中国药物警戒 ›› 2018, Vol. 15 ›› Issue (11): 668-673.

• 安全性评价与合理用药 • 上一篇    下一篇

阿德福韦酯致低磷性骨软化症相关因素分析

谢彦军1, 吴桂芝2, 许莉莉1, 崔小康1, 路长飞1, 田月洁1, *   

  1. 1 山东省药品不良反应监测中心,山东 济南 250013;
    2 国家食品药品监督管理局药品评价中心,北京 100045
  • 收稿日期:2019-01-09 修回日期:2019-01-09 出版日期:2018-11-20 发布日期:2019-01-09
  • 通讯作者: 田月洁,男,硕士,主任药师,药品不良反应监测。
  • 作者简介:谢彦军,女,本科,副主任药师,药品不良反应监测。

Analysis of Related Factors of Hypophosphatemic Osteomalacia Induced by Adefovir Dipivoxil

XIE Yanjun1, WU Guizhi2, XU Lili1, CUI Xiaokang1, LU Changfei1, TIAN Yuejie1, *   

  1. 1 Adverse Drug Reaction Monitoring Centre of Shandong, Shandong Jinan 250013, China; 2 Centre for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2019-01-09 Revised:2019-01-09 Online:2018-11-20 Published:2019-01-09

摘要: 目的 分析阿德福韦酯引起低血磷性骨软化症的发生特点及其影响因素。方法 对山东省6家三级甲等综合医疗机构临床使用抗乙肝病毒药物治疗的病例开展回顾性调查,采用描述性研究对用药年龄、性别、用药情况、不良反应的发生情况以及救治和转归情况进行统计与分析。结果 使用阿德福韦酯抗乙肝病毒,可导致低磷性骨软化症,以血磷、尿磷、肌酐等肾功能相关生化指标的变化为早期指征,低磷性骨软化症一般发生在用药后3~5年,高龄、营养状况不良及肝、肾慢性疾病患者更易发生此不良反应。结论 对于服用阿德福韦酯者,临床医生应充分了解此不良反应,常规监测肾功能和血清磷,加强对老年、营养状况不良、既往肾病史患者的用药监测。

关键词: 阿德福韦酯, 低磷性骨软化症, 回顾性分析

Abstract: Objective To analyze the characteristics and related factors of hypophosphatemic osteomalacia induced by adefovir dipivoxil. Methods Cases treated by anti-hepatitis B drugs from 6 tertiary comprehensive hospitals were investigated retrospectively. The status of drug use, age, sex, medication, adverse drug reactions and treatment outcomes were analyzed descriptively. Results Anti-hepatitis B virus with adefovir dipivoxil may cause osteomalacia hypophosphatemia. The changes in renal function-related biochemical indicators, such as blood phosphorus, urinary phosphorus and creatinine, are the early indications. Hypophosphatemia usually occurs 3~5 years after treatment beginning, and the changes in renal function-related biochemical indicators mainly involved were blood phosphorus, urinary phosphorus, creatinine, etc. Patients with advanced age, poor nutritional status, and chronic liver and kidney diseases are easier to develop the adverse reaction. Conclusion For the patients treated by adefovir, clinicians should fully understand this adverse reaction, and should regularly monitor renal function and serum phosphorus. Patients with poor nutrition and with history of kidney disease should be monitored more strongly.

Key words: adefovir dipivoxil, hypophosphatemic osteomalacia, retrospective analysis

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