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.The predictive value of pulse oxygen perfusion index and blood lactic acid concentration for early retinopathy of prematurity
Bing ZHANG ; Xiaoxiao ZHAO ; Yujuan HE ; Weixing ZHANG ; Ximin FENG
Recent Advances in Ophthalmology 2024;44(5):387-390
Objective To investigate the value of pulse oxygen perfusion index(PI)and blood lactic acid(BLA)concentration in early prediction of retinopathy of prematurity(ROP).Methods A retrospective case-control study was conducted on 128 preterm infants who met the inclusion criteria and were admitted to the neonatal intensive care unit of our hospital from September 2018 to December 2022.Among them,46 patients with ROP were in the ROP group,and 82 pa-tients without ROP were in the non-ROP group.Basic data of these preterm infants were recorded after admission.PI val-ues were continuously monitored with the Masimo Radical-7(USA)SpO2 blood oxygen saturation detector,and BLA con-centrations were detected with the ABL90FLEX blood gas analyzer.The receiver operating characteristic(ROC)curve and area under curve(AUC)were used to evaluate the value of PI and BLA concentration in early prediction of ROP.Results There were no significant differences in gestational age,birth weight,sex,and delivery mode between the two groups(all P>0.05).The PI values after birth were significantly different between the two groups(Fgroup=15.393,Pgroup<0.001).The PI values of preterm infants in the ROP group decreased significantly at 1 h,12 h and 24 h after birth and slightly at 48 h to 96 h after birth compared with the non-ROP group.The PI values of preterm infants in the two groups sta-bilized at 96 h after birth.The PI values of preterm infants in the ROP group were lower than those in the non-ROP group at all time points within 96 h after birth(all P<0.05).The PI values showed interaction effects between the two groups at different time points(Finteraction=5.061,Pinteraction<0.001).There was a significant difference in BLA concentration between the two groups after birth(Fgroup=91.158,Pgroup<0.001).In the ROP group,the BLA concentration increased significantly at 1 h after birth and slightly at 12 h and 24 h after birth compared with the non-ROP group.The BLA concentration in the ROP group was higher than that in the non-ROP group at all time points after birth(all P<0.05).The BLA concentration showed no interaction effects between the two groups at different time points(Finteraction=0.567,Pinteraction>0.05).The AUC of PI values at 1 h,12 h and 24 h after birth and BLA concentration at 1 h after birth for predicting ROP was 0.77,0.82,0.83,and 0.82,respectively.The AUC of combined PI values at 1 h,12 h and 24 h after birth and BLA concentration at 1 h after birth for predicting ROP was 0.94,higher than the predictive value of a single indicator.Conclusion PI and BLA concentration have good clinical value for early prediction of ROP.
4.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
5.An advanced machine learning method for simultaneous breast cancer risk prediction and risk ranking in Chinese population: A prospective cohort and modeling study
Liyuan LIU ; Yong HE ; Chunyu KAO ; Yeye FAN ; Fu YANG ; Fei WANG ; Lixiang YU ; Fei ZHOU ; Yujuan XIANG ; Shuya HUANG ; Chao ZHENG ; Han CAI ; Heling BAO ; Liwen FANG ; Linhong WANG ; Zengjing CHEN ; Zhigang YU
Chinese Medical Journal 2024;137(17):2084-2091
Background::Breast cancer (BC) risk-stratification tools for Asian women that are highly accurate and can provide improved interpretation ability are lacking. We aimed to develop risk-stratification models to predict long- and short-term BC risk among Chinese women and to simultaneously rank potential non-experimental risk factors.Methods::The Breast Cancer Cohort Study in Chinese Women, a large ongoing prospective dynamic cohort study, includes 122,058 women aged 25-70 years old from the eastern part of China. We developed multiple machine-learning risk prediction models using parametric models (penalized logistic regression, bootstrap, and ensemble learning), which were the short-term ensemble penalized logistic regression (EPLR) risk prediction model and the ensemble penalized long-term (EPLT) risk prediction model to estimate BC risk. The models were assessed based on calibration and discrimination, and following this assessment, they were externally validated in new study participants from 2017 to 2020.Results::The AUC values of the short-term EPLR risk prediction model were 0.800 for the internal validation and 0.751 for the external validation set. For the long-term EPLT risk prediction model, the area under the receiver operating characteristic curve was 0.692 and 0.760 in internal and external validations, respectively. The net reclassification improvement index of the EPLT relative to the Gail and the Han Chinese Breast Cancer Prediction Model (HCBCP) models for external validation was 0.193 and 0.233, respectively, indicating that the EPLT model has higher classification accuracy.Conclusions::We developed the EPLR and EPLT models to screen populations with a high risk of developing BC. These can serve as useful tools to aid in risk-stratified screening and BC prevention.
6.Effectiveness research of opportunistic screening for osteoporosis based on chest CT and deep convolutional neural network
Jing PAN ; Pengcheng LIN ; Kun ZHANG ; Shenchu GONG ; Bosheng HE ; Ze WANG ; Yujuan ZHANG ; Rui CAO ; Lin WANG
Journal of Practical Radiology 2024;40(1):145-150
Objective To analyze the feasibility and efficacy of a deep convolutional neural network(DCNN)model based on chest CT images to evaluate bone mineral density(BMD).Methods A total of 1 048 health check subjects'2 096 central level images of lumbar 1 and 2 vertebral bodies were used for experiments and analysis in this retrospective study.According to the results of quanti-tative computed tomography(QCT)BMD measurement,the subjects were divided into three categories:normal,osteopenia,osteopo-rosis(OP).Herein,a DCNN segmentation model was constructed based on chest CT images[training set(n=1 096),tuning set(n=200),and test set(n=800)],the segmentation performance was evaluated using the Dice similarity coefficient(DSC)to com-pare the consistency with the manually sketched region of vertebral body.Then,the DCNN classification models 1(fusion feature construction of lumbar 1 and 2 vertebral bodies)and model 2(image feature construction of lumbar 1 alone)was developed based on the training set(n=530).Model performance was compared in a test set(n=418)by the receiver operating characteristic(ROC)curve analysis.Results When the number of images in the training set(n=300)was adopted,the DSC value was 0.950 in the test set.The results showed that the sensitivity,specificity and area under the curve(AUC)of model 1 and model 2 in diagno-sing osteopenia and OP were 0.716,0.960,0.952;0.941,0.948,0.980;0.638,0.954,0.940;0.843,0.959,0.978,respectively.The AUC value of normal model 1 was higher than that of model 2(0.990 vs 0.983,P=0.033),while there was no significant difference in AUC values between osteopenia and OP(P=0.210,0.546).Conclusion A DCNN may have the potential to evaluate bone mass based on chest CT images,which is expected to become an effective tool for OP screening.
7.Application of the excellent doctor-oriented teaching evaluation method in the clinical teaching of dermatology and venereology
Ting LIU ; Ruimin JIANG ; Yujuan WANG ; Xi DUAN ; Jia HE ; Jie CHEN ; Liang LIU
Chinese Journal of Medical Education Research 2024;23(3):391-396
Objective:To investigate the application value of the teaching evaluation method guided by cultivating "excellent doctors" in the clinical teaching of dermatology and venereology.Methods:A non-simultaneous control study was conducted, and the medical students who received theoretical learning and clinical internship in Department of Dermatology and Venereology, Affiliated Hospital of North Sichuan Medical College, from March 2020 to February 2022, were enrolled as subjects. According to the order of enrollment, 32 students who were enrolled from March 2020 to February 2021 were set up as control group, and 31 students who were enrolled from March 2021 to February 2022 were set up as experimental group. The students in the control group received lecture-based learning, and those in the experimental group received clinical teaching using a teaching and evaluation method guided by cultivating "excellent doctors". After the course ended, the two groups were compared in terms of the scores of theoretical knowledge and operation skills, clinical thinking ability [Self-Assessment of Clinical Reasoning and Reflection (SACRR)], core competence [Mini-Clinical Evaluation Exercise (Mini CEX)], and degree of satisfaction with teaching. SPSS 25.0 software was used to perform the independent samples t-test, the Mann-Whitney U test, the chi-square test, and the rank sum test. Results:One student in the control group voluntarily withdrew from the study, and one student in the experimental group did not complete the contents of internship. Finally, 31 students in the control group and 30 in the experimental group were included in the study. After 4 weeks of internship, compared with the control group, the experimental group had significantly higher scores of theoretical knowledge (88.00±4.30 vs. 85.71±4.12, t=2.12, P=0.040) and operation skills (91.87±3.99 vs. 88.23±3.84, t=3.63, P<0.05). After 4 weeks of internship, compared with the control group, the experimental group had significantly higher information systematization score (47.23±3.11 vs. 45.16±3.00), analysis problem score (34.87±2.30 vs. 31.29±2.30), truth finding score (16.30±1.49 vs. 14.45±1.52), reflective ability score [3.50 (3.00, 4.00) vs. 3.00 (3.00, 3.00)], and total score of SACRR (101.87±4.47 vs. 93.90±4.47), with significant differences between the two groups ( t/ Z=2.65, 6.17, 4.79, 3.15, and 6.96, all P<0.05). After 4 weeks of internship, the experimental group had a significantly better core competence than the control group ( Z=2.12, P=0.030); compared with the control group, the experimental group had significantly higher classroom teaching score (20.17±1.98 vs. 18.45±2.23, t=3.17, P<0.05), clinical practice score (19.83±2.10 vs. 17.65±2.17, t=4.00, P<0.05), learning plan score (18.63±2.24 vs. 17.03±2.15, t=2.85, P<0.05), teaching resource score (20.07±1.82 vs. 18.58±2.00, t=3.04, P<0.05) and total score (78.70±3.67 vs. 71.71±4.13, t=6.98, P<0.05). Conclusions:The application of the teaching and evaluation method guided by cultivating "excellent doctors" in the clinical teaching of dermatology and venereology can improve clinical theoretical knowledge, practical operation skills, clinical thinking ability, and core ability among interns and thus help to improve teaching quality. Therefore, it holds promise for clinical application.
8.Clustering analysis of risk factors in high-incidence areas of esophageal cancer in Yanting county
Ruiwu LUO ; Heng HUANG ; Hao CHENG ; Siyu NI ; Siyi FU ; Qinchun QIAN ; Junjie YANG ; Xinlong CHEN ; Hanyu HUANG ; Zhengdong ZONG ; Yujuan ZHAO ; Yuhe QIN ; Chengcheng HE ; Ye WU ; Hongying WEN ; Dong TIAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(03):385-391
Objective To investigate the dietary patterns of rural residents in the high-incidence areas of esophageal cancer (EC), and to explore the clustering and influencing factors of risk factors associated with high-incidence characteristics. Methods A special structured questionnaire was applied to conduct a face-to-face survey on the dietary patterns of rural residents in Yanting county of Sichuan Province from July to August 2021. Univariate and multivariate logistic regression models were used to analyze the influencing factors of risk factor clustering for EC. Results There were 838 valid questionnaires in this study. A total of 90.8% of rural residents used clean water such as tap water. In the past one year, the people who ate fruits and vegetables, soybean products, onions and garlic in high frequency accounted for 69.5%, 32.8% and 74.5%, respectively; the people who ate kimchi, pickled vegetables, sauerkraut, barbecue, hot food and mildew food in low frequency accounted for 59.2%, 79.6%, 68.2%, 90.3%, 80.9% and 90.3%, respectively. The clustering of risk factors for EC was found in 73.3% of residents, and the aggregation of two risk factors was the most common mode (28.2%), among which tumor history and preserved food was the main clustering pattern (4.6%). The logistic regression model revealed that the gender, age, marital status and occupation were independent influencing factors for the risk factors clustering of EC (P<0.05). Conclusion A majority of rural residents in high-incidence areas of EC in Yanting county have good eating habits, but the clustering of some risk factors is still at a high level. Gender, age, marital status, and occupation are influencing factors of the risk factors clustering of EC.
9.Effect of aluminum-fluoride interactions on overall cognitive function of aluminum plant workers
Luyang HE ; Jingqi ZHANG ; Juan LI ; Baichun LI ; Yuhan SUN ; Yujuan GONG ; Xiaoting LU ; Jing SONG ; Qiao NIU ; Linping WANG
Journal of Environmental and Occupational Medicine 2023;40(6):695-699
Background Aluminum and fluoride are neurotoxic, and aluminum exposure alone is closely related to the overall cognitive function of operational workers. It is unclear about the effect of aluminum and fluoride interactions on cognitive function. Objective To evaluate a potential interaction effect of blood aluminum and urinary fluoride on the overall cognitive function of workers working in an aluminum plant. Methods Using cluster sampling, 230 workers in the electrolysis workshop of an aluminum group company in Shanxi Province were selected, and plasma aluminum concentrations were determined by inductively coupled plasma mass spectrometry (ICP-MS) and urinary fluoride by ion-selective electrode. The study participants were divided into a low blood aluminum group and a high blood aluminum group according to the median (M) of blood aluminum concentration, and a low urinary fluoride group and a high urinary fluoride group by a predetermined cutoff point (2.160 mg·L−1). The Montreal Cognitive Assessment-Beijing (MoCA-BJ) was used to assess overall cognitive function of the workers. Logistic regression model was used to analyze the relationship between blood aluminum, urinary fluoride, and mild cognitive impairment (MCI), including multiplicative interaction analysis and correlation analysis; R language was used to fit an additive interaction model of blood aluminum and urinary fluoride on MCI and to calculate synergy index (S), relative excess risk due to interaction (RERI), and attributable proportion due to interaction (API). Results Among the 230 operational workers, the median blood aluminum concentration (P25, P75) was 40.11 (25.16, 58.89) µg·L−1, and there were 104 cases of abnormal urinary fluoride, with an abnormality rate of 45.2%. There was a multiplicative interaction (OR=7.783, 95%CI: 1.377, 43.991) and no additive interaction (RERI=0.030, 95%CI: −0.498, 0.559; API=0.018, 95%CI: −0.279, 0.316; S=1.049, 95%CI: 0.519, 2.118) for the effect between blood aluminum and urinary fluoride on overall cognitive function of the workers. The logistic regression analysis showed that the risk of MCI was 12.105 (95%CI: 2.802, 52.287) times higher in workers with both high blood aluminum and high urinary fluoride than in those with low blood aluminum and low urinary fluoride, after adjusting for selected influencing factors. Conclusion Occupational exposure related high blood aluminum and high urinary fluoride are risk factors for cognitive dysfunction, and the coexistence of both indicators increases the risk of MCI in workers with occupational aluminum exposure, with a multiplicative interaction.
10.Effect of occupational aluminum exposure on the visuospatialconstruction ability
Yujuan GONG ; Juan LI ; Jingqi ZHANG ; Yuhan SUN ; Luyang HE ; Linping WANG
Journal of Preventive Medicine 2022;34(8):788-793
Objective:
To examine the correlation between visuospatial construction ability and occupational aluminum exposure among aluminum workers, so as to provide the evidence for early protection of occupational injury among aluminum workers.
Methods:
A total of 442 workers in an aluminum factory in Shanxi Province were selected using a cluster sampling method, and participants' demographic features and occupational history were collected. The blood aluminum concentration was measured using inductively coupled plasma mass spectrometry (ICP-MS), and the visuospatial construction ability was evaluated with the Cube Copying Test (CCT) of the Chinese version of the Montreal Cognitive Assessment (MoCA). The correlation between the visuospatial construction ability and blood aluminum concentration was examined using a multivariable logistic regression model.
Results:
A total of 442 aluminum workers were enrolled, and all participants were male, with a mean age of (43.40±7.31) years, labor service duration of (23.64±8.35) years and a mean blood aluminum concentration of 33.87 µg/L. Of all participants, there were 206 workers with impaired visuospatial construction ability (46.61%), including 127 workers with blood aluminum concentrations of >33.87 µg/L (61.65%); 190 workers with educational duration of 6 to 9 years (92.23%), 118 electrolytic aluminum workers (57.28%), 114 workers with work shifts (55.34%), and 123 workers with a very good sleep quality (59.71%). Multivariable logistic regression analysis revealed that blood aluminum concentrations of >33.87 µg/L (OR=2.490, 95%CI: 1.531-4.052), educational duration of 6 years or more (OR: 0.075-0.246, 95%CI: 0.015-0.622), work type as a non-electrolytic aluminum worker (OR=0.838, 95%CI: 0.425-0.987), work shift (OR=1.179, 95%CI: 1.078-1.435) and a very good sleep quality (OR=0.104, 95%CI: 0.012-0.896) significantly correlated with impaired visuospatial construction ability among aluminum worker.
Conclusion
Impaired visuospatial construction ability correlates with occupational aluminum exposure among aluminum workers.


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