Abstract: Objective To investigate clinical features of tebivudine (LdT) induced creatine kinase (CK) elevation and its risk factors in chronic hepatitis B (CHB) patients, and to evaluate safety of LdT.Methods A total of 527 CHB patients were enrolled in this study, and their clinical data was retrospectively analyzed. Among these patients, 91 received LdT plus adefovir dipivoxil (ADV) therapy and 436 received LdT monotherapy, including 19 with CHB concomitant chronic renal disease (CKD) and 58 pregnant women. The CK levels and muscle symptoms were dynamically observed, and virus, immune and biochemical markers both at baseline and the end of therapy were detected, respectively.Results Variable degrees of CK elevation occurred in 321 cases (60.91%), in which 281 cases (53.32%) were in grade 1-2 and 40 cases (7.59%) were in grade 3-4. Additionally, 14 patients (2.65%) were diagnosed as myositis. In patients with CK elevation of grade 3-4, there was no significant difference between the 2 groups (P=0.16). Male was a risk factor for CK elevation with LdT treatment(P<0.001), while pregnance and CKD were protective factors (P<0.001; P=0.003).Conclusion It is quite common of CK elevation in CHB patients treated with LdT, which suggests that strengthening monitor of CK is indispensable for avoiding LdT-induced serious adverse effects. In regard to LdT-induced CK elevation, application of LdT in HBV-infected pregnant women and patients with CHB concomitant CKD might be safe.

Key words: Chronic hepatitis B; Telbivudine; Creatine kinase; Myositis