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摘要：
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摘要：目的 明确黄芩苷胶囊联合恩替卡韦（entecavir，ETV）对慢性乙型肝炎
（chronic hepatitis B，CHB）患者乙型肝炎病毒（hepatitis B virus，HBV）前基因组RNA
（pregenomic ribonucleic acid，pgRNA）水平的影响。方法 选取2018年1月至2020年12月于
首都医科大学附属北京地坛医院、吉林省肝胆病医院、开封市传染病医院及兰州市第二
人民医院等就诊的79例初治CHB患者为研究对象进行队列研究，黄芩苷胶囊组（56例）
采用ETV联合黄芩苷胶囊治疗，对照组（23例）仅采用ETV治疗。收集患者基线人口学
（年龄、性别）、病毒学 [乙型肝炎病毒e抗原（hepatitis B virus e antigen，HBeAg）阳性、
HBV DNA、HBV pgRNA]、丙氨酸氨基转移酶（alanine aminotransferase，ALT）、肝硬化
及肝脏弹性检查（liver stiffness measurement，LSM）值等指标，治疗4周与12周时各随访1次。
比较两组患者治疗4周和12周HBV DNA及pgRNA下降情况。采用多因素Logistic回归分
析治疗12周HBV pgRNA下降≥ 1 × lg拷贝/ml的影响因素。结果 黄芩苷胶囊组和对照组
患者年龄、性别、肝硬化患者比例、HBeAg阳性患者比例、基线HBV DNA载量、基线
HBV pgRNA水平等差异无统计学意义（P均＞ 0.05）。治疗4周后，黄芩苷胶囊组和对
照组患者HBV DNA下降水平差异无统计学意义 [（2.88 ± 1.21）lg IU/ml vs（2.70 ±
1.41）lg IU/ml，t = 0.551，P = 0.583]，pgRNA下降≥ 1 × lg拷贝/ml患者比例差异无统计学意
义 [28.1%（16/56）vs 8.7%（2/23）；χ2 = 3.661，P = 0.056]。黄芩苷胶囊组与对照组分
别有50例与19例患者随访至12周，两组患者HBV DNA下降水平差异均无统计学意义
[（3.86 ± 1.30）lg IU/ml vs（3.25 ± 1.58）lg IU/ml；t = 1.548，P = 0.126]，黄芩苷胶囊组
HBV pgRNA下降≥ 1 × lg拷贝/ml患者比例显著高于对照组 [54.0%（27/50）vs 26.3%（5/19），χ2
= 4.243，P = 0.039]。多因素Logistic回归分析表明基线ALT水平（OR =
1.368，95%CI：1.073～1.743，P = 0.011）和联合黄芩苷胶囊治疗（OR = 4.247，
95%CI：1.090～16.545，P = 0.037）是影响患者12周HBV pgRNA下降≥ 1 × lg拷贝/ml的独立
预测因素。结论 本研究的初步证据提示在ETV抗病毒治疗基础上联合黄芩苷胶囊可进
一步降低CHB患者HBV pgRNA水平。
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Abstract: Objective To investigate the impact of Baicalin capsule and Entecavir (ETV)
combination therapy on hepatitis B virus (HBV) pregenomic ribonucleic acid (pgRNA)
of patients with chronic hepatitis B (CHB). Methods A total of 79 patients with CHB in
Beijing Ditan Hospital, Capital Medical University, Hepatobiliary Hospital of Jilin, Infectious
Diseases Hospital of Kaifeng and the Second People’s Hospital of Lanzhou City from
January 2018 to December 2020 were enrolled for this cohort study. Patients in Baicalin
capsule group (56 cases) were treated with Baicalin capsule and ETV and patients in control
group (23 cases) were treated with ETV only. Baseline demographic characteristics (age and
gender), virtuological indexes [hepatitis B virus e antigen (HBeAg), HBV DNA and HBV
pgRNA], alanine aminotransferase (ALT), liver cirrhosis and liver stiffness measurement
(LSM) value were collected. Follow-up was performed once each at 4 weeks and 12 weeks
of treatment. The decrease of HBV DNA and pgRNA were compared between the two groups
at 4 weeks and 12 weeks of treatment. Multivariate Logistic regression was used to analyze
the influencing factors of HBV pgRNA decline ≥ 1 × lg copy/ml 12 weeks after treatment.
Results There were no significant differences in age, gender, ratio of liver cirrhosis, ratio
of HBeAg-positive patients, baseline HBV DNA load and baseline HBV pgRNA level
between patients in Baicalin capsule group and control group (all P ＞ 0.05). After 4 weeks
of treatment, there was no significant difference in HBV DNA decline levels of patients in
Baicalin capsule group and control group [(2.88 ± 1.21) lg IU/ml vs (2.70 ± 1.41) lg IU/ml; t =
0.551, P = 0.583] and there was no significant difference in the proportion of HBV pgRNA
decline ≥ 1 × lg copy/ml of patients in Baicalin capsule group and control group [28.1%
(16/56) vs 8.7% (2/23); χ2 = 3.661, P = 0.056]. There were 50 cases and 19 cases who were
followed up to 12 weeks in Baicalin capsule group and control group, respectively. There
was no significant difference in HBV DNA decline levels of patients between the two groups
[(3.86 ± 1.30) lg IU/ml vs (3.25 ± 1.58) lg IU/ml; t = 1.548, P = 0.126]. The proportion of HBV
pgRNA decreased ≥ 1 × lg copy/ml of patients in Baicalin capsule group was significantly
higher than that in control group [54.0%(27/50) vs 26.3% (5/19); χ2 = 4.243, P = 0.039].
Multivariate Logistic regression analysis showed that baseline ALT level (OR = 1.368,
95%CI: 1.073～1.743, P = 0.011) and combination therapy with Baicalin capsule (OR = 4.247,
95%CI: 1.090～16.545, P = 0.037) were independent factors affecting HBV pgRNA decline ≥
1 × lg copy/ml. Conclusions Preliminary data from this study showed that Baicalin capsule
may further help to decrease HBV pgRNA additionally in CHB patients treated with ETV.
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