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.Clinical Characterization of Neurobrucellosis in Kashi Region
Shufang PAN ; Yanyu CHANG ; Xiaohong WANG ; Zulipiya·Moming ; Maimaitiaili·Tuerxun ; Yutian CHONG ; Jianyun ZHU
Journal of Sun Yat-sen University(Medical Sciences) 2024;45(4):649-656
[Objective]To explore the clinical characteristics of neurobrucellosis in Kashi,Xinjiang Uygur Autono-mous Region,thus improve the diagnosis and treatment.[Methods]A retrospective analysis was conducted on the clinical data of 18 cases of neurobrucellosis who were admitted to the First People's Hospital of Kashi Prefecture between Decem-ber 2019 and January 2024.[Results]The study included 9 males and 9 females,with a median age of 36 years(range:17-54.5).A clear epidemiological history was found in all the 18 brucllosis patients,12 of whom presented with meningo-encephalitis,5 meningitis,and 1 encephalitis.Two comorbided with spinal meningitis,2 osteoarthritis and 1 epididymitis.Most frequently reported clinical symptoms were headache,fever and fatigue.The prevalence rates of brucellosis by rose bengal plate agglutination test(RBPT)and serum agglutination test(SAT)were 11/12 and 8/9,respectively.Two of 10 patients had positive blood cultures,four of 16 had positive cerebrospinal fluid(CSF)cultures and five of five were detect-ed to be positive by next-generation sequencing(NGS)for pathogens in CSF.CSF showed exudative changes and elevated number of leukocytes,with predominance of single nucleated cells.All patients were treated with the combined use of two to four from the drugs like doxycycline,rifampicin,ceftriaxone,cefixime,minocycline,levofloxacin and sulfanilamide.Most patients had a favorable prognosis.[Conclusions]Neurobrucellosis should be considered in all patients with central nervous system manifestations from endemic areas.If there are exudative changes in CSF,differential diagnoses can be made by serological testing,blood culture,CSF culture and NGS.NGS could significantly increase the accuracy for neuro-brucellosis diagnosis.
4.Polysaccharide from Ganoderma lucidum improves intestinal barrier function and activates Wnt/β-catenin signal pathway in rats with short bowel syndrome
Xiaoxia DONG ; Yun LI ; Jian CHANG ; Lin LIU ; Shufang GUO ; Jinhong YU ; Bing DONG
Immunological Journal 2024;40(9):727-731
Objective To investigate the impacts of polysaccharide from Ganoderma lucidum(PSG-1)on intestinal barrier function and Wnt/β-catenin signal pathway in rats with short bowel syndrome(SBS).Methods Fifty male SD rats were randomly divided into sham operation group,low dose PSG-1 group(25 mg?kg-1?d-1),medium dose PSG-1 group(50 mg?kg-1?d-1)and high dose PSG-1 group(100 mg?kg-1?d-1).SBS rat model was built,intestinal permeability of rats was detected,intestinal histopathology was observed with HE staining,and the bacterial translocation rate was calculated,the contents of inflammatory cytokines such as interleukin-6(IL-6),interleukin-10(IL-10)and tumor necrosis factor-α(TNF-α)were measured by ELISA,immunofluorescence was used to detect the expression and distribution of tight junction protein in ileum,Western blot was used to detect the expression of Wnt and β-catenin.Results Compared with the control group,the villi of ileum in SBS group were sparse,and the villi length,recess depth,Fluorescein isothiocyanate-dextran(FD-40)concentration,bacterial translocation rate(MLN,liver,spleen),levels of IL-6 and TNF-α were significantly increased,the levels of IL-10,Wnt,β-catenin,and the fluorescence densities and protein levels of claudin-1 and occludin were significantly decreased;compared with rats in SBS group,the FD-40 concentration,bacterial translocation rate(MLN,liver,spleen),levels of IL-6 and TNF-α in PSG-1 low,middle and high dose groups were significantly reduced,the villus length,recess depth,the levels of IL-10,Wnt,β-catenin,and the fluorescence densities and protein levels of claudin-1 and occludin were significantly increased.Conclusion PSG-1 may reduce inflammatory reaction and intestinal permeability and improve intestinal barrier dysfunction by activating the expression of Wnt/β-catenin pathway protein in SBS rats.
5.Polysaccharide from Ganoderma lucidum improves intestinal barrier function and activates Wnt/β-catenin signal pathway in rats with short bowel syndrome
Xiaoxia DONG ; Yun LI ; Jian CHANG ; Lin LIU ; Shufang GUO ; Jinhong YU ; Bing DONG
Immunological Journal 2024;40(9):727-731
Objective To investigate the impacts of polysaccharide from Ganoderma lucidum(PSG-1)on intestinal barrier function and Wnt/β-catenin signal pathway in rats with short bowel syndrome(SBS).Methods Fifty male SD rats were randomly divided into sham operation group,low dose PSG-1 group(25 mg?kg-1?d-1),medium dose PSG-1 group(50 mg?kg-1?d-1)and high dose PSG-1 group(100 mg?kg-1?d-1).SBS rat model was built,intestinal permeability of rats was detected,intestinal histopathology was observed with HE staining,and the bacterial translocation rate was calculated,the contents of inflammatory cytokines such as interleukin-6(IL-6),interleukin-10(IL-10)and tumor necrosis factor-α(TNF-α)were measured by ELISA,immunofluorescence was used to detect the expression and distribution of tight junction protein in ileum,Western blot was used to detect the expression of Wnt and β-catenin.Results Compared with the control group,the villi of ileum in SBS group were sparse,and the villi length,recess depth,Fluorescein isothiocyanate-dextran(FD-40)concentration,bacterial translocation rate(MLN,liver,spleen),levels of IL-6 and TNF-α were significantly increased,the levels of IL-10,Wnt,β-catenin,and the fluorescence densities and protein levels of claudin-1 and occludin were significantly decreased;compared with rats in SBS group,the FD-40 concentration,bacterial translocation rate(MLN,liver,spleen),levels of IL-6 and TNF-α in PSG-1 low,middle and high dose groups were significantly reduced,the villus length,recess depth,the levels of IL-10,Wnt,β-catenin,and the fluorescence densities and protein levels of claudin-1 and occludin were significantly increased.Conclusion PSG-1 may reduce inflammatory reaction and intestinal permeability and improve intestinal barrier dysfunction by activating the expression of Wnt/β-catenin pathway protein in SBS rats.
6.Relationship between perceived teacher support and academic procrastination among high school students: a chain mediating effect of future orientation and academic engagement
Shufang LIU ; Zhaonan YANG ; Huimin NIU ; Chang FANG ; Shuiqing RONG ; Qiongyi WANG ; Yanjie YANG ; Xiaohui QIU ; Zhengxue QIAO ; Xiuxian YANG
Chinese Journal of Behavioral Medicine and Brain Science 2023;32(9):833-838
Objective:To explore the chain mediating effect of future orientation and academic engagement between perceived teacher support and academic procrastination in high school students.Methods:From December 2021 to February 2022, a survey was conducted on 550 high school students by the perceived teacher support questionnaire, the adolescent future orientation scale, the academic engagement scale, and the general procrastination scale-for student populations (GPS). Data were entered by EpiData 3.1 software, and SPSS 26.0 software was used to process and analyze the data by one-way ANOVA, Pearson correlation analysis and Bootstrap method test.Results:The scores of perceived teacher support, future orientation, academic engagement and academic procrastination were (3.77±0.80), (3.22±0.48), (68.11±18.08) and (52.32±11.78) respectively.The results of correlation analysis showed that academic procrastination was negatively correlated with perceived teacher support, future orientation and academic engagement ( r=-0.32, -0.38, -0.49, all P<0.01), while perceived teacher support was positively correlated with future orientation and academic engagement ( r=0.40, 0.43, both P<0.01). Future orientation was positively correlated with academic engagement ( r=0.56, P<0.01). The mediating effect analysis showed that perceived teacher support had a significant direct effect on academic procrastination (effect value: -0.10, 95% CI =-0.19--0.02), accounting for 32.26% of the total effect.The mediating effect between perceived teacher support and academic procrastination was found between future orientation and academic engagement (effect value: -0.05, 95% CI =-0.09- -0.02; effect values: -0.09, 95% CI=-0.15--0.05), accounting for 16.13% and 29.03% of the total effect respectively.Future orientation and academic engagement had a chain mediating effect between perceived teacher support and academic procrastination (effect value: -0.07, 95% CI=-0.10--0.04), accounting for 22.58% of the total effect. Conclusion:Perceived teacher support can influence academic procrastination, not only through the direct path, but also through the indirect path of future orientation and academic engagement, as well as chain mediating path between these two variables.
7.Construction and identification of shRNA lentiviral vector targeting TPX2 gene
Haiping CHANG ; Shufang SONG ; Jie REN
Basic & Clinical Medicine 2017;37(7):945-952
Objective To construct the lentiviral RNA interference vector targeting TPX2 and to obtain the human cervical cancer HeLa cell strain stably infected by TPX2-shRNA for studying the relationship between human cervical carcinoma and TPX2 gene.Methods By targeting TPX2 gene,four double-stranded DNA hairpin structures corresponding to shRNA were designed,synthesized and connected with Pglv2-U6-Puro to construct the recombinant plasmids.Then these recombinant plasmids were transformed into DH5α competent cells.The positive clone was extracted and transfected into 293T cells for virus packages after sequenced correctly.Human cervical carcinoma HeLa cell infected by these recombinant lentiviral was screened by Puromycin,then stable cell strain was obtained.The silencing effect of TPX2 in HeLa cell was detected by RT-fluorescent quantitative PCR and Western blot.Cell cycle and cell apoptosis wer detected by Flow cytometry.Results Sequencing results confirmed that 5 lentiviral was packaged successfully.The steady cell strain transfered TPX2-shRNA was screened with 0.4 μg/mL puromycin.HeLa cells infected by recombinant lentivirus all play the gene silencing effect especially in the group of TPX2-shRNA-1.In the group of TPX2-shRNA-1,TPX2mRNA (0.21 ± 0.07) and protein (0.19 ± 0.28) rela tive expression level is lower than those in the control group (1.08±0.07) (P<0.01) and(0.64±0.03) (P< 0.01)respectively;G2 and S-phase cells are higher than those in the control group (P<0.05)and the apoptosis rate was significantly more than those in the control group (P<0.05).Conclusions The effective TPX2 genetic interference sequence was obtained,lentiviral vectors carrying TPX2shRNA was successfully constructed,and the HeLa cell strain with TPX2 silenced was successfully screened,which lay the research foundation for the study of the role of TPX2 in cervical cancer.
8.Establishment and application of toxicity testing alternative system for chemicals(new drugs)
Chang SHI ; Huazhi MA ; Quanjun WANG ; Chunqi WU ; Ye YUAN ; Fujiang SHI ; Shufang JING ; Jianjing WANG ; Mingyang LIAO
Chinese Journal of Comparative Medicine 2017;27(5):6-8
There are some shortcomings of animal experiments applied in chemical toxicity testing, such as long period, large cost, species differences and dose differences, which limit the use of animal experiments' results in predicting human toxicity.Accordingly, we established a toxicity testing alternative screening system in line with the toxicity endpoints which required in chemical safety evaluation and risk assessment (genotoxicity, carcinogenicity, reproductive toxicity, acute toxicity and general toxicity) based on 3R principles (replacement, reduction, refinement) for animal experiments.This system covers most of the endpoints of toxicity assessment, and molecular biology technology was also applied to integrate the toxicity test, as well as some operation was optimized in order to shorten the experimental period, reduce experimental costs, improve animal welfare.Furthermore, the results from the screening system have higher clinical relevance because it is based on the toxicity mechanisms.
9.Study of macrophages as cell carriers to deliver floate modified oxygen loaded contrast agent
Juan HE ; Shufang CHANG ; Jiangchuan SUN ; Shenyin ZHU ; Na WEI ; Tingting LUO ; Rong MA ; Zhigang WANG
Chinese Journal of Ultrasonography 2016;25(2):178-182
Objective To investigate the feasibility of macrophages as cell carriers to deliver floate modified oxygen loaded ultrasound contrast agent . Methods The phagocytic activity of macrophages was analyzed by ink phagocytose test , and the expression of folate recepters ( FRs ) on macrophages cell membrane surface was tested by immunofluofluorescence assay . Oxygen/paclitaxel loaded lipid microbubbles( OPLMB) and folate‐targeted OPLMB ( TOPLMB) were synthesized by mechanical shock method and incubated with macrophages in vitro . According to different treatment conditions ,the cells were divided into three groups:group A ( OPLMB) ,group B ( free folic acid + TOPLMB) and group C ( TOPLMB) , the fluorescence intensity of the cells were observed under fluorescence microscope ,and the phagocytic percentage and the phagocytic index of macrophages uptake OPLMB and TOPLMB were observed by bright field microscope . Results The phagocytic percentage of macrophages phagocytose ink was (99 .3 ± 1 .0)% ,FRs was highly expressed on macrophages cultured in vitro . After incubation for 30 minutes ,the fluorescence intensity of group C was significantly higher than those of A and B ,the phagocytic percentage in three groups were (19 .5 ± 0 .2)% ,(21 .0 ± 0 .2)% and (81 .2 ± 10 .0)% respetively . The phagocytic percentage of group C were significantly higher than those in group A and group B ( P <0 .05) . Conclusions Macrophages cultured in vitro possess highly phagocytic activity and these cells highly express FRs ,and can be used as cell carriers to deliver floate modified oxygen loaded multimodality ultrasound contrast agent .
10.Clinical significance of fetal weight estimation by modiefied uterine fundal height
Xitong TANG ; Jiangchuan SUN ; Shufang CHANG ; Yadong WANG
Chongqing Medicine 2015;(25):3526-3528
Objective To investigate the accuracy of fetal weight estimation by modiefied uterine fundal height.Methods Totally 547 pregnant women admitted to maternity ward of the Second Affiliated Hospital of Chongqing Medical University from December 1,2013 to April 30,2014 with childbirth were chosen as the subject.The modified uterine fundal height were measured by the uterus inclination and modiefied fundal height admeasuring apparatus,normal uterine fundal height and and abdomen circumfer-ence were measured by tape.The fetal weight was estimated by utilizing modified uterine fundal height.Results The modified fun-dal height was(31.7±2.30)cm,which was significantly higher than that normal fundal height(34.7 ± 2.46 )cm(t = 54.25,P <0.01).The accuracy rate of modified uterine fundal height for fetal weight estimation with empirical formulas,Yuan′s,Zhuo′s,Lin′s,Zen′s,Gu′s were 68.4%,69.7%,59.4%,67.8%,69.3%,78.4%,respectively.The accuracy rate of normal uterine fundal height for fetal weight estimation with the same formulas were 53.4%,34.4%,54.3%,46.1%,38.8%,45.9%,respectively.The accuracy rate of modiefied uterine fundal height for fetal weight estimation with empirical formulas,Yuan′s,Lin′s,Zen′s,Gu′s were significantly higher than that of utilizing normal uterine fundal height estimation with the same formulas(P <0.01).Conclusion Modified uterine fundal height has better accuracy in estimating fetal weight,it has a important clinical significance.

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