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.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.
4.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.
5.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.
6.Clinical and genetic analysis of 5 pediatric patients with hemiplegic migraine presenting as acute encephalopathy
Xiuwei ZHUO ; Shuhong REN ; Shuai GONG ; Weihua ZHANG ; Jiuwei LI ; Yujuan ZHANG ; Changhong DING
Chinese Journal of Pediatrics 2021;59(4):316-321
Objective:To analyze the clinical and genetic characteristics, diagnosis and treatment of hemiplegic migraine (HM) manifested as acute encephalopathy in children, so as to improve the understanding of this disease.Methods:The clinical data of 5 children diagnosed with HM characterized by acute encephalopathy who were admitted to Beijing Children′s Hospital affiliated to Capital Medical University from August 2018 to June 2020 were retrospectively analyzed.Results:Among the 5 cases, 3 were males and 2 females with an age of 9.7 (3.9-12.7) years. The age of disease onset was 7.0(2.1-12.7) years. The peak symptoms of 5 children showed encephalopathy such as drowsiness and coma, as well as other clinical manifestations including headache, visual abnormality, hemiplegia, aphasia, convulsions, and fever, etc. The time to reach the peak was on the 2nd-6th day of the course of the disease. Before the onset of the disease 2 cases were found to have mild brain trauma and 2 cases had similar attacks in the past. Brain magnetic resonance imaging (MRI) showed hemispheric or partial cerebral cortex swelling and restricted diffusion of subcortical white matter in all cases, and cerebellar atrophy in 3 cases. All children received symptomatic treatment, and 2 of them were also treated with low-dose corticosteroids in the meantime. Finally all cases recovered clinically from the attack, but one had atrophic changes left in the affected area on brain MRI. Whole exon sequencing revealed variations of CACNA1A gene in all cases, among which 4 were de novo mutations and 1 case inherited from the mother who had migraine without aura. After the diagnosis, the 5 children were treated with long-term flunarizine and followed up for 22(7-29) months by telephone or in the outpatient clinic. Before the last follow-up, none of them showed weakness or encephalopathy, but one still had intermittent headaches and occasional transient right limb numbness.Conclusions:Hemipleg is often accompanied by impaired consciousness in addition to headache, hemiplegia, aphasia, visual abnormality, etc. Most patients recover completely after a short period, while a few recover slowly and may suffer sequelae such as brain atrophy and cognitive impairment and even death. CACNA1A gene variation is the most common genetic variation. Flunarizine could prevent recurrence of severe attack.
7.Levels of systemic and maternal-fetal interface oxidative stress in women with early pregnancy loss
Xian GONG ; Jianmei WANG ; Li SUN ; Xiaopei LI ; Yujuan ZHANG
Chinese Journal of Reproduction and Contraception 2021;41(7):631-637
Objective:To understand the correlation between systemic and local (at the maternal-fetal interface) oxidative stress in women with early pregnancy and the influencing factors of indicators, and to explore the associations between early pregnancy loss (EPL) and biomarkers of lipid peroxidation and total antioxidant capacity (T-AOC).Methods:A case-control study was performed. From December 2017 to July 2018, cases of EPL and controls of normal early pregnant women requesting induced abortions due to unintended pregnancies were recruited in the Family Planning Department of the Second Hospital of Tianjin Medical University. The levels of malondialdehyde (MDA) and T-AOC in serum of 103 participants and chorionic villous tissue of 60 participants in each group were measured. The influencing factors and the correlations between the levels of each biomarker in serum and villous were analyzed. The differences in the levels of each biomarker between the two groups were compared.Results:The levels of MDA and T-AOC in villi of case group and control group were both positively correlated with their serum markers, their correlation coefficients were r=0.744, P<0.001; r=0.312, P=0.015; r=0.712, P<0.001; r=0.650, P<0.001, respectively. Except for villus MDA in case group, serum and villus MDA and T-AOC increased with the increasing of gestational days in both groups. For each additional week of gestation in case group, serum MDA increased by 8.3% ( P=0.005), serum T-AOC increased by 4.2% ( P=0.002), villus T-AOC increased by 2.6% ( P=0.010), all of which were statistically significant; in control group, the serum MDA, serum T-AOC, villus MDA and villus T-AOC increased by 11.3% ( P=0.004), 5.4% ( P=0.007), 18.7% ( P=0.017) and 8.4% ( P=0.009) respectively for each additional week of gestation. After adjusting the gestational days, the serum T-AOC of the case group was 13.4% lower than that of control group ( P<0.001), the villus T-AOC was 33.7% lower than that of control group ( P<0.001), while the villus MDA was 30.1% higher than that of control group ( P=0.012). The serum MDA of the two groups had no statistic significance. Conclusion:The status of systemic oxidative stress is synchronized with that in the maternal-fetal interface in early pregnant women. Gestational age is an important factor affecting oxidative stress in serum and villous. EPL is associated with the reduction of systemic and maternal-fetal interface antioxidant capacity and maternal-fetal interface lipid peroxidation damage.
8.Levels of systemic and maternal-fetal interface oxidative stress in women with early pregnancy loss
Xian GONG ; Jianmei WANG ; Li SUN ; Xiaopei LI ; Yujuan ZHANG
Chinese Journal of Reproduction and Contraception 2021;41(7):631-637
Objective:To understand the correlation between systemic and local (at the maternal-fetal interface) oxidative stress in women with early pregnancy and the influencing factors of indicators, and to explore the associations between early pregnancy loss (EPL) and biomarkers of lipid peroxidation and total antioxidant capacity (T-AOC).Methods:A case-control study was performed. From December 2017 to July 2018, cases of EPL and controls of normal early pregnant women requesting induced abortions due to unintended pregnancies were recruited in the Family Planning Department of the Second Hospital of Tianjin Medical University. The levels of malondialdehyde (MDA) and T-AOC in serum of 103 participants and chorionic villous tissue of 60 participants in each group were measured. The influencing factors and the correlations between the levels of each biomarker in serum and villous were analyzed. The differences in the levels of each biomarker between the two groups were compared.Results:The levels of MDA and T-AOC in villi of case group and control group were both positively correlated with their serum markers, their correlation coefficients were r=0.744, P<0.001; r=0.312, P=0.015; r=0.712, P<0.001; r=0.650, P<0.001, respectively. Except for villus MDA in case group, serum and villus MDA and T-AOC increased with the increasing of gestational days in both groups. For each additional week of gestation in case group, serum MDA increased by 8.3% ( P=0.005), serum T-AOC increased by 4.2% ( P=0.002), villus T-AOC increased by 2.6% ( P=0.010), all of which were statistically significant; in control group, the serum MDA, serum T-AOC, villus MDA and villus T-AOC increased by 11.3% ( P=0.004), 5.4% ( P=0.007), 18.7% ( P=0.017) and 8.4% ( P=0.009) respectively for each additional week of gestation. After adjusting the gestational days, the serum T-AOC of the case group was 13.4% lower than that of control group ( P<0.001), the villus T-AOC was 33.7% lower than that of control group ( P<0.001), while the villus MDA was 30.1% higher than that of control group ( P=0.012). The serum MDA of the two groups had no statistic significance. Conclusion:The status of systemic oxidative stress is synchronized with that in the maternal-fetal interface in early pregnant women. Gestational age is an important factor affecting oxidative stress in serum and villous. EPL is associated with the reduction of systemic and maternal-fetal interface antioxidant capacity and maternal-fetal interface lipid peroxidation damage.
9.Effects of Shengmai San on oxidative damage in mentally stressed mice
Muxin GONG ; Lei WANG ; Qian WANG ; Yujuan LI ; Tetsuya KONISHI
Chinese Journal of Pathophysiology 1989;0(06):-
AIM: To investigate the preventive effects of Shengmai San (SMS) on oxidative damage in mentally stressed mice.METHODS: An oxidative stress mouse model was established by moustache-removed. Protein carbonyl and thiobarbituric acid reactive substance (TBARS) formation were determined as the oxidative stress markers.RESULTS: (1)Moustache-cut was founded to significantly enhance the behavioral movements of mice, especially large movements (movement 2 and rearing). SMS pre-administration inhibited the accelerated movements. (2) Protein carbonyl was increased in brain, heart, liver and kidney. TBARS in liver and heart increased in the moustache-cut mice, but SMS pretreatment inhibited the increased protein carbonyl and TBARS.CONCLUSION: SMS has the preventive effects on oxidative damage induced by emotional stress.


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