中国临床药学杂志

目的观察扶正化瘀胶囊联合恩替卡韦治疗慢性乙型肝炎肝纤维化的疗效及对血液流变学和血清白介素-17(IL-17)表达的影响。方法选择于2018年1月至2019年6月期间收治的慢性乙型肝炎肝纤维化患者120例,按照随机数字表法分为对照组与观察组,各60例。对照组给予恩替卡韦分散片5 mg,po,qd;观察组在对照组治疗基础上予扶正化瘀胶囊1.5 g,po,tid。2组疗程均为24周。比较2组治疗前后肝功能指标、肝纤维化指标、血液流变学指标和血清IL-17水平,以及治疗期间药物不良反应发生情况。结果 2组治疗后血清丙氨酸氨基转移酶(ALT)、总胆红素(TBIL)和天门冬氨酸氨基转移酶(AST)水平均较治疗前降低(观察组:t=30.306、17.519、33.898,对照组:t=17.792、0.605、19.988,P<0.05),且观察组均低于对照组(t=8.513、8.796、8.816,P<0.05)。2组治疗后血清Ⅲ型前胶原蛋白(PCⅢ)、Ⅳ型胶原蛋白(Ⅳ-C)、层粘连蛋白(LN)和透明质酸(HA)水平均较治疗前降低(观察组:t=21.797、17.314、27.771、33.133,对照组:t=13.582、11.156、14.537、19.847,P<0.05),且观察组均低于对照组(t=10.988、9.968、10.008、18.834,P<0.05)。2组治疗后全血黏度高切、全血黏度低切、血浆黏度、纤维蛋白原和血细胞比容水平均较治疗前降低(观察组:t=25.430、16.305、17.772、17.094、19.053,对照组:t=11.877、6.490、6.970、8.202、6.642,P<0.05),且观察组均低于对照组(t=14.040、12.404、12.836、12.964、10.742,P<0.05)。2组治疗后血清IL-17水平较治疗前降低(观察组:t=23.643,对照组:t=12.761,P<0.05),且观察组低于对照组(t=10.272,P<0.05)。结论扶正化瘀胶囊联合恩替卡韦治疗慢性乙型肝炎伴肝纤维化疗效良好,可改善患者血液流变学,降低血清IL-17表达,改善患者肝功能和肝纤维化,且用药安全性良好。

AIM To investigate the effect of Fuzheng Huayu capsule combined with entecavir in treatment of chronic hepatitis B with liver fibrosis and the influence of hemorheology and serum IL-17 expression. METHODSFrom January 2018 to June 2019, 120 patients with chronic hepatitis B liver fibrosis were randomly divided into control group(60 patients) and observation group(60 patients). The control group was given 5 mg of entecavir dispersible tablets, po, qd, and the observation group was given 1.5 g of Fuzheng Huayu capsule, po, tid, on the basis of the treatment of the control group. The course of treatment in both groups was 24 weeks. The changes of liver function index, liver fibrosis index, hemorheology index and serum IL-17 level before and after treatment were compared between 2 groups. RESULTS After treatment,the levels of ALT, TBIL and AST in the 2 groups were lower than those before treatment(observation group: t=30.306, 17.519, 33.898; control group: t=17.792, 0.605, 19.988, P<0.05). The levels of ALT, TBIL and AST in the observation group were lower than those in the control group(t=8.513, 8.796, 8.816, P<0.05). After treatment, the levels of type Ⅲ procollagen(PCⅢ), type Ⅳ collagen(Ⅳ-C), laminin(LN) and hyaluronic acid(HA) in the 2 groups were lower than those before treatment(observation group: t=21.797, 17.314, 27.771, 33.133; control group:t=13.582, 11.156, 14.537, 19.847, P<0.05). After treatment, the levels of PCⅢ, Ⅳ-C, LN and HA in the observation group were lower than those in the control group(t=10.988, 9.968, 10.008, 18.834, P<0.05). After treatment, the whole blood viscosity, fibrinogen and hematocrit levels of the 2 groups were lower than those before treatment(observation group: t=25.430, 16.305, 17.772, 17.094, 19.053; control group: t=11.877, 6.490, 6.970, 8.202, 6.642, P<0.05). After treatment, the whole blood viscosity, fibrinogen and hematocrit levels of the observation group were lower than those of the control group(t=14.040, 12.404, 12.836, 12.964, 10.742, P<0.05). The level of IL-17 in the 2 groups after treatment was lower than that before treatment(observation group: t=23.643; control group: t=12.761, P<0.05). The level of IL-17 in the observation group after treatment was lower than that in the control group(t=10.272, P<0.05). CONCLUSION Fuzheng Huayu capsule combined with entecavir has a good chemotherapy effect in the treatment of chronic hepatitis B liver fiber. It can improve the hemorheology of patients, reduce the expression of IL-17 in serum, and improve the liver function and liver fibrosis of patients, with few adverse reactions and good drug safety.