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本帖最后由 肝胆速递 于 2012-9-23 00:32 编辑
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2893.2012.01600.x/abstract
Randomized clinical trial: efficacy and safety of telbivudine and lamivudine in treatment-naïve patients with HBV-related decompensated cirrhosis随机对照临床试验:替比夫定和拉米夫定治疗乙肝相关肝硬化病人的有效性和安全性
H. L.Y. Chan1,
Y. C. Chen2,
E. J. Gane3,
S. K. Sarin4,
D. J. Suh5,
T. Piratvisuth6,
B. Prabhakar7,
S. G. Hwang8,
G. Choudhuri9,
R. Safadi10,
T. Tanwandee11,
A. Chutaputti12,
C. Yurdaydin13,
W. Bao14,
C. Avila15,
A. Trylesinski15
Article first published online: 15 MAR 2012
DOI: 10.1111/j.1365-2893.2012.01600.x
1 Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China
2 Liver Research Unit, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan
3 Liver Unit, Auckland City Hospital, Auckland, New Zealand
4 Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India
5 Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
6 NKC Institute of Gastroenterology and Hepatology, Songklanagarind Hospital, Prince of Songkla University, Hat Yai, Thailand
7 Osmania Medical College and General Hospital, Hyderabad, India
8 Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea
9 Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India
10 Holy Family Hospital, Nazareth & Hadassah Medical Center, Jerusalem, Israel
11 Siriraj Hospital, Bangkok, Thailand
12 Phramongkutklao Hospital, Bangkok, Thailand
13 University of Ankara Medical School, Ankara, Turkey
14 Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
15 Novartis Pharma AG, Basel, Switzerland
*Dr Henry Lik-Yuen Chan, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, 9/F Prince of Wales Hospital, 30–32 Ngan Shing Street, Shatin, Hong Kong SAR, China. E-mail: [email protected]
Summary. Patients with decompensated cirrhosis owing to chronic hepatitis B viral (HBV) infection have a high morbidity/mortality rate, and the treatment remains a challenge. We studied the safety and efficacy of telbivudine and lamivudine in such patients. This noninferiority, double-blind trial randomized 232 treatment-naive patients with decompensated HBV (1:1) in 80 academic hospitals to receive once-daily telbivudine 600 mg or lamivudine 100 mg for 104 weeks. Primary composite endpoint was proportion of patients with HBV DNA <10 000 copies/mL, normal alanine aminotransferase (ALT) and Child-Turcotte-Pugh score improvement/stabilization at week 52. Response rates using a post hoc modified endpoint (HBV DNA <300 copies/mL [57 IU/mL] and ALT normalization) in intent-to-treat analysis (missing = failure) were 56.3%vs 38.0% after 76 weeks (P = 0.018) and 45.6%vs 32.9% after 104 weeks (P = 0.093) for telbivudine vs lamivudine. Telbivudine treatment was an independent predictive factor for HBV DNA <300 copies/mL and ALT normalization (P = 0.037). Response rates with protocol-defined composite endpoint in intent-to-treat analysis (M = F) were 56.2 vs 54.0% (noninferiority not achieved) and 39.1%vs 36.4% (noninferiority achieved) in telbivudine and lamivudine groups at 52 and 104 weeks. Telbivudine treatment was associated with a significant improvement in glomerular filtration rate compared to lamivudine treatment and was also associated with a trend for improvement in survival (87%vs 79%). No cases of lactic acidosis were reported. Telbivudine compared to lamivudine was associated with a higher rate of patients with both viral suppression and ALT normalization, a trend towards a higher rate of survival and significant improvement in glomerular filtration.
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