|
| 2012年～2017上半年江苏省药品不良事件聚集性信号情况分析 |
| Analysis of Adverse Drug Events Aggregation Signals in Jiangsu Province from 2012 to the First Half of 2017 |
| |
| DOI： |
| 中文关键词: 聚集性信号 分析 中药注射剂 药品不良反应监测 |
| 英文关键词:Aggregation signals Statistical analysis TCM injections Adverse drug reactions monitoring |
| 基金项目: |
|
| 摘要点击次数: 3531 |
| 全文下载次数: 4114 |
| 中文摘要: |
| 摘 要 目的：分析近几年来我省药品不良事件聚集性信号情况，为保障公众用药安全提供参考。 方法：收集2012年1月～2017年6月国家药品不良反应监测系统预警平台生成的事发地为我省的聚集性信号，对筛选出的关注信号，分别从药品及不良事件表现、药品抽检、临床使用情况等方面进行统计分析。结果：41例关注信号涉及29种药品，其中有6种中药注射剂。对30个信号涉及的药品进行了抽样检验，收到25份检验报告，4份检验结果不符合规定。35个信号收到调查报告，涉及299例病例，临床用药不符合说明书规定的有78例次。结论：应提高中药注射剂质量标准，以保障中药注射剂疗效的稳定性和使用的安全性，临床用药中应对不合理用药行为及时干预，加强临床用药监测，切实保障公众用药安全。 |
| 英文摘要: |
| ABSTRACT Objective:Analysis on the adverse drug events aggregated signals in recent years of our province to provide reference for the public medicine safety. Methods:The aggregated signals of our province on national information system for monitoring adverse drug reaction system were collectted from January 2012 to June 2017. The statistical analysis of the concerned aggregation signals were conducted from the involved drugs, the adverse reactions, drug sampling and clinical use. Results:There were 29 drugs involved in the 41 signals, including 6 traditional Chinese medicine injections. In the sampling survey of the drugs related to 30 signals, 25 inspection reports were received, 4 of which were not in conformity with the requirements. Of the 299 cases in which the 35 survey reports were submitted, 78 cases of clinical medication did not meet the requirements of the specification. Conclusion:The quality standard of TCM injection should be improved to guarantee its stability and safety, irrational drugs use should be corrected timely and prescription monitoring was supposed to be strengthened, so as to ensure public medication safety. |
| 查看全文 查看/发表评论 下载PDF阅读器 |
| 关闭 |
