软肝化纤汤联合恩替卡韦治疗肝郁脾虚并瘀血阻络型慢性乙型肝炎肝纤维化患者临床疗效和生活质量观察

曾健; 张玲; 李军; 张星荣; 李祥永

doi:10.13422/j.cnki.syfjx.2017110177

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软肝化纤汤联合恩替卡韦治疗肝郁脾虚并瘀血阻络型慢性乙型肝炎肝纤维化患者临床疗效和生活质量观察

临床 | 更新时间：2024-01-04

- 软肝化纤汤联合恩替卡韦治疗肝郁脾虚并瘀血阻络型慢性乙型肝炎肝纤维化患者临床疗效和生活质量观察
- Curative Effect and Quality of Life of Chronic Hepatitis B Patients with Liver Fibrosis with Syndromes of Liver Depression, Spleen Deficiency and Blood Stasis Obstruction Treated with Ruangan Huaxian Decoction Combined with Entecavir
- 中国实验方剂学杂志 2017年23卷第11期页码：177-183
- 作者机构：
- 作者简介：
- 基金信息：
  
  江苏省中医药局科研项目（PY201509）
- DOI：10.13422/j.cnki.syfjx.2017110177
  中图分类号： R512.62;R575.2
- 纸质出版日期：2017
- 稿件说明：
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曾健, 张玲, 李军, 等. 软肝化纤汤联合恩替卡韦治疗肝郁脾虚并瘀血阻络型慢性乙型肝炎肝纤维化患者临床疗效和生活质量观察[J]. 中国实验方剂学杂志, 2017,23(11):177-183.

ZENG Jian, ZHANG Ling, LI Jun, et al. Curative Effect and Quality of Life of Chronic Hepatitis B Patients with Liver Fibrosis with Syndromes of Liver Depression, Spleen Deficiency and Blood Stasis Obstruction Treated with Ruangan Huaxian Decoction Combined with Entecavir[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(11): 177-183.
曾健, 张玲, 李军, 等. 软肝化纤汤联合恩替卡韦治疗肝郁脾虚并瘀血阻络型慢性乙型肝炎肝纤维化患者临床疗效和生活质量观察[J]. 中国实验方剂学杂志, 2017,23(11):177-183. DOI： 10.13422/j.cnki.syfjx.2017110177.

ZENG Jian, ZHANG Ling, LI Jun, et al. Curative Effect and Quality of Life of Chronic Hepatitis B Patients with Liver Fibrosis with Syndromes of Liver Depression, Spleen Deficiency and Blood Stasis Obstruction Treated with Ruangan Huaxian Decoction Combined with Entecavir[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(11): 177-183. DOI： 10.13422/j.cnki.syfjx.2017110177.

摘要

目的：观察软肝化纤汤联合恩替卡韦治疗肝郁脾虚并瘀血阻络型慢性乙型肝炎肝纤维化患者的疗效及其对患者生活质量的影响，探讨其作用机制。方法：采用随机对照单盲试验方法，将符合诊断标准的100例慢性乙型肝炎患者随机分为观察组和对照组，各50例。观察组给予恩替卡韦和软肝化纤汤联合治疗，对照组给予恩替卡韦和中药安慰剂治疗，疗程均为6个月。观察和比较治疗前后两组患者肝功能、纤维化指标、乙肝病毒病原学和生活质量变化情况。结果：治疗后观察组丙氨酸氨基转移酶（ALT）复常率明显高于对照组（P<0.05）。与同组治疗前比较，两组治疗后血清透明质酸（HA），Ⅳ型胶原（Ⅳ-C），Ⅲ型前胶原（PCⅢ）和层黏蛋白（LN）均有明显改善（P< 0.05，P< 0.01）；治疗后两组比较，观察组肝纤维化指标明显低于对照组（P< 0.05，P< 0.01）。治疗后，两组患者血清HBV-DNA转阴率，HBsAg转阴率，HBeAg转阴率和HBeAg转换率无明显差异。与治疗前比较，观察组治疗后肝脏斜径、门静脉内径、脾静脉内径、脾脏厚度均明显降低（P< 0.05），对照组各指标有所降低，但差异无统计学意义；治疗后两组各指标比较，观察组明显低于对照组（P< 0.05）。治疗组总有效率92%，对照组总有效率74%，治疗组高于对照组（P< 0.05）。两组患者治疗后慢性肝病问卷（CLDQ）量表腹部症状（AS），疲乏（FA），系统症状（SS）和活动（AC）评分均高于治疗前（P<0.05），并且观察组明显高于对照组；两组患者治疗后SF-36量表生理功能（PF），生理职能（RP），精力（VT），躯体疼痛（BP）和总体健康高于治疗前（P<0.05），并且观察组明显高于对照组。结论：软肝化纤汤和恩替卡韦联合治疗肝郁脾虚并瘀血阻络型慢性乙型肝炎肝纤维化安全可靠、疗效确切，能够明显改善患者生活质量。

Abstract

Objective: To observe the curative effect of Ruangan Huaxian decoction combined with Entecavir in treating hepatic fibrosis of chronic hepatitis B patients with syndromes of liver depression

spleen deficiency and blood stasis obstruction and its effect on their quality of life. Method: A total of 100 patients with chronic hepatitis B were randomly divided into treatment group and control group according to parallel experimental design and randomized controlled single blind test. The treatment group (50 cases) was given Entecavir and Ruangan Huaxian decoction

and control group (50 cases) was given Entecavir and traditional Chinese medicine placebo. The course of treatment was 6 months. The changes in liver function

fibrosis index and hepatitis B virus etiology and quality of life were observed and compared before and after treatment. Before and after treatment

Medical Outcome Study 36-itenl Short Form Health Survey (SF-36) and Chronic Liver Disease Questionnaire (CLDQ) scale were used to measure patient's quality of life in both groups. Result: After treatment

alanine transaminase (ALT) normalization rate in observation group was significantly higher than that of control group (P<0.05). There were significant differences in hyaluronan (HA)

laminin(LN)

Ⅳ-C and PCⅢ between two groups after treatment (P<0.05

P<0.01). After treatment

the liver fibrosis indexes in treatment group were significantly lower than those in control group (P<0.05

P<0.01). After treatment

there was no significant difference in HBV-DNA negative rate

HBsAg negative rate

HBeAg negative rate and HBeAg conversion rate between two groups. Compared with before treatment

the oblique diameter and the diameter of portal vein of liver

and the diameter of splenic vein and the thickness of spleen in treatment group were significantly lower after treatment (P<0.05). After treatment

the treatment group was significantly lower than control group

but with no statistical significance. The total effective rate was 92% in treatment group and 74% in control group. There was a significant difference between the treatment group and the control group (P<0.05). After treatment

two groups showed higher CLDQ scale abdominal symptoms (AS)

fatigue (FA)

systemic symptoms (SS) and activity (AC) scores than those before treatment

and the treatment group was significantly higher than control group (P<0.05). After treatment

two groups showed higher SF-36 scale physical functioning (PF)

role physical (RP)

vitality (VT)

body pain (BP) and general health (GH) than before treatment

and the treatment group was significantly higher than the control group (P < 0.05). Conclusion: Ruangan Huaxian decoction combined with Entecavir for chronic hepatitis B liver fibrosis with syndromes of liver depression

spleen deficiency and blood stasis obstruction is safe

reliable and effective. It can significantly improve the quality of life of CHB patients.

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