数有效剂量（IC50）为（2．49±1．88）μg／ml。ITLC法测得标记物的放化纯为90％～95％，ELISA测定结果表明标记后抗体保留了免疫活性。注射显像剂后1h，肺动脉血栓部位和后肢深静脉血栓部位均出现放射性浓聚。注射后3h，在体显像肺动脉血栓和后肢深静脉血栓栓塞模型的放射性靶／本底（T／B）比值分别为3．03±1．18和3．51±0.62。肺动脉血栓部位和后肢深静脉血栓部位的每克组织百分注射剂量率（％ID／g）分别为0．083％ID／g和0．076％ID／g。体外检测结果表明：肺动脉血栓与正常肺组织的单位质量放射性比值平均为12．8，后肢深静脉血栓与血液的单位质量放射性比值平均为5．2，与肌肉的比值平均为127.0。结论99^Tc^m-SZ21F（ab）2与人血小板具有较高的亲和力，有潜在的血栓显像应用前景。     

Loss of Anticoagulant Effect of Heparin During Circulation of Human Blood In Vitro

Device-induced thrombogenesis was studied in an in vitro model using human blood circulated through an artificial ventricle. A new constant pressure filtration technique was used to detect circulating microemboli, the activated partial thromboplastin time (APTT) test was used to monitor the blood for the presence of anticoagulant activity of heparin, and hemolysis was quantified by measuring the plasma free hemoglobin level. Circulation of blood through a 20-ml stroke volume pneumatically driven ventricle for 6-9 h resulted in a significant reduction of APTT, indicating the loss of the anticoagulant effect of heparin. Microemboli concentration was minimal until the APTT decreased below 125 s, at which time the microemboli concentration increased rapidly. This was presumed to be due to the formation of thrombi following a decrease in heparin activity. A significant increase in hemolysis was also noted when blood was pumped. None of these changes was noted in the nonpumped control blood. Spontaneous loss of heparin activity in blood circulated by a pneumatically driven pump may have clinical implications and may help understanding of the problems associated with device-induced thrombogenesis.     

中国肥厚型心肌病患者血栓栓塞事件风险预测模型的构建研究

背景 血栓栓塞（TE）事件是肥厚型心肌病（HCM）的重要并发症。目前针对HCM患者TE事件的风险预测,仅国外学者构建了两个模型：HCM Risk-CVA及French HCM score,然而,现有研究发现HCM Risk-CVA模型对于中国HCM患者的临床价值较为有限。目的 本研究拟构建适合中国HCM患者的TE事件风险预测模型。方法本研究系回顾性队列研究,收集2010—2018年在四川大学华西医院就诊的537例HCM患者的病例资料。本研究通过电话随访或电子病历系统查询患者就诊记录,每6～12个月随访1次,直至出现终点事件或死亡或研究拟定的评估日期（2019-12-31）,终点事件定义为复合性TE事件。采用单因素和多因素Cox回归分析构建风险预测模型,并使用自助重抽样的方法进行内部验证。结果 537例患者中,24例患者有不同程度的数据缺失,最终纳入513例患者。中位随访时间为4.2(1.3,6.2)年,随访过程中42例（8.18%）发生TE事件,年发病率为2.10%[95%CI(1.47%,2.73%)]。根据多因素Cox回归模型构建TE事件风险预测模型,最终纳入年龄、既往TE事件、心...     

住院患者VTE标准化防治管理体系构建与应用

静脉血栓栓塞症（VTE）防治是一项系统工程。围绕评估表单、救治流程、防治标准、监控指标等,分析VTE防治指南,采集医院业务系统患者基础数据,结合专家咨询,探索构建包含制度体系、组织体系、防治体系、评价体系和指标体系的VTE标准化防治管理体系。应用后,VTE风险评估率提升了93.64个百分点,出血评估率提升了99.36个百分点,预防率提升了63.68个百分点,治疗率提升了19.58个百分点,并发症发生率降低了0.05个百分点,实现了全面评估、规范预防、准确诊断与合理治疗,有效降低了医疗风险,提升了医疗质量,确保了患者安全。     

颅脑肿瘤术后并发静脉血栓栓塞症危险因素的Meta分析

目的明确颅脑肿瘤术后患者发生静脉血栓栓塞症(VTE)的危险因素。方法检索中国知网、万方、维普、中国生物医学文献、PubMed、The Cochrane Library、Web of Science、EMbase等数据库建库至2021年11月1日颅脑肿瘤术VTE危险因素的队列研究或病例对照研究。由两名研究人员独立进行文献筛选、资料提取以及文献质量评价。使用RevMan 5.4软件对纳入文献进行Meta分析。结果共纳入14篇文献,合计样本量40 552例,发生VTE1 801例。Meta分析结果显示,年龄＞45岁、术前D-二聚体升高、肥胖、女性、术前日常生活活动能力处于依赖状态、术前呼吸机依赖、术前曾患脓毒血症、高级神经胶质瘤、手术时间＞3.05 h、术后D-二聚体升高、术后下肢运动功能障碍、术后卧床不起、术后并发尿路感染为颅脑肿瘤术后患者发生VTE的危险因素。结论颅脑肿瘤术后VTE发生与多种因素有关。建议构建颅脑肿瘤术后VTE风险预测模型,关注高风险人群,落实规范化静脉血栓风险评估,注重血栓评估过程管控。