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  • 简介:AbstractAlbumin solutions derived from human plasma have demonstrated clinical benefits as intravenous fluid therapy in clinical settings such as liver disease, sepsis, intensive care, and surgery. For all plasma-derived medicinal products, there is a potential risk from pathogens, including relevant blood-borne viruses, emerging viruses, and prion proteins. To minimize the risk of transmissible infections, the production of human albumin solutions includes rigorous donor selection and plasma testing, and effective pathogen removal and inactivation methods such as fractionation and pasteurization. Compliance with international pharmacopeial standards for purity and prekallikrein activator and aluminum content is crucial, as is post-marketing pharmacovigilance for the continuous monitoring of adverse events. This review focuses on the effectiveness of manufacturing methods in the production of plasma-derived albumin, to ensure the safety of hyperoncotic solutions for volume expansion. We evaluated evidence identified through online database (PubMed) searches and from unpublished sources, on the manufacturing and pathogen safety of plasma-derived albumin solutions. The results confirmed the already established and evolving pathogen reduction capacity of the reviewed manufacturing methods. Up-to-date post-marketing pharmacovigilance data and log10 reduction factors for known and emerging pathogens during albumin production are included. Towards the goal of ever-increasing clinical safety, potential areas of improvement, such as compliance rates for the completion of donor health questionnaires, are also discussed. Taken together, the current manufacturing and pathogen reduction steps result in albumin products of greater purity than previous-generation products, with a high margin of pathogen safety against known and emerging pathogens, such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

  • 标签: Hyperoncotic albumin Human albumin solutions Viral reduction Pathogen safety Pasteurization Plasma-derived medicinal product
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  • 作者: JIN Weiyou
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  • 创建时间:2023-03-08
  • 出处:《护理医学论坛》 2023年第1期
  • 机构:Department of Geriatrics,Union Hospital,Tongji Medical College,Huazhong University of science and technology,Wuhan Hubei 430000,China
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  • 简介:摘要:本文针对目前建筑工程项目安全管理方面存在的问题,结合当下建筑工程企业工程项目安全管理工作的实际状况,从创新工程项目安全管理理念、组织机构、管理制度、人员管理和智慧管理五个方面,探析了建筑企业工程项目安全管理的创新措施,为建筑工程项目安全管理提供参考和借鉴。

  • 标签: 建筑企业 工程项目安全管理 创新措施
  • 简介:AbstractBackground:Preliminary studies have indicated that Shexiang Baoxin Pill (MUSKARDIA) has a coronary artery dilation effect and increases the coronary blood flow, relieving the symptoms of angina. This study aimed to evaluate the benefit of MUSKARDIA on patients with stable coronary artery disease (CAD) and diabetes mellitus (DM).Methods:This was a subgroup analysis of a multicenter, randomized, placebo-controlled phase IV trial. CAD patients with a medical history of DM or baseline fasting blood glucose (FBG) ≥7.0 mmol/L were grouped according to the treatment (standard therapy plus MUSKARDIA or placebo). The primary outcome was major adverse cardiovascular events (MACEs), which was the composite outcome of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. The secondary outcome was the composite outcome of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina or heart failure, and coronary angioplasty.Results:MACEs occurred in 2.6% (9/340) and 4.8% (18/376) of patients in the MUSKARDIA and placebo groups, respectively (P = 0.192). Secondary composite outcome was significantly less frequent with MUSKARDIA than with placebo (15.3% [52/340] vs. 22.6% [85/376], P = 0.017). Risk of MACEs (hazard ratio [HR] = 0.69, 95% confidence interval [CI]: 0.31-1.57) was comparable between two groups. In patients with uncontrolled DM (≥4 measurements of FBG ≥7 mmol/L in five times of follow-up), the risk of secondary outcome was significantly lower with MUSKARDIA (5/83, 6.0%) than with placebo (15/91, 16.5%) (HR= 0.35, 95%CI: 0.13-0.95).Conclusion:As an add-on to standard therapy, MUSKARDIA shows a trend of reduced MACEs in patients with stable CAD and DM. Furthermore, MUSKARDIA may reduce the frequency of all-cause death, hospitalization, and coronary angioplasty in this population, especially in those with uncontrolled DM.Trial Registration:ChiCTR.org.cn, ChiCTR-TRC-12003513

  • 标签: Shexiang Baoxin Pill MUSKARDIA Coronary artery disease Angina Diabetes mellitus Major adverse cardiovascular events
  • 简介:摘要:随着移动互联网的发展,尤其是智能手机的普及,近场通讯NFC技术随之发展,但在其发展过程中,NFC技术还不够完善,存在着安全性和不稳定性的威胁,严重制约这NFC技术的发展以及延伸,制约着NFC技术的使用和普及,为了保障NFC技术使用过程中的安全和稳定,本文提出了安全性和不稳定性的问题,并针对问题做出解决方法,且分析了解决方法对于问题的有效性,相信通过这些解决办法,有助于构建一种更加安全和稳定的NFC技术。

  • 标签: NFC技术 近场通讯 安全性 不稳定性
  • 简介:摘要:随着我国市场经济的不断发展,对各类资源的需求量增大,资源逐步匮乏,导致自然环境恶化,对人类生存与发展带来很大威胁,因此,需开发新能源满足市场需求的同时,降低对环境的影响。核电是新型能源的代表,其成本较低,对环境的污染较小,基于这些优点,在各个领域中发挥着重要作用。核电的应用虽然可以缓解能源短缺问题,但如果发生核电事故,则会对人类生命财产安全带来巨大影响,因此,需提升对核电厂安全问题的重视度,排除可能存在的安全隐患,保障运行安全。本文对核电厂运行常见安全问题进行阐述,对防范对策进行分析,旨在为核电厂提供安全的运营环境,为经济发展提供更多能源。

  • 标签: 核电厂 安全运行 安全问题 防范对策
  • 简介:摘要:某核电厂日常期间出现安全注入系统泵的中压电机冷却器泄露的异常,该电机所对应的这一列安注系统不可用,将会降低核安全冗余度,同时影响电厂发电能力,需要第一时间排查故障模式,锁定故障原因,并制定应对措施,以确保核电机组的安全稳定运行。

  • 标签: 核电厂 中压电机冷却器 泄露 探究与管理