医疗器械召回实施策略研究

对缺陷医疗器械实施召回是国际惯例,对保障公众用械安全起到了重要的作用.本文基于《医疗器械召回管理办法(试行)》,对医疗器械产品召回问题的界定、召回深度的确定、召回方式、召回信息发布和召回效果评估等五个方面进行了研究和探讨.     

关于我国药品召回制度中几个问题的探讨

目的探讨药章召回制度中召回的责任主体,召回的范围,以及药品召回制度与药品不良反应报告和监测制度之间的关系。方法对药品召回责任主体进行界定,辨析药品召回的范围,分析药品召回制度与药品不良反应监测与报告制度的关联。结论药品召回制度促使我国对缺陷药品的管理更加规范,有利于人民群众的用药安全。药品不良反应报告与监测制度的完善是药品召回制度运行的前提,药品召回降低药品不良反应发生几率,两种制度相互促进。     

美国医疗器械召回信息研究报告

通过分析美国医疗器械召回的相关法规,制度等,对美国医疗器械召回信息进行系统介绍;通过对美国医疗器械召回数据库召回信息进行汇总,分析,进行深入研究.对特定品种召回信息进行详细分析,为我国开展医疗器械召回提供学习借鉴.     

医疗器械警戒信息

一、美国FDA发布Advanced Sterilization Products公司的召回通告召回发起日期：2008—10—17信息发布日期：2008—11—21召回公司：Advanced Sterilization Products公司召回产品：STERRAD灭菌器（STERRAD 100 Ssterilzer）召回范围：编号为10101的所有产品召回级别：二级召回原因：①当注射剂灭菌程序中没有过氧化氢被输送到灭菌室时，灭菌器不能及时探测到。     

从注脚到蓝本——美国的药品召回制度及启示

在我们所意欲设立的药品召回制度中,可以看到美国药品召回制度中所涉及的召回类别、召回的分级、召回策略、召回的公众警示等的身影。但是《药品召回管理办法(征求意见稿)》的体例更适合中国人的思维方式。     

药械警戒快讯

美国FDA发布AngioScore公司的召回通告召回发起日期:2010-11-16信息发布日期:2011-01-04召回公司:AngioScore公司召回产品:AngioSculpt PTA积分球囊导管召回范围:型号为2076-5020的所有批号产品。     

中美两国药品召回制度比较

为了解我国药品召回过程中存在的问题,完善我国药品召回制度,通过比较中美两国药品召回制度产生的文化背景、法律依据、药品缺陷发现的途径、药品召回执行环节等,借鉴美国药品召回制度中适合于我国的经验。我国药品召回制度尚处于实践发展的探索期,需要进一步完善。     

信使

时政>>>>药品一级召回须24小时内实施SFDA近日正式公布了《药品召回管理办法》,按照这个管理办法,召回分为主动召回和责令召回两类。根据药品安全隐患的严重程度,药品召回还分为三级,其中使用某药品可能引起严重健康危害的为一级召回,须在24小时内实施。     

论药品召回制度存在的问题及对策

目的通过对《药品召回管理办法》的研究,探索建立药品召回制度的必要性,药品召回的实施情况,以及对医药企业的影响。方法从监管部门和医药企业两个不同的角度分析我国药品召回实施的不利因素以及改进措施。结果与结论在国际上召回制度早已存在,我国有必要建立药品召回制度;由于我国的药品召回尚处于起步阶段,在开展工作中会存在不利的因素,监管部门和医药企业都要采取积极的应对措施。     

中、澳两国药品召回制度比较研究

目的:为完善我国药品召回制度提供借鉴。方法:通过比较中、澳两国药品召回制度,分析目前我国药品召回制度仍存在的问题。结果与结论:我国应借鉴澳大利亚药品召回制度中适用于我国的经验,从完善法律制度和跟踪措施,确定药品召回分层和政府职责等多方面入手完善我国药品召回制度。     

学习与记忆模型研究

本文对大脑中信息痕迹量自然衰减建立指数回归方程，实测了多次重复学习后记忆衰减曲线，并建立了相应地学习与记忆模型。结果表明：人脑对某事物的信息痕迹量是一个指数衰减函数。但每重新学习一次，大脑中的信息痕迹量就有一次阶跃。其阶跃的幅度依赖于学习系数、回忆系数与重复学习的次数ｎ。     

老年人食管癌放射治疗的临床价值

目的评价老年人食管癌放射治疗的临床价值。方法回顾分析35例老年人食管癌采用电子直线加速器6MV—X线外照射治疗相关资料。结果35例老年人食管癌,完全缓解或部分缓解33例,无明显改善2例,总有效率（CR＋PR）为94．29％。结论老年人食管癌放射治疗能为老年食管癌患者耐受,对一般状况较好者可达到延长生存期和改善生存质量的治疗目的。     

Liking and wanting of drug and non-drug rewards in active cocaine users: the STRAP-R questionnaire

Few studies have examined the subjective value attributed to drug rewards specifically as it compares with the value attributed to primary non-drug rewards in addicted individuals. The objective of this study is to assess 'liking' and 'wanting' of expected 'drug' rewards as compared to 'food' and 'sex' while respondents report about three different situations ('current', and hypothetical 'in general', and 'under drug influence'). In all, 20 cocaine-addicted individuals (mean abstinence = 2 days) and 20 healthy control subjects were administered the STRAP-R (Sensitivity To Reinforcement of Addictive and other Primary Rewards) questionnaire after receiving an oral dose of the dopamine agonist methylphenidate (20 mg) or placebo. The reinforcers' relative value changed within the addicted sample when reporting about the 'under drug influence' situation (drug > food; otherwise, drug < food). This change was highest in the addicted individuals with the youngest age of cocaine use onset. Moreover, 'drug' 'wanting' exceeded 'drug' 'liking' in the addicted subjects when reporting about this situation during methylphenidate. Thus, cocaine-addicted individuals assign the highest subjective valence to 'drug' rewards but only when recalling cue-related situations. When recalling this situation, they also report higher 'drug' 'wanting' than hedonic 'liking', a motivational shift that was only significant during methylphenidate. Together, these valence shifts may underlie compulsive stimulant abuse upon pharmacological or behavioural cue exposure in addicted individuals. Additional studies are required to assess the reliability of the STRAP-R in larger samples and to examine its validity in measuring the subjective value attributed to experienced reinforcers or in predicting behaviour.     

Alcohol-Aggression outcome expectancies and their responsiveness to event recall

The aim was to examine the effects of describing alcohol-related aggression incidents on alcohol-aggression outcome expectancies. Male students (N = 122) were allocated to Aggression, Relaxation or Control conditions. Those in the Aggression condition recalled experiences of alcohol-related aggression; those in the Relaxation condition recalled experiences of alcohol-related relaxation; and those in the Control condition recalled neutral events. An alcohol-aggression (AA) outcome expectancy measure showed that recalling alcohol-related aggression led to a significant increase in AA immediately after the intervention, which fell to pre-intervention levels after two weeks. The risk of aggression or violence may be temporarily elevated by talking about AA experiences.     

The effects of trauma recall on smoking topography in posttraumatic stress disorder and non-posttraumatic stress disorder trauma survivors

Smoking topography was measured in trauma survivors with and without posttraumatic stress disorder (PTSD) after recalling trauma-related and neutral experiences. Analysis of covariance was performed on puff topography and mood measures using nicotine dependence scores and current major depressive disorder as covariates. Puff volumes were higher in the PTSD group than in the non-PTSD group. The PTSD group exhibited stable puff onset intervals while the non-PTSD group exhibited significantly shorter intervals following trauma recall. These findings support a "ceiling effect" hypothesis in which individuals with PTSD perpetually smoke in such a way as to maximize nicotine delivery, possibly reducing the potentially reinforcing effects of increased smoke delivery in negative affect-inducing situations.     

Patterns of facilitation of memory by nicotine

A single oral dose of 1.5mg of nicotine was administered to healthy young normal males in a placebo-controlled double-blind study. The nicotine produced a significant improvement in the number of words recalled from a 32 item list. An examination of the individual serial position curves showed that most subjects were recalling either predominantly from the first half of the list or predominantly from the second half of the list. Examination of these groups separately showed that nicotine improved recall for the part of the list that was being recalled better in the placebo condition. These results are consistent with the hypothesis that nicotine was supplying additional processing resources and that deployment of these is under the strategic control of the subject.     

Computational chemistry for green design in chemistry and pharmacy: Building awareness in the classroom

Pursuing sustainability requires the design of environmentally benign substances and materials and of sufficiently clean processes for their production, as well as careful attention to their usage throughout their life cycle and to their eventual fate. These requirements have prompted the birth of green chemistry and, more recently, of green pharmacy. The current work focuses on relevant common features of the two areas at educational level. After briefly recalling the reasons that have prompted their birth, and the main objectives of their approaches, it devotes major attention to the design of substances as a tool made increasingly more powerful by the continuous progress of computational chemistry. Particular attention is given to the importance of fostering sound attitudes in approaching molecules and of building awareness of the fundamental roles of conceptual and theoretical knowledge to ensure that the obtained results are meaningful.     

肿瘤放射增敏剂在鼻咽癌放射治疗的临床价值

目的探讨肿瘤放射增敏剂希美钠（CMNa）在鼻咽癌放射治疗的增敏作用和临床价值。方法回顾分析综合组（希美钠＋放射治疗组）和单纯组（放射治疗组）各35例。综合组采用希美钠800mg／m^2,用100ml生理盐水稀释溶解,于30min内完成静脉滴注,在60min内进行放射治疗。2-3次／周,连续用药至放射治疗结束,用药总量为6000-9000mg。单纯组仅单纯采用放射治疗。结果近期疗效综合组明显高于单纯组,其放射治疗疗效提高37.14％,远期疗效正进一步观察中。结论希美钠不良反应小,安全性高,对鼻咽癌放射治疗增敏效果显著。     

Henri Moissan: the man, the collector, the teacher

On December 10 1906, Henri Moissan was in Stockholm to receive the Nobel Prize for chemistry for his isolation of fluorine in 1886 and for his electric arc furnace he described for the first time in 1892 then later improved and which opened the way to the new field of high-temperature chemistry. This was the first Nobel Prize for chemistry awarded to a Frenchman and Moissan was the only French pharmacist to have received this high distinction. He died suddenly at the age of 54 years, two months after receiving his Nobel Prize. In this presentation, we report the main elements of his biography, recalling the man, the teacher and the great collector of paintings and autographs, particularly from the period of the French revolution. We have used several unpublished or little known documents concerning this great scientist who with is broad culture and malicious humor always found the time, despite his many obligations, to satisfy his literary and artistic tastes.