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。     

预防接种异常反应救济基金制度的设计

随着免疫规划工作疫苗种类和数量的增加,儿童免疫接种引起的异常反应越来越多.由此引起的受种者损害是否应当救济,采用何种方式救济等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,尤其是预防接种异常反应的法律救济缺位,亦无相应的损害救济制度,受种者损害难以得到补偿或赔偿.文章通过比较预防接种异常反应的各类救济制度,认为采用保险基金制度来建立预防接种异常反应救济制度是一项有效的途径,同时对我国预防接种异常反应救济制度的建立提供了初步意见.     

药品不良反应损害救济机制研究

探讨建立药品不良反应损害救济机制法律依据及模式,在产品责任理论基础上提出了我国应从行政主体、法律框架、保险体系等三方面建立药品不良反应救济制度。     

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。     

药品不良反应赔偿制度的国际比较与借鉴

近年来,中国药品不良反应事件频发,给患者及其家庭带来了严重的伤害,而中国现行法律对于药品不良反应受害人无法提供有效救济。本文通过分析德国、瑞典、日本、美国以及中国台湾地区药品不良反应救济制度的成功经验,结合中国药品不良反应事件现状及赔偿困境,建议建立以基金模式为主的药品不良反应赔偿制度。     

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。     

论我国药品不良反应的归责原则

药品不良反应的归责原则一直广受关注,直接影响药品不良反应受害者的救济可能性.文章在对德国、日本、美国药品不良反应归责原则发展轨迹进行考察的同时,也总结出了由合同责任到侵权责任,由过错责任到无过错责任的趋势.同时在考察了我国药品不良反应归责现状的基础上,提出了我国在药品不良反应救济方面宜采用无过错责任原则,并建立相应的配套制度.     

日本的药品副作用被害救济制度

药品副作用被害救济制度,是一种对患者或者家属迅速给予救济的公共制度。用于医生恰当地使用药品,但却发生副作用而造成健康受到损害的时候,对此实行各种救济补助。基于酞胺呱啶酮等药品的副作用,而造成健康受到损害的教训,     

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。     

医务人员锐器伤的分析与防护对策

目的：对医务人员锐器伤进行分析,探讨发生原因及预防措施。方法：对2006-2009年笔者所在医院54例锐器伤的登记报告进行统计分析。结果：工龄低于5年的工作人员发生锐器伤所占比例最高,占87.1%;发生锐器伤人群中护士比例居首位,高达72.2%,其次是实习护生14.8%,医生9.3%;致锐器伤的操作环节以拔除针头时和输液结束拔除针头后处理过程中发生率最高,分别为64.8%和12.9%,其次是抽血和套回针帽发生率,分别为5.6%,手术缝合皮肤和处理医疗废物时发生率分别为3.7%。结论：加强医务人员职业安全教育,提高安全防护意识,规范操作流程,建立健全锐器伤上报制度,定时跟踪随访,保障医务人员身心健康。     

Assumption of medical risks and the problem of medical liability in ancient Roman law

The claim of an individual to assure his health and life, to assume and compensate the damage from diseases and accidents, had already appeared in the system of the ancient Roman law in the form of many singular legal institutions. In lack of a unified archetype of regulation, we have to analyse the damages caused in the health or corporal integrity of different personal groups: we have to mention the legal interpretation of the diseases or injuries suffered by serves, people under manus or patria potestas and free Roman citizens. The fragments from the Digest od Justinian do not only demonstrate concrete legal problems, but they can serve as a starting point for further theoretical analyses. For example: if death is the consequence of a medical failure, does the doctor have any kind of liability? Was after-care part of the healing process according to the Roman law? Examining these questions, we should not forget to talk about the complex liability system of the Roman law, the compensation of the damages caused in a contractual or delictual context and about the lex Aquilia. Although these conclusions have no direct relation with the present legal regulation of risk assumption, we have to see that analysing the examples of the Roman law can be useful for developing our view of a certain theoretical problem, like that of the modern liability concept in medicine as well.     

医疗不良事件报告体系研究

医疗不良事件是指因诊疗活动而非疾病本身造成的损害。建立医疗不良事件报告制度是医院医疗安全体系建设的重要措施之一。医疗不良事件报告应实行非惩罚性报告和奖励措施,要做到“早发现、早报告、早处置、早控制”,目的是及时发现医院安全系统存在的不足,分析整个医疗服务系统中存在的不安全因素,防范医疗事故,保护患者利益。     

艾滋病防治中的"社会排斥"问题与政府干预研究--以HIV/AIDS人群及其高危人群为研究对象

文章以HIV／AIDS人群及其高危人群为研究对象，通过社会排斥的社会政策创造论、社会结构生成论和自载贡任论的归因分析，剖析了政府干预艾滋病防治的瓶颈缘于政策的负导向功能、社会结构的不平等和社会排斥客体自身边缘化的行为及态度，并提出政府有效干预艾滋病防治应促进社会融合，树立全新艾滋观；调整相关社会政策，适应社会结构；完善信息系统，减少外延作用；健全政策和法律保障，建立社会支持环境；发挥第三部门优势，满足社会多层次需要等。     

Clinically relevant drug interactions in the elderly

About 15% of hospital admissions of elderly patients in the Netherlands are caused by adverse effects of drugs. With polypharmacy there is an increased chance of adverse effects occurring. It is not always possible to reduce polypharmacy in the elderly. Polypharmacy is often associated with drug interactions which result in an increased or decreased effect, or the occurrence of adverse effects. Due to changes in the pharmacokinetic and pharmacodynamic properties of drugs in the elderly, the effect of interactions is more clinically relevant. Pharmacokinetic interactions influence absorption, liver metabolism or excretion by the kidneys. In particular, interactions with drugs that have a narrow pharmacotherapeutic spectrum can result in serious adverse effects: anticonvulsives, anti-Parkinson drugs, antipsychotics, coumarin derivates, digitalis preparations, lithium salts, opiates, sulphonylurea derivates, tricyclic antidepressants and verapamil. The most important pharmacodynamic changes in the elderly concern an increased sensitivity of the target organ. This is particularly the case for substances which have an effect on the central nervous system, such as antidepressants and antipsychotics, but also applies to benzodiazepines, coumarin derivatives and digoxin. When an unexpected adverse effect occurs in a patient or a previously effective therapy suddenly fails, it is wise to consider drug interaction as a possible cause.     

Adverse drug reactions

There are many methods of surveillance of new drugs for adverse reactions once they have been fully marketed. The yellow card system run by the Committee on Safety of Medicines is not well used by doctors: perhaps there is some other way of reporting adverse reactions?     

Importance of pharmacogenetics

Pharmacogenetics deals with the differences in effect of drugs caused by genetic variation. Differences can occur in therapeutic effect and in adverse events. Genetic variation in metabolism may result in high concentrations of drugs and an increased risk of adverse effects in slow metabolizers, which is important when using for example antidepressants or chemotherapy. Genetic variation also occurs in proteins interacting with drugs, which may change the effect of e.g. asthma drugs and antipsychotics. The selection of drugs and their dosages may be improved, and the number of adverse effects reduced by pharmacogenetic investigations. However, it may be important also in case of medical examinations for insurances and job appointments, since some patients may turn out to need expensive drugs or to be susceptible to a certain disease. Therefore, the use of genetic data in these instances has to be regulated.     

药物治疗骨关节炎的疗效比较:网络Meta分析

目的 比较骨关节炎5种药物（对乙酰氨基酚、塞来昔布、氨基葡萄糖、硫酸/盐酸软骨素、氨基葡萄糖和软骨素联合）疗效和不良反应并进行概率排序。方法 系统检索电子数据库中公开发表关于对乙酰氨基酚、塞来昔布、氨基葡萄糖、硫酸/盐酸软骨素、安慰剂随机对照试验（截止日期为2017年10月）。通过贝叶斯网络Meta和传统Meta分析相对和绝对疗效及不良反应。结果 共纳入58篇文献,包含25 045例患者的61个随机对照试验。研究表明,在缓解疼痛方面,塞来昔布优于其他方案（SMD=-0.32,95%CI:-0.38~-0.25）,其次为关节保护药物。在提高功能方面,除对乙酰氨基酚以外（SMD=-0.14,95%CI:-0.27~0.01）均优于安慰剂。改善僵直方面,氨基葡萄糖（SMD=-0.36,95%CI:-0.67~-0.06）与塞来昔布（SMD=-0.29,95%CI:-0.51~-0.08）优于其他方案。塞来昔布虽然在疗效方面效果显著,但最有可能出现不良反应事件;关节保护类药物也有较为显著表现,且具有较低不良事件发生率。对乙酰氨基酚相对疗效最差且具有较高不良事件发生率。结论 塞来昔布优于其他药物,但不良反应发生率较高。关节保护类药物也具有较好疗效且不良反应发生率较低。