新发传染病相关的药品技术战略储备思考

目的： 对新发传染病相关的药品技术战略储备进行探讨,旨在为战胜此次新冠肺炎疫情,更为下一次可能的疫情做好准备。方法： 梳理了世界卫生组织、欧盟、美国对与公共健康威胁相关的药品技术储备情况,主要阐述了新发传染病相关的疫苗技术储备信息,给出WHO建议的新型冠状病毒肺炎（COVID-19）药品研发信息,EMA在公共健康威胁（例如大流行性流感）相关药品方面的技术储备情况,并总结了EMA对大流行防备疫苗的技术要求。结果与结论： 建议在我国建立由国家主导并投资的与公共健康威胁相关的预防用疫苗或治疗用药物的技术和产品战略储备,例如为新发传染病的疫苗开发制定清晰的计划、法规和程序。药品技术和产品的战略储备可包括：1）政府部门制定与公共健康威胁相关疾病的清单,例如可能引起重大流行病的突发疾病用药优先研发清单;2）审评审批方面可考虑制定大流行性疾病疫苗（包括大流行防备疫苗）、大流行性疾病治疗药物研发的技术要求,涉及质量、非临床、临床、申报程序等内容;3）通过国家科技立项等方式投资预防用疫苗及治疗用药物的研制;4）引导生产企业进行相关的药品战略储备。     

Overview: Bacterial Lipoproteins as Vaccines Candidates and Patent Considerations

A series of compounds incorporating an aromatic scaffold based on isoxazolines were prepared in the patent application (WO2012151158). The new compounds from the patent are defined to be biologically active metabolites, prodrugs, isomers, stereoisomers, solvates, hydrates and pharmaceutically acceptable salts, they are claimed to be useful for treating immunological conditions because of their inhibitory activities on matrix metalloproteinase (MMP-13), although no specific MMP-13 inhibition data or other rationale to explain their biological effects is provided. The compounds have a broad potential utility with osteoarthritis, rheumatoid arthritis, juvenile arthritis, psoriatic arthritis, degenerative joint disease or systemic lupus erythematosus among the likely preferred indications.     

Blue Moon Neurovirology: The Merits of Studying Rare CNS Diseases of Viral Origin

While measles virus (MV) continues to have a significant impact on human health, causing 150,000–200,000 deaths worldwide each year, the number of fatalities that can be attributed to MV-triggered central nervous system (CNS) diseases are on the order of a few hundred individuals annually (World Health Organization 2009). Despite this modest impact, substantial effort has been expended to understand the basis of measles-triggered neuropathogenesis. What can be gained by studying such a rare condition? Simply stated, the wealth of studies in this field have revealed core principles that are relevant to multiple neurotropic pathogens, and that inform the broader field of viral pathogenesis. In recent years, the emergence of powerful in vitro systems, novel animal models, and reverse genetics has enabled insights into the basis of MV persistence, the complexity of MV interactions with neurons and the immune system, and the role of immune and CNS development in virus-triggered disease. In this review, we highlight some key advances, link relevant measles-based studies to the broader disciplines of neurovirology and viral pathogenesis, and propose future areas of study for the field of measles-mediated neurological disease.     

Bigels as drug delivery systems: From their components to their applications

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对我国罕见病用药法规建设的思考及建议

罕见病用药是当前全球临床需求面临的重要问题之一,推动罕见病用药研发是监管方和工业界共同面对的问题。当前我国药品监管机构已出台了诸多政策,在实践中已取得了切实的成果,但我国罕见病药物研发整体起步较晚,在供给侧改革中尚需完善相关制度。本文对当下国内罕见病用药现状以及目前研发注册方面的激励政策进行了总结,结合部分法规中的薄弱环节提出相关建议,为未来我国罕见病用药政策制定提供参考。     

漾濞县1976～2005年法定报告传染病流行趋势分析

目的 对漾濞县30年来传染病流行特征进行分析,预测流行趋势,为制订防制策略提供科学依据.方法 采用描述性流行病学方法对漾濞县1976～2005年30年间甲、乙类传染病疫情资料进行分析.结果 1976～2005年全县传染病报告发病率在224.02/10万～14511.62/10万之间,年均发病率2266.97/10万.20世纪80年代发病率呈直线下降,90年代以来发病态势持续平稳.肠道传染病发病率1976～2000年排位居于第一位,以其降幅最大,由70年代的5348.79/10万降到78.25/10万;呼吸道传染病在大幅度下降后的90年代后期开始回升,到21世纪构成比占比第一;血源及性传播疾病占比逐年上升,达35.35%,艾滋病1996年首发病例报告,2001年后发病率迅速上升,2005年度发病率达13.91/10万.肺结核、肝炎、痢疾、麻疹、艾滋病年均发病率2000年以来居各种传染病前5位.结论 漾濞县传染病总发病率呈平稳态势.传染病谱由肠道传染病为主转为以血源及性传播疾病为主,提示工作重点是加大肝炎、艾滋病、淋病防治力度.     

In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung Diseases

Dry powder inhalers (DPIs) are used to deliver locally acting drugs (e.g., bronchodilators and corticosteroids) for treatment of lung diseases such as asthma and chronic obstructive pulmonary disease (COPD). Demonstrating bioequivalence (BE) for DPI products is challenging, primarily due to an incomplete understanding of the relevance of drug concentrations in blood or plasma to equivalence in drug delivery to the local site(s) of action. Thus, BE of these drug/device combination products is established based on an aggregate weight of evidence, which utilizes in vitro studies to demonstrate equivalence of in vitro performance, pharmacokinetic or pharmacodynamic studies to demonstrate equivalence of systemic exposure, and pharmacodynamic and clinical endpoint studies to demonstrate equivalence in local action. This review discusses key aspects of in vitro studies in supporting the establishment of BE for generic locally acting DPI products. These aspects include comparability in device resistance and equivalence in in vitro testing for single inhalation (actuation) content and aerodynamic particle size distribution.     

A Review of Thimerosal (Merthiolate) and its Ethylmercury Breakdown Product: Specific Historical Considerations Regarding Safety and Effectiveness

Thimerosal (Merthiolate) is an ethylmercury-containing pharmaceutical compound that is 49.55% mercury and that was developed in 1927. Thimerosal has been marketed as an antimicrobial agent in a range of products, including topical antiseptic solutions and antiseptic ointments for treating cuts, nasal sprays, eye solutions, vaginal spermicides, diaper rash treatments, and perhaps most importantly as a preservative in vaccines and other injectable biological products, including Rho(D)-immune globulin preparations, despite evidence, dating to the early 1930s, indicating Thimerosal to be potentially hazardous to humans and ineffective as an antimicrobial agent. Despite this, Thimerosal was not scrutinized as part of U.S. pharmaceutical products until the 1980s, when the U.S. Food and Drug Administration finally recognized its demonstrated ineffectiveness and toxicity in topical pharmaceutical products, and began to eliminate it from these. Ironically, while Thimerosal was being eliminated from topicals, it was becoming more and more ubiquitous in the recommended immunization schedule for infants and pregnant women. Furthermore, Thimerosal continues to be administered, as part of mandated immunizations and other pharmaceutical products, in the United States and globally. The ubiquitous and largely unchecked place of Thimerosal in pharmaceuticals, therefore, represents a medical crisis.     

Considerations in the design and development of transport inhibitors as adjuncts to drug therapy

With the realization of the importance of drug efflux transporters in disease processes and treatment, development of inhibitors to these transporters has been sought for use as adjuncts to therapy. To date, inhibitors that have been best studied are modulators of P-glycoprotein, a transporter important in the removal of anticancer agents from cells and overexpression of this transporter results in multidrug resistance. There is a delicate balance between efficacy and toxicity. This review summarizes key learning points in the development of P-glycoprotein inhibitors. Topics covered include specificity of the inhibitor for the target transporter, effect on metabolism of coadministered drugs, pharmacokinetic interactions, toxicity and the salient features needed for efficacy. These points will have general application to the development of inhibitors of transporters.     

疫情时期慢性病患者用药储备、信念及依从性研究

目的：了解疫情时期我国慢性病患者用药储备、用药信念及用药依从性等情况,为在疫情常态化阶段保障慢性病患者用药安全、有效和便利提供参考。方法：2022年4月-5月采用自制“疫情时期慢性病患者用药储备、信念及依从性调查问卷”进行线上调研,运用SPSS 26.0软件对所采集的数据进行分析。结果：248名受访者中有56.50%的患者家中常备所患慢性病药品,疫情时期有48.79%的患者药品储备量增加。慢性病患者用药信念总分为（30.55±8.42）分、用药依从性总分为（3.40±2.24）分。在疫情时期,63.70%的患者表示出行受限,无法到药店购买药品,64.50%的患者希望药师能够提供互联网用药指导。结论：疫情时期,我国慢性病患者的用药信念和用药依从性较低;受疫情影响,慢性病患者家中药品储备量增加。在疫情时期,慢性病患者在药品获取时遇到了困难,希望能够得到更完善的药学服务。     

The Obesity Epidemic and Food Addiction: Clinical Similarities to Drug Dependence

Abstract

As of 2010 nearly 70% of adult Americans were overweight or obese. Specifically, 35.7% of adult Americans are obese, and this is the highest level of obesity in the recorded history of the United States. A number of environmental factors, most notably the number of fast food outlets, have contributed to the obesity epidemic as well as to the binge prone dynamic. There is evidence that bingeing on sugar-dense, palatable foods increases extracellular dopamine in the striatum and thereby possesses addictive potential. Moreover, elevated blood glucose levels catalyze the absorption of tryptophan through the large neutral amino acid (LNAA) complex and its subsequent conversion into the mood-elevating chemical serotonin. There appear to be several biological and psychological similarities between food addiction and drug dependence including craving and loss of control. Nonetheless there is at least one apparent difference: acute tryptophan depletion does not appear to induce a relapse in recovering drug-dependent individuals, although it may induce dysphoria. In some individuals, palatable foods have palliative properties and can be viewed as a form of self medication. This article will examine environmental factors that have contributed to the obesity epidemic, and will compare the clinical similarities and differences of food addiction and drug dependence.     

基于COVID-19疫情常态化防控的门诊药房管理模式探究

目的:分析基于COVID-19疫情常态化防控形势的门诊药房管理模式,避免院内感染和促进药学服务.方法:根据COVID-19的传播方式,通过加强环境卫生管理,遏制病毒的传播,保证环境安全;建立健全长效管理机制、促进药学服务开展,减少慢性病患者往返医院次数;积极推进"互联网+药学服务"以保证工作正常有序开展;加强服务管理,...     

新冠肺炎疫情防控药学应急管理工作模式的构建与应用

目的 提升医院药剂科新型冠状病毒肺炎(简称新冠肺炎)疫情防控的药学应急能力.方法 根据国家、上海市及医院的相关文件规定和要求,结合既往医院药学管理经验及具体实际情况,构建具有该院特色的疫情防控药学应急管理工作模式并实践.结果 成功构建了新冠肺炎疫情防控药学应急管理工作模式,并应用于疫情防控相关知识培训,药学人员和工作环...