Abstract:

Objective　To investigate the clinical efficacy of entecavir combined with Fufang Biejia Ruangan tablets in the treatment of patients with HBeAg-positive decompensated cirrhosis. Methods　One hundred patients with HBeAg-positive decompensated cirrhosis admitted to Yantai Qishan Hospital from September 2017 to September 2021 were prospectively selected as the study objects, and were randomly divided into an observation group and a control group, with 50 cases in each group. There were 30 males and 20 females in the control group; they were (43.29±5.02) years old. There were 26 males and 24 females in the control group; they were (40.16±6.25) years old. The control group were treated with entecavir, and the observation group with entecavir and Fufang Biejia Ruangan tablets. The therapeutic efficacies, liver function indicators, such as alanine aminotransferase (ALT), aspartate transferase (AST), albumin (ALB), and total bilirubin (TBiL), and liver fibrosis indicators, such as laminin (LN), procollagen type Ⅲ (PC Ⅲ), collagen type Ⅳ (CⅣ), and hyaluronic acid (HA) before and after the treatment were compared between the two groups. The changes in portal vein diameter and spleen thickness scores, as well as drug safety were also compared. t test was used for the measurement data, and χ² test for the counting data. Results　The total clinical efficacy in the observation group was higher than that in the control group [92.00% (46/50) vs. 70.00% (35/50); χ²=7.862, P=0.005]. After the treatment, the levels of ALT, AST, and TBiL in the observation group were significantly lower than those in the control group [(90.35±35.52) U/L vs. (127.96±48.32) U/L, (62.27±30.28) U/L vs. (100.91±42.21) U/L, and (35.09±15.23) μmol/L vs. (51.15±20.57) μmol/L; t=4.435, 5.259, and 4.437; all P<0.05]; the ALB level in the observation group was significantly higher than that in the control group [(34.98±8.34) g/L vs. (28.33±6.35) g/L; t=4.486, P<0.05]. After the treatment, the levels of LN, PCⅢ, CⅣ, and HA in the observation group were significantly lower than those in the control group [(103.25±32.52) μg/L vs. (129.36±60.33) μg/L, (96.17±30.28) μg/L vs. (120.08±52.16) μg/L, (56.12±26.19) µg/L vs. (78.33±30.22) μg/L, and (155.42±72.71) μg/L vs. (194.34±100.29) μg/L; t=2.694, 2.803, 3.927, and 2.222; all P<0.05]. After the treatment, the portal vein diameter and spleen thickness of the observation group were significantly lower than those of the control group [(1.03±0.18) cm vs. (1.35±0.27) cm and (3.27±0.39) vs. (4.33±0.31); t=6.973 and 15.045, both P<0.05]. There was no statistical difference in the incidence of adverse reactions between the two groups. Conclusions　Entecavir combined with Fufang Biejia Ruangan tablets in the treatment of patients with HBeAg-positive decompensated cirrhosis is significantly effective, an can improve their liver fibrosis and control the disease progress. At the same time, the medication has a high safety profile and does not significantly increase adverse reactions.

Key words:

Entecavir, Fufang Biejia Ruangan tablets, HBeAg-positive, Decompensated cirrhosis

摘要：

目的　探讨恩替卡韦联合复方鳖甲软肝片治疗HBeAg阳性失代偿期肝硬化患者的临床疗效。方法　前瞻性选取2017年9月至2021年9月于烟台市奇山医院收治的100例HBeAg阳性失代偿期肝硬化患者为研究对象，随机数字表法分为观察组、对照组，各50例。对照组男30例，女20例，年龄（43.29±5.02）岁，给予恩替卡韦治疗；观察组男26例，女24例，年龄为（40.16±6.25）岁，给予恩替卡韦联合复方鳖甲软肝片治疗。对比两组患者治疗疗效及治疗前后的肝功能指标［丙氨酸转氨酶（ALT）、天冬氨酸转氨酶（AST）、白蛋白（ALB）、总胆红素（TBIL）］、肝纤维化程度指标［层黏蛋白（LN）、Ⅲ型前胶原（PCⅢ）、Ⅳ型胶原（CⅣ）、透明质酸（HA）］、门静脉内径及脾厚度评分变化水平以及用药安全性。计量资料采用t检验，计数资料用χ²检验。结果　观察组临床总有效率为92.00%（46/50），高于对照组［70.00%（35/50）］（χ²=7.862，P=0.005）。治疗后，观察组ALT（90.35±35.52）U/L、AST（62.27±30.28）U/L、TBIL（35.09±15.23）μmol/L，均低于对照组［（127.96±48.32）U/L、AST（100.91±42.21）U/L、TBIL（51.15±20.57）μmol/L］（t=4.435、5.259、4.437，均P<0.05）；观察组ALB（34.98±8.34）g/L，高于对照组［（28.33±6.35）g/L］（t=4.486，P<0.05）。治疗后，观察组LN（103.25±32.52）μg/L、PCⅢ（96.17±30.28）μg/L、CⅣ（56.12±26.19）μg/L、HA（155.42±72.71）μg/L，均低于对照组［（129.36±60.33）μg/L、（120.08±52.16）μg/L、（78.33±30.22）μg/L、（194.34±100.29）μg/L］（t=2.694、2.803、3.927、2.222，均P<0.05）。治疗后，观察组门静脉内径（1.03±0.18）cm、脾厚度（3.27±0.39）cm，均明显低于对照组［（1.35±0.27）cm、（4.33±0.31）cm］（t=6.973、15.045，均P<0.05）。两组不良反应发生率比较，差异无统计学意义。结论　恩替卡韦联合复方鳖甲软肝片治疗HBeAg阳性失代偿性肝硬化患者的临床疗效显著，能改善肝纤维化，控制病情发展，同时用药具有较高安全性，不会明显增加不良反应。

关键词:

恩替卡韦, 复方鳖甲软肝片, HBeAg阳性, 失代偿性肝硬化