替比夫定联合复方牛胎肝提取物治疗慢性乙型肝炎患者疗效及安全性评价

摘要

Objective To investigate the efficacy and safety of combined therapy of telbivudine and compound embryonic bovine liver extract in patients with chronic hepatitis B(CHB). Methods Eighty-seven patients with chronic hepatitis B were randomly divided into combination treatment group(n=43)and control group(n=44). Patients in combination treatment group were treated with compound embryonic bovine liver extract plus telbivudine,and those in control group were treated with telbivudine alone. The data of liver function index, renal function index,serum hyaluronic acid(HA),laminin(LN),type IV collagen(IV-C),type III procollagen,N-terminal peptide(P IIINP),creatine kinase(CK),HBV DNA undetectable rates,HBeAg loss rates and adverse reaction rates were compared between the two groups. Results At the end of 24 weeks of treatment,serum alanine transaminase(ALT),aspartate aminotransferase(AST)levels in combination treatment group were(25.4 ± 8.5)U/L,(23.8±6.5)U/L,respectively,significantly lower than those in control group [(46.3±9.3)U/L,(49.0±7.3) U/L,P<0.05];serum HA,LN,Ⅳ-C,PⅢNP levels in combination treatment group were(128.4±83.2)μg/L,(88.4± 64.3)μg/L,(64.4 ±49.0)μg/L,(112.3 ±73.8)μg/L,respectively,significantly lower than those in control group [(249.3 ±82.1)μg/L,(163.1 ±55.1)μg/L,(98.2 ±50.3)μg/L,(183.2 ±63.2)μg/L,P<0.01];serum HBV DNA undetectable,HBeAg loss and adverse reaction rates in the two groups were not significantly different(P>0.05). Conclusions Telbivudine combined with compound embryonic bovine liver extract can significantly improve the liver function and liver fibrosis in patients with CHB,and have a good safety profile.%目的 评价替比夫定联合复方牛胎肝提取物治疗慢性乙型肝炎(CHB)患者的疗效及安全性.方法 将87例CHB患者随机分为对照组44例和观察组43例.给予对照组口服替比夫定600mg,1次/d,观察24w;观察组在对照组治疗的基础上,给予口服复方牛胎肝提取物片80mg,3次/d,观察24w.比较两组患者治疗前后肝功能、肾功能、透明质酸(HA)、层粘蛋白(LN)、Ⅳ型胶原(Ⅳ-C)、Ⅲ型前胶原氨端肽(PⅢNP)和肌酸激酶(CK)变化情况,以及HBV DNA和HBeAg转阴率和不良反应发生率.结果 在治疗24w末,观察组血清谷丙转氨酶(ALT)、谷草转氨酶(AST)水平分别(25.4±8.5)U/L、(23.8±6.5)U/L,显著低于对照组的[(46.3±9.3)U/L、(49.0±7.3)U/L,P<0.05];观察组血清HA、LN、Ⅳ-C、PⅢNP水平分别为(128.4±83.2)μg/L、(88.4±64.3)μg/L、(64.4±49.0)μg/L、(112.3±73.8)μg/L,显著低于对照组的[(249.3±82.1)μg/L、(163.1±55.1)μg/L、(98.2±50.3)μg/L、(183.2±63.2)μg/L,P<0.01];两组血清HBV DNA和HBeAg转阴率和不良反应发生率无显著差异.结论 替比夫定联合复方牛胎肝提取物片治疗CHB患者,可显著改善肝功能和肝纤维化指标,且安全性良好.