Staged Efficacy of Qijia Rougan Prescription Combined with Entecavir for Chronic Hepatitis B-related Hepatic Fibrosis with Qi Deficiency and Collateral Stasis Syndrome Based on "Zhu Ke Jiao" Theory
10.13422/j.cnki.syfjx.20251193
- VernacularTitle:基于“主客交”理论的芪甲柔肝方联合恩替卡韦对气虚络阻证慢性乙型肝炎肝纤维化的分期疗效
- Author:
Baixue LI
1
;
Xin WANG
1
;
Jibin LIU
1
;
Li WEN
1
;
Cen JIANG
1
;
Wenjun WU
1
;
Dong WANG
1
;
Shuwan LIU
2
;
Huabao LIU
2
;
Yongli ZHENG
3
;
Liang HUANG
3
;
Yue SU
1
;
Song ZHANG
4
;
Yanan SHANG
5
;
Hang ZHOU
1
;
Quansheng FENG
1
Author Information
1. School of Basic Medical Sciences，Chengdu University of Traditional Chinese Medicine（TCM），Chengdu 610066，China
2. Chongqing TCM Hospital，Chongqing 400020，China
3. Public Health Clinical Center of Chengdu，Chengdu 610000，China
4. Hospital of Chengdu University of TCM，Chengdu 610072，China
5. Meishan TCM Hospital，Meishan 620032， China
- Publication Type:Journal Article
- Keywords:
Qijia Rougan prescription;
entecavir;
chronic hepatitis B-related hepatic fibrosis （CHB-HF）;
multicenter randomized controlled study;
staged efficacy
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(9):180-188
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveThis paper aims to investigate and evaluate the staged efficacy and safety of the representative empirical prescription of the “Zhu Ke Jiao” theory， Qijia Rougan prescription， combined with entecavir in the treatment of hepatic fibrosis in chronic hepatitis B. MethodsA multicenter randomized controlled clinical study was conducted， and 101 patients diagnosed with chronic hepatitis B-related hepatic fibrosis （CHB-HF） who met the diagnosis and inclusion criteria were randomly assigned to an observation group （Qijia Rougan prescription + entecavir） and a control group （entecavir）. The treatment duration was 24 weeks. Liver stiffness measurement （LSM）， fibrosis-4 index （FIB-4）， portal vein diameter， hepatitis B serology， biochemical indicators， hepatic fibrosis markers in serum ［hyaluronic acid （HA）， laminin （LN）， procollagen Ⅲ peptide （PⅢP）， and type Ⅳ collagen （Ⅳ-C）］， and traditional Chinese medicine syndrome scores were used as efficacy evaluation indicators. Efficacy assessments and explorations of different staged subgroups of Qijia Rougan prescription were conducted according to LSM values based on the Metavir pathological staging standard. ResultsA total of 98 cases were included for statistical analysis， with 49 cases in the observation group and 49 in the control group. The general data of the patients in both groups were comparable. Compared with the same group before treatment， the observation group showed a significant reduction in LSM and FIB-4 （P<0.01）， as well as notable improvements in LN， Ⅳ-C， and various TCM syndrome scores （P<0.05， P<0.01）. When compared to the control group after treatment， the observation group demonstrated significant improvements in LSM， FIB-4， and various TCM syndrome score indicators （P<0.05， P<0.01）， indicating that the observation group performed better than the control group. Subgroup analysis of the regression of hepatic fibrosis stages showed that compared to the same group before treatment， the observation group had better improvement in regression of stages F2 and F3 （P<0.05）. When compared to the control group after treatment， the observation group exhibited superior improvement in regression of stage F3 （P<0.05）. No adverse events occurred in either group during the treatment period. ConclusionCompared with entecavir alone， the combination of Qijia Rougan prescription and entecavir significantly improves the degree of hepatic fibrosis and clinical TCM symptoms in patients. The optimal intervention period is primarily during stage F3， which is a potential “interception” point of the “Zhu Ke Jiao” theory.
