补肾生髓成肝方加减联合聚乙二醇干扰素α-2b治疗慢性乙型肝炎的效果及对患者肝功能及肝纤维化的影响

Clinical efficacy of modified Bushen Shengsui Chenggan Preparation combined with pegylated interferonα-2b in the treatment of chronic hepatitis B and its influence on liver function and liver fibrosis

目的观察补肾生髓成肝方加减联合聚乙二醇干扰素α-2b治疗慢性乙型肝炎(CHB)的效果及对患者肝功能、肝纤维化的影响。方法采用随机数字表法将2017年9月至2019年12月湖北省中医院收治的70例CHB患者分为观察组(35例)和对照组(35例)。对照组予以聚乙二醇干扰素α-2b治疗,观察组予以补肾生髓成肝方加减联合聚乙二醇干扰素α-2b治疗,比较两组中医症候评分,治疗前后肝功能指标[血清总胆红素(TBil)、丙氨酸氨基转移酶(ALT)、天门冬酸氨基转移酶(AST)、血清白蛋白(ALB)],肝纤维化指标[Ⅲ型前胶原(PCⅢ)、Ⅳ型胶原(Ⅳ-C)、层粘连蛋白(LN)、透明质酸酶(HA)],乙肝病毒标志物[ALT复常率、乙型肝炎病毒(HBV)-DNA转阴率及乙型肝炎e抗原(HBeAg)阴转率]及不良反应发生情况。结果治疗前两组中医症候评分比较,差异无统计学意义(P>0.05);治疗后两组中医症候评分较治疗前降低,且观察组低于对照组(P<0.05)。治疗前两组肝功能指标(TBil、ALT、AST、ALB)比较,差异无统计学意义(P>0.05);治疗后两组ALB水平较治疗前升高,TBil、ALT、AST水平降低,且观察组ALB水平高于对照组,TBil、ALT、AST水平低于对照组(P<0.05)。治疗前两组肝纤维化指标(PCⅢ、Ⅳ-C、LN、HA)比较,差异无统计学意义(P>0.05);治疗后两组PCⅢ、Ⅳ-C、LN、HA水平较治疗前降低,且观察组低于对照组(P<0.05)。随访6个月,观察组HBeAg阴转率高于对照组(P<0.05);两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论补肾生髓成肝方加减联合聚乙二醇干扰素α-2b治疗CHB有助于改善患者肝功能和肝纤维化,效果显著,安全性好,值得在临床上推广应用。

Objective To explore the clinical efficacy of modified Bushen Shengsui Chenggan Preparation combined with pegylated interferonα-2b in the treatment of chronic hepatitis B(CHB)and its influence on liver function and liver fibrosis.Methods A total of 70 CHB patients in Hubei Hospital of Traditional Chinese Medicine from September 2017 to December 2019 were divided into the observation group(35 cases)and the control group(35 cases)by random number table method,the control group was treated with pegylated interferonα-2b,and the observation group was treated with modified Bushen Shengsui Chenggan Preparation combined with pegylated interferonα-2b,the traditional Chinese medicine symptom score,liver function index(serum total bilirubin[TBil],alanine aminotransferase[ALT],asparagine aminotransferase[AST],serum albumin[ALB]),liver fibrosis index(typeⅢprocollagen[PCⅢ],collagen typeⅣ[Ⅳ-C],layer mucins[LN],hyaluronidase[HA]),HBV markers(ALT normalization rate,hepatitis B virus[HBV]-DNA negative conversion rate and Hepatitis B E antigen[HbeAg]negative conversion rate)before and after treatment and adverse reactions were compared between the two groups.Results Before treatment,there were no significant differences in traditional Chinese medicine symptom scores between the two groups(P>0.05);after treatment,traditional Chinese medicine symptom scores of the two groups were lower than before treatment,and the observation group was lower than the control group(P<0.05).Before treatment,there were no significant differences in liver function indexes(TBil,ALT,AST,ALB)between two groups(P>0.05);after treatment,the ALB levels of the two groups were higher than those before treatment,while the TBil,ALT,AST levels were lower than before treatment,and the ALB levels of the observation group were higher than the control group,while the TBil,ALT,and AST levels were lower than the control group(P<0.05).Before treatment,there was no significant difference in liver fibrosis indexes(PCⅢ,Ⅳ-C,LN,and HA)between the two groups(P>0.05).After treatment,the levels of PCⅢ,Ⅳ-C,LN,and HA in the two groups were lower than those before treatment,and the observation group was lower than the control group(P<0.05).After six month follow-up,the HBeAg negative conversion rate of the observation group was significantly higher than those of the control group(P<0.05).There was no significant difference in the incidence of adverse reactions between two groups(P>0.05).Conclusion Modified Bushen Shengsui Chenggan Preparation combined with pegylated interferon α-2b in the treatment of CHB is helpful to improve liver function and liver fibrosis.It has significant curative effect and good safety,and is worthy of clinical application.