Objective: To investigate the clinical efficacy of entecavir combined with Biejiajian pills and its influence on TCM syndrome scores during the treatment of chronic hepatitis B with hepatic fibrosis and blood stasis syndrome by prospective, randomized and controlled study. Methods: Patients with chronic hepatitis B with hepatic fibrosis and blood stasis syndrome were selected as the research subjects and randomly divided into a treatment group and a control group. Entecavir plus Biejiajian pills or entecavir plus a simulant of Biejiajian pills were given for 48 weeks. The changes in liver stiffness measurement (LSM) and TCM syndrome scores before and after treatment were compared between the two groups to analyze the correlation. The data between groups were analyzed by t-test/Wilcoxon rank sum test or χ(2) test. Pearson correlation coefficient was used to analyze the correlation between TCM syndrome scores and LSM values. Results: After 48 weeks of treatment, the LSM values of the two groups were significantly lower than those of the baseline (P < 0.001), liver fibrosis was significantly improved, and the LSM values of the treatment group were lower than those of the control group [(8.67 ± 4.60) kPa and (10.13 ± 4.43) kPa, t = -2.011, P = 0.049]. After 48 weeks of treatment, the TCM syndrome scores of the two groups were significantly reduced compared with the baseline (P < 0.001), and the clinical symptoms were significantly relieved, and the total effective rates of the improvement of the TCM syndrome scores in the two groups were 74.19% and 72.97%, respectively, but the differences between the groups were not statistically significant (χ(2) = 0.013, P = 0.910). Correlation analysis showed that there was no obvious trend between TCM syndrome scores and LSM values. There were no serious adverse reactions associated with the drug during the observation period of this study. Conclusion: Based on antiviral treatment with entecavir, regardless of whether it is combined with the Biejiajian pill, it can effectively reduce the LSM value, improve liver fibrosis, reduce TCM syndrome scores, and alleviate symptoms in patients with chronic hepatitis B with liver fibrosis and blood stasis syndrome. Compared with entecavir alone, the combined Biejia pill has greater efficacy in improving liver fibrosis and a favorable safety profile, meriting its implementation and widespread application.
目的： 采用前瞻性、随机、对照研究，探讨恩替卡韦联合鳖甲煎丸治疗慢性乙型肝炎肝纤维化瘀血内阻证患者的临床疗效及其对中医证候积分的影响。 方法： 选择慢性乙型肝炎肝纤维化瘀血内阻证患者为研究对象，随机分为治疗组与对照组，分别接受恩替卡韦加鳖甲煎丸或恩替卡韦加鳖甲煎丸模拟剂治疗48周。比较两组患者治疗前后肝组织硬度检测（LSM）值及中医证候积分的变化，分析两者之间的相关性。对组间数据采用t检验/Wilcoxon秩和检验或χ(2)检验进行分析，采用Pearson相关性系数分析中医证候积分和LSM值之间的相关性。 结果： 两组患者治疗48周后LSM值较基线均显著降低（P < 0.001），肝纤维化明显改善，且治疗组LSM值低于对照组[（8.67±4.60）kPa与（10.13±4.43）kPa，t = -2.011，P = 0.049]。两组患者治疗48周后中医证候积分较基线均显著降低（P < 0.001），临床症状明显缓解；两组中医证候积分改善总有效率分别达74.19%、72.97%，但组间比较差异无统计学意义（χ(2) = 0.013，P = 0.910）。相关性分析显示中医证候积分与LSM值之间无明显的相关趋势；本研究观察期内未发生与研究药物相关的严重不良反应。 结论： 在恩替卡韦抗病毒治疗的基础上不管是否联合鳖甲煎丸均能有效降低慢性乙型肝炎肝纤维化瘀血内阻证患者的LSM值，改善肝纤维化，降低中医证候积分，缓解症状。联合鳖甲煎丸较单用恩替卡韦在改善肝纤维化方面更具有优势，且安全性良好，值得推广应用。.
Keywords: Bijiajian pill; Chronic hepatitis B; Entecavir; Fibrosis; TCM syndrome; Yu blood resistance syndrome.