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目的分析替比夫定致肌病和周围神经病的临床特点、相关因素、处置方法及预后。方法筛选北京市药品不良反应监测网络2010年1月1日至2011年6月30日收到的替比夫定严重不良反应报告中致肌病和周围神经病的报告,对纳入报告所涉及患者的一般情况、用药情况、临床症状、实验室检查、处置方法及预后等资料进行分析。结果共纳入报告27份,涉及患者27例,其中肌病25例(92.6%),周围神经病2例(7.4%)。替比夫定和所述不良反应的关联性评价均为“可能”。肌病患者中男性24例,女性1例,平均年龄(33±12)岁。均为口服替比夫定600 mg,1次/d。用药时间6～<10个月者6例(24.0%),10～15个月者13例(52.0%),>15个月者6例(24.0%)。临床症状多表现为肌肉酸痛、肌肉压痛;血清肌酸激酶水平均升高(651～14 466 U/L)。停药及对症治疗后痊愈1例,好转21例(84.0%),死亡2例;1例发生横纹肌溶解症和难治性乳酸性酸中毒的男性患者放弃治疗。2例周围神经病患者临床表现为指端、脚趾和足部麻木、温度感觉异常,1例停药后予对症治疗好转,1例至报告时症状未改善。结论长期服用替比夫定可引起肌病及周围神经病等严重不良反应,停药及对症治疗后大部分患者好转。
Objective To analyze the clinical characteristics, related factors, treatment and prognosis of telbivudine induced myopathy and peripheral neuropathy. Methods Screening Beijing ADR surveillance network from January 1, 2010 to June 30, 2011 telbivudine serious adverse reactions reported in the myopathy and peripheral neuropathy report, for the inclusion of the reported patients General situation, medication, clinical symptoms, laboratory tests, treatment methods and prognosis data analysis. Results A total of 27 reports were included, including 27 cases of myopathy, 25 cases of myopathy (92.6%) and 2 cases of peripheral neuropathy (7.4%). The correlation between telbivudine and the adverse reactions was evaluated as “probable”. Myopathy patients, 24 males and 1 females, the average age (33 ± 12) years old. All were telbivudine 600 mg, 1 time / d. There were 6 cases (24.0%) in 6 ~ <10 months, 13 cases (52.0%) in 10 ~ 15 months and 6 cases (24.0%) in> 15 months. More clinical manifestations of muscle soreness, muscle tenderness; serum creatine kinase levels were elevated (651 ~ 14 466 U / L). One patient recovered after stopping and symptomatic treatment, 21 patients (84.0%) improved and 2 patients died. One male patient with rhabdomyolysis and refractory lactic acidosis gave up treatment. The clinical manifestations of peripheral neuropathy in 2 patients were numbness of fingers, numbness of feet and feet, abnormal temperature sensation, symptomatic treatment of 1 patient after stopping the treatment, and 1 patient did not improve until the report was reported. Conclusion Long-term telbivudine can cause serious adverse reactions such as myopathy and peripheral neuropathy. Most patients after stopping and symptomatic treatment improved.