Randomized,Controlled Clinical Study about Treaing HBeAg Positive Chronic Asymptomatic Hepatitis B Virus Carriers Based on ‘Kidney Deficiency Fuxie’ Theory

ZHANG Chuan-tao; HU Xiao-yu; ZHOU Dao-jie; FAN Xin-jian; WU Jiang; WANG De-li

doi:10.11653/syfj2014030175

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Randomized,Controlled Clinical Study about Treaing HBeAg Positive Chronic Asymptomatic Hepatitis B Virus Carriers Based on ‘Kidney Deficiency Fuxie’ Theory

更新时间：2024-01-04

- Randomized,Controlled Clinical Study about Treaing HBeAg Positive Chronic Asymptomatic Hepatitis B Virus Carriers Based on ‘Kidney Deficiency Fuxie’ Theory
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 20, Issue 3, Pages: 175-179(2014)
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- DOI：10.11653/syfj2014030175
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- Published：2014
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ZHANG Chuan-tao, HU Xiao-yu, ZHOU Dao-jie, et al. Randomized,Controlled Clinical Study about Treaing HBeAg Positive Chronic Asymptomatic Hepatitis B Virus Carriers Based on ‘Kidney Deficiency Fuxie’ Theory[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(3): 175-179.
DOI：

ZHANG Chuan-tao, HU Xiao-yu, ZHOU Dao-jie, et al. Randomized,Controlled Clinical Study about Treaing HBeAg Positive Chronic Asymptomatic Hepatitis B Virus Carriers Based on ‘Kidney Deficiency Fuxie’ Theory[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(3): 175-179. DOI： 10.11653/syfj2014030175.

摘要

目的：研究“肾虚伏邪”理论论治乙肝病毒e抗原（HBeAg）阳性慢性无症状乙型肝炎病毒携带者抗病毒疗效。方法：在“肾虚伏邪”理论指导下拟定中药复方温透解方。采用随机、对照方法，60例HBeAg阳性慢性无症状乙型肝炎病毒携带者随机分为治疗组35例、对照组25例，治疗组采用温补透解方治疗，对照组不给予任何药物，分别在治疗前、24，48周时采血检测肝功、乙肝病毒脱氧核糖核酸（HBVDNA）、乙肝标志物等指标，并观察血常规、尿常规、心电图等安全性指标变化。结果： 24，48周时温补透解方降低血清HBVDNA（下降≥2 log10）作用明显强于对照组（P < 0.05，P < 0.01），且具有时间依赖性（P < 0.05），但仅在48周时温补透解方对HBVDNA转阴率高于对照组（P < 0.05），未表现出时间依赖性。仅48周时治疗组HBeAg阴转率明显优于对照组，差异有统计学意义（P < 0.05）。温补透解方可以升高外周血CD4+T细胞数量、降低CD8+T细胞数量（P < 0.05），恢复T细胞亚群比例。肝功、肾功、心电图等未出现明显变化，该方具有较好安全性。结论：温补透解方临床治疗HBeAg阳性慢性无症状乙型肝炎病毒携带者有一定的抗病毒作用，且安全，中医“肾虚伏邪”理论论治HBeAg阳性慢性无症状乙型肝炎病毒携带者安全、可行，可能与升高CD4+T细胞、降低CD8+T细胞有关。

Abstract

Objective: To research the antiviral efficacy of ‘kidney deficiency Fuxie’ theory on the treatment of hepatitis B virus e antigen(HBeAg)-positive chronic asymptomatic hepatitis B virus carriers. Method: Under the theoretical guidance of ‘kidney deficiency Fuxie’

we developed the herbal compound Wenbu Toujie prescription. A randomized

control methods

60 HBeAg-positive chronic asymptomatic hepatitis B virus carriers were randomly divided into a treatment group(35) and the control group(25)

the treatment group treated with Wenbu Toujie prescription

the control group was not given any medication

treatment for 48 weeks. Before treatment

24 weeks

48 weeks of treatment

collected blood to detect liver function

hepatitis B virus deoxyribonucleic acid(HBVDNA) and HBV markers respectively

and observed the changes of the blood

urine

ECG and other safety indicators. Result: When 24 weeks and 48 weeks

Wenbu Toujie prescription significantly stronger than the control group (P < 0.05

P < 0.01) in reducing serum of HBVDNA (≥2log10 decline)

with a time-dependent manner (P < 0.05). Only when 48 weeks Wenbu Toujie prescription stronger than the control group (P < 0.05) in the HBVDNA seroconversion rate

without a time-dependent manner (P < 0.05). Only when 48 weeks

HBeAg seroconversion rate was significantly better than the control group

the difference was statistically significant (P < 0.05)

Wenbu Toujie prescription elevated peripheral blood CD4+T cell count

lowered CD8+T cell count (P < 0.05)

thereby restoring the proportion of T cell subsets. No significant changes in liver function

renal function

electrocardiogram

suggesting that the party has a good security. Conclusion: Wenbu Toujie prescription has antiviral activity in clinical treatment in HBeAg-positive chronic asymptomatic hepatitis B virus carriers

and safe

prompting the TCM ‘kidney deficiency Fuxie’ theory is feasible and safe on the treatment of HBeAg-positive chronic asymptomatic hepatitis B virus carriers

may be related to elevating CD4+T cells

reducing CD8+T cells.

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