Effects of nucleos(t)ide analogues initial treatment on virology and complications in hepatitis B virus related decompensated liver cirrhosis: a multicenter, prospective and observational study / 中华消化杂志

ABSTRACT

Objective To evaluate the effects of nucleos (t)ide analogues initial treatment on virology and complications in hepatitis B virus (HBV) related decompensated liver cirrhosis.Methods From May 2012 to October 2013,a total of 209 patients with HBV related decompensated liver cirrhosis of 18 hospitals in China were enrolled.According to antiviral medicine taken by them,they were divided into entecavir (ETV) group (n =161),lamivudine (LAM) monotherapy or combined with adefovir (ADV)group (n=48,LAM 22 cases,LAM+ADV 26 cases).During the 12-month follow up period,ChildPugh scores,the level of HBV DNA and complications of liver cirrhosis were documented every three months,the safety evaluation was also carried out.The t-test or chi-square test was performed for statistical analysis.Results In ETV group,before treatment and 12 months after treatment,Child-Pugh scores were 7.91±2.05 and 5.75±1.72,respectively,and the latter was lower than the former (t=10.130,P＜0.01); in LAM alone or combined with ADV group,Child-Pugh scores were 8.08±2.23 and 5.85±1.44,respectively,and the latter was lower than the former (t=5.480,P＜0.01).However there was no significant difference in Child-Pugh scores between the two groups in different time points (both P＞0.05).The undetectable rates of HBV DNA gradually increased along with the treatment period.After 12 months treatment,the undetectable rate of HBV DNA of ETV group was 91.0％ (61/67),and that of LAM alone or combined with ADV group was 87.5％ (35/40),there was no significant difference between the two groups (P＞0.05).Before treatment and 12 months after treatment,the incidences of ascites were 59.4％ (82/138) and 15.0％ (12/80) in ETV group,the latter was lower than the former (x2 =40.740,P＜0.01) ; the incidences of ascites in LAM alone or combined with ADV group were 62.2％ (28/45) and 8.1％ (3/37),and the latter was lower than the former (x2=25.290,P＜ 0.01).After 12 months treatment,the rates of esophageal varices disappearance of ETV group and LAM alone or combined with ADV group were 26.6％ (33/124) and 25.0％ (7/28),accordingly the rates of gastric varices disappearance were 2.5％ (1/40) and 1/19,and the difference was not statistically significant between the two groups (both P＞0.05).There was no significant difference in serum urea nitrogen,serum creatinine and estimated glomerular filtration rates between the two groups before treatment and at different time points after treatment (all P＞0.05).Conclusion The efficacy and safety of ETV and LAM alone or combined with ADV are similar in patients with HBV related decompensated liver cirrhosis,however,the long-term efficacy should be identified by further clinical observation.