Management of massive gastrointestinal haemorrhage

Acute gastrointestinal bleeding is a common medical emergency, accounting for approximately 85,000 admissions in the United Kingdom per annum. It is associated with significant morbidity and mortality. GI haemorrhage is commonly categorized according to source of blood loss; either upper GI (above the ligament of Treitz) or lower GI (below the ligament of Treitz). Rapid assessment, resuscitation and correction of coagulopathy should be undertaken to stabilize the haemodynamically compromised patient and definitive intervention should not be delayed. Clinicians may use of a range of treatment modalities, including endoscopic and interventional radiological techniques in order to get control of haemorrhage, which should be tailored to the site of bleeding and pathology. Where control is not achieved the clinician should consider either repeat intervention, use of alternative haemostatic techniques or different modalities to achieve haemostasis. Rarely is surgery the chosen treatment modality and surgical intervention should only be undertaken where all other measures to control haemorrhage have failed.     

基于肥厚型心肌病临床数据管理系统的设计与应用

目的设计一款简单易操作的数据管理系统,解决目前零散的肥厚型心肌病临床数据,将临床信息科学有效地进行整合管理,便于医生及科研人员查询、统计。方法采用Foxtable搭建一个数据库管理软件框架,并建立局域网外部数据源,实现数据的存储、查询、共享、导出。结果基于肥厚型心肌病数据管理系统的设计与应用能够满足临床医生和科研人员的基本工作需求,很大程度上节省了数据整理时间。结论该系统操作简单、移植性高、实用性强,广泛适用于各临床科室有科研项目的小型数据库管理。     

Signal Management in Pharmacovigilance: A Review of Activities and Case Studies

PurposeAfter nearly 12 decades of pharmaceutical catastrophes and the associated groundbreaking regulatory innovations, pharmacovigilance has come down to us in the present day as 3 interlocking core disciplines: case management, signal management, and benefit–risk management. This review provides a state-of-the-art introduction to the great variety of sources of safety information, both dependent on and independent of the Individual Case Safety Report (ICSR), and explains how this content undergoes management-system processes with globally accepted definitions, standards, and structures that make possible the ongoing safe use of a pharmaceutical product throughout its lifecycle. This occurs in the context of: (1) new products coming to market with new risks for drug–drug interactions, and (2) new global threats to safe manufacturing and distribution.MethodsThis narrative review, reflective of the author's experience, uses a large-frame system of signal management developed by the Council for International Organizations of Medical Sciences VIII Working Group and modified by the author to include governance. A key feature of the review is the regular inclusion of relevant case studies to provide a backdrop of the unexpected, with resulting tragic outcomes, to the ever-evolving regulatory landscape.FindingsRegarding content, beyond the commonly appreciated sources of safety information that find their way into ICSRs are non–ICSR-based sources, including preclinical data, manufacturing data, findings from subject-matter experts who participate on data-monitoring committees, outside expert panels, advocacy groups, and independent investigator studies. Regarding process, it is important to recognize that governance is crucial in the effective conduct of signal management, in that subject-matter experts are essential to the scientific and medical aspects of decision making, and business and policy executives are essential in determining the final courses of action, as these decisions have implications for the company.ImplicationsSignal management is an integral part of pharmacovigilance practices that strive to obtain all of the information necessary for maintaining the safety profiles of a company's pharmaceutical and biological products, to support favorable benefit–risk balances, and to ensure safe use by health care providers and their patients.     

药物临床试验伦理审查质量风险的管理研究

目的:为提高我国药物临床试验伦理审查质量、保障受试者权益提供参考。方法:以风险管理理论为指导,运用文献研究法、专家意见法和层次分析法对药物临床试验伦理审查流程进行梳理,提取并确定影响伦理审查质量的风险因素及其权重,并对我国药物临床试验伦理审查工作提出改进建议。结果与结论:构建的药物临床试验伦理审查风险指标体系包括5个方面共31个影响因素,其中影响药物临床试验伦理审查质量的5个方面的重要性(权重)排序依次为医学伦理委员会的自身建设(0.2635)、审查会议的管理(0.2514)、跟踪审查(0.1945)、审查申请的受理与处理(0.1892)、文件档案的管理(0.1014);权重较高的影响因素包括"讨论投票过程利益冲突人员回避(0.0787)""对方案修改、知情同意修改、严重不良事件等情形及时审查或召开会议讨论(0.0705)""明确伦理审查工作流程及时间并对外公示(0.0598)""统一、规范的审查标准与批准标准(0.0521)"等。建议可通过讨论投票环节利益冲突人员予以回避,对方案修改、知情同意修改、严重不良事件等情形及时审查或召开伦理会议讨论,明确伦理审查工作流程及时间,建立统一、规范的审查标准和批准标准等方式提高药物临床试验伦理审查的质量。