Clinical trial of thymosin α 1 injection combined with entecavir capsules in the treatment of cirrhosis with decompensated liver function
10.13699/j.cnki.1001-6821.2017.11.004
- VernacularTitle:胸腺肽α1注射剂联合恩替卡韦胶囊治疗肝硬化肝功能代偿期的临床研究
- Author:
Yun-Hui DIAO
1
;
Meng XUE
;
Hong-Wei FAN
;
Jin-Ping SHA
;
Chang-Yu SUN
Author Information
1. 南阳市中心医院消化内科
- Keywords:
entecavir capsule;
thymosin α1 injection;
cirrhosis;
decompensated liver function;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(11):974-976
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of thymosin α1 injection combined with entecavir capsules in the treatment of cirrhosis with decompensated liver function.Methods Eighty patients with hepatitis B virus (HBV) e antigen (HBeAg) positive patients with decompensated liver function were randomly divided into control group (n =40 cases) and treatment group (n =40 cases).Control group was received oral entecavir 0.5 mg qd.Treatment group was given subcutaneous injection of thymosin α1 1.6 mg biw,on the basis of control group.Two groups were treated for 24 weeks.The clinical efficacy,alanine aminotransferase (ALT),aspartate aminotransferase (AST),total bilirubin,negative rates of HBV-DNA and HBeAg,adverse drug reactions were compared in two groups.Results After treatment,the total rates of treatment and control groups were 92.50％ (37/40 cases) and 75.00％ (30/40 cases) with significant difference (P ＜ 0.05).After treatment,the main indexes in treatment and control groups were compared,ALT were (51.39 ± 8.17),(64.12 ± 6.24) U·L-1;AST were (33.49 ± 5.14),(40.05 ± 5.28)U · L-1;total bilirubin were (17.59 ± 1.59),(16.32 ±1.32)mmol · L-1;negative rates of HBV-DNA were 77.50％,40.00％;negative rates of HBeAg were 70.00％,32.50％;conversion rates of HBeAg/anti-HBe were 35.00％,22.50％,there were statistically significant difference (P ＜ 0.05).Adverse drug reactions in treatment group were nausea,vomiting and dizziness,which in control group were nausea,vomiting,dizziness and allergies.The incidence of adverse drug reactions were 7.50％ and 17.50％ in treatment and control groups,with significant difference (P ＜0.05).Conclusion Thymosin α1 injection combined with entecavir capsules has a definitive clinical efficacy and safety for the treatment of HBeAg positive cirrhosis with decompensated liver function.
