英国医疗器械现场安全纠正措施及其对我国的启示

通过介绍英国医疗器械现场安全纠正措施及我国的医疗器械召回制度,比较英国和我国医疗器械召回制度的不同,为完善我国医疗器械召回制度提供参考和借鉴。     

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.     

医疗器械召回典型案例研究

通过分析、研究国内外医疗器械召回的典型案例,阐明国内外召回事件的处理过程与处理原则,为进一步完善我国的医疗器械召回制度提供借鉴.     

我国出台《医疗器械召回管理办法(试行)》

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,也体现了医疗器械生产企业是产品质量第一责任人的理念。为逐步建立健全符合我国监管实际的医疗器械召回制度,《医疗器械召回管理办法(试行)》(以下简     

加强国际医疗器械召回信息监测,提高上市后医疗器械监管能力

召回是医疗器械上市后监管的重要措施,能显著消除或减少缺陷医疗器械的风险和危害。我国医疗器械召回管理在法规制度、信息监测等方面与发达国家相比都存在很大差距,应借鉴国外医疗器械召回管理的有效经验。其中,加强对全球医疗器械召回信息的监测是重要途径之一。     

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.     

我国出台《医疗器械召回管理办法(试行)》

<正>本刊讯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,也体现了医疗器械生产企业是产品质量第一责任人的理念。为逐步建立健全符合我国监管实际的医疗器械召回制度,《医疗器械召回管理办法(试行)》(以下简称《办法》)已于2011年5月20日发布,2011年7月1日起正式实施。《办法》共六章三十八条,分别从医疗器械召回的监管体     

医疗器械产品召回的"实战"与思考

日前,北京药监昌平分局和辖区内某医疗器械生产企业成功完成了一批骨关节产品的召回行动.笔者全面回顾了此次医疗器械产品召回的过程.总结了成功召回的原因和现实意义.通过此次行动.笔者认为,日常监管中除对产品生产工艺、检验过程(原料、半成品、出厂)等环节监控外,也应注意产品上市后跟踪措施的制定以及是否具有可执行性.这也是医疗器械缺陷产品成功召回的决定性因素.     

浅析基层医疗器械监管现状及对策

目的研究国内基层医疗器械监管现状,深入剖析医疗器械监管中存在的问题。方法提出改进基层医疗器械监管的建议和对策。结果与结论加强医疗器械上市后监管,开展不良事件监测和产品再评价,建立医疗器械召回制度,提高技术监督支撑能力,加强医疗器械监管队伍建设,加快立法步伐,才能保证公众用械安全有效。     

国内外医疗器械召回制度比较研究

通过检索国内外有关医疗器械召回的法律法规与文献资料,在比较分析的基础上,提出在我国建立医疗器械召回制度的必要性及所面临的问题。     

Marijuana: Effects on free recall and subjective organization of pictures and words

The free recall of pictures and words was compared following the administration of marijuana or placebo in a multitrial free recall task. Since pictures are thought to be registered in both visual and verbal memory stores with this encoding being mediated by some form of mental imagery, it was predicted that marijuana would produce a greater deficit in word recall in comparison to picture recall because the drug has been reported to facilitate imagery. A trend in the opposite direction followed intoxication; picture recall was inferior to word recall in the later stages of acquisition. Although overall recall was inferior under marijuana, no differences were found between the treatment conditions in subjective organization as determined by a variety of clustering measures. Recall performance following marijuana intoxication was positively related to level of recall performance in the placebo condition.     

Clinical evaluation of two strategies for improving patient recall of prior drug therapy

The ability to recall details of current and prior drug therapy was evaluated in two studies employing a total of 94 patients with inflammatory polyarthritis. Ten per cent of patients were unable to completely recall the names of their current anti-inflammatory drugs and eighty-three per cent of patients to completely recall the details of prior anti-inflammatory drug therapy. Prompting firstly with the proprietary names of drugs and thereafter with a pill board substantially enhanced recall particularly for prior NSAID therapy. Nineteen per cent of responses obtained with verbal prompting were inaccurate. No such problems were encountered in responses obtained using the pill board. These findings indicate that a complete and accurate drug history can only be obtained in the majority of patients using recall enhancement strategies.     

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。     

Effects of a benzodiazepine on free recall of semantically related words

Although it is widely known that benzodiazepines impair episodic memory, few studies have investigated their effects upon specific processes involved in free recall. This study evaluated the acute effects of flunitrazepam (1.0 mg; 1.3 mg) and placebo in healthy volunteers on immediate and delayed free recall of word lists considering serial positions as well as semantic relations between words inserted in the middle of the lists (e.g. milk-cheese-butter). Flunitrazepam promoted a global amnestic effect, impairing recall in all serial positions except the last words (recency effect). Primacy and recency effects were preserved as indexed, respectively, by larger recall of the first and last words in relation to adjacent items. Facilitation in recall of semantically related words was not impaired by the drug when compared to recall in adjacent positions, in spite of a dose-dependent diminution of the number of words recalled also in mid-list positions. Flunitrazepam-induced deficits were interpreted as impairment in the formation of new associations between items, or groups of items in the case of related words, and context.     

Marijuana and memory impairment: the effect of retrieval cues on free recall.

In an attempt to ascertain the effect of retrieval cues on recall deficits which occur following intoxication with marijuana, 40 male volunteers were presented with word lists following the smoking of a single one gram marijuana (0.94% delta 9 -THC) or placebo cigarette and then were required to recall these words immediately after presentation. Recall occurred under a condition in which cues representative of to-be-remembered words were present or in an uncued condition. Results indicated that recall was depressed following marijuana administration under both cued and uncued conditions with cues being only mildly effective in reversing the recall deficit. There was no increase in the number of internal intrusions under marijuana, but the number of external intrusions was significantly elevated under the cued conditions.     

2010～2012年某市新生儿先天性甲状腺功能低下的筛查分析

目的为了解贵港市新生儿先天性甲状腺功能低下的情况。方法对2010～2012年贵港市新生儿先天性甲状腺功能低下筛查资料按年度进行统计分析。结果 2010～2012年贵港市新生儿先天性甲状腺功能低下筛查共132 482例,筛查阳性551例,筛查阳性率为0.42%;筛查阳性551例中召回389例,占筛查阳性的70.60%;召回389例中,有52例确诊为先天性甲状腺功能低下,占召回的13.36%,52例均得到了治疗。结论加强先天性甲状腺功能低下筛查宣传力度、增加公益资金投入,提高筛查率及阳性召回率是早发现、早治疗先天性甲状腺功能低下新生儿的有效方法。     

Differential effects of caffeine on free recall after semantic and rhyming tasks in high and low impulsives

The effects of caffeine on free recall after acquisition on semantic and rhyming tasks were examined. Following a between-subjects design, high and low impulsive male postgraduate students were administered placebo and four doses of caffeine citrate (1, 2, 3 and 4 mg/kg body weight) in a laboratory situation. A double blind procedure was adopted for drug administration. The study supports the following conclusions: (1) under no drug condition, high impulsives recall more after semantic acquisition while their counterparts, the low impulsives, recall more after rhyming acquisition; (2) caffeine facilitates recall in high impulsives after rhyming acquisition but hinders it after semantic acquisition; (3) caffeine does not reliably influence recall of low impulsives.     

Stress Enhances Retrieval of Drug-Related Memories in Abstinent Heroin Addicts

Stress is associated with relapse to drugs after abstinence, but the mechanisms for this association are unclear. One mechanism may be that stress enhances abstinent addicts'' recall of memories of drugs as stress relievers. This study assessed the effects of stress on free recall and cued recall of 10 heroin-related and 10 neutral words learned 24 h earlier by 102 abstinent heroin addicts. These participants were randomly assigned to three experiments that also assessed attention and working memory. Experiment 1 used a psychosocial stressor (Trier social stress test (TSST)) before testing for recall of heroin-related words. Experiment 2 added administration of the β-adrenoceptor antagonist propranolol 1 h before the psychosocial stressor. Experiment 3 added administration of either cortisol with propranolol, cortisol alone, or propranolol alone 1 h before word recall to determine whether stress enhancement of heroin-related word recall required noradrenergic-glucocorticoid interactions. We found that free recall of heroin-related words in abstinent addicts was enhanced after stress or cortisol administration when compared with a non-stress condition or placebo, respectively, whereas these interventions had no effect on neutral word recall. β-adrenergic blockade blocked the enhancing effect of stress or cortisol on free recall of heroin-related words. Neither stress nor cortisol affected cued recall, attention, or working memory. The potential of β-adrenergic blockade to reduce or block stress-induced enhancement of drug-related memory retrieval may be relevant to preventing stress-induced relapse in abstinent heroin addicts.     

美国药品召回规制对我国的借鉴意义

目的：思考完善我国药品召回规制的方式。方法：对缺陷药品相关概念进行阐述,分析我国药品召回规制现状及问题,并对美国药品召回规制现状进行介绍。结果与结论：我国可借鉴美国药品召回规制措施,进一步完善我国政府规制。