1.Efficacy and safety of Babaodan Capsule in patients with chronic hepatitis B virus infection comorbid with gallbladder polyps
Qianqian NIU ; Huan CHEN ; Ying ZHENG ; Chunyan GOU ; Chen XU ; Li LI ; Xinxin WANG ; Jianping LIU ; Zhaolan LIU ; Xiuhui LI
Journal of Clinical Hepatology 2026;42(2):304-311
ObjectiveTo investigate the efficacy and safety of Babaodan Capsule (BBD) in the treatment of patients with chronic hepatitis B virus (HBV) infection with damp-heat in the liver and gallbladder comorbid with gallbladder polyps. MethodsA randomized, double-blinded, placebo-controlled single-center trial was conducted among 120 patients with chronic HBV infection who were admitted to Beijing YouAn Hospital, Capital Medical University, from August 2020 to April 2023, and they were divided into treatment group (BBD) and control group (placebo), with 60 patients in each group. The course of treatment was 24 weeks, and follow-up assessments were conducted every 4 weeks. The primary outcome measures were the number and maximum diameter of gallbladder polyps (assessed by ultrasound), and the secondary outcome measures included traditional Chinese medicine (TCM) syndrome score, blood lipid levels, and liver function parameters. The independent-samples t test or the Wilcoxon rank-sum test was used for comparison of continuous data between two groups, and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups; the Wilcoxon rank-sum test was used for comparison of ranked data between two groups; the generalized estimating equation was used to analyze repeated measures data. ResultsAfter 8 weeks of treatment, the treatment group had a significantly smaller diameter of polyps and a significantly lower number of polyps than the control group (Z=-1.76 and -1.80, both P<0.05), and after 24 weeks of treatment, the treatment group had a significantly higher polyp reduction rate than the control group (30.51% vs 10.91%, P<0.05). The subgroup analysis showed that patients receiving combined antiviral therapy, male patients, patients with a diameter of polyps of <5 mm, and patients with multiple polyps tended to achieve significantly greater benefits. At week 8 of treatment, the treatment group had a significantly better TCM syndrome score than the control group (Z=-2.35, P<0.05); after treatment, compared with the control group, the treatment group had a significantly greater increase in high-density lipoprotein (Z=-1.85, P<0.05) and significantly lower levels of alanine aminotransferase (Z=-2.06, P <0.05), aspartate aminotransferase (Z=-2.13, P<0.05), total bilirubin (Z=-2.12, P<0.05), and direct bilirubin (Z=-3.09, P<0.05). No serious adverse events were reported in either group. ConclusionBBD can effectively reduce the size of gallbladder polyps, improve TCM syndrome score, and reduce the level of bilirubin in patients with chronic HBV infection with damp-heat in the liver and gallbladder, with a favorable safety profile, and it may be more suitable for patients receiving combined antiviral therapy and specific subgroups (male patients, patients with a diameter of polyps of <5 mm, and patients with multiple polyps.
2.The application of human serum albumin in liver cirrhosis and its complications
Journal of Clinical Hepatology 2025;41(3):409-414
Albumin is synthesized in the liver, and in case of severe liver injury, albumin synthesis is reduced with structural alterations (such as an increase in methylation and glycosylation), leading to a significant reduction in effective albumin in circulation. Albumin not only maintains plasma oncotic pressure, but also has the functions of antioxidation, anti-inflammation, immunomodulation, and transport. Current guidelines recommend the short-term application of human serum albumin in the treatment of large-volume paracentesis, hepatorenal syndrome, and spontaneous bacterial peritonitis in patients with liver cirrhosis, as it is shown that human serum albumin can help to reduce mortality. In addition, human serum albumin may improve the prognosis of cirrhotic patients with hyponatremia, non-SBP infections, and hepatic encephalopathy. However, there are still controversies over the application of human serum albumin in liver cirrhosis and related complications in terms of optimal dose and long-term efficacy.
3.Prevalence, influencing factors, and fibrosis risk stratification of metabolic dysfunction-associated fatty liver disease in the health check-up population in Beijing, China
Haiqing GUO ; Mingliang LI ; Feng LIU ; Jing ZHANG
Journal of Clinical Hepatology 2025;41(4):643-649
ObjectiveTo identify the patients with metabolic dysfunction-associated fatty liver disease (MAFLD) among the health check-up population, and to perform stratified management of patients with the low, medium, and high risk of advanced fibrosis based on noninvasive fibrosis scores. MethodsA cross-sectional study was conducted among 3 125 individuals who underwent physical examination in Beijing Physical Examination Center from December 2017 to December 2019, and they were divided into MAFLD group with 1 068 individuals and non-MAFLD group with 2 057 individuals. According to BMI, the MAFLD group was further divided into lean MAFLD group (125 individuals with BMI<24 kg/m2) and non-lean MAFLD group (943 individuals with BMI≥24 kg/m2). Indicators including demographic data, past history, laboratory examination, and liver ultrasound were compared between groups. Fibrosis-4 (FIB-4) score, NAFLD fibrosis score (NFS), aspartate aminotransferase-to-platelet ratio index (APRI), and BARD score were calculated for the patients in the MAFLD group to assess the risk of advanced fibrosis. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U rank sum test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test or the Fisher’s exact test was used for comparison of categorical data between groups. A logistic regression analysis was used to investigate the influence of each indicator in MAFLD. ResultsCompared with the non-MAFLD group, the MAFLD group had significantly higher age (Z=-9.758, P<0.05), proportion of male patients (χ2=137.555, P<0.05), and levels of body weight (Z=-27.987, P<0.05), BMI (Z=-32.714, P<0.05), waist circumference (Z=-31.805, P<0.05), hip circumference (Z=-26.342, P<0.05), waist-hip ratio (Z=-28.554, P<0.05), alanine aminotransferase (ALT) (Z=-25.820, P<0.05), aspartate aminotransferase (AST) (Z=-16.894, P<0.05), gamma-glutamyl transpeptidase (GGT) (Z=-25.069, P<0.05), alkaline phosphatase (Z=-12.533, P<0.05), triglyceride (Z=-27.559), total cholesterol (Z=-7.833, P<0.05), low-density lipoprotein cholesterol (LDL-C) (Z=-8.222, P<0.05), and uric acid (UA) (Z=-20.024, P<0.05), as well as a significantly higher proportion of patients with metabolic syndrome (MetS) (χ2=578.220, P<0.05), significantly higher prevalence rates of hypertension (χ2=241.694, P<0.05), type 2 diabetes (χ2=796.484, P<0.05), and dyslipidemia (χ2=369.843, P<0.05), and a significant reduction in high-density lipoprotein cholesterol (HDL-C) (Z=23.153, P<0.001). The multivariate logistic regression analysis showed that male sex (odds ratio [OR]=1.45, 95% confidence interval [CI]: 1.203 — 1.737), ALT (OR=1.05, 95%CI: 1.046 — 1.062), LDL-C (OR=1.23, 95%CI: 1.102 — 1.373), and comorbidity with MetS (OR=5.97, 95%CI: 4.876 — 7.316) were independently associated with MAFLD. Compared with the non-lean MAFLD group, the lean MAFLD group had significantly higher age (Z=3.736, P<0.05) and HDL-C (Z=2.679, P<0.05) and significant reductions in the proportion of male patients (χ2=28.970, P<0.05), body weight (Z=-14.230, P<0.05), BMI (Z=-18.188, P<0.05), waist circumference (Z=-13.451, P<0.05), hip circumference (Z=-13.317, P<0.05), ALT (Z=-4.519, P<0.05), AST (Z=-2.258, P<0.05), GGT (Z=-4.592, P<0.05), UA (Z=-4.415, P<0.05), the proportion of patients with moderate or severe fatty liver disease or MetS (χ2=42.564, P<0.05), and the prevalence rates of hypertension (χ2=12.057, P<0.05) and type 2 diabetes (χ2=3.174, P<0.05). Among the patients with MAFLD, 10 patients (0.9%) had an FIB-4 score of >2.67, 4 patients (0.4%) had an NFS score of >0.676, 8 patients (0.7%) had an APRI of >1, and 551 patients (51.6%) had a BARD score of ≥2. ConclusionThere is a relatively high prevalence rate of MAFLD among the health check-up population in Beijing, but with a relatively low number of patients with a high risk of advanced fibrosis, and such patients need to be referred to specialized hospitals for liver diseases.
4.Characteristics and lifestyles of patients with metabolic dysfunction-associated fatty liver disease based on the physical examination population
Haiqing GUO ; Mingliang LI ; Feng LIU ; Yali LIU ; Jing ZHANG
Journal of Clinical Hepatology 2025;41(6):1090-1096
ObjectiveTo screen for the patients with metabolic dysfunction-associated fatty liver disease (MAFLD) among the physical examination population, to observe the characteristics of MAFLD patients, and to compare the differences in lifestyle between the MAFLD population and the non-MAFLD population. MethodsA cross-sectional study was conducted among 6 206 individuals who underwent physical examination in a physical examination institution in Beijing from December 2015 to December 2019, and according to the new diagnostic criteria for MAFLD, the examination population was divided into MAFLD group and non-MAFLD group. Based on body mass index (BMI), the MAFLD group was further divided into lean MAFLD group (BMI<24 kg/m2) and non-lean MAFLD group (BMI ≥24 kg/m2). Related data were compared between groups, including demographic indicators, education level, work pressure, physical measurement indicators, and lifestyles such as sleep, diet, and exercise. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, and the chi-square test was used for comparison of categorical data between groups. ResultsOf all individuals in this study, 1 926 (31.1%) had MAFLD and 4 280 (68.9%) did not have MAFLD. Compared with the non-MAFLD group, the MAFLD group had significantly higher age (Z=-14.459, P<0.001), proportion of male patients (χ2=72.004, P<0.001), work pressure (χ2=7.744, P=0.005), body weight (Z=-43.508, P<0.001), BMI (Z=-47.621, P<0.001), waist circumference (Z=-48.515, P<0.001), hip circumference (Z=-42.121, P<0.001), and waist-hip ratio (Z=-43.535, P<0.001), as well as a significantly lower education level (χ2=33.583, P<0.001). In terms of behavior, the MAFLD group had a significantly shorter sleep time (χ2=5.820, P=0.016) and a significantly faster eating speed (χ2=74.476, P<0.001). In terms of diet, the patients in the MAFLD group consumed more high-sodium, high-sugar, and high-calorie diets (χ2=42.667, P<0.001) and low-fiber diet (χ2=4.367, P=0.008). In terms of exercise, the MAFLD group had a significantly higher proportion of patients without exercise habits (χ2=10.278, P=0.001). Further analysis showed that there were 202 individuals (10.5%) in the lean MAFLD group and 1 724 (89.5%) in the non-lean MAFLD group. Compared with the non-lean MAFLD group, the lean MAFLD group had significantly higher age (Z=3.368, P=0.001) and education level (χ2=9.647, P=0.002) and significantly lower proportion of male patients (χ2=27.664, P<0.001), body weight (Z=-18.483, P<0.001), BMI (Z=-23.286, P<0.001), waist circumference (Z=-18.565, P<0.001), and hip circumference (Z=-18.097, P<0.001), and in terms of behavior, the non-lean MAFLD group had a significantly faster eating speed (χ2=4.549, P=0.033). ConclusionThere is a relatively high prevalence rate of MAFLD among the physical examination population in Beijing, with a higher number of people with unhealthy lifestyles compared with the non-MAFLD population.
6.Effect of different culture time on immunomembrane proteins of human monocyte-derived dendritic cells and their exosomes.
Shumin LUO ; Fang XU ; Pengpeng LU ; Yiyue WANG ; Chuanyun LI ; Weihua LI
Chinese Journal of Cellular and Molecular Immunology 2025;41(11):971-977
Objective To investigate how culture duration affects the expression of immune membrane proteins in human monocyte-derived dendritic cells (DCs) and their exosomes (DEXs). Methods Human monocytes were induced with recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin 4 (IL-4) to differentiate into DCs and were subsequently matured with tumor necrosis factor α(TNF-α). Exosomes were isolated by ultracentrifugation, and DEXs were identified by transmission electron microscopy and Amnis imaging flow cytometry, which were also used to quantify the expression of immune membrane proteins on DCs and DEXs. Results On the 10th day of culture, DCs displayed high surface expression of CD11c, CD80, CD86, major histocompatibility complex class I (MHC-I), and MHC-II. Expression peaked at day 18(CD11c: 78.66%±20.33%, CD80: 76.41%±10.02%, CD86: 96.43%±0.43%, MHC-I: 84.71%±2.96%, MHC-II: 80.01%±7.03%). After day 24, the overall expression showed a declining trend, with statistically significant differences observed for all markers except CD80 and MHC-II. By day 30, 80% of the DCs still expressed CD80, CD86, and MHC-II. The expression of immune membrane proteins on DEX surfaces also reached its peak on day 18, followed by an overall decline with prolonged culture time, with statistically significant differences observed for all markers except CD80. Correlation analysis revealed a significant positive relationship between the expression levels of immune membrane proteins on DC and DEX surfaces (CD11c: r=0.98; CD80: r=0.65; CD86: r=0.82; MHC-I: r=0.86; MHC-II: r=0.93). Conclusion Human monocyte-derived DCs in vitro express high expression of immune membrane proteins and maintain stable expression over a specific period. The exosomes secreted by these cells similarly demonstrate high surface expression of immune membrane proteins, with temporal trends aligned with those of the parent DCs.
Humans
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Dendritic Cells/immunology*
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Exosomes/immunology*
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Monocytes/metabolism*
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Cells, Cultured
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Time Factors
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B7-1 Antigen/metabolism*
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Membrane Proteins/immunology*
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Cell Culture Techniques/methods*
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B7-2 Antigen/metabolism*
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Cell Differentiation
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CD11c Antigen/metabolism*
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Granulocyte-Macrophage Colony-Stimulating Factor/pharmacology*
7.Real-world efficacy and safety of azvudine in hospitalized older patients with COVID-19 during the omicron wave in China: A retrospective cohort study.
Yuanchao ZHU ; Fei ZHAO ; Yubing ZHU ; Xingang LI ; Deshi DONG ; Bolin ZHU ; Jianchun LI ; Xin HU ; Zinan ZHAO ; Wenfeng XU ; Yang JV ; Dandan WANG ; Yingming ZHENG ; Yiwen DONG ; Lu LI ; Shilei YANG ; Zhiyuan TENG ; Ling LU ; Jingwei ZHU ; Linzhe DU ; Yunxin LIU ; Lechuan JIA ; Qiujv ZHANG ; Hui MA ; Ana ZHAO ; Hongliu JIANG ; Xin XU ; Jinli WANG ; Xuping QIAN ; Wei ZHANG ; Tingting ZHENG ; Chunxia YANG ; Xuguang CHEN ; Kun LIU ; Huanhuan JIANG ; Dongxiang QU ; Jia SONG ; Hua CHENG ; Wenfang SUN ; Hanqiu ZHAN ; Xiao LI ; Yafeng WANG ; Aixia WANG ; Li LIU ; Lihua YANG ; Nan ZHANG ; Shumin CHEN ; Jingjing MA ; Wei LIU ; Xiaoxiang DU ; Meiqin ZHENG ; Liyan WAN ; Guangqing DU ; Hangmei LIU ; Pengfei JIN
Acta Pharmaceutica Sinica B 2025;15(1):123-132
Debates persist regarding the efficacy and safety of azvudine, particularly its real-world outcomes. This study involved patients aged ≥60 years who were admitted to 25 hospitals in mainland China with confirmed SARS-CoV-2 infection between December 1, 2022, and February 28, 2023. Efficacy outcomes were all-cause mortality during hospitalization, the proportion of patients discharged with recovery, time to nucleic acid-negative conversion (T NANC), time to symptom improvement (T SI), and time of hospital stay (T HS). Safety was also assessed. Among the 5884 participants identified, 1999 received azvudine, and 1999 matched controls were included after exclusion and propensity score matching. Azvudine recipients exhibited lower all-cause mortality compared with controls in the overall population (13.3% vs. 17.1%, RR, 0.78; 95% CI, 0.67-0.90; P = 0.001) and in the severe subgroup (25.7% vs. 33.7%; RR, 0.76; 95% CI, 0.66-0.88; P < 0.001). A higher proportion of patients discharged with recovery, and a shorter T NANC were associated with azvudine recipients, especially in the severe subgroup. The incidence of adverse events in azvudine recipients was comparable to that in the control group (2.3% vs. 1.7%, P = 0.170). In conclusion, azvudine showed efficacy and safety in older patients hospitalized with COVID-19 during the SARS-CoV-2 omicron wave in China.
8.Amyloid-like fibrils derived from β-sheets of gp120 contribute to the neuronal pathology of HIV-associated neurocognitive disorders.
Chan YANG ; Ruyu WANG ; Chen CHENG ; Jiaqi YU ; Kunyu LU ; Haobin LI ; Jinshen WANG ; Guodong HU ; Hao YANG ; Jianfu HE ; Hao SU ; Qingping ZHAN ; Suiyi TAN ; Tong ZHANG ; Shuwen LIU
Acta Pharmaceutica Sinica B 2025;15(4):2273-2277
9.Influence of SH2B1 rs7359397 polymorphism on hepatic fibrosis in patients with metabolic dysfunction-associated steatotic liver disease aged ≥65 years in Beijing, China
Sitong CHEN ; Shuang ZHANG ; Jinhan ZHAO ; Xiaodie WEI ; Yaning LI ; Lixia QIU ; Jing ZHANG
Journal of Clinical Hepatology 2025;41(11):2286-2293
ObjectiveTo investigate the association of SH2B1 rs7359397 (C>T) polymorphism with the progression to hepatic fibrosis in the elderly patients with metabolic dysfunction-associated steatotic liver disease (MASLD) in Beijing, China, and to provide an important genetic basis for the precise subtyping, prognostic evaluation, and individualized treatment of elderly MASLD patients in China. MethodsA total of 505 elderly patients (aged ≥65 years) who participated in regular physical examination in Mentougou Kuangshan Hospital of Beijing Jingmei Group General Hospital from November 2020 to September 2021 and were diagnosed with MASLD by abdominal ultrasound were enrolled as MASLD group, and 381 elderly population who underwent physical examination in the same community hospital during the same period of time and were not found to have MASLD by abdominal ultrasound were enrolled as control group. FibroScan was used to measure liver fat content and determine fibrosis stage. The 96-well microfluidic chip technique was used to identify SH2B1 rs7359397 polymorphism. The independent-samples t test was used for comparison of normally distributed continuous data between the two groups, and the chi-square test or the adjusted chi-square test was used for comparison of categorical data between the two groups. Univariate and multivariate Logistic regression analyses were used to identify the independent predictive factors for MASLD and its comorbidities. ResultsCompared with the control group, the MASLD group had a significantly younger age and significantly higher levels of waist circumference, hip circumference, waist-hip ratio, body mass index (BMI), alanine aminotransferase, aspartate aminotransferase, triglyceride, platelet count, and fibrosis-4 (FIB-4) index, as well as a significantly lower level of high-density lipoprotein cholesterol (all P<0.05). Among the 381 patients in the control group, 264 (69.29%) had genotype CC and 117 (30.71%) had genotype CT+TT, while among the 505 patients in the MASLD group, 317 (62.77%) had genotype CC and 188 (37.23%) had genotype CT+TT, suggesting that the MASLD group had a significantly higher proportion of patients with genotype CT+TT compared with the control group (χ2=4.09, P=0.043). In the MASLD group, compared with the genotype CC group, the genotype CT+TT group had a significantly lower proportion of patients with FIB-4 ≥2 or atherosclerotic cardiovascular diseases (P<0.05). The multivariate Logistic regression analysis showed that after adjustment for age, sex, and BMI, carrying T allele was a protective factor against progressive hepatic fibrosis (odds ratio [OR]=0.481, 95% confidence interval [CI]: 0.249 — 0.929, P=0.029). In the subgroups of comorbidities with hypertension, metabolic syndrome, and obesity, genotype CT+TT was associated with a significant reduction in the risk of progressive hepatic fibrosis (hypertension: OR=0.27, 95%CI:0.09 — 0.77, P=0.014; metabolic syndrome: OR=0.30, 95%CI: 0.11 — 0.79, P=0.015; obesity: OR=0.11, 95%CI: 0.03 — 0.48, P=0.003). After adjustment for age, sex, and BMI, in the patients with MASLD, the patients with genotype CT+TT had a significant reduction in the prevalence rate of atherosclerotic cardiovascular diseases compared with those with genotype CC (OR=0.506, 95%CI:0.336 — 0.761, P=0.001). ConclusionSH2B1 rs7359397 (C>T) polymorphism is associated with the reduction in the risk of hepatic fibrosis and atherosclerotic cardiovascular diseases in MASLD patients.
10.The Effects of Huqi Zhengxiao Formula (槲芪癥消方) on the Survival Rate and Quality of Life of Patients of Stage Ⅲ Hepatitis B-Associated Primary Liver Cancer with Syndrome of Healthy Qi Deficiency, Toxic Stasis Accumulation After Transcatheter Arterial Chemoembolisation Treatment
Wenjun XU ; Jingying LI ; Xiaojun WANG ; Chun ZHANG
Journal of Traditional Chinese Medicine 2024;65(4):382-387
ObjectiveTo observe the effects of Huqi Zhengxiao Formula (槲芪癥消方) on the survival rate and quality of life of patients with stage Ⅲ hepatitis B-associated primary liver cancer (PLC) with syndrome of healthy qi deficiency and toxic stasis accumulation after transcatheter arterial chemoembolisation (TACE) treatment. MethodsOne hundred and twenty-six patients with stage Ⅲ hepatitis B-associated PLC who were identified as syndrome of healthy qi deficiency and toxic stasis accumulation after TACE treatment were selected, and were randomly assigned to 63 cases each of the treatment group and the control group in a ratio of 1∶1 by using the random number table method; the control group was given symptomatic supportive treatments with western internal medicine, and the treatment group was given the addition of Huqi Zhengxiao Formula on the basis of the control group. All patients were treated for a period of 48 weeks, and were followed up at weeks 4, 8, 12, 24, 36, and 48 of the treatment process. The primary effectiveness index was the 1-year survival rate, and the secondary effectiveness index was the Karnofsky score and the traditional Chinese medicine (TCM) syndrome score. Survival analysis was performed using the Kaplan-meier method, and Log-rank test was used to compare the differences between the survival curves of each group. ResultsSix withdrawals in the treatment group and seven withdrawals in the control group, and finally 57 patients in the test group and 56 patients in the control group were included in the statistical analysis. The 1-year survival rate of patients in the treatment group was 56.1% (32/57), which was higher than that of 33.9% (19/56) in the control group (P = 0.033). The mean survival time was (275.30±15.50) days in the treatment group, higher than (227.16±17.11) days in the control group (P = 0.039). Thirty-two patients in the treatment group and 19 patients in the control group completed the Karnofsky score and TCM symptom score at each time point. At weeks 4, 8, 12 and 36, the difference in the Karnofsky score between the two groups was not statistically significant (P>0.05); at weeks 24 and 48, the Karnofsky score in the treatment group was higher than that in the control group at the same time point (P<0.05); analysis of variance of repeated measurements found that the downward trend of the Karnofsky score in the treatment group was slower than that in the control group (F = 4.47, P = 0.037). The difference between the TCM symptom scores of the two groups at each follow-up observation point was not statistically significant (P>0.05); there was a tendency for the TCM symptom scores of the two groups to increase, but the ANOVA of repeated measurements found that the difference between the two groups was not statistically significant either (F = 0.31, P = 0.58). Concusion The oral administration of Huqi Zhengxiao Formula can improve the survival rate, prolong the survival time, and improve the quality of life of patients with stage Ⅲ hepatitis B-associated PLC with syndrome of healthy qi deficiency and toxic stasis accumulations after TACE treatment.

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