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.The rescue of and pathogenicity of recombinant Muscovy duck parvovirus
Zhixian WANG ; Xiaoyan GONG ; Wanmei LI ; Jueyi LING ; Zhiwei JIANG ; Wei ZHANG ; Jian YIN ; Yufeng LI ; Guoqiang ZHU ; Jianye WANG
Chinese Journal of Veterinary Science 2025;45(10):2142-2147
In order to delve into the molecular mechanism underlying the increased pathogenicity of the recombinant Muscovy duck parvovirus(rMDPV)towards Muscovy ducklings,two sub-genom-ic fragments of the rMDPV strain ZW were cloned into the plasmid pBluescript Ⅱ(SK)to gener-ate the recombinant plasmid pZW.A single nucleotide mutation was engineered in the VP3 gene of pZW to discriminate from the parental strain ZW.pZW plasmid-lipid complex was transfected into the chorioallantoic membrane of 11-day-old embryonated Muscovy duck embryos,resulting in res-cue of infectious virus,rZW,carrying the genetic marker.The rescued virus was passaged in 12-day-old embryonated Muscovy duck embryos and exhibited the similar medium embryo lethal dose(ELD50)value and growth curve compared to the parental strain ZW.Both rZW and strain ZW led to 100%mortality in the infection tests performed with 3-day-old Muscovy duckling.Postmortem necropsy revealed a characteristic intestine embolism formed in the rZW-infected ducklings.Taken together,the generation of the infectious clone pZW lays a solid foundation for deciphering the pathogenesis of rMDPV.
3.The rescue of and pathogenicity of recombinant Muscovy duck parvovirus
Zhixian WANG ; Xiaoyan GONG ; Wanmei LI ; Jueyi LING ; Zhiwei JIANG ; Wei ZHANG ; Jian YIN ; Yufeng LI ; Guoqiang ZHU ; Jianye WANG
Chinese Journal of Veterinary Science 2025;45(10):2142-2147
In order to delve into the molecular mechanism underlying the increased pathogenicity of the recombinant Muscovy duck parvovirus(rMDPV)towards Muscovy ducklings,two sub-genom-ic fragments of the rMDPV strain ZW were cloned into the plasmid pBluescript Ⅱ(SK)to gener-ate the recombinant plasmid pZW.A single nucleotide mutation was engineered in the VP3 gene of pZW to discriminate from the parental strain ZW.pZW plasmid-lipid complex was transfected into the chorioallantoic membrane of 11-day-old embryonated Muscovy duck embryos,resulting in res-cue of infectious virus,rZW,carrying the genetic marker.The rescued virus was passaged in 12-day-old embryonated Muscovy duck embryos and exhibited the similar medium embryo lethal dose(ELD50)value and growth curve compared to the parental strain ZW.Both rZW and strain ZW led to 100%mortality in the infection tests performed with 3-day-old Muscovy duckling.Postmortem necropsy revealed a characteristic intestine embolism formed in the rZW-infected ducklings.Taken together,the generation of the infectious clone pZW lays a solid foundation for deciphering the pathogenesis of rMDPV.
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.Experimental study of en-bloc resection of bladder tumors by transurethral single-port laparoscopy in vivo animal models
Weifeng WANG ; Jun ZHANG ; Jiansheng WAN ; Siming LIU ; Yuan ZOU ; Shaoqiu ZHENG ; Jidong HAO ; Guoqiang LIAO ; Hua GONG ; Lei OUYANG
Journal of Modern Urology 2024;29(2):179-182
【Objective】 To explore the feasibility of en-bloc resection of bladder tumors by flexible cystoscope combined with laparoscopic instruments through urethra and to provide reference for the clinical application of this technique. 【Methods】 Self-designed and processed transurethral single-hole PORT and Olympus electronic cystoscope were used as observation mirror; Φ1.8 mm soft grasper, tissue scissors, electric hook, and ultrasonic scalpel were used as instruments; the porcine bladder was used as a model.The PORT was placed through the urethra, and the cystoscope was inserted to observe the inner wall of the bladder and the condition of the mucosa.After the lesion site was identified in the bladder cavity, the soft grasper was inserted to pull the mucosa to be removed, which was then fixed with tension at the target position to maintain a satisfactory feild of view.The surgeon held the cystoscope in the left hand, and operated the laparoscopic instruments into the bladder cavity through the PORT with the right hand.Observing with the cystoscope and lifting and pulling the mucosa with the grasper, the surgeon simulated the cutting and pushing actions to realize the en-bloc resection of the lesioned mucosa. 【Results】 The mucosa at 4 different locations were successfully resected on 2 in vitro porcine bladder models. 【Conclusion】 The in vitro experiments show that the combination of flexible electronic cystoscope and laparoscopic instruments achieves synergistic effects in en-bloc resection of bladder tumor by transurethral single-hole laparoscope without additional iatrogenic bladder injury caused by percutaneous bladder incision.This method is feasible in the treatment of bladder tumors, and has the potential of clinical application after further optimization.
6.Influence of limb-lead combination on the accuracy of the estimation of cardiac electrical axis
Yanjun LI ; Weibo LIU ; Guoqiang GONG ; Lin ZHANG ; Jinzhong SONG ; Yijing YANG
Space Medicine & Medical Engineering 2024;35(3):137-142
Objective There are 6 leads of limb lead ECG,and the cardiac electrical axis can be estimated by any combination of two leads.In this paper,the estimation accuracy of all 15 pairs of limb-lead combinations was compared.Methods Using the open database of 12-lead electrocardiograms(at a sampling frequency of 500 Hz with duration of 10 seconds during resting state)from PhysioNet,totally 21 306 ECG records were extracted with age≥18 years which labeled as single sinus type(axis normal),including 6 153 records with Sinus Rhythm,10 916 records with Sinus Bradycardia,3 466 records with Sinus Tachycardia,and 771 records with Sinus Irregularity.Moreover,totally 2 323 axis deflection recordings with age≥18 years were extracted,including 1 526 records with Axis left shift,and 797 records with Axis right shift.Cardiac electrical axis was estimated with the net amplitude(or area)of QRS complex(algebraic sum of positive and negative amplitude or area)by any pair of leads from{Ⅰ,Ⅱ},{Ⅰ,Ⅲ},{Ⅰ,aVR},{Ⅰ,aVL},{Ⅰ,aVF},{Ⅱ,Ⅲ},{Ⅱ,aVR},{Ⅱ,aVL},{Ⅱ,aVF},{Ⅲ,aVR},{Ⅲ,aVL},{Ⅲ,aVF},{aVR,aVL},{aVR,aVF},{aVL,aVF},respectively.Results For the amplitude-based method,the recognition accuracy for the normal,left and right axes from{Ⅰ,Ⅱ}and{Ⅱ,aVL}is 93.56%and 93.50%,respectively,which is better than that of the traditional classical method{I,aVF}(92.93%).For the area-based method,the recognition accuracy from{Ⅲ,aVR},{Ⅰ,aVR},{Ⅰ,Ⅱ},{aVR,aVF},{Ⅱ,aVL}and{Ⅱ Ⅲ}is 92.66%,92.53%,92.29%,92.19%,92.10%and 91.91%,respectively,which is better than the traditional classical method{Ⅰ,aVF}(91.82%).Conclusion The accuracy of amplitude-based method is higher than that of area-based method.Lead pair{Ⅰ,Ⅱ}and{Ⅱ,aVL}have higher accuracy than traditional classical{Ⅰ,aVF}in automatic estimation of cardiac electrical axis for both amplitude and area method.
7.Sleep Stages classification based on electrooculogram and electromyogram toward manned spaceflight
Yanjun LI ; Guoqiang GONG ; Yu ZHANG ; Zengyuan YIN ; Congmiao SHAN
Space Medicine & Medical Engineering 2024;35(5):282-288
Objective In order to simplify the hygiene processing and reduce the load of sleep monitoring,a method of sleep quality assessment on orbit without EEG is explored.Methods Using the open database ISRUC-Sleep with AASM standard,the training set(n=20)and the test set(sleep disorder group(n=10)and health group(n=10))are completely independent.The electrooculogram(EOG)features include the energy,the root mean square,correlation coefficients and phase-locked values between different frequency bands of two-channel EOG.The electromyogram(EMG)features include fractal dimension,root mean square,the mean value,the maximum value and the root mean square of EMG envelope.Linear support vector machine(LSVM)and random forest(RF)were used to classify wakefulness,REM sleep,light sleep and deep sleep.The accuracy was compared with the results that derived from six-channel electroencephalogram(EEG),two-channel EOG and one-channel EMG.Results Using 50 normalized features of EOG(44 features)and EMG(6 features),for sleep disorder group,kappa coefficients were both 0.75 by RF and by LSVM;for healthy group,the kappa coefficients were 0.73 by RF and 0.70 by LSVM.As a reference for AASM standard,using 140 normalized features of EEG(90 features),EOG(44 features)and EMG(6 features),for sleep disorder group,kappa coefficients were 0.78 by RF and 0.79 by LSVM;for healthy group,kappa coefficients were 0.74 by RF and 0.76 by LSVM.Conclusion The accuracy of sleep scoring from two-channel EOG and one-channel EMG is comparable with that of the gold standard,and can be applied to evaluate the sleep quality during manned spaceflight.
8.Chinese Fetal Growth: A Multicenter Cohort Study Based on Fetal Ultrasound Measurements
Xiaoli GONG ; Tianchen WU ; Xiaoli WANG ; Lizhen ZHANG ; Yiping YOU ; Hongwei WEI ; Xifang ZUO ; Ying ZHOU ; Xinli XING ; Zhaoyan MENG ; Qi LYU ; Zhaodong LIU ; Jian ZHANG ; Liyan HU ; Junnan LI ; Li LI ; Chulin CHEN ; Chunyan LIU ; Guoqiang SUN ; Aiju LIU ; Jingsi CHEN ; Yuan LYU ; Yuan WEI ; Yangyu ZHAO
Maternal-Fetal Medicine 2023;05(1):16-26
Objective::To build a reference fetal growth chart for the Chinese population based on fetal ultrasound measurements.Methods::This was a multicenter, population-based retrospective cohort study. Longitudinal ultrasound measurement data were collected from 24 hospitals in 18 provinces of China from 1 st September through 31 st October of 2019. The estimated fetal weight (EFW) was calculated based on head circumference, abdominal circumference, and femur length using Hadlock formula 3. Fetal growth curves were estimated using a two-level linear regression model with cubic splines. All participants were divided into two groups: the northern group ( n = 5829) and the southern group ( n = 3246) based on the geographical division of China and male fetus group ( n = 4775) and female fetus group ( n = 4300) based on fetal gender. The EFW was compared by fetal gender and geographical group. All statistical models were adjusted for maternal sociodemographic characteristics. Results::A total of 9075 participants with 31,700 ultrasound measurement records were included in this study. Male fetuses demonstrated significantly larger EFW compared to female ones starting at 16 weeks of gestation and extending to delivery (global test P < 0.01). The overall geographic difference in EFW was significant (global test P = 0.03), and week-specific comparisons showed that the northern group had a greater EFW starting at 15 weeks of gestation and extending to 29 weeks of gestation, although this difference did not extend to the time of delivery. The Z-score of EFW confirmed that our Chinese fetal growth charts differed from previously published standards. Conclusion::This study provides EFW and ultrasound biometric reference measurements for Chinese fetuses and reveals differences from other fetal growth charts. The chart is worth promoting in more regions of China but should be tested prudently before use.
9.Chinese Fetal Growth: A Multicenter Cohort Study Based on Fetal Ultrasound Measurements
Xiaoli GONG ; Tianchen WU ; Xiaoli WANG ; Lizhen ZHANG ; Yiping YOU ; Hongwei WEI ; Xifang ZUO ; Ying ZHOU ; Xinli XING ; Zhaoyan MENG ; Qi LYU ; Zhaodong LIU ; Jian ZHANG ; Liyan HU ; Junnan LI ; Li LI ; Chulin CHEN ; Chunyan LIU ; Guoqiang SUN ; Aiju LIU ; Jingsi CHEN ; Yuan LYU ; Yuan WEI ; Yangyu ZHAO
Maternal-Fetal Medicine 2023;05(1):16-26
Objective::To build a reference fetal growth chart for the Chinese population based on fetal ultrasound measurements.Methods::This was a multicenter, population-based retrospective cohort study. Longitudinal ultrasound measurement data were collected from 24 hospitals in 18 provinces of China from 1 st September through 31 st October of 2019. The estimated fetal weight (EFW) was calculated based on head circumference, abdominal circumference, and femur length using Hadlock formula 3. Fetal growth curves were estimated using a two-level linear regression model with cubic splines. All participants were divided into two groups: the northern group ( n = 5829) and the southern group ( n = 3246) based on the geographical division of China and male fetus group ( n = 4775) and female fetus group ( n = 4300) based on fetal gender. The EFW was compared by fetal gender and geographical group. All statistical models were adjusted for maternal sociodemographic characteristics. Results::A total of 9075 participants with 31,700 ultrasound measurement records were included in this study. Male fetuses demonstrated significantly larger EFW compared to female ones starting at 16 weeks of gestation and extending to delivery (global test P < 0.01). The overall geographic difference in EFW was significant (global test P = 0.03), and week-specific comparisons showed that the northern group had a greater EFW starting at 15 weeks of gestation and extending to 29 weeks of gestation, although this difference did not extend to the time of delivery. The Z-score of EFW confirmed that our Chinese fetal growth charts differed from previously published standards. Conclusion::This study provides EFW and ultrasound biometric reference measurements for Chinese fetuses and reveals differences from other fetal growth charts. The chart is worth promoting in more regions of China but should be tested prudently before use.
10.Geritinib in the targeted therapy of acute myeloid leukemia with FLT3 mutation: report of 5 cases and review of literature
Weiling LIANG ; Jihao ZHOU ; Yun CAI ; Lixin WANG ; Guoqiang LI ; Bingbing WEN ; Weiqiang ZHAO ; Gong ZHONG ; Jun WANG ; Jianliang CHEN ; Xiaolin PEI ; Li ZHOU ; Zhimei ZHU ; Hua YANG
Journal of Leukemia & Lymphoma 2022;31(11):669-674
Objective:To investigate the efficacy and safety of geritinib in the treatment of acute myeloid leukemia (AML) with FLT3 mutation.Methods:The clinical data of 5 AML patients with FLT3 mutation who were diagnosed in the University of Hong Kong-Shenzhen Hospital, Shenzhen People's Hospital, Shenzhen Second People's Hospital, Shenzhen University General Hospital from March 2020 to April 2021 were retrospectively analyzed. Relapsed patients concurrently received two- or three-drug chemotherapy combined with geritinib. Blood routine was checked once a week; liver function and renal function were checked once every 2 weeks during treatment. Bone marrow puncture was performed once every 1 to 3 months to monitor the bone marrow morphology, minimal residual disease (MRD) and FLT3 mutation expression levels. The efficacy, side effects, overall survival of these patients were analyzed after treatment with geritinib.Results:The white blood cell was increased in all the 5 patients at the initial diagnosis. FLT3 mutations analysis showed FLT3-internal tandem duplication (ITD) (3 cases) and FLT-3 tyrosine-kinase domain (TKD) (2 cases). Among 5 patients, 1 patient was relapse-free with maintenance therapy of oral geritinib after hematological stem cell transplantation (HSCT) for 60 days; among other 4 relapsed and refractory patients, 1 female patient after pregnancy relapsed after transplantation and then achieved complete remission followed by the maintenance therapy with geritinib after oral geritinib, 1 16-year-old patient achieved treatment outcome close to the complete remission after treatment with geritinib, 1 patient achieved complete remission after treatment with geritinib, and then underwent haplo-HSCT followed by the maintenance therapy with geritinib and the other 1 relapsed patient achieved complete remission after treatment with geritinib. After transplantation, 3 patients receiving maintenance treatment of geritinib did not relapse. The main side effects included anemia, decreased neutrophil count, rash, and increased aminotransferase. The median follow-up time of 5 patients was 15 months (6-20 months). All 5 cases survived until the last follow-up in November 2021 and 4 patients were disease-free.Conclusions:Relapsed and refractory AML patients with FLT3 mutation can achieve complete remission after treatment with geritinib and get a chance for transplantation. Geritinib may reduce the risk of recurrence after transplantation and improve survival rate. No serious side effects occur in geritinib treatment.

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