药品不良事件

药品不良事件的成因与责任研究

Studies on the Contributing Factors and Responsibilities for Adverse Drug Events

近年来，我国药品不良事件频发，有的不良事件造成了多人死伤的严重后果，药品安全问题成为公众关注的焦点。

In recent years , the practice shows that some serious drug adverse reaction events have cause harm to public health , and the problem of drug safety have become the focus of public concern .

所有患者在治疗过程中均未出现严重药品不良事件，试验组和对照组不良反应发生率分别为10.77%和20.90%。

There was no severe side effect in the two groups . The adverse drug reactions were mild with incidence of 10 . 77 % in the test group and 20 . 90 % in the control group .

药品不良事件层出不穷，严重影响了人民的健康和生命，使受害者受到精神与物质的双重打击，药品安全管理已引起社会高度关注。

Adverse drug events emerge in so endlessly that seriously affect the health and life of people . And adverse drug events make people to be victim of a double-whammy of spiritual and material . Those have aroused great concern on drug safety .

所谓的ADR信号指的是药品与不良事件间可能存在因果关系的报告信息，这种关系是未知的或者以前的文献资料不能充分证实的。

The signal is denoted as possible causal relationship between drug and adverse event , which is unknown or can not be fully confirmed by the previous literature .

尤其近几年国内外药品不良反应事件频发，药品不良反应事件越来越引起社会的广泛关注。

In recent years , ADR arouses more and more wide concerns .

药品不良反应/事件报告评价方法研究

Study on Methods of Adverse Drug Reaction / Event Reporting Assessment

江苏省2005年《药品不良反应/事件报告表》质量分析

The quality analysis of ADR reports of year 2005 in Jiangsu province

48份《药品不良反应/事件报告表》的系统分析

Systematic Analysis of Drug Adverse Reaction Reports from the Hospital

247例严重药品不良反应/事件分析

Analysis of 247 Severe Adverse Drug Reaction / Event Cases

315例药品不良反应/事件病例报告分析

Analysis of 315 Cases of ADR / ADE

天津市2005年《药品不良反应/事件定期汇总表》审核分析

The quality analysis of ADR / ADE Periodic Safety Reports in Tianjin in 2005

阐述自2009年药品不良反应的主要事件以及预防事故发生的安全措施和程序。

It will elaborate the main issues from ADR2009 as well as safety measures and procedures in case of accidents .

但与此同时，也带来了药品质量问题纠纷和药品不良事件的出现，更为严重的是药害事件的频繁发生。

But at the same time , it also leads to drug quality problems and adverse drug events .

世界药品的发展史也是药品监管的发展史，随着重大药品不良事件的发生人们认识到药品的安全性和有效性同等重要。

The history of the development of drug supervising and medical development in the world is parallel . With some serious drug adverse reaction events , people aware of the importance of drug safety .

方法对2004年北京市药品不良反应监测中心收到医疗机构上报的7868份《药品不良反应/事件报告表》质量进行统计分析。

Method Statistical analyze the quality of 7868 share report forms received by Beijing Center for ADR Monitoring in 2004.The forms were reported by medical organization in Beijing .