中国药物警戒 ›› 2015, Vol. 12 ›› Issue (11): 693-696.

• 械安全性研究 • 上一篇    下一篇

阿奇霉素致不良反应/事件报告分析

李郁, 刘磊*, 傅存冀   

  1. 乌鲁木齐市第一人民医院,新疆 乌鲁木齐 830000
  • 收稿日期:2016-02-02 修回日期:2016-02-02 出版日期:2015-11-08 发布日期:2016-02-02
  • 通讯作者: 刘磊,女,硕士,副主任医师,内分泌。E-mail：391812492@qq.com
  • 作者简介:李郁,女,硕士,副主任药师,临床药学。

Analysis of Adverse Drug Reactions/Events Induced by Azithromycin

LI Yu, LIU Lei*, FU Cun-ji   

  1. First People's Hospital of Urumqi, Xingjiang Urumqi 830000, China
  • Received:2016-02-02 Revised:2016-02-02 Online:2015-11-08 Published:2016-02-02

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摘要： 目的探讨阿奇霉素致不良反应/事件（ADR/ADE）的规律与特点,寻找风险因素,为临床安全合理使用提供参考。方法采用回顾性研究方法,对1 353例阿奇霉素致ADR/ADE的报告,从患者情况、原患疾病、ADR/ADE发生时间、累及系统-器官及临床表现、转归等方面进行统计分析。结果在1 353例阿奇霉素致ADR/ADE的报告中,81.95%发生于治疗感染性疾病,18.05%发生于治疗非感染性疾病;75.16%的ADR/ADE集中在14~55岁;静脉用药55.82%发生在用药后1 h内,口服用药50.73%发生在用药后10 min~24 h;累及消化系统56.05%、皮肤及附件15.78%、全身性损害10.91%、神经系统6.71%、心血管系统4.87%、不详2.61%、呼吸系统1.69%、听觉及前庭0.51%、运动系统0.46%、泌尿生殖系统0.41%。在积极对症治疗后,痊愈及好转率98.74%。结论不合理使用阿奇霉素是ADR/ADE发生的重要因素之一。在临床应用期间应加强对神经系统及心血管系统引起的ADR/ADE监测,减少或避免严重的ADR/ADE的发生。

关键词: 阿奇霉素, 不良反应/事件, 分析, 合理用药

Abstract: ObjectiveTo explore the regularity and characteristics of adverse drug reaction/event (ADR/ADE) induced by azithromycin and search for risk factors in order to provide a reference for safe clinical use. Methods1 353 cases of azithromycin ADR/ADE reports were analyzed in terms of the patient's condition, original disease, ADR/ADE occurring time, organ function, clinical manifestation and outcome by using retrospective study method. Results 81.95% cases of azithromycin ADR/ADE occurred for the treatment of infectious diseases, 18.05% for non-infectious diseases. 75.16% cases of ADR/ADE occurred between 14~55 years old. 55.82% cases with intravenous drip occurred within 1 h after using medicine, 50.73% cases with oral medicine occurred in 10 min~24 h after drug use. The involved systems and organs included digestive system (56.05%), skin and accessories (15.78%), systemic damage (10.91%), nervous system (6.71%), cardiovascular system (4.87%), not in detail (2.61%), respiratory system (1.69%), auditory and vestibular apparatus(0.51%), kinetic system apparatus (0.46%) and urogenital system (0.41%). After active symptomatic treatment, recovery and improvement rate was 98.57%. ConclusionThe unreasonable use of azithromycin is one of the important factors of ADR/ADE. During the period of clinical application of azithromycin, we should strengthen the monitoring of ADR/ADE involving nervous system and cardiovascular system in order to reduce or avoid the occurrence of severe ADR/ADE.

Key words: azithromycin, adverse reactions/events, analysis, rational use of drugs

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