中国药物警戒 ›› 2016, Vol. 13 ›› Issue (8): 489-491.

• 安全性评价与合理用药 • 上一篇    下一篇

193例正清风痛宁缓释片不良反应报告分析

吴昭昭, 龙丽萍*, 陈希, 陈光建   

  1. 湖南省药品审评认证与不良反应监测中心,湖南 长沙,410000
  • 收稿日期:2016-09-14 修回日期:2016-09-14 出版日期:2016-08-20 发布日期:2016-09-14
  • 通讯作者: 龙丽萍,女,本科,主任药师,药械不良反应监测与再评价。E-mail：540630649@qq.com

Analysis of 193 Cases of Adverse Drug Reactions Induced by Zhengqingfengtongning Sustained Release Tablets

WU Zhao-zhao, LONG Li-ping*, CHEN Xi, CHEN Guang-jian   

  1. Hunan Center for Drug Evaluation Certification & ADR Monitoring, Hunan Changsha, 410013 China
  • Received:2016-09-14 Revised:2016-09-14 Online:2016-08-20 Published:2016-09-14

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摘要： 目的 了解正清风痛宁缓释片不良反应发生率及临床表现,为临床用药提供参考。方法 收集湖南省内7家三甲医院4 064例使用了正清风痛宁缓释片的所有患者（门诊和住院患者）。应用SPSS软件,描述其各类频数及构成比。用卡方检验对不同因素发生率进行分析。结果 本次研究中不良反应发生率为193例（4.75%）,不良反应主要累及皮肤及附件（41.23%）、消化系统（35.53%）,不良反应临床表现复杂多样,以皮疹、瘙痒居多。结论 正清风痛宁缓释片不良反应以皮肤及附件和消化系统为主。医务人员要熟悉正清风痛宁缓释片的常见不良反应,及时发现并处理不良反应,以确保临床用药安全。

关键词: 正清风痛宁缓释片, 青藤碱, 不良反应

Abstract: Objective To investigate the incidence of adverse drug reactions and clinical symptoms of Zhengqingfengtongning sustained release tablets. Methods 4 064 cases of patients who used Zhengqingfengtongning sustained release tablets were collected (including outpatients and inpatients from 7 hospitals in Hunan province). The frequency and constituent ratio were described by SPSS software. The incidence rate of different affecting factors was compared by chi-square test. Results The incidence of Zhengqingfengtongning sustained release tablets adverse events was 4.75% (193 in 4 063). The main ADR/ADE damages involved skin and its accessories (41.23%), gastrointestinal system (35.53%). The clinical symptoms of ADR were various, of which the erythra and itching occurred the most. Conclusion The lesions of skin and its accessories and gastrointestinal system are the predominant presentation of ADRs of Zhengqingfengtongning sustained release tablets. Clinicians should be familiar with the common ADRs of Zhengqingfengtongning sustained release tablets, discover and deal with the ADRs in time in order to ensure clinical drug safety.

Key words: Zhengqingfengtongning sustained release tablet, sinomenine, adverse drug reaction(ADR)

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