Randomized Controlled Trial on Compound Huanglu Oral Liquid in Treatment of Chronic Hepatitis B with Syndrome of Damp-Heat Stagnation

LIU Fen; ZHANG Da-kun; SU Feng

doi:10.13422/j.cnki.syfjx.2017030175

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Randomized Controlled Trial on Compound Huanglu Oral Liquid in Treatment of Chronic Hepatitis B with Syndrome of Damp-Heat Stagnation

更新时间：2024-01-04

- Randomized Controlled Trial on Compound Huanglu Oral Liquid in Treatment of Chronic Hepatitis B with Syndrome of Damp-Heat Stagnation
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 23, Issue 3, Pages: 175-180(2017)
- 作者机构：
- 作者简介：
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- DOI：10.13422/j.cnki.syfjx.2017030175
  CLC： R259
- Published：2017
- 稿件说明：
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LIU Fen, ZHANG Da-kun, SU Feng. Randomized Controlled Trial on Compound Huanglu Oral Liquid in Treatment of Chronic Hepatitis B with Syndrome of Damp-Heat Stagnation[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(3): 175-180.
DOI：

LIU Fen, ZHANG Da-kun, SU Feng. Randomized Controlled Trial on Compound Huanglu Oral Liquid in Treatment of Chronic Hepatitis B with Syndrome of Damp-Heat Stagnation[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(3): 175-180. DOI： 10.13422/j.cnki.syfjx.2017030175.

摘要

目的：探讨复方黄栌口服液治疗慢性乙型肝炎（CHB）湿热蕴结证的临床疗效及对血清干扰素-γ（IFN-γ），白细胞介素-10（IL-10），IL-21和IL-22水平的影响。方法：将146例CHB患者采用随机按数字表法分为对照组72例和观察组74例。对照组口服恩替卡韦片，0.5 mg/次，1次/d；观察组在对照组治疗的基础上，加服复方黄栌口服液，20 mg/次，3次/d。两组疗程均为48周。于治疗前、治疗后24周和48周检测乙型肝炎E抗原（HBeAg）和乙肝病毒基因（HBV-DNA）；每3个月检测1次谷丙氨酸氨基转移酶（ALT），天门冬氨酸氨基转移酶（AST）和血清总胆红素（TBIL）；进行治疗前后湿热蕴结证评分；检测治疗前后血清IFN-γ，IL-10，IL-21和IL-22水平。结果：治疗48周后观察组的应答率为89.19%，对照组为73.61%，观察组高于对照组（χ2=5.875，P<0.05）；治疗48周后观察组中医证候疗效总有效率为86.49%，对照组为58.33%，观察组高于对照组（χ2=14.541，P<0.01）；观察组HBeAg阴转率为41.89%高于对照组复常率的26.39%（χ2=3.895，P<0.05），HBV-DNA阴转率为82.43%，高于对照组的68.06%（χ2=4.06，P<0.05）；治疗后观察组AST，ALT和TBIL水平低于对照组（P<0.01）；治疗后观察组ALT复常率为86.49%，高于对照组的72.22%（χ2=4.548，P<0.05），AST复常率为89.19%，高于对照组的75%（χ2=5.019，P<0.05）；治疗后观察组血清IFN-γ和IL-21水平均高于对照组，IL-10和IL-22水平均低于对照组（P<0.01）。结论：复方黄栌口服液联合恩替卡韦片治疗CHB，能提高生化学、病毒学和血清学应答，改善中医临床症状，并能调节患者免疫功能，提高机体清除病毒的能力，值得临床使用。

Abstract

Objective: To discuss the clinical efficacy of compound Huanglu oral liquid in treating chronic hepatitis B(CHB) syndrome of damp-heat stagnation and investigate its effects on levels of interferon-γ (IFN-γ)

interleukin-10 (IL-10)

IL-21 and IL-22. Method: One hundred and forty-six CHB patients were randomly divided into control group (72 cases) and observation group (74 cases) by random number table. Patients in control group took entecavir tablets

0.5 mg/time

1 time/day. Based on the treatment in control group

the patients in observation group added compound Huanglu oral liquid

20 mg/time

3 time/day. The treatment course was 48 weeks in both groups. Before treatment

and at the 24th week and 48th week

the levels of Hepatitis B e antigen (HBeAg) and human hbv gene (HBV-DNA) were detected. For every 3 months

the levels of glutamic-pyruvic transaminase (ALT)

glutamic-oxalacetic transaminease (AST) and serum total bilirubin (TBIL) were detected. Scores of syndrome of damp-heat stagnation were graded before and after treatment. Levels of IFN-γ

IL-10

IL-21 and IL-22 were detected before and after treatment. Result: Response rate was 89.19% in observation group

higher than 73.61% in control group at the 48th week after treatment (χ2=5.875

P<0.05). The total effective rate for traditional Chinese medicine(TCM)symptoms was 86.49% in observation group

higher than 58.33% in control group (χ2=14.541

P<0.01). Negative rate of HBeAg was 41.89% in observation group

higher than 26.39% in control group (χ2=3.895

P<0.01). Negative rate of HBV-DNA was 82.43% in observation group

higher than 68.06% in control group (χ2=4.06

P<0.05). After treatment

the levels of AST

ALT and TBIL in observation group were lower than those in control group (P<0.01). Complex constant effect of ALT was 86.49% in observation group

higher than 72.22% in control group after treatment (χ2=4.548

P<0.05). The complex constant effect of AST was 89.19% in observation group

higher than 75% in control group (χ2=5.019

P<0.05). Levels of IFN-γ and IL-21 in observation group were higher than those in control group

levels of IL-10 and IL-22 were lower than those in control group (P<0.01). Conclusion: compound Huanglu oral liquid combined with entecavir tablets can increase biochemistry

viral and serological response

ameliorate TCM symptoms

regulate immune function and improve the body's virus removal ability in the treatment of CHB

so it is worthy to be used in clinical.

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