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作 者:邱华[1] 毛德文[1] 胡振斌[1] 龙富立[1] 王明刚[1] 张荣臻[1] 黄鹏 QIU Hua;MAO De-wen;HU Zhen-bin(Department of Hepatology, The First Affiliated Hospital of Guangxi University of Chinese Medicine(Nanning Guangxi,530023)China)
机构地区:[1]广西中医药大学第一附属医院肝病科,广西南宁530023
出 处:《中西医结合肝病杂志》2019年第2期121-123,139,共4页Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases
基 金:国家自然科学基金项目(No.81660827;81860889);广西科技厅重点研发计划(No.2017AB45166)
摘 要:目的:评价白花香莲解毒颗粒治疗HBeAg阳性慢性乙型肝炎病毒(HBV)免疫耐受期患者的临床疗效及安全性。方法:采用随机、安慰剂对照的临床研究方法,将160例HBeAg阳性慢性HBV免疫耐受期感染受试者随机分为治疗组(80例),对照组(80例),治疗组患者采用白花香莲解毒颗粒,对照组患者口服安慰剂,疗程为48周。检验及记录两组受试者在0、12、24、48wk时的血清HBV DNA、乙肝两对半定量、肝功能、肝脏硬度值、症状积分及不良事件。结果:治疗组患者血清HBV DNA水平从治疗24wk开始显著降低,与对照组比较,差异有显著性意义(P<0.05)。治疗48wk时治疗组患者HBV DNA阴转率为13.75%,对照组为1.25%,差异具有显著性意义(P<0.05)。治疗组患者HBeAg滴度、症状积分随着治疗时间的延长逐渐下降,显著优于对照组(P<0.05)。治疗48wk时,治疗组患者肝脏硬度值较0wk时显著下降,差异具有统计学意义(P<0.05);较对照组治疗40wk时也下降显著P<0.05。结论:白花香莲解毒颗粒能显著改善慢性HBV感染者免疫耐受期的不适症状,抑制HBV DNA复制及HBeAg分泌,并降低肝纤维化的评分,安全性良好。Objective:To evaluate the antiviral therapeutic effects and safety of Baihua xianglian detoxification granule to the immunotolerant phase in Chronic HBV Infection with HBeAg positive.Methods:With the randomized and placebo-controlled methods,160 cases of the immunotolerant phase in Chronic HBV Infection with HBeAg positive were double-blinded randomized into 2 groups,with 80 cases in treated group and 80 cases in controlled group.During the 48-week treatments,Baihua xianglian detoxification granule was applied in treated group and placebo prescription was adopted in controlled group.The serum HBV DNA,Hepatitis B Virus Markers,liver function,liver stiffness measurement,symptom score and adverse events were examined and recorded at 0,12,24 and 48 weeks.Results:The serum HBV DNA level in the treatment group was significantly lower than that in the control group from 24 wk, the difference was statistically significant compared with the control group(P<0.05).After 48 wk treatment,the negative conversion rate of HBV DNA in the treatment group was 13.75% and that in the control group was 1.25%,the difference was statistically significant(P<0.05).HBeAg titer and symptom score of treatment group decreased gradually with the prolongation of treatment time,which was significantly better than that of control group(P<0.05).After 48 wk treatment,liver stiffness measurement of treatment group decreased significantly compared with 0 wk and control group,and the difference was statistically significant(P<0.05).There was no case of serious adverse effects during the treatments.Conclusion:The Baihua xianglian detoxification granule can significantly improve the uncomfortable symptoms of chronic HBV infection during immune tolerance period,inhibit HBV DNA replication and HBeAg secretion,and reduce the score of liver fibrosis,with good safety.
关 键 词:乙型肝炎病毒 E抗原阳性 免疫耐受期 白花香莲解毒颗粒
分 类 号:R259[医药卫生—中西医结合]
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