替诺福韦联合安络化纤丸治疗HBeAg阴性慢性乙型肝炎患者疗效及其血清肝纤维化指标的变化研究

Prelim inary study on the efficacy of combination of tenofovir and Anluo Huaxian pill in the treatm ent of patients with HBeAg-negative chronic hepatitis B

目的观察应用替诺福韦联合安络化纤丸治疗HBeAg阴性慢性乙型肝炎患者的疗效。方法2015年3月~2017年5月我院诊治的HBeAg阴性慢性乙型肝炎患者68例,采用随机数字表法分为联合组和对照组,两组均为34例。给予对照组患者替诺福韦口服治疗,联合组患者在对照组治疗的基础上加用安络化纤丸口服治疗,两组均观察治疗48 w。采用ELISA法检测血清白细胞介素(IL)-6、IL-2、肿瘤坏死因子-α(TNF-α)水平,采用放射免疫法检测血清III型前胶原(PC-III)、透明质酸(HA)、层粘连蛋白(LN)和IV型胶原(IV-C)水平。结果在治疗48 w末,联合组血清HA、LN、IV-C和PC-III水平分别为(94.5±31.5)ng/ml、(113.2±51.6)ng/ml、(72.4±20.3)g/L和(102.4±19.6)g/L,显著低于对照组[分别为(121.6±37.5)ng/ml、(132.5±53.8)ng/ml、(94.6±22.1)g/L和(134.7±21.5)g/L,P<0.05];联合组患者血清IL-2水平为(173.6±28.3)ng/L,显著高于对照组[(145.7±26.4)ng/L,P<0.05],而血清IL-6和TNF-α水平分别为(94.5±16.2)pg/ml和(26.6 6.8)pg/ml,显著低于对照组[分别为(112.6±17.8)pg/ml和(35.7±8.3)pg/ml,P<0.05];联合组血清HBV DNA转阴率为91.2%,与对照组的88.2%比,无统计学差异(P<0.05);两组血清ALT复常率均为94.1%。结论应用替诺福韦联合安络化纤丸治疗HBeAg阴性慢性乙型肝炎患者疗效显著,可有效降低血清肝纤维化指标和细胞因子水平,可能与减轻了肝内炎症反应有关。

Objective The aim of this study was to investigate the efficacy of of combination of tenofovir and Anluo Huaxian pill,a herbal medicine,in the treatment of patients with HBeAg-negative chronic hepatitis B(CHB).Methods A total of 68 patients with HBeAg-negative CHB were recruited in our hospital bwtween March 2015 and May 2017,and were divided randomly into two groups,with 34 patients in each.The patients in the control group were treated with tenofovir orally and those in the observation were treated with combination of tenofovir and Anluo Huaxian pill for 48 weeks.Serum interleukin(IL)-6,IL-2,and tumor necrosis factor-α(TNF-α)by enzyme-linked immunosorbent assay,and serum type III procollagen(PC-III),hyaluronic acid(HA),laminin(LN)and type IV collagen(IV-C)were detected by radioimmunoassay.Results At the end of 48 w treatment,serum HA,LN,IV-C,and PC-III levels in the combination group were(94.5±31.5)ng/ml,(113.2±51.6)ng/ml,(72.4±20.3)g/L and(102.4±19.6)g/L,significantly lower than[(121.6±37.5)ng/ml,(132.5±53.8)ng/ml,(94.6±22.1)μg/L and(134.7±21.5)g/L,respectively,P<0.05]in the control;serum IL-2 level was(173.6±28.3)ng/L,significantly higher than[(145.7±26.4)ng/L,P<0.05],while serum IL-6 and TNF-αlevels were(94.5±16.2)pg/ml and(26.6±6.8)pg/ml,significantly lower than[(112.6±17.8)pg/ml and(35.7±8.3)pg/ml,respectively,P<0.05]in the control;serum HBV DNA loss were 91.2%and 88.2%in the two groups(P<0.05)and serum ALT normalization rates in the two groups were 94.1%and 94.1%.Conclusion The administration of tenofovir and Anluo Huaxian pills is effective in the treatment of patients with HBeAg-negative CHB,which might alleviate liver fibrosis and reduce intrahepatic inflammation.