替比夫定所致肌酸激酶升高及肌病的临床观察

Clinical cases observation of telbivudine-related myopathy and creatine kinase elevation

目的：观察服用替比夫定的慢性乙型肝炎患者血清肌酸激酶（CK）水平及肌病发生情况,探讨CK升高及肌病的特点,分析该药临床安全性。方法：将92例慢性乙型肝炎患者随机分为两组,观察组54例口服替比夫定片600mg/次,1次/d;对照组38例口服拉米夫定片,100mg/次,1次/d。疗程均为两年。观察用药期间CK变化和肌病发生情况。结果：观察组在56周、104周时发生CK升高1~4级的比率为59.3%和70.4%,均明显高于对照组（P〈0.05）;两组患者CK均值在56周、104周时比较,观察组明显高于对照组（P〈0.05）;观察组有1例患者发生肌炎,未见横纹溶解病例,对照组未见肌病发生病例。结论：替比夫定所致CK水平升高,绝大多数是安全的良性过程,可自行恢复,少见肌病发生。该药仍不失为安全高效的抑制乙肝病毒的药物。

Objective：To investigate creatine kinase（CK） level and myopathy occurrence on 54 chronic hepatitis B patients with telbivudine treatment,discusses its CK elevation and myopathy′s characteristic and the clinical security.Methods：One group of 54 patients treated with telbivudine tablets and the other group of 38 patients treated with lamivudine tablets,both were oral monotherapy.Then CK level and myopathy occurrence were compared between the two groups.Results： In telbivudine group,59.3%were observed CK elevation at 1~4 level at 56 weeks,70.4% were observed CK elevation at 1~4 level at 104 weeks,both were significantly higher than lamivudine group（P0.05）;telbivudine group were significantly higher than lamivudine group in CK elevation level at 56 weeks and 104 weeks（P0.05）.One myositis case and no rhabdomyolysis was observed.Conclusion： Most of telbivudine-related CK elevation is benign and self-recovery,rare withdrawal and myopathy occur.Telbivudine is safe and high-performance of inhibiting hepatitis B virus drugs,but CK level and muscle situation should be monitored during treatment.