补肾健脾方联合恩替卡韦治疗HBeAg阳性慢性乙型肝炎患者的临床研究  

The clinical research of Bushenjianpi formulae combined entecavir in treating hepatitis HBeAg positive chronic hepatitis B

作　　者：周振华[1] 孙学华[1] 朱晓骏[1] 高亚婷[1] 高月求[1] ZHOU Zhen-hua;SUN Xue-hua;ZHU Xiao-jun;GAO Yue-qiu(Hepatic department of Shuguang hospital affiliated to Shanghai University of traditional Chinese medicine(Shanghai,201203),China)

机构地区：[1]上海中医药大学附属曙光医院肝病科,上海201203

出　　处：《中西医结合肝病杂志》2021年第7期590-592,共3页Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases

基　　金：国家自然科学基金(No.81774268);“十三五”国家科技重大专项(No.2018ZX10725-504);上海市“科技创新行动计划”临床医学领域项目(No.19401972500);上海市卫生行业临床研究专项计划(No.201840012)。

摘　　要：目的:探讨补肾健脾方联合恩替卡韦治疗HBeAg阳性慢性乙型肝炎(ALT 1~2×ULN)患者的临床疗效。方法:采用随机双盲、安慰剂对照的临床试验方法,将符合入组标准的256例HBeAg阳性慢性乙型肝炎(ALT 1~2×ULN)患者随机分为试验组及对照组。在恩替卡韦抗病毒治疗的基础上,试验组患者予以补肾健脾方治疗,对照组患者予以安慰剂治疗,疗程为12个月,随访12个月。治疗前后,观察两组患者HBV DNA水平、HBeAg水平和阴转率、HBsAg水平、肝脏病理的变化。结果:治疗后,两组患者HBV DNA、HBeAg和HBsAg水平均较治疗前明显降低(P<0.01或P<0.05)。试验组患者的HBeAg阴转率明显高于对照组(P<0.05)。两组患者肝脏炎症分级和纤维化分期均较治疗前改善,但治疗后两组患者肝脏病理改善率比较差异无统计学意义(P>0.05)。结论:补肾健脾方联合恩替卡韦治疗慢性乙型肝炎可提高HBeAg阴转率,在一定程度上可改善肝脏炎症及纤维化。Objective:To observe the clinical effects of bushenjianpi formulae combined entecavir in treating hepatitis B e antigen(HBeAg)positive chronic hepatitis B(ALT 1~2×ULN).Methods:A randomized,double-blind and placebo-controlled trial was carried out.256 patients with HBeAg positive chronic hepatitis B were divided into treatment group and control group.The treatment group was treated with bushenjianpi formulae and the control group was treated with herb placebo,based on those two groups were treated with entecavir.The treatment course was 12 months and follow-up the course was 12 months too.The levels of hepatitis B virus DNA(HBV DNA),HBeAg,hepatitis B surface antigen(HBsAg),the rate of HBeAg negative conversion,and the change of liver pathological were observed before and after the treatment.Results:The levels of HBV DNA,HBeAg,HBsAg were decreased in two groups after treatment(P<0.01 or P<0.05),and the rate of HBeAg negative conversion was significantly improved in the treatment group(P<0.05).The liver pathological was ameliorated in both groups after 12 months of treatment,but the difference of liver pathological improvement was not statistically significant between the two groups(P>0.05).Conclusion:The treatment of bushenjianpi formulae combined entecavir could improve the rate of HBeAg negative conversion,and ameliorate the liver tissue inflammation and fibrosis after treatment.

关 键 词：慢性乙型肝炎 补肾健脾方 恩替卡韦 

分 类 号：R575.1[医药卫生—消化系统]