复方鳖甲软肝片联合恩替卡韦片对慢性乙型肝炎瘀血阻络证型患者肝功能及胆红素的影响

Effects of Compound Biejia Ruangan Tablets Combined with Entecavir Tablets on Liver Function and Hematoidin of Patients with Chronic Hepatitis B Blood Stasis Syndrome

目的:观察复方鳖甲软肝片联合恩替卡韦片对慢性乙型肝炎瘀血阻络证型患者肝功能及胆红素的影响。方法:选取2015年1-12月内江市第二人民医院、西南医科大学附属医院、宜宾市第一人民医院收治的110例慢性乙型肝炎瘀血阻络证型患者,按分层区组随机方法分为对照组和观察组,各55例。对照组患者给予恩替卡韦片0.5 mg,po,qd;观察组患者在此基础上给予复方鳖甲软肝片2.0 g,po,tid。两组患者均连续治疗12个月。观察两组患者治疗前后中医证候评分,肝功能指标[包括天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)、碱性磷酸酶(ALP)和谷氨酰转移酶(GGT)]、血清胆红素[包括总胆红素(TBIL)、直接胆红素(DBIL)和间接胆红素(IBIL)]、肝纤维化指标[包括层粘连蛋白(LN)、透明质酸(HA)、Ⅲ型前胶原(PⅢP)和Ⅳ型胶原蛋白(Ⅳ-C)]和肝瞬时弹性硬度(FS)水平,并记录不良反应发生情况。结果:观察组脱落2例,对照组脱落3例。治疗前,两组患者中医证候评分、肝功能指标、血清胆红素、肝纤维化指标和FS水平比较,差异均无统计学意义(P>0.05)。治疗后,两组患者中医证候评分和TBIL、IBIL、LN、HA、PⅢP、Ⅳ-C、FS水平均明显降低,DBIL水平明显升高,且观察组明显优于对照组,差异均有统计学意义(P<0.05);观察组患者AST、ALT水平明显降低,ALP、GGT水平明显升高,且观察组明显优于对照组,差异均有统计学意义(P<0.05)。观察组患者不良反应发生率(9.09%)与对照组(10.91%)比较,差异无统计学意义(P>0.05)。结论:复方鳖甲软肝片联合恩替卡韦片治疗慢性乙型肝炎瘀血阻络证型患者,可改善其肝功能指标及胆红素水平,抑制肝纤维化,且安全性较好。

OBJECTIVE： To observe the effects of Compound biejia ruangan tablets combined Entecavir tablets on liver function and hematoidin of patients with chronic hepatitis B （CHB） blood stasis syndrome. METHODS： Totally 110 patients with CHB blood stasis syndrome were selected from Neijiang Second People’s Hospital, the Affiliated Hospital of Southwest Medical University and Yibin First People’s Hospital during Jan.-Dec. 2015. They were divided into control group and observation group by stratified blocked randomitation, with 55 cases in each group. Control group was given Entecavir tablets 0.5 mg,po,qd; observation group was additionally given Compound biejia ruangan tablets 2.0 g, po, tid. Both groups received treatment for 12 months. TCM syndrome scores, the levels of liver function indexes （AST, ALT, ALP, GGT）, serum bilirubin （TBIL, DBIL, IBIL）, liver fibrosis indexes （LN, HA, PⅢP, Ⅳ-C） and Fibroscan （FS） were observed in 2 groups before and after treatment. The occurrence of ADR was recorded. RESULTS： In observation group, 2 patients withdrew from the study, and 3 patients of control group withdrew from the study. Before treatment, there was no statistical significance in TCM syndrome scores, the levels of liver function indexes, serum bilirubin, liver fibrosis indexes and FS between 2 groups （P〉0.05）. After treatment, TCM syndrome scores, the levels of TBIL, IBIL, LN, HA, PⅢP, Ⅳ-C and FS in 2 groups were significantly decreased, while DBIL level was increased significantly, and the observation group was significantly better than control group, with statistical significance （P〈0.05）. The levels of AST and ALT in observation group were decreased significantly, while the levels of ALP and GGT were increased significantly, and the observation group was significantly better than control group, with statistical significance （P〈0.05）. There was no statistical significance in the incidence of ADR between observation group （9.09%） and control group （10.91%） （P〉0.05）. CONCLUSIONS： For CHB blood stasis syndrome, Compound biejia ruangan tablets combined with Entecavir tablets can improve liver function indexes and bilirubin level, and inhibit liver fibrosis with good safety.