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基于自发呈报系统药品不良反应信号检测方法的研究进展 总被引:1,自引:0,他引:1
药品不良反应监测是药品上市后安全性再评价的重要工作之一。国外很早就开始了研究基于自发呈报系统(spontane-ous reporting system,SRS)的不良反应信号的检测方法,但具体采用的检测方法各有不同,目前尚无信号检测方法的金标准。该文阐述了国内外经典的药品不良反应(adverse drug reaction,ADR)信号检测方法和联合用药 ADR 信号检测方法及其应用情况,比较各检测方法的优缺点。探讨适合我国 ADR 监测体系的信号检测方法,以期为我国不良反应信号检测工作的推进提供参考。 相似文献
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赵彬 《药物不良反应杂志》2023,(8):449-453
药物不良反应(ADR)信号检测是药物上市后药物警戒的一种重要研究方法。近年来, 我国ADR信号检测研究文献的数量明显增加。但该类研究中尚存在许多问题, 如对ADR信号的概念认识不清、信号检测研究的目的不明、信号来源局限、对检测数据未进行很好的处理、数据挖掘算法单一、数据选择的时间范围过短、未对信号检测中的偏倚进行处理和分析等。本文对这些常见问题谈一些看法, 希望对我国ADR信号检测研究的质量提升有所帮助。 相似文献
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目的:探讨药物流行病学在中药上市后安全性研究中的应用,为中药上市后的安全性研究提供参考。方法:结合药物流行病学研究方法与相关实例,概述各种研究方法的特点及在中药上市后安全性研究中的应用。结果与结论:药物流行病学的各种研究方法在中药上市后安全性研究中发挥了重要作用,其中描述性研究是药物上市后研究的起点;分析性研究可以筛选与检验病因假设;实验性研究尤其随机对照试验是评价药物疗效的金标准,但通常不能专门用于药品不良反应的确证;二次研究可用于汇总证据,强化因果关系论证的力度;多种药物流行病学的新方法,在中药上市后安全性研究中具有广阔的应用前景。应灵活运用多种药物流行病学研究方法对中药的安全性实施科学、客观的评价。 相似文献
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摘 要 目的:采取不良反应信号检测的方法,发掘抗感染药物的不良反应信号。方法:运用MHRA综合标准法对药品不良发应构成比排名前5位的抗感染药物信号检测,准确高效的挖掘不良反应信号。结果:不良反应信号检测一共检测出8个信号,分别为头孢匹胺 红斑疹、头孢匹胺 皮疹、左氧氟沙星 恶心、左氧氟沙星 腹痛、头孢地嗪 过敏样反应、哌拉西林 过敏性休克、哌拉西林 皮疹、头孢曲松 瘙痒。结论:检测出的抗感染药物不良反应信号验证该药品与该不良反应之间有一定的关联性,有效信号提示药物安全性问题,为临床用药安全提供参考依据。 相似文献
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目的:建立以药师为主导的药品上市后安全性监测工作模式。方法:医疗结构设立安全性监测工作的组织机构,制定工作流程、职责分工及完善质量控制。开展以药师为主体、药护结合的工作模式,采用综合诺式评估量表法进行不良反应评价。结果:通过实施以药师为主体、药护结合的工作模式,监测过程质量得到良好控制,经临床实践证实,监测结果真实,不良反应评价可靠。结论:此种药物安全性监测模式保证了临床监测数据的整体性、真实性及准确性。 相似文献
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金慧萍 《中国食品药品监管》2012,(8):64-67
药品不良反应监测中,对风险信息及时准确的把握和提炼应贯穿于整个监测过程。药品不良反应信号筛选和发生特点(如不良反应类型、发生时间与患者年龄、性别、给药途径的相关性;聚集性信号与药品质量的相关性等)的探寻是药物警戒和药品上市后安全性评价的重要研究内容之一。 相似文献
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对广东省自发呈报的药品不良反应系统数据库进行信号检测。方法应用贝叶斯判别可信区间递进神经网络模型比值失衡测量法,对广东省2002年4月28日到2007年7月10日上报的所有数据,进行信号检测。结果信号检测方法能发现9144条药品/药类一不良事件/不良事件类组合,其中2529条有信号,56条是强信号。结论信号检测有助于发现新的药品不良反应信号,及突出的药品安全性问题,可以极大地提高药品不良反应监测工作的效率,是将来药物警戒的研究重点之一。 相似文献
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Most regulatory agencies and pharmaceutical companies focus the majority of their pharmacovigilance on safety signal identification in large databases. GlaxoSmithKline (GSK) has > 100 drugs marketed worldwide. In order to determine which database has the highest statistical power to detect safety signals in three large global databases, ten GSK marketed drugs were randomly selected for review in the three databases. At the time of data lock, the FDA database (Adverse Event Reporting System [AERS]) contained approximately 6.2 million total records of adverse drug reactions (ADRs). The WHO database (VIGIBASE) contained 7.2 million total records of ADRs. GSK's global safety database (OCEANS) contained approximately 2 million total ADRs for all of its marketed drugs. For the ten drugs selected, there was an average of 7566 reports found in AERS, 8661 reports found in VIGIBASE and 15,496 reports in OCEANS. The information from all three databases was used in pairs (AERS/OCEANS; AERS/VIGIBASE; and OCEANS/VIGIBASE) to calculate power using the maximum likelihood estimation. The OCEANS database contained more ADRs for all 10 drugs than AERS. OCEANS also contained more ADRs for 8/10 drugs than VIGIBASE. The highest statistical power to detect safety signals was determined by the pair of databases which had the greatest number of reports for the given drug. Based on this data, it was concluded that the highest power may be achieved by combining those databases with the most drug-specific data. It is also believe that early safety signal detection should involve the use of multiple large global databases because this permits the use of the largest number of reports for a given drug, and that reliance on a single database may reduce statistical power and diversity of ADRs. 相似文献
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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. 相似文献
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通过对目前药品不良反应监测方法的概述,了解其研究现状,发现各方法的不足。建议在本领域研究中应将信号检测方法与信号验证性研究两者相结合,取长补短,从而得到确切的不良反应与药品之间的因果关系。 相似文献
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药品不良反应报告常用信号检测方法应用研究 总被引:1,自引:0,他引:1
目的:为指导临床安全、合理用药和进一步评价药品安全风险提供参考。方法:通过收集我区2007-2010年药品不良反应(ADR)监测网络ADR报告8795份,运用频数法中的比例报告(PRR)法、报告比值比(ROR)法和贝叶斯判别可信区间递进神经网络模型(BCPNN)法进行定量检测,对生成的可疑信号进行比较分析,探索以自发呈报系统数据库为基础的定量信号检测方法的运用和科学的ADR信号检测途径。结果与结论:通过对869种Drug-ADR组合和66种Drugs-ADR组合进行3种常用方法信号定量检测,发现对部分已知信号能够检出,PRR法、ROR法结果相近,BCPNN法差别较大,3种方法信号强度各不相同。 相似文献
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《Prescrire international》2002,11(61):150-151
(1) Some serious adverse drug reactions only emerge once a drug has been released on to the market. (2) 10% of the new drugs marketed in the United States over the last 25 years were subsequently withdrawn or were the subject of major warnings about serious or life-threatening side effects. The number of patients affected is unknown. (3) Patients must not be placed at risk because doctors prescribe a new drug when a reliable alternative is available or when the condition treated is mild. (4) Prevention should be based on improved quality of clinical trials and on upgraded procedures for marketing approval. Other measures include encouraging the correct use of recently marketed drugs; closer monitoring of these drugs; better notification of side effects; and improved quality and transparency of pharmacovigilance data. 相似文献
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