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.Surveillance report of data of nosocomial infections in a three-A general hospital of Jiangsu Province from 2014 to 2023
Hao GONG ; Shufang JIANG ; Chengyi FENG ; Jia DI
Chinese Journal of Nosocomiology 2025;35(6):939-944
OBJECTIVE To explore the current status of surveillance data of nosocomial infections in a three-A hos-pital of Jiangsu Province and find out the problems in prevention and control of the nosocomial infection so as to provide scientific bases for formulating targeted prevention strategies.METHODS The related data of all infection cases from Changzhou First People's Hospital between 2014 and 2023 were exported from information real-time surveillance system and were analyzed by using Excel 2021 and R 4.3.2 software.RESULTS The average incidence rate of hospital-associated infection was 1.32%from 2014 to 2023,declining from 2.11%in 2014 to 0.97%in 2023,and it showed a downward trend(Z=-30.010,P<0.001).The incidence rate of hospital-associated infec-tion was 19.86%in neurosurgery department(Z=-3.041,P=0.002),10.27%in hematology department(Z=5990,P<0.001),8.85%in neurology department(Z=-1.437,P=0.151),7.00%in critical care medicine de-partment(Z=5.907,P<0.001),6.28%in gastrointestinal surgery department(Z=-4.435,P<0.001),thorac-ic surgery department(Z=1.696,P=0.090),4.52%in cardiothoracic surgery department(Z=13.218,P<0.001),2.95%in oncology department(Z=9.064,P<0.001).Among the patients with hospital-associated infec-tions,the patients with lower respiratory tract infection accounted for 46.71%(the highest),increasing from 34.94%to 51.67%(Z=12.532,P<0.001),the patients with upper respiratory tract infection 10.37%(Z=-10.229,P<0.001),the patients with urinary tract infection 6.92%(Z=1.489,P=0.137),the patients with urinary catheter-related infection 3.71%(Z=13.218,P=0.317).Totally 13,593 strains of pathogens were isola-ted,65.26%of which were gram-negative bacteria and did not show a significant changing trend,24.62%were gram-positive bacteria,and 10.12%were fungi;Klebsiella pneumoniae(15.76%)and Acinetobacter baumannii(15.34%)were the predominant species of the gram-negative bacteria;Staphylococcus aureus(8.37%)and Corynebacterium striatum(3.60%)were dominant among the gram-positive bacteria;Candida albicans(5.13%)and Candida tropicalis(0.96%)were the major species of the fungi.The percentage of central venous catheteriza-tion was the highest(27.04%)among the risk factors for the hospital-associated infection,increasing from 14.87%to 21.75%(Z=17.482,P<0.001).CONCLUSIONS The control of hospital-associated infection has been made remarkable achievement.It is necessary to strengthen the construction of infection control team,push for-ward the whole process and delicacy management,normalize the use of antibiotics,reduce the unnecessary inva-sive procedures and shorten the duration of invasive operations so as to further improve the medical quality.
3.Surveillance report of data of nosocomial infections in a three-A general hospital of Jiangsu Province from 2014 to 2023
Hao GONG ; Shufang JIANG ; Chengyi FENG ; Jia DI
Chinese Journal of Nosocomiology 2025;35(6):939-944
OBJECTIVE To explore the current status of surveillance data of nosocomial infections in a three-A hos-pital of Jiangsu Province and find out the problems in prevention and control of the nosocomial infection so as to provide scientific bases for formulating targeted prevention strategies.METHODS The related data of all infection cases from Changzhou First People's Hospital between 2014 and 2023 were exported from information real-time surveillance system and were analyzed by using Excel 2021 and R 4.3.2 software.RESULTS The average incidence rate of hospital-associated infection was 1.32%from 2014 to 2023,declining from 2.11%in 2014 to 0.97%in 2023,and it showed a downward trend(Z=-30.010,P<0.001).The incidence rate of hospital-associated infec-tion was 19.86%in neurosurgery department(Z=-3.041,P=0.002),10.27%in hematology department(Z=5990,P<0.001),8.85%in neurology department(Z=-1.437,P=0.151),7.00%in critical care medicine de-partment(Z=5.907,P<0.001),6.28%in gastrointestinal surgery department(Z=-4.435,P<0.001),thorac-ic surgery department(Z=1.696,P=0.090),4.52%in cardiothoracic surgery department(Z=13.218,P<0.001),2.95%in oncology department(Z=9.064,P<0.001).Among the patients with hospital-associated infec-tions,the patients with lower respiratory tract infection accounted for 46.71%(the highest),increasing from 34.94%to 51.67%(Z=12.532,P<0.001),the patients with upper respiratory tract infection 10.37%(Z=-10.229,P<0.001),the patients with urinary tract infection 6.92%(Z=1.489,P=0.137),the patients with urinary catheter-related infection 3.71%(Z=13.218,P=0.317).Totally 13,593 strains of pathogens were isola-ted,65.26%of which were gram-negative bacteria and did not show a significant changing trend,24.62%were gram-positive bacteria,and 10.12%were fungi;Klebsiella pneumoniae(15.76%)and Acinetobacter baumannii(15.34%)were the predominant species of the gram-negative bacteria;Staphylococcus aureus(8.37%)and Corynebacterium striatum(3.60%)were dominant among the gram-positive bacteria;Candida albicans(5.13%)and Candida tropicalis(0.96%)were the major species of the fungi.The percentage of central venous catheteriza-tion was the highest(27.04%)among the risk factors for the hospital-associated infection,increasing from 14.87%to 21.75%(Z=17.482,P<0.001).CONCLUSIONS The control of hospital-associated infection has been made remarkable achievement.It is necessary to strengthen the construction of infection control team,push for-ward the whole process and delicacy management,normalize the use of antibiotics,reduce the unnecessary inva-sive procedures and shorten the duration of invasive operations so as to further improve the medical quality.
4.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
5.Study on extraction and enrichment technology of 2 active components in Tibetan medicine Chrysosplenium axillare
Yunfen LI ; Si CHEN ; NIZHEN ; Jiamei XIANG ; Zejing MU ; Yuye ZHU ; Shufang GONG ; Gang REN
China Pharmacy 2023;34(5):544-547
OBJECTIVE To study the extraction and enrichment technology of chrysosplenides A (CA) and I (CI) in Tibetan medicine Chrysosplenium axillare. METHODS HPLC method was used to determine the contents of CA and CI. The orthogonal experiment was used to optimize the extraction technology of CA and CI in C. axillare using total transfer rate of CA and CI as evaluation indexes, with volume fraction of ethanol, extraction temperature, extraction times and solid-liquid ratio as factors. The validation test was also performed. The enrichment technology of CA and CI in C. axillare was optimized using D101 macroporous adsorption resin as adsorbent, total contents of CA and CI as evaluation indexes, with the volume fraction and dosage of eluent for impurities and target components. The validation test was also performed. RESULTS The optimum extraction conditions of CA and CI from C. axillare were as follows: the medicinal powder of C. axillare was extracted by ultrasound at room temperature for 45 min at one time with 8 times of 50% ethanol. Results of validation tests showed that total transfer rate of CA and CI in C. axillare was 95.43% in average (RSD=1.02%, n=3). The optimal enrichment technology was as follows: the sample solution was added into D101 macroporous adsorption resin column and stood for 1 hour; the impurities were eluted with 20% ethanol 4 BV (column volume), and CA and CI were eluted with 50% ethanol 4 BV. The results of validation tests showed that total content of CA and CI was 322.7 mg/g in average (RSD=1.05%, n=3), with average enrichment multiple of 11.61 times. CONCLUSIONS The study has successfully optimized the extraction and enrichment technology of CA and CI from C. axillare, and can provide reference for the development and utilization of CA and CI.
6.Role of Bruton′s tyrosine kinase in endotoxin/lipopolysaccharide-induced pyroptosis of intestinal cells in scalded mice
Xu JIN ; Jia WAN ; Shufang DUAN ; Yuzhou GONG ; Fei WANG ; Xulin CHEN
Chinese Journal of Burns 2021;37(6):546-554
Objective:To investigate the role of Bruton's tyrosine kinase (BTK) in pyroptosis of intestinal cells caused by endotoxin/lipopolysaccharide (LPS) in scalded mice.Methods:The experimental research method was applied. One hundred and twenty-eight male C57BL/6 mice aged 6-8 weeks were divided into sham injury group, scald alone group, scald+LPS group, scald+LPS+3 mg/kg LFM-A13 group, scald+LPS+10 mg/kg LFM-A13 group, and scald+LPS+30 mg/kg LFM-A13 group. There were 8 mice in sham injury group, and there were 24 mice in the other 5 groups, respectively. Mice in 5 scald groups were inflicted with 10% total body surface area full-thickness scald on the back, and mice in sham injury group were sham injured on the back. At post injury hour (PIH) 0 (immediately), mice in sham injury group and scald alone group were intraperitoneally injected with normal saline, mice in scald+LPS group were intraperitoneally injected with LPS, and mice in scald+LPS+3 mg/kg LFM-A13 group, scald+LPS+10 mg/kg LFM-A13 group, and scald+LPS+30 mg/kg LFM-A13 group were intraperitoneally injected with LPS and LFM-A13 in corresponding doses. Mice in sham injury group were sacrificed at PIH 0 to collect serum and intestinal tissue, and 8 mice in each group of 5 scald groups were sacrificed at PIH 0, 12, and 24 to collect intestinal tissue and serum at PIH 12. Immunohistochemistry was used to detect phosphorylation of BTK in intestinal tissue of mice. Western blotting was used to detect the protein expressions of phosphorylated BTK (p-BTK), cleaved cysteine aspartic acid specific protease 1 (caspase-1), and cleaved caspase-11 in intestinal tissue of mice. Enzyme-linked immunosorbent assay method was used to detect interleukin-1β (IL-1β) in serum and intestinal tissue of mice. Data were statistically analyzed with one-way analysis of variance and least significant difference test.Results:There was no obvious phosphorylation of BTK in intestinal tissue of mice in 6 groups at PIH 0 and scald alone group at PIH 12 and 24. Phosphorylation of BTK in intestinal tissue of mice in scald+LPS group at PIH 12 and 24 were obviously increased compared with those in scald alone group. Phosphorylation of BTK in intestinal tissue of mice in scald+LPS+3 mg/kg LFM-A13 group, scald+LPS+10 mg/kg LFM-A13 group, and scald+LPS+30 mg/kg LFM-A13 group were obviously decreased compared with those in scald+LPS group, and the degrees of decline gradually increased with increase of dose in LFM-A13. Compared with (0.130±0.010) of sham injury group and (0.120±0.040 and 0.110±0.040) of scald alone group, protein expressions of p-BTK in intestinal tissue of mice in scald+LPS group at PIH 12 and 24 were obviously increased (0.470±0.090 and 0.430±0.080, P<0.01). Compared with those in scald+LPS group, protein expressions of p-BTK in intestinal tissue of mice in scald+LPS+3 mg/kg LFM-A13 group at PIH 24, and scald+LPS+10 mg/kg LFM-A13 group and scald+LPS+30 mg/kg LFM-A13 group at PIH 12 and 24 were obviously decreased (0.280±0.060, 0.300±0.120, 0.150±0.050, 0.280±0.090, 0.140±0.040, P<0.05 or P<0.01). Compared with those in scald+LPS+3 mg/kg LFM-A13 group, protein expressions of p-BTK in intestinal tissue of mice in scald+LPS+10 mg/kg LFM-A13 group and scald+LPS+30 mg/kg LFM-A13 group at PIH 24 were obviously decreased ( P<0.01). Compared with those in sham injury group and scald alone group, protein expressions of cleaved caspase-1 and caspase-11 in intestinal tissue of mice in scald+LPS group were obviously increased at PIH 12 and 24 ( P<0.01). Compared with those in scald+LPS group, protein expressions of cleaved caspase-1 at PIH 12 and cleaved caspase-11 at PIH 12 and 24 in intestinal tissue of mice in scald+LPS+3 mg/kg LFM-A13 group and protein expressions of cleaved caspase-1 and caspase-11 in intestinal tissue of mice in scald+LPS+10 mg/kg LFM-A13 group and scald+LPS+30 mg/kg LFM-A13 group at PIH 12 and 24 were obviously decreased ( P<0.01). Compared with those in scald+LPS+3 mg/kg LFM-A13 group, protein expressions of cleaved caspase-1 and caspase-11 in intestinal tissue of mice in scald+LPS+10 mg/kg LFM-A13 group and scald+LPS+30 mg/kg LFM-A13 group at PIH 12 and 24 were obviously decreased ( P<0.05 or P<0.01). At PIH 12, content of IL-1β in intestinal tissue and serum of mice in scald+LPS group were obviously higher than those in sham injury group and scald alone group ( P<0.01), and content of IL-1β in intestinal tissue and serum of mice in scald+LPS+30 mg/kg LFM-A13 group were obviously lower than those in scald+LPS group ( P<0.01). Conclusions:Phosphorylation of BTK is related to increases of cleaved caspase-1 and caspase-11 in intestinal tissue, and IL-1β content in intestinal tissue and serum of scalded septic mice caused by LPS. Phosphorylation of BTK mediates intestinal cell pyroptosis of scalded mice caused by LPS. Inhibiting phosphorylation of BTK can alleviate intestinal cell pyroptosis of scalded mice, with protective effect on intestinal injury intestine.
7. The association of pre-pregnancy body mass and weight gain during pregnancy with macrosomia: a cohort study
Ping FENG ; Xiaoyu WANG ; Zhiwen LONG ; Shufang SHAN ; Danting LI ; Yi LIANG ; Mengxue CHEN ; Yunhui GONG ; Rong ZHOU ; Dagang YANG ; Ruonan DUAN ; Tian QIAO ; Yue CHEN ; Jing LI ; Guo CHENG
Chinese Journal of Preventive Medicine 2019;53(11):1147-1151
Objective:
To examine the association of pre-pregnancy body mass and weight gain during pregnancy with macrosomia.
Methods:
From January 2015 to December 2015, a total of 20 477 pregnant women were recruited by probabilistic proportional scale sampling with simple randomization in Sichuan, Yunnan and Guizhou Provinces. Basic information of pregnant women, weight gain during pregnancy and weight of newborn were collected. A multiple logistic regression model was used to assess the association between the pre-pregnancy body mass and gestational weight gain indicators with macrosomia.
Results:
20 321 mother-infant were included in the final analysis. 20 321 pregnant women were (30.09±4.10) years old and delivered at (39.20±1.29) weeks, among which 12 341 (60.73%) cases were cesarean delivery. The birth weight of 20 321 infants were (3 292.26±431.67) grams, and 970 (4.77%) were macrosomia. The multiple logistic regression model showed that after adjusting for the age of women, compared to the normal weight group in the pre-pregnancy, the overweight and obesity group elevated the risk of macrosomia, with
9.The association of pre?pregnancy body mass and weight gain during pregnancy with macrosomia:a cohort study
Ping FENG ; Xiaoyu WANG ; Zhiwen LONG ; Shufang SHAN ; Danting LI ; Yi LIANG ; Mengxue CHEN ; Yunhui GONG ; Rong ZHOU ; Dagang YANG ; Ruonan DUAN ; Tian QIAO ; Yue CHEN ; Jing LI ; Guo CHENG
Chinese Journal of Preventive Medicine 2019;53(11):1147-1151
Objective To examine the association of pre?pregnancy body mass and weight gain during pregnancy with macrosomia. Methods From January 2015 to December 2015, a total of 20 477 pregnant women were recruited by probabilistic proportional scale sampling with simple randomization in Sichuan, Yunnan and Guizhou Provinces. Basic information of pregnant women, weight gain during pregnancy and weight of newborn were collected. A multiple logistic regression model was used to assess the association between the pre?pregnancy body mass and gestational weight gain indicators with macrosomia. Results 20 321 mother?infant were included in the final analysis. 20 321 pregnant women were (30.09 ± 4.10) years old and delivered at (39.20 ± 1.29) weeks, among which 12 341 (60.73%) cases were cesarean delivery. The birth weight of 20 321 infants were (3 292.26 ± 431.67) grams, and 970 (4.77%) were macrosomia. The multiple logistic regression model showed that after adjusting for the age of women, compared to the normal weight group in the pre?pregnancy, the overweight and obesity group elevated the risk of macrosomia, with OR (95%CI) about 1.99 (95%CI: 1.69-2.35) and 4.05 (95%CI: 3.05-5.39), respectively. After adjusting for the age, the pre?pregnancy BMI, delivery weeks, delivery mode and infant's gender, compared to the weight?gain appropriate group, higher weight gain rate in the mid?pregnancy and excessive total gestational weight gain elevated the risk of macrosomia, with OR (95%CI) about 1.99 (95%CI:1.66-2.39) and 1.80 (95%CI: 1.55-2.08), respectively. Conclusion The overweight before pregnancy, obesity before pregnancy, the rate of weight gain in the second trimester and the high total weight gain during pregnancy could increase the risk of macrosomia.
10.The association of pre?pregnancy body mass and weight gain during pregnancy with macrosomia:a cohort study
Ping FENG ; Xiaoyu WANG ; Zhiwen LONG ; Shufang SHAN ; Danting LI ; Yi LIANG ; Mengxue CHEN ; Yunhui GONG ; Rong ZHOU ; Dagang YANG ; Ruonan DUAN ; Tian QIAO ; Yue CHEN ; Jing LI ; Guo CHENG
Chinese Journal of Preventive Medicine 2019;53(11):1147-1151
Objective To examine the association of pre?pregnancy body mass and weight gain during pregnancy with macrosomia. Methods From January 2015 to December 2015, a total of 20 477 pregnant women were recruited by probabilistic proportional scale sampling with simple randomization in Sichuan, Yunnan and Guizhou Provinces. Basic information of pregnant women, weight gain during pregnancy and weight of newborn were collected. A multiple logistic regression model was used to assess the association between the pre?pregnancy body mass and gestational weight gain indicators with macrosomia. Results 20 321 mother?infant were included in the final analysis. 20 321 pregnant women were (30.09 ± 4.10) years old and delivered at (39.20 ± 1.29) weeks, among which 12 341 (60.73%) cases were cesarean delivery. The birth weight of 20 321 infants were (3 292.26 ± 431.67) grams, and 970 (4.77%) were macrosomia. The multiple logistic regression model showed that after adjusting for the age of women, compared to the normal weight group in the pre?pregnancy, the overweight and obesity group elevated the risk of macrosomia, with OR (95%CI) about 1.99 (95%CI: 1.69-2.35) and 4.05 (95%CI: 3.05-5.39), respectively. After adjusting for the age, the pre?pregnancy BMI, delivery weeks, delivery mode and infant's gender, compared to the weight?gain appropriate group, higher weight gain rate in the mid?pregnancy and excessive total gestational weight gain elevated the risk of macrosomia, with OR (95%CI) about 1.99 (95%CI:1.66-2.39) and 1.80 (95%CI: 1.55-2.08), respectively. Conclusion The overweight before pregnancy, obesity before pregnancy, the rate of weight gain in the second trimester and the high total weight gain during pregnancy could increase the risk of macrosomia.

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