健脾柔肝方联合恩替卡韦治疗慢性乙型病毒性肝炎肝纤维化的临床研究

Clinical study on Jianpi Rougan Recipe combined with entecavir in the treatment of chronic hepatitis B with hepatic fibrosis

目的:观察健脾柔肝方联合恩替卡韦治疗慢性乙型病毒性肝炎(CHB)肝纤维化的临床疗效。方法:将符合纳入标准的92例CHB患者随机分为治疗组46例和对照组46例。治疗组采用健脾柔肝方联合恩替卡韦治疗,对照组采用恩替卡韦治疗,治疗周期均为6个月。分别于治疗前及治疗3个月、6个月时,评价并比较两组患者的中医症状评分,检测患者的乙型肝炎病毒(HBV)表面抗原(HBsAg)、HBV DNA、肝脏硬度测量值(LSM)及CD4、CD8 T淋巴细胞水平,比较两组患者的CD4/CD8比值。结果:研究最终对89例患者的数据进行统计分析,包括治疗组44例、对照组45例。治疗3个月、6个月时,两组患者的各主要临床症状评分较治疗前均降低(P<0.05),且治疗组患者的评分低于对照组(P<0.05);两组患者的中医症状总积分较治疗前均明显降低(P<0.05),且治疗组患者的总积分低于对照组(P<0.05)。治疗6个月时,治疗组患者的HBsAg水平较治疗前降低(P<0.05);治疗3个月、6个月时,两组患者的HBV DNA水平较治疗前均明显降低(P<0.05)。治疗3个月、6个月时,两组患者的LSM较治疗前均降低(P<0.05);治疗6个月时,治疗组患者的LSM低于对照组(P<0.05)。治疗3个月、6个月时,治疗组患者的CD4 T淋巴细胞水平及CD4/CD8比值较治疗前均明显升高(P<0.05),CD8 T淋巴细胞水平较治疗前明显降低(P<0.05);对照组患者的CD8 T淋巴细胞水平较治疗前亦明显降低(P<0.05),CD4/CD8比值较治疗前明显升高(P<0.05);且治疗组患者的CD4 T淋巴细胞水平及CD4/CD8比值明显高于对照组(P<0.05)。治疗6个月时,治疗组患者的CD8 T淋巴细胞水平亦明显低于对照组(P<0.05)。结论:健脾柔肝方联合恩替卡韦治疗CHB,可明显改善患者的临床症状,调节免疫功能,延缓肝纤维化的进展。

Objective:To observe the clinical efficacy of Jianpi Rougan Recipe combined with entecavir in the treatment of chronic hepatitis B(CHB) with hepatic fibrosis. Methods:A total of 92 patients with CHB who met the inclusion criteria were randomly divided into the treatment group(46 cases) and the control group(46 cases). The patients in the treatment group were treated with Jianpi Rougan Recipe combined with entecavir, and the patients in the control group were treated with entecavir alone. The treatment course was 6 months. Before treatment, and after treatment for 3 and 6 months, the Chinese medical symptom scores were evaluated and compared in both groups, the levels of hepatitis B virus(HBV) surface antigen(HBsAg), HBV DNA, the liver stiffness measurement(LSM) value and the CD4,CD8 T lymphocytes were detected,and the CD4/CD8 ratio was compared between the two groups. Results: The data of 89 patients,including 44 cases in the treatment group and 45 cases in the control group,were finally analyzed in this study. After treatment for 3 and 6 months,the scores of main clinical symptoms in both groups were decreased compared with treatment before( P<0.05),and the scores of the treatment group were lower than those of the control group( P<0.05);the total scores of Chinese medical symptoms in both groups were significantly decreased compared with treatment before( P<0.05),and the total score of the treatment group was lower than that of the control group( P<0.05). After treatment for 6 months,the level of HBsAg in the treatment group was decreased compared with treatment before( P<0.05). After treatment for 3 and 6 months,the level of HBV DNA in both groups was significantly decreased compared with treatment before( P<0.05). After treatment for 3 and 6 months,the level of LSM in both groups was decreased compared with treatment before( P<0.05);after treatment for 6 months,the level of LSM in the treatment group was lower than that in the control group( P<0.05). After treatment for 3 and 6 months,the level of CD4 T lymphocytes and the CD4/CD8 ratio in the treatment group were significantly increased compared with treatment before( P<0.05),and the level of CD8 T lymphocytes was significantly decreased compared with treatment before( P<0.05);the level of CD8 T lymphocytes in the control group was also significantly decreased compared with treatment before( P<0.05),and the CD4/CD8 ratio was significantly increased compared with treatment before( P<0.05);and the level of CD4 T lymphocytes and the CD4/CD8 ratio in the treatment group were significantly higher than those in the control group( P<0.05). After treatment for 6 months,the level of CD8 T lymphocytes in the treatment group was also significantly lower than that in the control group( P<0.05). Conclusion: Jianpi Rougan Recipe combined with entecavir can obviously improve the clinical symptoms,regulate the immune function,and delay the progression of hepatic fibrosis in the treatment of CHB.