药物安全:不良反应及其监测

药品是疾病治疗的重要手段,如何发挥药品的最大疗效,降低其不良反应,一直是关注的热点问题.近年来,随着新药的不断上市,药物不良反应发生率呈上升趋势.针对这种情况,从如何认识、判定、预防、处理四个方面,对药物不良反应进行了分析,旨在使药物不良反应得到关注,使用药安全、有效.     

药物不良反应补偿体系国际比较研究

药品在治疗疾病过程中有着不可或缺的作用,但药品在使用过程中也往往容易发生药物不良反应,并造成患者很重的经济负担,很多国家都针对药品不良反应建立救济保险制度。从基金筹资、补偿制度、管理等角度对国际上几个国家的药物不良反应补偿体系进行分析,以期我们在建立自己相应的药物不良反应补偿体系时有所借鉴。     

药物不良反应侵权诉讼问题研究

药物不良反应侵权诉讼是一种特殊的民事侵权诉讼。药品的生产者、药品经营者以及医疗机构都可能成为诉讼中的被告。药物不良反应侵权诉讼中的许多案件事实实行举证倒置。主要举证倒置事实有:药品缺陷、因果关系、免责事由、医疗过错等。     

药物政策与药品获得

讨论药物政策的完善与否,及其推行实效对药品获得的影响等问题,探讨如何制定与健全我国的药物政策,尤其是国家基本药物政策,以保证政府责任的有效实现和社会公众药品获得障碍的消除。     

药物政策与药品获得

讨论药物政策的完善与否,及其推行实效对药品获得的影响等问题,探讨如何制定与健全我国的药物政策,尤其是国家基本药物政策,以保证政府责任的有效实现和社会公众药品获得障碍的消除.     

安全有效用药的伦理思考

药物除了治疗疾病作用外 ,还有毒副作用。在预防、诊断、治疗疾病或调节生理机能过程中使用药物后出现的任何有害的与用药目的无关的反应称药品不良反应 (ａｄｖｅｒｓｅｄｒｕｇｒｅａｃｔｉｏｎｓ ,ＡＤＲ) ,程度严重导致机体组织或器官发生功能性或器质性损害 ,甚至死亡的称药源性疾病 (ｄｒｕｇ -ｉｎｄｕｃｅｄｄｉｓｅａｓｅｓ ,ＤＩＤ)。我们的祖先早就认识到 ,服用药物后会使人产生难受的症状。《神农本草经》收载了 365种药物 ,并把药品分为上、中、下三品 ,初步提出了合理用药、安全用药的概念。今天医药科技事业的高速发展 ,市场…     

医院临床药学管理要注重药物经济学评价与研究

通过对医院临床药学管理的药物经济学评价与研究的重要性、药物经济学评价与研究的基本方法和技术的论述,提出在进行临床药学管理的同时,应注重和开展药物经济学评价与研究,使之成为医院临床药学管理重要方面。目前医院临床药物管理中需关注的评价与研究项目,包括医院药品费用评价和控制研究、医院用药目录评价和规范医生行为研究、药物的适用范围评价与科学合理性研究、患者选择药物行为评价和正确帮助择药研究。     

一些传统药物为何退出“历史舞台”

一个与当前的社会热点问题——药品价格虚高问题同样重要的问题——许多安全有效的传统药物正在退出“历史舞台”的问题,应该引起社会各界的足够重视,传统药物不应被抛弃。因为人们对于传统药物的了解,无论是在药理作用上,还是在不良反应方面,都大大优于新药。     

细菌耐药性与抗菌药物的合理应用

面对细菌耐药性的客观存在,分别从四个方面讨论抗菌药物的合理应用,即首先是人类如何对待细菌、真菌等微生物,第二是人类如何对待抗菌药物,第三是人类如何认识细菌耐药性,第四是临床医师如何合理应用抗菌药物以确保最佳疗效及遏制细菌耐药性。笔者提出“六化”,即做到用药适应证规范化,做到感染性疾病病原学诊断常规化,提倡感染性疾病病原学治疗选药合理化,逐步做到推广病原菌耐药性信息监测与反馈制度化,强调抗感染治疗用药方案个体化,评价疗效制度日常化。它是追求抗感染疗效最佳化,遏制病原菌耐药性有效化,力争抗菌药物不良反应最小化的基本措施。     

细菌耐药性与抗菌药物的合理应用

面对细菌耐药性的客观存在,分别从四个方面讨论抗菌药物的合理应用,即首先是人类如何对待细菌、真菌等微生物,第二是人类如何对待抗菌药物,第三是人类如何认识细菌耐药性,第四是临床医师如何合理应用抗菌药物以确保最佳疗效及遏制细菌耐药性。笔者提出“六化”,即做到用药适应证规范化,做到感染性疾病病原学诊断常规化,提倡感染性疾病病原学治疗选药合理化,逐步做到推广病原菌耐药性信息监测与反馈制度化,强调抗感染治疗用药方案个体化,评价疗效制度日常化。它是追求抗感染疗效最佳化,遏制病原菌耐药性有效化,力争抗菌药物不良反应最小化的基本措施。     

评价和控制药物不良反应的认识与思考

用科学的世界观和方法论指导药物不良反应的评价和控制。从药物不良反应的发生机制、临床表现、因果关系的判定原则出发,与马克思主义哲学的基本观点相结合,提出了几点认识和思考。药物治疗作用与副作用既对立又统一;药物治疗效应向毒性反应的转变是量变到质变的过程;药物过敏反应的发生是内因外因相互作用的结果;药物与不良反应联系强度的判定必须符合前因后果性;药物与不良反应联系强度的判定必须排除混杂因素的干扰,找到内在的、本质的联系。     

药物治疗的风险及其处理

造成药物治疗风险的因素包括药物因素、病情因素、患者因素、用药因素及管理因素等。通过对药物进行严格监管,对医药从业人员加强培训和教育,对民众开展科普教学和用药指导,可以降低药物治疗的风险。风险事件主要表现为用药差错、药物不良反应或药物治疗无效。在药物治疗中,首先必须时刻警惕和及时发现风险;其次需要全面评估风险,还要对疾病风险和药物治疗风险进行比较。应尽可能避免药物治疗的风险,对于必须承受的风险,需采取相应措施,减少风险事件发生的概率和严重程度。如果存在较大风险,务必同时设计处理风险事件的预案,并与患者及其家属保持良好的交流和沟通。     

Most family physicians report communicating the risks of adverse drug reactions in words (vs. numbers)

Family physicians can communicate to patients the risk of adverse drug reactions using words or numbers, and this format has important implications for patients' ability to make informed decisions. The present study (a) assessed which formats family physicians preferred to communicate the risk of a given side effect, (b) tested whether the severity of this adverse drug reaction affected this preference, and (c) investigated the type of quantifiers physicians preferred to use in general (e.g., ratios, percentages). In a format selection task, a sample of 131 family physicians reported that they mostly use words to communicate to patients the risk of mild and severe adverse drug reactions, but the verbal preference was weaker for severe adverse drug reactions. The quantifier selection task showed that the most common quantifiers were verbal frequencies and verbal probabilities. Family physicians and patients should be aware of the implications of this preference.     

非肝病治疗药物导致慢性乙型肝炎病毒携带者肝损害现状分析

随着药物种类的增多,药物性肝病的发病率亦增加。由于乙型肝炎病毒携带者肝组织已存在不同程度的损害,比非乙型肝炎病毒感染者更容易发生药物性肝炎。因此,非肝病治疗药物导致慢性乙型肝炎病毒携带者肝损害应引起高度重视。     

Children's Representations of the World of Drugs

The changing profile of drug use has highlighted the need for age-appropriate education which requires insight into children's representations of drugs. Representations were elicited from 134 children aged between 5 and 11 years, drawn from two schools, by asking them to draw and write their responses to questions relating to a story about losing and finding a bag of drugs. Relevant responses were generated by 119 children aged between 8 and 11 years. A content analysis of these responses revealed differences with school and age. Older children were more likely to recognize that drugs can be good or bad depending on type, quantity taken and reason for use. The children had firm ideas about who takes drugs and their motivations and were knowledgeable about methods of use. They recognized that drugs can be dangerous, but had little understanding of how or why. The children's representations were characterized by fear and uncertainty and most wanted to know more. These findings are used to argue that there is a need for child-centred constructivist approaches to drug education which seek to demystify drugs and drug use and to orientate children to the realities of the world of drugs in the 1990s.     

关于阿尔茨海默病个体化治疗的思考

阿尔茨海默病（Alzheimer＇s disease ,AD）患者是亟需社会关注的特殊群体,因老年人常罹患多个系统疾病,用药种类繁多,考虑到药物不良反应与相互作用,临床医生在针对老年人用药时,在注重整体性的同时更要关注个体化治疗,辩证施治。药物基因组学是研究基因多态性及其他形式变异引起药物代谢酶、药物转运体和药物作用靶点功能异常,导致药动学和药效学在群体和个体差异的一门科学。它以药物效应及安全性为目标,研究各种基因突变与药效及安全性的关系,掀起了临床用药观念的颠覆性变革,为阿尔茨海默病个体化治疗提供了崭新的视角。     

Effects of amphetamine-CNS depressant combinations and of other CNS stimulants in four-choice drug discriminations

Three pigeons were trained to discriminate among 5 mg/kg pentobarbital, 2 mg/kg amphetamine, a combination of these two drugs at these doses, and saline using a four-choice procedure (amphetamine-pentobarbital group). Three other pigeons were trained to discriminate among 5 mg/kg morphine, 2 mg/kg methamphetamine, a combination of these two drugs at these doses, and saline (methamphetamine-morphine group). After 10 to 13 months of training, the pigeons averaged more than 90% of their responses on the appropriate key during training sessions. In subsequent testing, dose-response curves were determined for the individual drugs, for a wide range of dose combinations of the training drugs, and for two drugs to which the pigeons had not been exposed previously (pseudoephedrine and nicotine). After low test doses of the training drugs, pigeons responded on the saline key. As the dose increased, responding on the key associated with that drug during training sessions increased. When training drugs were combined at doses that were not discriminable when given alone, responding occurred on the saline key. When a discriminable dose of one training drug was combined with a nondiscriminable dose of the other training drug, responding occurred on the key associated with the discriminable dose. When both drugs were given at discriminable doses, responding almost always occurred on the drug-combination key. The response-rate decreasing effects of pentobarbital and amphetamine were mutually antagonized when the drugs were combined, but the rate-decreasing effects of morphine and methamphetamine were not. After low doses of pseudoephedrine and nicotine, pigeons in both groups responded on the saline key. After higher doses of pseudoephedrine and nicotine, responding in the amphetamine-pentobarbital group occurred primarily on the amphetamine key. In the methamphetamine-morphine group, higher doses of pseudoephedrine and especially nicotine engendered more responding on the combination key than had occurred in the other group. The four-choice procedure can reveal subtle effects in the discrimination of individual drugs and drug combinations that are not apparent with procedures offering fewer response alternatives.