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.A phase Ⅱ clinical study of the efficacy and safety of antaitasvir phosphate combined with yiqibuvir for the treatment of chronic hepatitis C in adults
Lai WEI ; Hongxin PIAO ; Jinglan JIN ; Shufen YUAN ; Xuan AN ; Jia SHANG ; Wenhua ZHANG ; Jiabao CHANG ; Tong SUN ; Yujuan GUAN ; Bo NING ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2024;32(7):637-642
Objective:To evaluate the efficacy and safety of antaitasvir phosphate 100 mg or 200 mg combined with yiqibuvir for 12 weeks in patients with various genotypes of chronic hepatitis C, without cirrhosis or compensated stage cirrhosis.Methods:Patients with chronic hepatitis C (without cirrhosis or compensated stage cirrhosis) were randomly assigned to the antaitasvir phosphate 100 mg+yiqibuvir 600 mg group (100 mg group) or the antaitasvir phosphate 200 mg+yiqibuvir 600 mg group (200 mg group) in a 1∶1 ratio. The drugs were continuously administered once a day for 12 weeks and observed for 24 weeks after drug withdrawal. The drug safety profile was assessed concurrently with the observation of the sustained virological response (SVR12) in the two patient groups 12 weeks following the drug cessation. The intention-to-treat concept was used to define as closely as possible a full analysis set, including all randomized cases who received the experimental drug at least once. The safety set was collected from all subjects who received the experimental drug at least once (regardless of whether they participated in the randomization group) in this study. All efficacy endpoints and safety profile data were summarized using descriptive statistics. The primary efficacy endpoint was SVR12. The primary analysis was performed on a full analysis set. The frequency and proportion of cases were calculated in the experimental drug group (antaitasvir phosphate capsules combined with yiqibuvir tablets) that achieved "HCV RNA
4.Age-associated changes in ultrastructure and H+-K+-ATpase of gastric parietal cell in the elderly
Yan ZHUANG ; Songbai ZHENG ; Li XIAO ; Danian JI ; Ping XIANG ; Yulei YIN ; Wei ZHANG ; Jie DU
Chinese Journal of Geriatrics 2012;31(5):413-416
Objective To investigate the age-associated changes of ultrastructure,mRNA and protein expressions of H+-K+-ATPase in elderly gastric parietal cell. Methods Fifty patients with relative normal stomach without gastroduodenal diseases were enrolled,including younger group (aged 20-59 years,n=19) and elderly group (aged≥60 years,n=31).Furthermore,the elderly group was divided into 3 subgroups:60-69 years old (n =11 ),70-79 years old (n=10 ),above 80 years old (n =10).The ultrastructure of gastric parietal cell was observed under electron microscope.The expression of H+-K+-ATPase α subunit mRNA and H+-K+-ATPase β subunit protein were assessed by quantitative real-time PCR and Western-blot,respectively.The ageing-associated changes of all these data were respectively compared. Results No significant difference was showed in the morphology of gastric parietal cell and acid-secretion-associated organelles among all the groups.The average ratio Am to Ac (Am means the area of mitochondria,Ac means the area of cytoplasm) of gastric parietal cell and the average At to Ac ratio (At means the area of secretory canaliculi and tubulovesicular system )between younger group and elderly group had no significant difference[(48.4±7.5) % vs.(50.6±7.6) %,t=-0.775,P=0.444; (13.8±4.1) % vs.(12.2±4.7) %,t=0.984,P=0.332].Meanwhile,there were no distinctions in the expression of H+-K+ -ATPase α subunit mRNA and H+-K+-ATPase protein among all elderly subgroups(F=1.522,2.32,P=0.24,0.114).However,the mRNA expression of H+-K+-ATPase a subunit was higher in the elderly group than in the younger group(t=-3.682,P=0.001).Furthermore,the expression of H+ -K+ -ATPase protein in the elderly group was increased as compared with younger group(t=-3.389,P=0.004). Conclusions Acidsecretion-associated organelles of human gastric parietal cell have no degeneration and the expression of H + -K+-ATPase is in trend of increase with aging,indicating that healthy elderly people have the basis of ultrastructure and molecular biology to maintain well function of acid secretion.
5.Chemical constituents of fresh celery.
Kailan ZHOU ; Bing WU ; Yulei ZHUANG ; Liqin DING ; Zhihui LIU ; Feng QIU
China Journal of Chinese Materia Medica 2009;34(12):1512-1515
OBJECTIVETo study the chemical constituents of the whole plant of fresh celery (Apium graveolens).
METHODThe constituents were isolated and purified by silica gel, Sephadex LH-20, ODS column chromatography, PTLC, HPLC, and their structures were elucidated on the basis of spectral evidences.
RESULTTwenty compounds were obtained and identified as falcariondiol (1), (9Z) 1,9-heptadecadiene-4,6-diyne-3,8,11-triol (2), oplopandiol (3), bergapten (4), 5,8-dimethoxy psoralen (5), isofraxidin (6), eugenic acid (7), trans-ferulic acid (8), trans-cinnamic acid (9), p-hydroxyphenylethanol ferulate (10), caffeoylquinic acid (11), 5-p-trans-coumaroylquinic acid (12), sedanolide (13), lunularin (14), lunularic acid (15), 2-(3-methoxy-4-hydroxyphenol)-propane-1,3-diol (16), D-allitol (17), beta-sitosterol (18), benzolic acid (19), succinic acid (20).
CONCLUSIONCompounds 2, 3, 6, 10, 12, 14-17 were isolated from genus Apium for the first time.
Apium graveolens ; chemistry ; Drugs, Chinese Herbal ; analysis ; isolation & purification

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