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World J Gastroenterol. Jun 14, 2008; 14(22): 3549-3553
Published online Jun 14, 2008. doi: 10.3748/wjg.14.3549
Clinical features of adverse reactions associated with telbivudine
Xue-Song Zhang, Rui Jin, Shi-Bin Zhang, Ming-Ling Tao
Xue-Song Zhang, Rui Jin, Shi-Bin Zhang, Ming-Ling Tao, Department of GI and Hepatology, Beijing Youan Hospital affiliated to Capital Medical University, Beijing 100069, China
Author contributions: Jin R designed the research; Zhang SB, Tao ML and Zhang XS performed the research; Zhang SB and Tao ML collected and analyzed the data; and Zhang SB wrote the paper.
Correspondence to: Rui Jin, Professor, Department of GI and Hepatology, Beijing Youan Hospital Affiliated to Capital Medical University, Beijing 100069, China. jinrui@public.bta.net.cn
Telephone: +86-10-83997117
Fax: +86-10-63395319
Received: March 3, 2008
Revised: April 22, 2008
Accepted: April 29, 2008
Published online: June 14, 2008
Abstract

AIM: To analyze the clinical features and risk factors of adverse reactions associated with telbivudine.

METHODS: Clinical data were collected from cases that presented with serious adverse reactions to telbivudine. We analyzed general information and medicine status, clinical features, results of examination, and misdiagnosis.

RESULTS: Out of 105 patients who were treated with telbivudine for hepatitis B in an outpatient department from January, 2007 to January, 2008, five presented with serious adverse drug reactions. Most of these five patients had used other nucleoside analogues in the past. Four were treated with a combination of telbivudine and interferon or another nucleoside analogue, while the other received an increased dose of telbivudine. The main adverse reactions were myalgia and general weakness. This was accompanied by cardiac arrhythmia in one patient, and nervous symptoms in three. Serum creatine kinase was elevated. The rate of misdiagnosis was high.

CONCLUSION: The adverse reactions were related to telbivudine, but the biological mechanism of the reactions is not yet clear. Combination therapy with interferon or another nucleoside analogue and a high dose may increase the risk of adverse reactions.

Keywords: Adverse drug reaction; Hepatitis B; Mitochondria; Nucleoside analogue; Telbivudine