中美疫苗异常反应救济制度的比较与启示

疫苗接种是一种有益社会的行为,对于因此而遭受异常反应的受害者应由社会给予救济。我国现有的补偿制度有加重政府和企业负担之嫌。借鉴美国的救济制度,在我国建立异常反应损害的基金补偿制度,并使因果关系的认定标准客观化,是实现公平、效率的救济目标的重要途径。     

德日两国药品不良反应救济制度的运行模式对我国的启示

药品不良反应损害已日益发展成为一个社会问题，各国政府都在尝试建立完善的救济制度，而目前我国在这方面仍属空白。文章在比较分析德、日两种类型救济模式的基础上，提出了构建我国药品不良反应损害救济基金会的设想和具体运作形式。     

浅析我国台湾地区药害救济法及制度借鉴

目的 借鉴我国台湾地区的药害救济制度,探索我国大陆的药害救济制度.方法 详细解析我国台湾地区的药害救济法的立法背景、目的以及药害救济法的具体内容.结果与结论 这种制度对于我国大陆医药制度的改革和发展具有一定的借鉴和参照的价值.     

药品不良反应损害救济制度探讨

药品不良反应是在正常使用合格药品时产生的有害或意外反应。药品发生不良反应会给患者及其家庭带来严重的伤害,受害者理应得到补偿救济。而我国现行法律对药品不良反应损害的规定缺位。我国应及早建立和完善药品不良反应救济机制,实行药品不良反应救济基金制度。     

药品不良反应补偿救济制度运行机制研究——基金运作模式研究

药品发生不良反应会给患者及其家庭带来严重的伤害，受害者理应得到补偿救济．但我国在此项制度建立方面仍是空白。通过研究已经建立药品不良反应救济制度国家的制度运行机制，结合我国的实际情况分析不同运作模式的利弊．探讨基金运作模式的可行性，并在此基础上提出建议。     

再论药品不良反应救济的保险模式

目的:探索适合现状的药品不良反应损害救济模式.方法:阐述药品不良反应相关理论依据及当前探索中的ADR救济模式,分析ADR责任险构建的可行性.结果:提出保险形式构建ADR救济机制的具体措施.结论:建立ADR保险救济机制有利于解决当前ADR补偿问题,有利于构建和谐社会.     

当前药品不良反应损害救济立法刍议

药品不良反应的损害救济在我国是个尚未解决的难题。文章通过我国当前药品不良反应立法现状的分析,对立法提出一些建议并有助于我国医药企业的立法和谐的发展。     

药品不良反应保险救济机制研究

通过对药品不良反应定义的分析,探析我国建立药品不良反应保险救济机制的可行性,结合近期＂严重药品不良反应综合保险＂的失败经验,提出了完善法律法规、累积数据、建立鉴定中心、政府补贴并强制购买等政策建议。     

艾滋病患者法律救济制度的缺陷与完善

对艾滋病患者的法律救济是防止艾滋病传播流行的一项重要措施.分析我国在艾滋病患者公力救济和私力救济上的局限性,并提出如何完善我国相关法律救济制度.     

药品不良反应损害救济机制探讨

药品不良反应损害是否应当救济,或在多大范围内救济,采用何种方式救济?这一系列问题都需由法律予以判断和裁决。而我国现行法律制度对药品不良反应的法律责任规定缺位,亦无相应的损害救济制度,受到药品不良反应损害的消费者或其他相关人员因而难以得到补偿或赔偿。文章通过比较药品不良反应各类救济制度,认为采用保险基金制度来建立药品不良反应救济制度是一项有效的途径,同时对我国药品不良反应救济制度的建立提供了初步意见。     

Passive surveillance for generalized vaccinia in the United States using the Vaccine Adverse Event Reporting System (VAERS)

BACKGROUND: Generalized vaccinia (GV) is an adverse event specifically associated with smallpox vaccination, but shares clinical features with many common non-vaccine related rashes. We assessed the utility of passive reporting for GV surveillance by reviewing all Vaccine Adverse Event Reporting System (VAERS) reports of any post-smallpox vaccination rash in civilians and military personnel. METHODS: We reviewed all reports submitted to VAERS between 12/12/2002 and 3/1 2004 for post-smallpox vaccine (SPV) rashes concerning civilians and military personnel. We evaluated the information contained in the reports independent of VAERS adverse event coding (GV or not GV). We classified the rash reports based on the recently published GV case definition from the Centers for Disease Control and Prevention. RESULTS: Of the 936 rash reports after SPV, 92 were coded as GV. We classified 12 of the 92 as probable GV, and 1 as confirmed GV (14% probable or confirmed). Among the 844 reports not coded as GV, we classified 32 as either probable or confirmed GV (4%). Probable or confirmed reports that were coded as GV were similar to probable or confirmed reports not coded as GV with respect to demographic characteristics of the report subjects, and the location and phenotype (e.g., pustular, vesicular, etc.) of the rashes. CONCLUSIONS: A prospective study that applies well-defined clinical, histopathological, and laboratory criteria to smallpox-vaccinated patients with rashes would be necessary to distinguish GV from common alternative diagnoses with which it is easily confused.     

Human Papillomavirus Prevalence in Oropharyngeal Cancer before Vaccine Introduction,United States

We conducted a study to determine prevalence of HPV types in oropharyngeal cancers in the United States and establish a prevaccine baseline for monitoring the impact of vaccination. HPV DNA was extracted from tumor tissue samples from patients in whom cancer was diagnosed during 1995–2005. The samples were obtained from cancer registries and Residual Tissue Repository Program sites in the United States. HPV was detected and typed by using PCR reverse line blot assays. Among 557 invasive oropharyngeal squamous cell carcinomas, 72% were positive for HPV and 62% for vaccine types HPV16 or 18. Prevalence of HPV-16/18 was lower in women (53%) than in men (66%), and lower in non-Hispanic Black patients (31%) than in other racial/ethnic groups (68%–80%). Results indicate that vaccines could prevent most oropharyngeal cancers in the United States, but their effect may vary by demographic variables.     

Decolonizing health policy and practice: Vaccine hesitancy in the United States

Using 2021 data and information related to COVID-19, this paper discusses the contribution of colonization, medical mistrust and racism to vaccine hesitancy. Vaccine hesitancy is defined as ‘delay in acceptance or refusal of vaccines despite availability’. Colonization is described as the ‘way the extractive economic system of capitalism came to the United States, supported by systems of supremacy and domination, which are a necessary part of keeping the wealth and power accumulated in the hands of the colonizers and ultimately their financiers’. The system of colonization results in policies and practices, including those related to health, that continue to create oppression and support racism. Persons experience trauma as the byproduct of colonization. Chronic stress and trauma create chronic inflammation and all diseases, whether genetic or lifestyle, have a common pathogenesis that is a component of inflammation. Medical mistrust is the absence of trust that healthcare providers and organizations genuinely care for patients' interests, are honest, practice confidentiality and have the competence to produce the best possible results. Finally, racism is described as everyday racism and perceived racism in healthcare.     

美国医院降低再入院率的策略与启示

由于政府公共卫生报告的公开和对高再入院率医院的经济处罚,促使美国医院越发重视降低再入院率。总结了美国医院降低再入院率的措施,包括患者教育、随访、开发再入院危险因素预测模型等。参考美国经验,建议我国医院优化出院流程;加强出院后随访;促进患者加强自我管理;重点关注高危患者等。减少可避免的再入院能够降低医疗成本,提高医疗质量并改善患者就医体验     

Endogenous Endophthalmitis Caused by ST66-K2 Hypervirulent Klebsiella pneumoniae,United States

We describe a case of endogenous endophthalmitis caused by sequence type 66-K2 hypervirulent Klebsiella pneumoniae in a diabetic patient with no travel history outside the United States. Genomic analysis showed the pathogen has remained highly conserved, retaining >98% genetic similarity to the original strain described in Indonesia in 1935.     

Cost-effectiveness of an Adjuvanted Recombinant Zoster Vaccine in older adults in the United States

In the United States, herpes zoster (HZ) and related complications are estimated to result in approximately $1.3 billion in medical care costs and $1.7 billion in indirect costs annually. In this study, we compared the cost-effectiveness of a new Adjuvanted Recombinant Zoster Vaccine (RZV), containing recombinant varicella-zoster virus glycoprotein E and the AS01_B Adjuvant System, versus No Vaccine, as well as versus the live attenuated HZ vaccine (Zoster Vaccine Live (ZVL)) in subjects aged 60+ years of age (YOA) and other age cohorts aged 50+ YOA. A multi-cohort Markov model was developed which follows 1 million individuals over their remaining lifetimes from the year of vaccination with annual cycle lengths. Second dose compliance for RZV was assumed to be 69%. Efficacy and waning parameters were derived from clinical trials for both vaccines. Epidemiological parameters, costs and utility model inputs were derived from US-specific population-based data. Costs and outcomes were discounted at 3% per year. Deterministic and probabilistic sensitivity analysis, along with scenario and threshold analysis were carried out to explore the overall uncertainty in the model. The model estimated that, compared to No Vaccine against HZ, RZV would prevent 103,603 HZ cases, 11,197 postherpetic neuralgia (PHN) cases, and 14,455 other complications, at an incremental cost of $11,863 per quality-adjusted life-year saved from a societal perspective. Compared to ZVL, the model estimated that, RZV would prevent 71,638 additional HZ cases, 6403 PHN cases, and over 10,582 other complications, resulting in net total societal cost savings of over $96 million. The results were robust to a wide range of sensitivity analyses. Vaccination against HZ with RZV is cost-effective compared to No Vaccine and cost-saving compared to ZVL, in the US population aged 60+ YOA.Clinicaltrial.gov. registered#: NA.