深圳市药品不良反应监测工作初探

药品不良反应（adverse drug reaction，ADR）监测工作是药品监督管理的重要内容，是加强药品管理、提高药品质量、促进医疗水平提高的重要手段，是保证人民用药安全的有效途径，是我国药品监管部门和卫生行政部门的共同任务。它针对上市药品在使用过程中出现的安全性问题进行收集、检测、评价，为政府部门、医药卫生专业人员、社会公众提供及时、准确的科学信息，促进安全、合理用药，减少或避免ADR的发生和蔓延。为推进ADR监测工作水平，现结合深圳市开展ADR监测工作现状进行一些探讨。     

药品不良反应监测与药物警戒

本文阐述了对于药品不良反应监测、药物警戒的理解和认识,并从本质属性、监测的对象范围、监测方法,监测目的分析二者之间的联系和区别.     

做好药品不良反应监测工作保障人民用药安全

通过对药品不良反应危害的严重性、开展药品不良反应监测工作的重要性和我国《药品不良反应监测管理办法（试行）》以及药品生产、经营企业和医疗单位开展药品不良反应工作进行详细的阐述,以进一步宣传和推动这项工作的开展。     

药物不良反应监测的制约因素

随着科学的进步和发展，医药工业也得到迅速发展，大量高效、高选择性的药物不断上市。复方制剂大量推出，联合用药机会增加，药物不良反应（ADR）发生率相应增加。我国自20世纪90年代开始实施ADR监测工作，然而在现阶段ADR监测工作仍受到多方面因素的制约。     

发达国家药物不良反应监测概况

药物不良反应(ADRs)是世界医疗界的难题,本文对欧美等发达国家药物不良反应发生现状、监管现状及避免ADRs增进药物安全性的方法等几方面进行综合评述,以助于吸取有效经验。     

做好基层医疗单位药品不良反应监测工作

科学技术的飞速发展，新药的不断问世，给人们战胜疾病带来了希望。但是，药品作为一种特殊的商品，上市前虽经过各种药理试验和一系列临床试验，囿于时间和病例的限制，     

药品不良反应监测与安全用药

目的认识药品不良反应监测的重要性。方法采用文献研究分析方法,了解我国ADR监测的现状,提出对策。结果我国ADR监测与国际相比存在较大差距,国人对ADR危害性认识不足,认知度较低。结论宣传ADR基本知识,加强ADR监测和报告,健全该项工作法规体系和监测机构网络,加大投入是减少药害,达到安全用药的根本保证。     

上海市杨浦区中心医院药品不良反应分析

近年来,随着众多新药的不断上市,合并用药的现象增多,药品在发挥治疗作用的同时,ADR发生率也随之增加。为了解上海市杨浦区中心医院2008年ADR监测情况,寻找发生ADR的一般规律,保障临床安全、合理用药,作者对本院2008年上报的69例ADR病例报告进行了分析。     

做好基层医疗单位药品不良反应监测工作

科学技术的飞速发展 ,新药的不断问世 ,给人们战胜疾病带来了希望。但是 ,药品作为一种特殊的商品 ,上市前虽经过各种药理试验和一系列临床试验 ,囿于时间和病例的限制 ,使得其潜在的危害难以发现。药物不良反应 (ADR)监测就是依法对已批准生产上市药品的安全性进行监测 ,保证人民用药安全、有效 ,减少药害事故发生 ,促进临床合理用药的有效措施。它是药品再评价工作的重要组成部分。我院自 2 0 0 2年开展了ADR监测工作 ,因缺乏经验、监测网络的不完善及部分医务人员认识上的误区 ,监测工作举步维艰 ,效果差强人意。 2 0 0 3年底 ,在充分…     

174例药品不良反应回顾性分析

药品不良反应（adverse drug reaction，ADR）是指合格药品在正常用法用量下出现的与用药目的无关或意外的有害反应。根据我国2002年《药品管理法实施细则》和2004年《药品不良反应报告和监测管理办法》的有关规定，国家实行ADR报告制度，通过上报汇总，及时发现药品使用过程中存在的问题，并采取积极有效的措施，及时避免类似事件的发生，保证用药的安全、有效。本研究通过对复旦大学附属中山医院青浦分院2006年收集上报的174例ADR进行回顾性分析，了解本院ADR发生的情况和影响ADR发生的因素，为及时判断与减少ADR提供资料。     

Communication in pharmacovigilance

Pharmacovigilance is a field where communication is paramount. Information, such as single case reports, is transferred from health professionals to National Regulatory Administrations and between administrations and industry. The cumulation of reports may be used for information purposes, and to assist in the identification of possible signals. These are then assessed by the analysis of individual and aggregate cases, the latter being exchanged between administrations for multinational analysis at the European level. Once a decision has been made on a possible alert, the decisions and the reasons thereof must be transmitted to administrations and to other correspondents, such as health professionals, the pharmaceutical industry and WHO. Within the CARE project of the DGXIII European Nervous System telematics research programme, the Pharmacovigilance Pilot, consisting of representatives of the French, Spanish, and UK pharmacovigilance systems, set out to identify and describe the messages corresponding to these communication needs, and the methods best suited to effective telematic transmission. The messages identified concern: the transmission of individual case reports, the transmission of cumulative and aggregate case reports, and of regulatory decisions. Each of these information messages have been structured for future inclusion into a network for electronic data interchange between administrations in pharmacovigilance. In time they should provide a common electronic vocabulary enabling all parties involved in pharmacovigilance to communicate telematically. Transmission options have been considered also. In view of the large number of existing and potential partners involved in the communication processes in pharmacovigilance, EDI (electronic data interchange) seems the most appropriate method to exchange these messages. Two of these, concerning the single case and the aggregate cases (rapid alerts) have been submitted to the Western European EDIFACT Board MD9 for integration into EDIFACT (as MEDADR and MEDPHV).     

上海市乡村医生队伍建设的实践探索与前瞻

本文概述乡村医生的历史沿革与工作特色,讨论解决乡村医生面临困境的主要问题,分析乡村医生队伍建设的瓶颈,对上海市乡村医生培训工作进行了系统回顾与展望,突出了新一代乡村医生的创新培养机制,提出通过职业前与职业后教育的贯通、通过继续医学教育提升职业能力,乡村医生的职业愿景会更加美好.     

Rational pharmacotherapy and pharmacovigilance

Pharmacovigilance is defined as "the detection, evaluation, understanding and prevention of adverse drug reactions (ADRs)". The ultimate aim of pharmacovigilance is the optimization of the risk-benefit ratio of marketed drugs at the individual level (i.e. the choice of the most suitable treatment for a given patient) and at the population level (i.e. maintenance or removal of a drug from the market, informing prescribers of its potential risks, etc.). Prevalence of drug-related morbidity and mortality increase in correlation with the increase in drug use. Both physicians and patients prefer polypharmacy because of different reasons such as insufficient knowledge, lack of enough time for the patients, being misled by non-scientific newspaper/TV news, etc. Polypharmacy is among the major causes of drug-related morbidity and requires additional medication as treatment. On the other hand, adverse reactions might be minimized by adequate knowledge and rational prescribing, simply by reducing inappropriate polypharmacy. Therefore, physicians' prescribing habits based on rational pharmacotherapy processes which include choosing suitable drug(s), at an optimum dose and duration of use, among the effective and safe treatment alternatives, and informing patients about the diagnosis and treatment, can be a major contribution to optimize the risk-benefit ratio of drugs. As an essential step in the rational pharmacotherapy process, giving adequate information to the patients about their treatment (i.e. dosage, use instructions, warnings, effects, side effects, etc.) may prevent some of the drug-related problems. In addition, informed patients are more likely to seek advice from their physicians to seek advice for ADRs. In this review article, therefore, the influence of rational pharmacotherapy training on the pharmacovigilance of drugs will be discussed.     

上海生物医药研发基地现状及展望

上海市生物医药研发基地包括研发公共服务平台、上海市工程技术研究中心和上海市重点实验室,是上海市加快建设科创中心、优化科技创新布局的重要内容。作为我国生物医药领域的创新高地,在政府大力支持推动下,经多年建设和整合,上海市生物医药研发基地已经走在全国前列,具有“覆盖范围广、技术水平精、服务能效高”的特点。本文对上海市生物医药领域研发基地现状进行了梳理,并对平台未来发展提出设想和展望。     

Evolving paradigms in pharmacovigilance

All medicines have adverse effects as well as benefits. The aim of pharmacovigilance is to protect public health by monitoring medicines to identify and evaluate issues and ensure that the overall benefits outweigh the potential risks. The tools and processes used in pharmacovigilance are continually evolving. Increasingly sophisticated tools are being designed to evaluate safety data from clinical trials to enhance the likelihood of detecting safety signals ahead of product registration. Methods include integration of safety data throughout development, meta-analytical techniques, quantitative and qualitative methods for evaluation of adverse event data and graphical tools to explore laboratory and biometric data. Electronic data capture facilitates monitoring of ongoing studies so that it is possible to promptly identify potential issues and manage patient safety. In addition, GSK employs a number of proactive methods for post-marketing signal detection and knowledge management using state-of-the-art statistical and analytical tools. Using these tools, together with safety data collected through pharmacoepidemiologic studies, literature and spontaneous reporting, potential adverse drug reactions can be better identified in marketed products. In summary, the information outlined in this paper provides a valuable benchmark for risk management and pharmacovigilance in pharmaceutical development.     

海洋抗肿瘤物质研究概况与展望

目的：对海洋生物来源的抗肿瘤物质的研究进展作一综述，供研究者参考。方法：查阅国内外文献，对动物体外细胞毒成分，动物体内抗肿瘤活性成分和进入临床研究阶段的抗肿瘤活性成分作了详细的介绍。结果：通过分析研究现状，对海洋抗肿瘤物质今后的发展作了展望，提出了建议。结论：海洋抗肿瘤物质的研究和海洋抗癌药物的开发是很有前途的研究领域。     

药物流行病学在药品不良反应监测中的应用

在药品不良反应监测中使用药物流行病学的方法，可以评价药品和不良反应之间的关系，寻找诱发不良反应的危险因素。本文对国内外药物流行病学的发展及应用情况作一综述，旨在提高药物流行病学在我国药品不良反应监测中的地位，推动我国药品不良反应监测工作向纵深发展。