中国药物警戒 ›› 2014, Vol. 11 ›› Issue (12): 753-756.

• 药械安全性研究 • 上一篇    下一篇

苦碟子注射液重点监测的探索与实践

刘一奇1, 金锋2, 李波1 *, 殷雨天1, 蒋玲玲1, 张越1, 曲毅2, 关瑜2   

  1. 1吉林大学公共卫生学院,吉林 长春 130021;
    2吉林省食品药品安全监测中心,吉林 长春 130062
  • 收稿日期:2014-11-17 修回日期:2016-02-03 出版日期:2014-12-08 发布日期:2016-03-02
  • 通讯作者: 李波,女,博士,教授,流行病学。
  • 作者简介:刘一奇,女,在读硕士,药物流行病学研究。

Practice and Exploration in Intensive Monitoring of Kudiezi Injection

LIU Yi-qi1, JIN Feng2, LI Bo1, *, YIN Yu-tian1, JIANG Ling-ling1, ZHANG Yue1QU Yi2, GUAN Yu2   

  1. 1School of Public Health, Jilin University, Jilin Changchun 130021, China; 2Jilin Safety Monitoring Center for Food And Drug, Jilin Changchun 130062, China
  • Received:2014-11-17 Revised:2016-02-03 Online:2014-12-08 Published:2016-03-02
  • Contact: 英文通讯作者
  • About author:英文作者简介
  • Supported by:
    英文基金

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摘要： 目的通过对苦碟子注射液开展前瞻性、非干预性的医院集中监测,探索药品重点监测的实践。方法采取医院集中监测的方法对苦碟子注射液进行主动监测,监测时间为2012年6月~2014年3月,监测范围为吉林省辖区内7家医疗卫生机构住院患者,对观察样本进行流行病学统计分析。结果共观察2 986例有效病例,观察对像中,男女比例接近1:1;用药患者中50岁以上的中老年人居多,占78.57%;药物主要应用于神经内科和心血管内科;用药适应证、给药途径、给药剂量基本符合说明书指导要求;本次研究中不良反应有皮疹、呼吸困难、肿胀,均为一般不良反应,无需特殊处理,停药即可痊愈。结论苦碟子注射液重点监测采取医院集中监测的方法易于组织实施,该方法用于住院患者用药的重点监测可以节省成本,并提高效率。

关键词: 苦碟子注射液, 临床应用, 重点监测, 不良反应

Abstract: ObjectiveThrough the development of intensive hospital monitoring of Kudiezi injection which is prospective and non-interventional, explore the practice of drug intensive monitoring. MethodsAdopt the intensive hospital monitoring of Kudiezi injection at seven hospitals in Jilin province from June 2012 to March 2014, and make an epidemiological statistical analysis for the results of samples. ResultsWe collected 2 986 effective questionnaires, the sex ratio is nearly equal, and 78.57% patients are over 50 years old. Kudiezi injections are mostly used in neurology and cardiology. The indications, administration and dosage are consistent with the drug instruction. The symptoms of adverse reactions are rash, difficult breathing and swelling, which are all common, and need nothing special treating, just stop using the drugs to recover. ConclusionThe intensive hospital monitoring of kudiezi injection is easy to organize and implement. This method will save the cost and increase efficiency if it can be used in intensive monitoring.

Key words: Kudiezi injection, clinical application, intensive monitoring, adverse drug reaction

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