1.A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C
Lai WEI ; Jia SHANG ; Xuan AN ; Guoqiang ZHANG ; Yujuan GUAN ; Hongxin PIAO ; Jinglan JIN ; Lang BAI ; Xingxiang YANG ; Daokun YANG ; Xinhua LUO ; Shufang YUAN ; Yingren ZHAO ; Yingjie MA ; Guangming LI ; Feng LIN ; Xiaoping WU ; Jiawei GENG ; Guizhou ZOU ; Jiabao CHANG ; Zuojiong GONG ; Xiaorong MAO ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2025;33(6):560-569
Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA
2.A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C
Lai WEI ; Jia SHANG ; Xuan AN ; Guoqiang ZHANG ; Yujuan GUAN ; Hongxin PIAO ; Jinglan JIN ; Lang BAI ; Xingxiang YANG ; Daokun YANG ; Xinhua LUO ; Shufang YUAN ; Yingren ZHAO ; Yingjie MA ; Guangming LI ; Feng LIN ; Xiaoping WU ; Jiawei GENG ; Guizhou ZOU ; Jiabao CHANG ; Zuojiong GONG ; Xiaorong MAO ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2025;33(6):560-569
Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA
3.Progress on the cell therapy strategy of mesenchymal stem cells
DUAN Xingxiang ; ZHANG Rui ; HE Yan ; PENG Youjian ; YE Qingsong
Journal of Prevention and Treatment for Stomatological Diseases 2023;31(10):745-750
Cell therapy based on mesenchymal stem cells (MSCs) has been a hot research topic in recent years, including the traditional cell therapy strategy based on living cells and the new cell-free therapy strategy based on soluble proteins or bioactive molecules such as extracellular vesicles (EVs). At present, MSC-induced cells have mature functions and specific structures, and insitu transplantation combined with biomaterials or organic technology has greatly improved the settlement rate and function. On the other hand, as the large-scale culture technique and EVs separation technique evolve, it is possible to obtain a large number of pure EVs, and EVs are gradually becoming a hot spot of current research. An increasing number of studies have shown that the therapeutic effect of MSCs not only occurs by implantation and differentiation but also manifests as the paracrine effect of MSCs. In this review, we discuss the emerging outcomes of cell therapies and acellular therapies to alleviate these pathological conditions.
4.Application of China consensus on the protocol of early gastric cancer screening in Guangdong province
Wenrui XIE ; Lihao WU ; Min ZHANG ; Yu CHEN ; Yu YUAN ; Jieyi CAI ; Xingxiang HE
Chinese Journal of Digestive Endoscopy 2020;37(7):491-494
Objective:To assess the application value of China consensus on the protocol of early gastric cancer screening in Guangdong province.Methods:A new quantitative scoring system was used in Cantonese residents who underwent early gastric cancer screening from March 2018 to March 2019. According to the scores of initial screening, patients were divided into high-risk, medium-risk and low-risk groups. The detection rates of early gastric cancer, precancerous diseases and precancerous lesions under gastroscopy in each group were compared. Chi-square test was performed for statistical analysis.Results:A total of 545 individuals were selected for gastroscopy, in which 32 cases were classified into high-risk group, 184 into medium-risk group and 329 into low-risk group. The results of gastroscopy examination showed that high-risk group had the highest detection rate of early gastric cancer (12.5%), followed by medium-risk group (1.1%) and low-risk group (0) ( χ2=41.85, P<0.01); the detection rates of precancerous diseases exhibited a similar pattern: high-risk group (60.9%) > medium-risk group (52.4%) > low-risk group (34.3%) ( χ2=18.00, P<0.01). The detection rates of precancerous lesions were 17.9%, 8.8% and 8.8%, respectively, with no significant difference ( χ2=2.58, P=0.28). In terms of the positive rate of endoscopy, high-risk group (71.9%) showed the highest positive rate, followed by medium-risk group (57.1%) and low-risk group (40.1%) ( χ2=21.54, P<0.01). Conclusion:China consensus on the protocol of early gastric cancer screeing is of application value for the screening of early gastric cancer and precancerous lesions in the populations at risk of gastric cancer in Guangdong province.
5.Dose-Dense Rituximab-CHOP versus Standard Rituximab-CHOP in Newly Diagnosed Chinese Patients with Diffuse Large B-Cell Lymphoma: A Randomized, Multicenter, Open-Label Phase 3 Trial
Xueying LI ; He HUANG ; Bing XU ; Hongqiang GUO ; Yingcheng LIN ; Sheng YE ; Jiqun YI ; Wenyu LI ; Xiangyuan WU ; Wei WANG ; Hongyu ZHAN ; Derong XIE ; Jiewen PENG ; Yabing CAO ; Xingxiang PU ; Chengcheng GUO ; Huangming HONG ; Zhao WANG ; Xiaojie FANG ; Yong ZHOU ; Suxia LIN ; Qing LIU ; Tongyu LIN
Cancer Research and Treatment 2019;51(3):919-932
PURPOSE: Rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone administered every 3 weeks (R-CHOP-21) is the standard care for diffuse large B-cell lymphoma (DLBCL). It is unknown whether the dose-dense R-CHOP (R-CHOP-14) could improve the outcome of the disease in Asian population. MATERIALS AND METHODS: Newly diagnosed DLBCL patients were centrally, randomly assigned (1:1) to receive R-CHOP-14 or R-CHOP-21. R-CHOP-14 was administered every 2 weeks, and R-CHOP-21 was administered every 3 weeks. Primary end point was disease-free survival (DFS). Secondary end points included overall survival (OS), progression-free survival (PFS), response rate and toxicities. RESULTS: Seven hundred and two patients were randomly assigned to receive R-CHOP-14 (n=349) or R-CHOP-21 (n=353). With a median follow-up of 45.6 months, the two groups did not differ significantly in 3-year DFS (79.6% for R-CHOP-14 vs. 83.2% for R-CHOP-21, p=0.311), 3-year OS (77.5% for R-CHOP-14 vs. 77.6% for R-CHOP-21, p=0.903), or 3-year PFS (63.2% for R-CHOP-14 vs. 66.1% for R-CHOP-21, p=0.447). Patients with an International Prognostic Index (IPI) score ≥ 2 had a poorer prognosis compared to those with an IPI score < 2. Grade 3/4 hematologic and non-hematologic toxicities were manageable and similar between R-CHOP-14 and R-CHOP-21. CONCLUSION: R-CHOP-14 did not improve the outcome of DLBCL compared to R-CHOP-21 in Asian population. With manageable and similar toxicities, both of the two regimens were suitable for Asian DLBCL patients. For high-risk patients with IPI ≥ 2, new combination regimens based on R-CHOP deserve further investigation to improve efficacy.
Asian Continental Ancestry Group
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B-Lymphocytes
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Cyclophosphamide
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Disease-Free Survival
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Doxorubicin
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Follow-Up Studies
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Humans
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Lymphoma, B-Cell
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Prednisone
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Prognosis
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Rituximab
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Vincristine
6.Microbiota transplantation: concept, methodology and strategy for its modernization.
Faming ZHANG ; Bota CUI ; Xingxiang HE ; Yuqiang NIE ; Kaichun WU ; Daiming FAN ; FMT-standardization Study Group
Protein & Cell 2018;9(5):462-473
Fecal microbiota transplantation (FMT) has become a research focus of biomedicine and clinical medicine in recent years. The clinical response from FMT for different diseases provided evidence for microbiota-host interactions associated with various disorders, including Clostridium difficile infection, inflammatory bowel disease, diabetes mellitus, cancer, liver cirrhosis, gut-brain disease and others. To discuss the experiences of using microbes to treat human diseases from ancient China to current era should be important in moving standardized FMT forward and achieving a better future. Here, we review the changing concept of microbiota transplantation from FMT to selective microbiota transplantation, methodology development of FMT and step-up FMT strategy based on literature and state experts' perspectives.
Clostridium Infections
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therapy
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Fecal Microbiota Transplantation
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methods
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standards
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Host Microbial Interactions
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Humans
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Inflammatory Bowel Diseases
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therapy
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Metabolic Diseases
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therapy
7. Chronic liver disease increases with damage to intestinal barrier function
Fenfen LIANG ; Jie WANG ; Lan LI ; Yu YUAN ; Wenrui XIE ; Lihao WU ; Xingxiang HE
Chinese Journal of Hepatology 2018;26(8):612-617
Objective:
To probe into the correlation between chronic liver disease and intestinal barrier function.
Methods:
1 491 cases of hospitalized patients were enrolled, of which 741 cases were of chronic liver diseases, including 397 cases of fatty liver diseases, 230 cases of chronic hepatitis, 114 cases of liver cirrhosis, and 750 cases of non-hepatic diseases. All admitted patients’ intestinal barrier function like diamine oxidase (DAO), D-lactate, lipopolysaccharide, and biochemical indicators of liver functions were tested. According to different data, statistical analysis was done using
8.Synbiotics adjust intestinalmicroecology to treat rat NASH and its effect on TLR4
Jieyi CAI ; Danping LUO ; Yang ZHANG ; Yu YUAN ; Xingxiang HE
Basic & Clinical Medicine 2017;37(9):1263-1269
Objective To observe the change of intestinal microflora on the process of nonalcoholic steatohepatitis(NASH),and to explore the synbiotics therapeutic effect on NASH.Methods Rats were administrated with high fat diet to establish NASH model.In the process of NASH rats modeling,the level of triglyceride (TG), total cholesterol (TC), high-density lipoprotein (HDL), low density lipoprotein (LDL), fasting blood sugar (FBS) and fasting insulin (FINS) was dynamically tested by automatic biochemical analyzer.The change of main intestinal flora was detected by 16 S rRNA fluorescence quantitative polymerase chain reaction.NAFLD activity score was calculated.HE staining was used to observe the hepaticpathological changes and the TLR4 expression was detected by using enzyme-linked immunosorbent assay and immunohistochemical method.Until the 4th,8th,10th weekin the process of NASH modeling, 10 rats were feeded with synbiotics for 2 weeks, and all of above indicators were tested and observed.Results 1)With the extension of a high-fat diet feeding time, the degree of hepatocyte steatosis obviously increased.NAFLD score was significantly heightened(P<0.01).2)Number of independent activities of rats significantly increased, the serological level of TG, TC, LDL, FBS and FINS were lower significantly after intervention with synbiotics for 2 weeks(P<0.05).3)Synbiotics intervention for two weeks significantly increased the amount of bifidobacterium and lactobacillus and decrease the amount of enterococcus significantly(P<0.05).4)The expression of TLR4 was gradually increased in the process of NASH rats modeling(P<0.05),but decreased after 2 weeks of the synbiotics-intervention (P<0.05).Conclusions Intestinal microecology change is closely related to the development of NASH,therefor, synbiotics could improve the quality of life and biochemical indicators of NASH rats through adjusting intestinal microecology and the expression level of TLR4 protein might been involved.
9.The correlation between chronic hepatic diseases and small intestinal inflammation
Lihao WU ; Meihui CHEN ; Jieyi CAI ; Yu YUAN ; Xingxiang HE
Chinese Journal of Digestive Endoscopy 2017;34(5):322-325
Objective To investigate the correlation between chronic hepatic diseases and small intestinal inflammation.Methods Patients who received capsule endoscopy in The First Affiliated Hospital of Guangdong Pharmaceutical University were divided into groups of liver cirrhosis,non-alcoholic fatty liver disease(NAFLD),chronic hepatitis and non-hepatic disease according to clinic data from August 2011 to August 2015.The severity of small intestinal mucosal inflammation was graded according to Lewis Scoring system and incidence of small intestinal lesions in different groups and Lewis scores were compared.The liver function was also graded with liver noninvasive scoring systems.Then the correlation between liver function damage and small intestinal lesions was investigated.Results A total of 338 cases were enrolled in the study,including 25 cases of liver cirrhosis,47 cases of NAFLD,20 cases of chronic hepaitis and 246 cases of non-hepatic disease.There were 22 (88.0%),36 (76.6%),12 (60.0%) and 78 (31.7%) cases with lesions in small intestine in the four group respectively with significant differences(P<0.001).Rate of small intestinal villi edema was significantly higher in liver cirrhosis group,NAFLD group,chronic hepatitis group than that in non-hepatic disease group(all P<0.017).Small intestinal villi edema was found mainly in the upper and one third of middle parts in small intestine (P =0.033).Lewis scores of liver cirrhosis group (190.80±228.42)and NAFLD group(125.38± 191.31) were higher than those of non-hepatic disease group (42.91±97.69,P=0.021,P =0.034).Forns score,FIB-4 score,NAFLD-FS score and Child-Pugh score were positively correlated with Lewis score (correlation coefficient:0.247,0.244,0.223,0.284respectively,all P<0.001).Conclusion Chronic hepatic diseases such as liver cirrhosis,NAFLD,chronic hepatitis might be risk factors for small intestinal mucosal inflammation,and the severity of chronic hepatic diseases may be positively correlated with that of small intestinal mucosal lesions.
10.Progress of the application of stem cell therapy for end-stage liver disease
Xingxiang DUAN ; Yang WANG ; Jingjing HE ; Yingying PENG ; Juan YU ; Yi SUN
Journal of Central South University(Medical Sciences) 2017;42(4):457-462
Many risk factors lead to hypohepatia and hepatic failure,causing people suffering from end-stage liver disease.The conventional treatment for end-stage liver disease is not good enough.Orthotopic liver transplantation is effective.However,the high cost,lack of liver source,immune rejection and other factors limit the large-scale clinical application.Thus,cell therapy is a good option.Studies on common cell sources for the treatment of liver disease and the induction of hepatocytes by embryonic stem cells or pluripotent stem cells have made progress.With the development of stem cell technology,cell transplantation has become a new option,which brings hope to people with end-stage liver diseasetransplantation has become a new option.It brings hope to people with endstage liver disease.


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