恩替卡韦联合软肝散结方治疗慢性乙型肝炎患者临床疗效研究*

doi:10.3969/j.issn.1672-5069.2026.02.005

摘要/Abstract

摘要： 目的观察恩替卡韦(ETV)联合软肝散结方治疗慢性乙型肝炎(CHB)患者的临床疗效。方法 2022年7月~2024年7月我院诊治的124例CHB患者,中医证型均为肝郁脾虚型,被分为A组(n=62)和B组(n=62),分别给予ETV或ETV联合软肝散结方治疗观察48周。根据胁下痞块、腹胀、纳减乏力和面色灰暗等表现进行中医证型评分,采用ELISA法检测血清透明质酸(HA)、层粘连蛋白(LN)、Ⅳ型胶原(Ⅳ-C)和Ⅲ 型前胶原(PCⅢ)水平,使用流式细胞仪检测外周血T淋巴细胞亚群。结果在治疗48周末,B组胁下痞块、腹胀、纳减乏力和面色灰暗中医证候积分分别为(1.4±0.8)分、(2.4±0.9)分、(2.1±0.9)分和(1.8±0.6)分,均显著低于A组[分别为(2.7±1.2)分、(3.1±1.6)分、(2.9±1.1)分和(2.6±1.3)分,P＜0.05];B组血清ALT和AST水平均显著低于A组(P＜0.05);B组血清HA、LN、Ⅳ-C和PCⅢ水平分别为(62.9±15.2)μg/mL、(94.1±18.8)ng/mL、(78.6±12.7)ng/mL和(99.7±18.1)ng/mL,均显著低于A组[分别为(85.7±17.9)μg /mL、(132.9±21.7)ng/mL、(112.9±18.2)ng/mL和(159.8±26.9)ng/mL,P＜0.05];B组外周血CD3⁺、CD4⁺和CD4⁺/CD8⁺细胞比值分别为(68.1±5.3)%、(37.6±4.1)%和(1.3±0.4),均显著高于A组[分别为(61.9±4.9)%、(32.4±3.8)%和(1.0±0.3),P＜0.05];两组血清HBV DNA阴转率分别为96.8%和95.2%,无显著性差异(P>0.05)。结论应用ETV联合软肝散结方治疗CHB患者可改善中医症状,或有抗肝纤维化和促进T淋巴细胞功能作用。

关键词: 慢性乙型肝炎, 恩替卡韦, 软肝散结方, 肝纤维化, T淋巴细胞, 治疗

Abstract: Objective The aim of this study was to investigate entecavir (ETV) in combination with Ruangan Sanjie prescription, a herbal medicine formula, in the treatment of patient with chronic hepatitis B (CHB). Methods A total of 124 patients with CHB were enrolled in this study between July 2022 and July 2024, and the recruited patients belonged to CTM liver-depression/spleen deficiency syndrome, and were randomly assigned to receive ETV in 62 cases in group A, or receive ETV and the herbal medicine combination in another 62 cases in group B for 48 weeks. The scores of main TCM syndromes, such as lateral thorax lumps, abdominal distension, fatigue due to anorexia and pale complexion were evaluated. Serum hyaluronic acid (HA), laminin (LN), IV collagen (IV-C) and III procollagen (PCIII) levels were detected by ELISA, and peripheral blood T lymphocyte subsets were determined by FCM. Results By end of 48-week of treatment, TCM lateral thorax lumps, abdominal distension, fatigue due to anorexia and pale complexion scores in group B were(1.4±0.8)points, (2.4±0.9)points, (2.1±0.9)points and (1.8±0.6)points, all much lower than [(2.7±1.2)points,(3.1±1.6)points,(2.9±1.1)points and (2.6±1.3)points, respectively P＜0.05] in group A;serum ALT and AST levels were much lower than in group A(P＜0.05); serum HA, LN, Ⅳ-C and PCⅢ levels were (62.9±15.2)μg/mL, (94.1±18.8)ng/mL, (78.6±12.7)ng/mL and (99.7±18.1)ng/mL, all significantly lower than [(85.7±17.9)μg /mL, (132.9±21.7)ng/mL, (112.9±18.2)ng/mL and (159.8±26.9)ng/mL,respectively, P＜0.05] in group A;percentages of peripheral blood CD3⁺ and CD4⁺ cells, and CD4⁺/CD8⁺ cell ratio were (68.1±5.3)%, (37.6±4.1)% and (1.3±0.4), all much higher than [(61.9±4.9)%, (32.4±3.8)% and (1.0±0.3),respectively P＜0.05] in group A;serum HBV DNA negative rates in the two groups were 96.8% to 95.2%,not significantly different (P>0.05). Conclusion Combination of ETV and herbal medicine, Ruangan Sanjie Prescription , in the treatment of patients with CHB could improve TCM syndromes, and even ameliorate liver fibrosis, which might be related to modulation of body immune system.

Key words: Hepatitis B, Liver fibrosis, Entecavir, Ruangan Sanjie prescription, herbal medicine, T lymphocyte subsets, Therapy

何红梅, 沙志虎, 邵建国, 徐姝嫣. 恩替卡韦联合软肝散结方治疗慢性乙型肝炎患者临床疗效研究^*[J]. 实用肝脏病杂志, 2026, 29(2): 179-182.

He Hongmei, Sha Zhihu, Shao Jianguo, et al. Clinical observation of entecavir in combination with Ruangan Sanjie prescription in the treatment of patient with chronic hepatitis B[J]. Journal of Practical Hepatology, 2026, 29(2): 179-182.

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恩替卡韦联合软肝散结方治疗慢性乙型肝炎患者临床疗效研究^*

Clinical observation of entecavir in combination with Ruangan Sanjie prescription in the treatment of patient with chronic hepatitis B

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