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 We evaluated evidence identified through online database (PubMed) searches and from unpublished sources, on the manufacturing and pathogen safety of plasma-derived albumin solutions.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).
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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
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。