Development of an IgG-Fc fusion COVID-19 subunit vaccine,AKS-452

AKS-452 is a biologically-engineered vaccine comprising an Fc fusion protein of the SARS-CoV-2 viral spike protein receptor binding domain antigen (Ag) and human IgG1 Fc (SP/RBD-Fc) in clinical development for the induction and augmentation of neutralizing IgG titers against SARS-CoV-2 viral infection to address the COVID-19 pandemic. The Fc moiety is designed to enhance immunogenicity by increasing uptake via Fc-receptors (FcγR) on Ag-presenting cells (APCs) and prolonging exposure due to neonatal Fc receptor (FcRn) recycling. AKS-452 induced approximately 20-fold greater neutralizing IgG titers in mice relative to those induced by SP/RBD without the Fc moiety and induced comparable long-term neutralizing titers with a single dose vs. two doses. To further enhance immunogenicity, AKS-452 was evaluated in formulations containing a panel of adjuvants in which the water-in-oil adjuvant, Montanide™ ISA 720, enhanced neutralizing IgG titers by approximately 7-fold after one and two doses in mice, including the neutralization of live SARS-CoV-2 virus infection of VERO-E6 cells. Furthermore, ISA 720-adjuvanted AKS-452 was immunogenic in rabbits and non-human primates (NHPs) and protected from infection and clinical symptoms with live SARS-CoV-2 virus in NHPs (USA-WA1/2020 viral strain) and the K18 human ACE2-trangenic (K18-huACE2-Tg) mouse (South African B.1.351 viral variant). These preclinical studies support the initiation of Phase I clinical studies with adjuvanted AKS-452 with the expectation that this room-temperature stable, Fc-fusion subunit vaccine can be rapidly and inexpensively manufactured to provide billions of doses per year especially in regions where the cold-chain is difficult to maintain.     

High-Risk Drinking across the Transition from High School to College

Alcohol use and related problems were studied from the senior year in high school to the first autumn in college for 366 heavy drinking students. Four risk factors-subject sex, family history of drinking problems, prior conduct problems, and type of college residence-were evaluated as predictors of: (1) differential changes in drinking rates, (2) differential changes in alcohol-related problems, and (3) alcohol dependence symptoms during the first college term. Results suggest that both dispositional and environmental factors are associated with changes in drinking rates and the existence of dependence symptoms. Increases in the frequency of drinking were specifically and strongly associated with residence in a fraternity (men) or sorority (women). Three risk factors were associated with increased quantity of drinking: male gender, residence in a fraternity or sorority, and a history of conduct problems. Prior conduct problems were also consistently associated with dependence symptoms during the first term in college. A family history of alcohol problems was not consistently related to changes in use rates or problems, although some analyses suggest interactive effects. Early interventions on college campuses should target individuals using additive risk profiles.     

以合理用药绩效管理促进医院高质量发展

合理用药是保障医疗质量与安全的重要举措之一。通过设置合理用药绩效考核指标,管控重点药品涉及的科室及医生,审核处方、医嘱优化药物治疗方案,动态监测与超常预警异常用药,限制重点监控药品用量以及实时公示药品使用情况等一系列管控方法,2017年-2021年次均药品费用均保持在较低水平,处方合格率总体上升;2021年门急诊次均药品费用和住院次均药品费用均较2020年下降,处方合格率达99.05%,合理用药绩效指标整体完成情况良好,达到了预期目标。还需继续加大抗菌药物合理使用管理力度,强化临床药师实时审核医嘱,优化抗感染治疗方案等。     

以重点监控药品管理促进合理用药水平提升

通过开展以“合理用药”为核心的重点监控药品管理,促进合理用药水平提升。采取事后处方点评及处方前置审核,建立和完善重点监控药品管理方案,对不合理用药进行拦截、宣教、绩效处罚、限量采购、约谈等,实现了重点监控药品规范化管理。实践后,不合理医嘱减少,处方点评合格率提升,辅助用药种类减少。认为建立重点监控药品管理的相关制度及流程,对提升合理用药水平有一定促进作用。     

陕西省血液调配机制建立与运行

建立血液调配机制,可缓解医疗资源相对丰富的中心城市临床血液供需矛盾,逐渐实现采供血服务均衡化。建立了陕西省血液调配机制,实现了省域中心城市与周边城市血液资源的均衡化。认为不断优化血液调配机制,加强中心城市与周边城市采供血机构间的沟通合作,是实现省域内血液资源均衡、缓解中心城市季节性供血紧张的有效方法之一。     

广西基层医疗机构的医疗器械使用及管理现状

目的了解基层医疗机构的医疗器械使用及管理现状,为加强基层医疗机构中医疗器械的管理提供参考。方法采用问卷调查的方法,对广西壮族自治区的65个基层医疗机构的医疗器械使用及管理状况进行调查。结果65个基层医疗机构中,仅有26个(40.00%)医疗机构对医疗器械法律法规实施过学习培训;62个(95.38%)医疗机构的医疗器械进货查验记录真实、完整、准确;仅有11个(16.92%)医疗机构植入和介入类医疗器械具备使用记录且记录完整,满足追溯要求。结论广西基层医疗机构对医疗器械使用及质量管理方面尚存在不同程度的问题,需进一步建立、健全管理制度,监管部门亦应加强监督管理。     

国产自体-2000型血液回收机临床应用探讨

目的探讨由北京精医疗设备有限公司研制的自体-2000型血液回收机的临床应用效果。方法自2002年6月～2003年12月,我院应用北京精医疗设备有限公司自体-2000型血液回收机进行术中回收血液100例,其中男41例、女59例,年龄12～63岁,体重19～68公斤,手术包括外伤如肝破裂、大血管损伤、破裂脊柱外伤、脑外伤、器官移植手术。术中监测心电图、血压、血氧饱和度、尿量。结果全组病例中,总手术时间62～180分钟,平均102分钟,全部患者抢救成功,无死亡,无出现血尿现象。结论自体-2000型血液回收机安装使用安全、可靠、操作方便、血液回收效果好,经过滤、分离、清洗、净后再输回病人可以节约大量用血,又能避免异体输血传染疾病,是一种值得在临床广泛推广的国产血液回收机。     

住院患者抗生素临床应用现状

目的：通过分析某市立医院住院患者抗生素使用情况，探讨抗生素临床应用的合理性。方法：统计2003年7月20日全院住院患者处方590张中抗生素总药量、总用药天数、联合用药情况以及2003年7月1～31日为期1个月全院临床科室所用抗生素的给药途径、用药总量。结果：住院患者抗生素的使用量很大．但由DUI值可见日剂量基本正常。联合用药比例大，两联及两联以上占使用抗生素处方的95．6％。头孢呋辛钠、头孢曲松钠、头孢唑林钠的总DDD数远大于其他各种抗生素占据前3位。结论：不规范的联合用药导致抗生素重复用药，用量过大，抗生素滥用明显。