浅谈药物流行病学在我国药品不良反应监测中的常规应用

药物流行病学方法贯穿于药品不良反应监测工作的始终,从评价药品和不良反应之间的关系,挖掘信号,确认信号,到采取措施,验证措施的有效性的全过程.本文对药物流行病学、我国药品不良反应监测工作进行了简要介绍,着重探讨了药物流行病学在药品不良反应监测工作中的常规应用,旨在促进药物流行病学在我国药品不良反应监测中的全面发展.     

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。     

药物流行病学在药品不良反应监测与评价中的应用

药物流行病学是临床药理学与流行病学两个学科相互交叉、渗透、延伸而发展起来的新的医学研究领域,是运用流行病学技术与方法研究人群中药物利用及作用规律的药学分支学科。药物流行病学常用研究方法包括病例对照研究、队列研究、系统综述评价和横断面研究等。其在药品不良反应监测和评价领域具有广泛而深入的使用空间。     

我国药品上市后的再评价

1基本理论药品上市后再评价是通过药品不良反应监测、药物流行病学调查和临床试验等方法,对药品在使用过程中的疗效、不良反应、药物相互作用、特殊人群的用药情况及药物风险/效益比等进行监测和评价。其中包括:药品有效性研究(疗效评价),药品不良反应研究(安全性评价),药物经济学研究(经济性评价),药品质量评价。     

药物流行病学研究新方法概述-药物流行病学研究新方法系列讲座（一）

药物流行病学（pharmacoepidemiology）是临床药理学与流行病学两个学科相互渗透、延伸而发展起来的新的医学研究领域,形成于二十世纪八十年代,是应用流行病学的原理和方法,研究人群中药物的利用及其效应的一门应用科学。药物流行病学是在与药害作斗争的过程中发展起来的,主要用于药物上市后研究。最初的研究内容以药物不良反应为主,但近些年来研究领域不断扩大,从不良反应监测扩大到药物警戒,从安全性信号的检出到风险管理,从强调药物利用扩大到研究有益的药物效应,以及对药物的卫生经济学评价、生命质量评价和循证评价等。近十年来,由于药品安全性问题日趋严重,引起了世界各国的广泛关注,药物流行病学研究的重要性和迫切性得以彰显;     

我国药品上市后安全性再评价研究进展

<正>药品上市后再评价是通过药品不良反应(Adverse drug reactions,简称ADR)监测、药物流行病学调查和临床试验等方法,对药品在使用过程中的疗效、ADR、药物相互作用、特殊人群的用药情况及药物风险-效益比等进行监测和评价,其中包括药品有效性研究(疗效评价)、药品ADR研究(安全性评     

药物流行病学研究中处理偏倚的方法

摘要：药物流行病学是在应对处理药源性疾病、药物不良反应过程中发展起来的一门医药学领域的综合应用性学科,是流行病学的分支之一。正确评价药物在人群中的利用及其效应主要取决于合理的研究设计和得当的实施和分析方法来控制系统误差。本文基于《中国药物流行病学研究方法学指南》,检索相关文献,并结合实例,对药物流行病学研究中处理偏倚的方法进行解读,系统理解处理偏倚的方法。当前国内药物流行病学研究对偏倚处理的方法仍需加强,需重点关注选择偏倚、错分偏倚、混杂偏倚、时间依赖性偏倚、系统评价,根据产生原理及过程,在试验设计阶段使用随机化、盲法、限制、匹配等方法消除或减少偏倚,系统评价时采用漏斗图、秩相关分析法、回归分析法、剪补法等评估发表偏倚,提高药物流行病学在医学中的价值,促进全民健康发展。     

药物流行病学在中药上市后安全性研究中的应用

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。     

氨甲蝶呤、阿糖胞苷鞘内注射致严重脊椎神经损害分析

目的:促进临床合理用药.方法:以氨甲蝶呤、阿糖胞苷鞘内注射所发生的严重不良反应为例,对药品使用安全风险的防范从临床药品不良反应/事件的鉴别、药品自身的安全性、药品质量、药品监管、药品性质的认识、药品使用方法以及药物浓度动态监测、药物过量解救等问题进行分析、评价.结果与结论:建立药物警戒平台,不良反应信息员、临床药师应介入药物治疗过程,以儿科、血液科、肿瘤科、呼吸科为切入点收集临床不良事件信息进行分析、评价,全方位提供药学服务,重点对细胞毒性药物开展药物警戒.     

关于我国药品上市后再评价制度的探讨

药品上市后再评价是指药品正式批准上市后,要运用医药学的最新技术成果和学术水平,从药理学、药剂学、临床医学、药物流行病学、药物经济学、药品质量等方面对其安全性、有效性和费用效益等方面进行更为科学的评价和估计[1].每种药品批准上市后,并不意味着对其评价的结束,而是表明已具备在社会范围内对其进行更深入研究的条件.     

An overview of pharmacoepidemiology

Pharmacoepidemiology is the application of epidemiological principles and methods to the study of drug effects in human populations. The goal of this discipline is to characterize, control and predict the effects and uses of pharmacological treatment modalities.Pharmacoepidemiology is also concerned with the economic impact and health benefits of unintended drug effects. The increasing importance of pharmacoepidemiology has been created by the need to develop a more accurate portrait of how drugs are used in the general population. Sophisticated and potent drug carefully controlled clinical trials of Phases I, II and III. Case-control and cohort studies, which allow scientists to evaluate the effects of patient variables on clinical outcomes, provide a wealth of information regarding the study of unexpected drug effects, drug utilization, treatment costs and the individualization of therapy.     

Current status,and future prospects of pharmaco-epidemiology and post-marketing surveillance in Saudi Arabia: A review of literature

Background

Pharmacoepidemiology is the concept used for evaluating the impact of drugs among a large number of people in the post-marketing phase. The use of this concept makes it increasingly necessary to detect the recurrence of drug-related anomalies that mostly occur through health care professionals or patients themselves. Pharmacoepidemiology is important since it helps to provide the right balance of benefits versus risks of the drug products while remaining an excellent tool to prepare the risk/benefit balance profile.

Pharmacoepidemiology: a basic science for drug administration and drug safety

Pharmacoepidemiology is defined as the study of medicines as determinants of health and disease in populations. It is a bridge science bringing together pharmacology and pharmacy, clinical specialties, epidemiology, biostatistics, demography and social sciences. Epidemiology and clinical pharmacology are the two main bridgeheads. The development of more and more potent but also increasingly expensive medicines will accentuate the need for skilled practitioners of drug administration and drug safety, of which pharmacoepidemiology is the basic science. Strategies in education have to be developed to meet such needs.     

The interface between pharmacoepidemiology and pharmacogenetics

One of the most challenging areas of research in pharmacoepidemiology is to understand why individuals respond differently to drug therapy, both in terms of beneficial and adverse effects. Pharmacogenetics focuses on the question to what extent variability in genetic make-up is responsible for these observed differences. Pharmacoepidemiologic research can contribute to pharmacogenetics by explaining the observed variability in drug response in ‘real life’ patient populations with known polymorphisms in their genetic profile. Genetic pharmacoepidemiologists also are interested in the distribution of polymorphisms and correlated frequencies of responders and non-responders in the general population, and in searching for unknown genetic links to variability in drug response. In the future, we will probably have fewer drugs that suit all individuals. Genetic pharmacoepidemiology is going to play a major role in the development and evaluation of the concept of ‘tailor-made’ pharmacotherapy.     

Causal association in pharmacovigilance and pharmacoepidemiology: thoughts on the application of the Austin Bradford-Hill criteria.

The methods used for the evaluation of drug safety signals (including major signals leading to withdrawal of products from the market) are inconsistent and sometimes of poor quality. While the assessment of the safety of medicines needs to consider specific issues such as drug interactions and variation in compliance, the general principles, which are used to study environmental hazards, can be applied for this purpose. The criteria proposed by Sir Austin Bradford-Hill more than 35 years ago for attributing disease causation to environmental factors have been used widely in epidemiology, are applicable to pharmacovigilance and pharmacoepidemiology. The Austin Bradford-Hill criteria include strength, consistency, specificity, temporality, biological gradient, plausibility, coherence, experimental evidence and analogy. The paper reviews each of these criteria with emphasis on pharmacovigilance and pharmacoepidemiology and with some examples. The application of the Austin Bradford-Hill criteria to the evaluation of causal association in pharmacovigilance and pharmacoepidemiology is very useful. However, it requires understanding of the limitations of the data, such as, under-reporting, poor quality of information from third parties and misclassification. Further work is required to develop strategies to handle these limitations.     

药物的心脏毒性及其评价方法的研究进展

药物的心脏毒性研究已经成为药物临床安全性评价的一项重要内容。随着上市药物的逐步增多,心脏毒性药物不良反应的报道也呈现上升趋势,近年来药物心脏毒性评价的研究也越来越受到国内外学者的青睐,但是药物心脏毒性评价还没有建立一套客观准确的体外方法。拟全面归纳了心脏毒性药物的分类,整合了药物心脏毒性评价的方法,并对药物心脏毒性评价新技术进行了介绍,为心脏毒性药物的安全性评价工作的开展提供了思路。     

国内外皮肤局部外用仿制药等效性评价对比

皮肤局部外用制剂的给药部位为皮肤表面,药物通过皮肤吸收发挥疗效,剂型繁多,其仿制药等效性评价方法也与口服制剂不同.通常,体内药代动力学研究是各监管机构最为认可的等效性评价方法,但大部分外用制剂难以通过此方法证明其等效性;以临床终点为指标的等效性研究是应用最广泛的等效性评价方法,然而此类研究成本高,周期长,且准确性、灵敏度和重现性均较差;针对特定的外用制剂品种,研究人员开发了血管收缩试验、体外BE研究等方法进行等效性评价,被各国监管机构广泛接受;对于外用水溶液制剂,通过理化性质等药学研究方法即可证明生物等效性.本文总结了中国、美国、日本、欧洲关于皮肤局部外用制剂仿制药生物等效性研究的相关法规及指导原则,对比四个国家或地区等效性评价的常规方法,为国内外用制剂仿制药的开发提供参考.     

Challenges and opportunities for pharmacoepidemiology in drug-therapy decision making

Pharmacoepidemiology is a relatively new and evolving science that attempts to quantify mainly adverse drug events and patterns of drug use in a large population. The strength of pharmacoepidemiology over randomized trials is the ability to quantify rare adverse events that may occur over long periods. Recently, discordance in the results of pharmacoepidemiologic studies has made it difficult for clinicians and policy makers to make informed drug-therapy decisions. This commentary addresses the strength of pharmacoepidemiology and the advances in the methodology of pharmacoepidemiologic studies over the years. We also discuss the potential problem of discordant results and urge pharmacoepidemiologists to develop good practice guidelines for the conduct of pharmacoepidemiologic studies.