目的 探讨虎驹乙肝胶囊联合恩替卡韦治疗慢性乙型肝炎的临床疗效。方法 选择2011年8月-2014年8月如皋市人民医院收治的慢性乙型肝炎患者100例,随机分为治疗组和对照组,每组各50例,对照组口服恩替卡韦分散片,0.5 mg/次,1次/d;治疗组患者在对照组的基础上服用虎驹乙肝胶囊,5粒/次,3次/d;两组患者均治疗3个月。治疗后6个月,随访1次。比较两组的临床疗效,血清乙肝标志物相关指标乙肝表面抗原(HBsAg)、乙肝病毒基因(HBV-DNA),血清肝功能相关指标丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶(AST),以及血清肝纤维化相关指标透明质酸(HA)、层黏蛋白(LN)、Ⅲ型胶原蛋白(PCⅢ)、Ⅳ型胶原蛋白(ⅣC)。结果 治疗组总有效率(90%)明显高于对照组总有效率(84%);随访发现,治疗组复发率(25.0%)明显低于对照组的复发率(34.3%),两组比较差异具有统计学意义(P < 0.05);治疗后,治疗组的HBsAg转阴率、HBV-DNA转阴率均明显高于对照组,两组比较差异具有统计学意义(P < 0.05);治疗后,两组患者的ALT和AST均显著低于同组治疗前(P < 0.05),但治疗组的下降幅度均显著高于同期对照组(P < 0.05);随访期,两组的ALT和AST仍显著低于同组治疗前(P < 0.05),但与同组治疗刚结束时相比均无统计学意义,治疗组的ALT和AST仍显著低于同期对照组(P < 0.05);治疗后,两组患者的HA、LN、PCⅢ、ⅣC均显著低于同组治疗前(P < 0.05),且治疗组各指标均显著低于同期对照组(P < 0.05);随访期,两组的HA、LN、PCⅢ、ⅣC仍显著低于同组治疗前(P < 0.05),但与同组治疗刚结束时相比均无统计学意义,治疗组的HA、LN、PCⅢ、ⅣC仍显著低于同期对照组(P < 0.05)。结论 虎驹乙肝胶囊联合恩替卡韦治疗慢性乙型肝炎具有较好的临床疗效,具有一定的临床推广应用价值。

Objetive To investigate the clinical effect of Huju Yigan Capsules combined with entecavir in treatment of chronic hepatitis B. Methods Patients (100 cases) with chronic hepatitis B in the People's Hospital of Rugao from August 2011 to August 2014 were randomly divided into control and treatment groups. Each group had 50 cases. Patients in control group were po administered with Entecavir Dispersible Tablets, 0.5 mg/time, once daily; Patients in treatment group were po administered with Huju Yigan Capsules, 5 pills/time, three times daily on the basis of control group. The patients in two groups were treated for 3 months. After treatment for 6 months, patients were followed up. The efficacy, related indicators of HBV markers in serum hepatitis B surface antigen (HbsAg) and hepatitis B gene (HBV-DNA), related indicators of liver function in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and related indicators of hepatic fibrosis in serum hyaluronic acid (HA), layer fibronectin (LN), collagen Ⅲ (PCⅢ), and collagen Ⅳ (ⅣC) were compared. Results The clinical efficacy in treatment group (90%) was higher than that in control group (84%) with significant difference (P < 0.05). The follow-up data found that the recurrence rate in treatment group (25.0%) was lower than that in control group (34.3%) with significant difference (P < 0.05). After treatment, the HBsAg negating rate and HBV-DNA negating rate were higher than those in control group with significant difference (P < 0.05). After treatment, ALT and AST were lower than those in same group before treatment, and the difference was significant (P < 0.05). But the descend range in treatment group was higher than that in control group at same period with significant difference (P < 0.05). The follow-up data found that ALT and AST of two groups were lower than those in same group before treatment, but there was no significant difference. ALT and AST in treatment group were still lower than those in control group at same period with significant difference (P < 0.05). After treatment, HA, LN, PCⅢ, and ⅣC were lower than those in same group before treatment, and the difference was significant (P < 0.05). And these indicators in treatment group improved better than those in the control group at same period with significant difference (P < 0.05). The follow-up data found that HA, LN, PCⅢ, and ⅣC of two groups were lower than those in same group before treatment, but there was no significant difference. HA, LN, PCⅢ, and ⅣC in treatment group were still lower than those in control group at same period with significant difference (P < 0.05). Conclusion Huju Yigan Capsules combined with entecavir has good clinical efficacy in treatment of chronic hepatitis B, which has a certain clinical application value.