摘要
目的观察扶正化瘀胶囊联合核苷(酸)类似物(NAs)治疗NAs单药治疗后获得完全病毒学应答,但肝纤维化指标仍改善不佳的代偿期乙肝肝硬化患者的1年疗效。方法将已接受NAs初始治疗至少2年,获得完全病毒学应答6个月以上,但肝纤维化指标仍改善不佳的代偿期乙肝肝硬化患者100例随机分为试验组和对照组,每组50例。试验组给予NAs治疗,同时联合扶正化瘀胶囊治疗,对照组则继续单用NAs治疗,疗程均为48周。观察治疗前后肝功能、HBV-DNA定量、透明质酸(HA)、Ⅲ型前胶原(PCⅢ)、Ⅳ型胶原(ⅣC)、层黏蛋白(LN)、肝脾B超的变化,部分患者行肝穿检查。结果基线时两组以上观察指标差异均无统计学意义(P>0.05),两组治疗24周时各项观察指标比较差异无统计学意义(P>0.05)。治疗48周时,两组肝功能、HBV-DNA定量结果均无明显差异(P>0.05),试验组HA、PCⅢ、ⅣC、LN、门静脉内径和脾厚度均较治疗前明显下降(P<0.05),且各项观察指标均优于对照组(P<0.05)。试验组22例患者治疗前及治疗后48周接受肝脏穿刺活检,其中63.6%肝纤维化分期有改善,对照组21例接受肝穿刺活检,14.3%有改善,两组比较差异有统计学意义(P<0.05)。结论 NAs抗病毒治疗后,HBV即使获得完全病毒学应答,仍然有部分代偿期乙肝肝硬化患者肝纤维化无法改善,在此基础上,联合扶正化瘀胶囊,可以使肝纤维化指标得到明显的改善。
Objective To investigate the one year efficacy of Fuzhenghuayu（FZHY） Capsules combined with nucleos（t）ide analogues（NAs） in patients with hepatitis B cirrhosis compensatory phase. Methods One hundred patients with HBV related liver cirrhosis who had received NAs for more than 2 years and achieved sustained virological response（SVR） but with abnormal serum markers of liver fibrosis were randomly divided into two groups ： NAs plus FZHY capsule and NAs only for 48 weeks. Liver function, HBV-DNA level, serum fibrosis markers [hyaluronic acid（HA）, amino terminal propeptide of type Ⅲ procollagen（PCⅢ）, Ⅳ collagen（Ⅳ C） and laminin（LN）] and B ultrasonic wave were observed before（baseline） and after treatment.43 patients were accepted liver biopsy. Results There was no significant differences of baseline indexes between two groups（P〉0.05）. After 24 weeks′ treatment, all the indexes was not significantly different between two groups（P〉0.05）. After 48 weeks′ treatment, liver function and HBV-DNA level were not significantly different between two groups（P 〉0.05）. The levels of all of the serum fibrosis markers（HA, PCⅢ, Ⅳ C and LN）, portal vein inner diameter and spleen thickness of the experimental group were significantly lower than those of the control group and the baseline（ P〈 0. 05）. 22 cases in the experimental group accepted liver biopsy before and after 48 weeks′ treatment, and 63.6% showed improvement in liver fibrosis stages. 21 cases in the control group accepted liver biopsy before and after 48 weeks′ treatment, and only 14.3% showed improvement in liver fibrosis stages. There was significantly difference between two groups（P〈0.05）. Conclusion For patients with HBV related liver cirrhosis who achieve SVR by antiviral treatment with NAs,but unsatisfactory improvement in liver fibrosis indexes; combining FZHY capsule with continuous NAs therapy should be an effective treatment.
出处
《热带医学杂志》
CAS
2016年第7期859-862,F0004,共5页
Journal of Tropical Medicine
基金
江门市科技局项目(江科(2015)73号-11)
