http://jcps.bjmu.edu.cn

中国药学(英文版) ›› 2016, Vol. 25 ›› Issue (1): 66-72.DOI: 10.5246/jcps.2016.01.008

• 【研究论文】 • 上一篇    下一篇

替比夫定致横纹肌溶解症不良反应的回顾与分析

易湛苗1, 汤诗蝶2, 刘芳1*, 翟所迪1, 焦立公3   

  1. 1. 北京大学第三医院 药剂科, 北京 100191
    2. Department of Pharmaceutical Sciences, College of Pharmacy, University of Kentuky, Lexington, USA
    3. 北京市药品不良反应监测中心, 北京 100024
  • 收稿日期:2015-08-12 修回日期:2015-10-09 出版日期:2016-01-27 发布日期:2015-11-10
  • 通讯作者: Tel.: 86-10-82266682, E-mail: liufang8-111@163.com
  • 基金资助:
    Foundation of Peking University Third Hospital, China (Grant No. BYSY-SEEDFUND-Y86447-01).

Evaluation on telbivudine-associated rhabdomyolysis

Zhanmiao Yi1, Shidie Tang2, Fang Liu1*, Suodi Zhai1, Ligong Jiao3   

  1. 1. Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
    2. Department of Pharmaceutical Sciences, College of Pharmacy, University of Kentuky, Lexington, USA
    3. Beijing Center for ADR Monitoring, Beijing 100054, China
  • Received:2015-08-12 Revised:2015-10-09 Online:2016-01-27 Published:2015-11-10
  • Contact: Tel.: 86-10-82266682, E-mail: liufang8-111@163.com
  • Supported by:
    Foundation of Peking University Third Hospital, China (Grant No. BYSY-SEEDFUND-Y86447-01).

摘要:

为调查替比夫定致横纹肌溶解症不良反应的临床特征和相关因素,检索了国内外相关医学文献数据库,并筛选北京市药品不良反应监测网络收到的替比夫定不良反应报告中致横纹肌溶解症的报告。病例收集时间截止至2014,分析患者的一般情况、用药情况和不良反应发生时间、临床表现、治疗措施和转归等资料。阅读226篇文献和41篇不良反应报告后,最终共纳入22个病例。纳入的病例均为男性患者,平均年龄(34.5±11.2),原发疾病均为慢性乙型肝炎,替比夫定用药剂量均为600 mg/d。不良反应发生的时间存在差异,用药后5个月及以内、6–10个月、11–15个月和15个月以上发生不良反应者分别为1(4.5%)11(50.0%)7(31.8%)3(13.6%)。不良反应的首发症状多为恶心、呕吐、心悸、下肢乏力水肿。患者经停药及对症治疗后,12例好转, 4例遗留有身体功能损害, 2例结局不明, 4例死亡。患者的年龄(P = 0.61)、用药疗程(P = 0.54)、肌酸激酶(P = 0.07)的水平与死亡无统计学相关性。临床医师使用替比夫定时应监测患者临床表现,必要时检查血清肌酸激酶水平。出现不良反应后应及时停药并给予对症治疗。

关键词: 替比夫定, 横纹肌溶解症, 临床特征

Abstract:

To investigate clinical characteristics and related factors of telbivudine-associated rhabdomyolysis (RM), we searched domestic and foreign medical literature databases as well as Beijing Adverse Drug Reaction Monitoring Database. Cases of telbivudine-associated RM were collected. General information of patients and information of medications were extracted. Onset of adverse drug reactions (ADRs), clinical manifestations, treatments and outcomes were investigated and analyzed. After reviewing226 literatures and 71 reports, a total of 22 RM cases were collected. All the cases were male patients with an average age of (34.5±11.2) years, and all these patients had chronic hepatitis B and received telbivudine 600 mg/day. The occurrence time of RM varied. One case occurred within 5 months (4.5%), 11 cases occurred within 6 to 10 months (50.0%), 8 cases occurred within 11 to 15 months (31.8%), and 3 cases occurred after 15 months (13.6%). Clinical manifestations were mostly nausea, vomiting, palpitations, weakness and edema of the lower extremities. After the telbivudine treatment was discontinued and symptomatic treatments were provided, 12 patients were clinically improved, 4 patients were physically impaired, 2 patients showed unknow results, and 4 deaths were reported. However, age (P = 0.61), duration of medication (P = 0.54) and CK value (P = 0.07) were not statisticallyassociated with death. Clinicians are advised to monitor clinical manifestations in patients receiving telbivudine. Monitoring on serum creatinine level is suggested if necessary. Telbivudine should be promptly discontinued, and symptomatic treatment should be given when ADRs occur.

Key words: Telbivudine, Rhabdomyolysis, Clinical characteristics

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