中国药物警戒 ›› 2017, Vol. 14 ›› Issue (8): 486-488.

• 安全性评价与合理用药 • 上一篇    下一篇

365例鲑降钙素制剂不良反应的回顾性分析

刘志军, 袁兴东, 张薇, 徐玉茗*   

  1. 江西省药品不良反应监测中心,江西 南昌 330006
  • 收稿日期:2017-05-31 修回日期:2017-09-26 出版日期:2017-08-20 发布日期:2017-09-26
  • 通讯作者: 徐玉茗,男,硕士,教授级工程师,药品不良反应监测与评价。E-mail: jiangxi@adrs.org.cn
  • 作者简介:刘志军,男,硕士,药师,药品不良反应监测与评价。
  • 基金资助:
    江西省食品药品监督管理局课题(2016YP03):基于监测数据的联合用药不良反应信号检测方法研究。

Retrospective Analysis on 365 Cases of Adverse Drug Reaction of Salcatonin Preparations

LIU Zhi-jun, YUAN Xing-dong, ZHANG Wei, XU Yu-ming*   

  1. Jiangxi Adverse Drug Reaction Monitoring Center, Jiangxi Nanchang 330006, China
  • Received:2017-05-31 Revised:2017-09-26 Online:2017-08-20 Published:2017-09-26

摘要: 目的 分析鲑降钙素制剂不良反应(ADR)的发生特点,为临床合理用药提供科学依据。方法 回顾性分析2010年~2016年江西省药品不良反应监测中心收集到的365例鲑降钙素制剂导致的ADR报告,总结患者的人口学分布特征、原发疾病与过敏史、给药方法,ADR发生的时间分布、因果关系及转归、累计系统-器官等。结果 发生ADR的患者中女性占比达81.64%,60岁以上患者比例为69.59%;日使用剂量占比最高的为50 IU,占比54.80%;ADR发生在用药后10 min内的占比达34.79%;ADR累及系统-器官多达十余个,其中以胃肠道系统损伤最多。结论 临床应加强对鲑降钙素制剂的用药后监测,同时生产企业应对药品说明书进一步补充和完善,以减少鲑降钙素制剂ADR的发生。

关键词: 鲑降钙素制剂, 药品不良反应, 回顾性分析

Abstract: Objective To analyze the characteristics of adverse drug reaction (ADR) of salcatonin preparations and provide scientific basis for rational drug use. Methods 365 cases of ADR reports of salcatonin preparations, from 2010 to 2016, were analyzed retrospectively. Demographic characteristics, primary diseases and allergies, method of treatment, distribution time of ADR, causality and outcome, systems or organs involved were summarized. Results ADR occurred in female accounted for 81.64%, and age over 60 years accounted for 69.59%; The highest ratio of daily use dose were 50 IU, accounted for 54.80% ; ADR occurred within 10 min after medication accounted for 34.79%. Systems or organs involved were up to 10, and the gastrointestinal system were damaged most. Conclusions To reduce the occurrence of ADR of salcatonin preparations, medication monitoring should be strengthened, while drug instructions ought to make supplement and complete by production enterprises.

Key words: salcatonin preparations, adverse drug reaction, retrospective analysis

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