中国药物警戒 ›› 2015, Vol. 12 ›› Issue (8): 487-490.

• 药械安全性研究 • 上一篇    下一篇

160例阿德福韦酯不良反应特征及骨软化的风险因素分析

许莉莉1, 田月洁1, 谢彦军1, 崔小康1, 翟淑越2   

  1. 1. 山东省药品不良反应监测中心,山东 济南 250013;
    2. 淄博市药品不良反应监测中心,山东 淄博 255000
  • 收稿日期:2015-09-02 修回日期:2015-09-02 出版日期:2015-08-08 发布日期:2015-09-02
  • 通讯作者: 田月洁,男,硕士,副主任药师,药品不良反应监测与评价。E-mail:tianyuejie@sdfda.gov.cn
  • 作者简介:许莉莉,女,硕士,药师,药品不良反应监测与评价。

Analysis of 160 Cases of Adverse Drug Reaction Characteristics and Risk Factors of Osteomalacia Induced by Adefovir

XU Li-li1, TIAN Yue-jie1, XIE Yan-jun1, CUI Xiao-kang1, ZHAI Shu-yue2   

  1. 1. Shandong Center for ADR Monitoring,Shandong Jinan 250013, China;
    2. Center for ADR Monitoring of Zibo, Shandong Zibo 255000, China
  • Received:2015-09-02 Revised:2015-09-02 Online:2015-08-08 Published:2015-09-02

摘要: 目的 探讨阿德福韦酯致不良反应(ADR)发生的一般规律、特点及风险因素,为临床安全用药提供参考。方法 对山东省ADR数据库中160例涉及阿德福韦酯的ADR报告进行回顾性分析,对不良反应表现的时间分布等进行了探讨,重点对骨骼系统损害和低磷血症的不良反应进行分析。结果 阿德福韦酯的ADR主要累及胃肠系统损害、皮肤及其附件损害;严重ADR主要累及骨骼肌肉系统损害、泌尿系统损害,多于长时间用药后发生。胃肠系统损害、皮肤及其附件损害主要是用药半年内出现,肝肾功能异常、血磷降低可于用药半年以上出现,骨骼肌肉损害可于用药1年以上出现,骨软化症可于用药4年以上出现。结论 阿德福韦酯的ADR的具有时间关联性,长期用药产生肾毒性而导致血磷降低和骨软化症,高龄和肝硬化患者可能更易发生严重ADR,应加强用药期间的肝肾功能及血磷的定期监测,正确诊断,及时治疗。

关键词: 阿德福韦酯, 药品不良反应, 时间效应关系, 骨骼系统损害

Abstract: Objective To probe into the general rules, characteristics and risk factors of the ADR induced by adefovir so as to provide references for clinical safe medication. Methods We retrospectively analyzed 160 ADR cases induced by adefovir which were collected by Shandong adverse drug reaction database, discussed the time distribution of the ADRs, and emphatically analyzed the ADRs of the skeletal muscle system lesions and hypophosphatemia. Results The ADRs induced by adefovir mainly involved in stomach intestinal system lesions and skin and local lesions. The serious ADRs by adefovir mainly involved in skeletal muscle system lesions and urinary system lesions, and usually appeared after a long-term administration. Stomach intestinal system lesions and skin and local lesions usually appeared within half a year, abnormal liver and renal function and hypophosphatemia usually appeared after half a year, skeletal muscle system lesions usually appeared after one year, osteomalacia usually appeared after four years. Conclusion The ADRs induced by adefovir were related to administration time, and would lead to nephrotoxicity, hypophosphatemic and osteomalacia after long-term administration of adefovir. The serious ADRs by adefovir were easy to appeare in the patients with liver cirrhosis or who were elderly. The regular monitoring of liver and renal function and serum phosphorus should be strengthened with correct diagnosis and timely treatment.

Key words: adefovir, adverse drug reaction(ADR), time-effect relationship, skeletal muscle system lesions

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