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.Potential utility of albumin-bilirubin and body mass index-based logistic model to predict survival outcome in non-small cell lung cancer with liver metastasis treated with immune checkpoint inhibitors.
Lianxi SONG ; Qinqin XU ; Ting ZHONG ; Wenhuan GUO ; Shaoding LIN ; Wenjuan JIANG ; Zhan WANG ; Li DENG ; Zhe HUANG ; Haoyue QIN ; Huan YAN ; Xing ZHANG ; Fan TONG ; Ruiguang ZHANG ; Zhaoyi LIU ; Lin ZHANG ; Xiaorong DONG ; Ting LI ; Chao FANG ; Xue CHEN ; Jun DENG ; Jing WANG ; Nong YANG ; Liang ZENG ; Yongchang ZHANG
Chinese Medical Journal 2025;138(4):478-480
3.Development of the Adolescent Mental Health Computerized Adaptive Test
Siyang LIU ; Xiaorong GUO ; Weijun WANG ; Xiaosong SHEN ; Qian CHEN ; Yongjian JIAN
Chinese Mental Health Journal 2025;39(5):447-453
Objective:To develop the Adolescent Mental Health Computerized Adaptive Test(AMH-CAT)for assessing psychological crises in adolescents using item response theory(IRT).Methods:A total of 8 679 students,aged 9 to 19 years,were sampled from 14 primary and secondary schools.The item bank was constructed by examining unidimensionality,independence,discrimination,and Differential Item Functioning(DIF).The AMH-CAT algorithm was developed using R software and validated for reliability and validity through real and simulated data.The School Psychological Interview Evaluation Form served as the criterion tool to assess the predictive validi-ty of AMH-CAT in evaluating psychological crises levels.Results:The item bank,consisting of 43 items,demon-strated unidimensionality and independence,with discrimination values>0.80 and no DIF across genders.Under va-rious stopping rules,AMH-CAT showed ABS values<0.40,RMSE values<0.50,and a correlation(r)>0.87(P<0.001)between estimated and true psychological crises levels.Real participants answered an average of 10 items under the SE(θ)≤0.4 stopping rule,with a reliability of 0.89,and the scores were positively correlated with the complete item bank scores(r=0.95,P<0.001).The predictive accuracy for Level 1 and Level 2 concerns was 0.89 and 0.90,respectively.Conclusion:The Adolescent Mental Health Computerized Adaptive Test(AMH-CAT)demonstrates excellent validity,reliability and assessment efficiency for evaluating adolescent psychological crises.
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.Development of the Adolescent Mental Health Computerized Adaptive Test
Siyang LIU ; Xiaorong GUO ; Weijun WANG ; Xiaosong SHEN ; Qian CHEN ; Yongjian JIAN
Chinese Mental Health Journal 2025;39(5):447-453
Objective:To develop the Adolescent Mental Health Computerized Adaptive Test(AMH-CAT)for assessing psychological crises in adolescents using item response theory(IRT).Methods:A total of 8 679 students,aged 9 to 19 years,were sampled from 14 primary and secondary schools.The item bank was constructed by examining unidimensionality,independence,discrimination,and Differential Item Functioning(DIF).The AMH-CAT algorithm was developed using R software and validated for reliability and validity through real and simulated data.The School Psychological Interview Evaluation Form served as the criterion tool to assess the predictive validi-ty of AMH-CAT in evaluating psychological crises levels.Results:The item bank,consisting of 43 items,demon-strated unidimensionality and independence,with discrimination values>0.80 and no DIF across genders.Under va-rious stopping rules,AMH-CAT showed ABS values<0.40,RMSE values<0.50,and a correlation(r)>0.87(P<0.001)between estimated and true psychological crises levels.Real participants answered an average of 10 items under the SE(θ)≤0.4 stopping rule,with a reliability of 0.89,and the scores were positively correlated with the complete item bank scores(r=0.95,P<0.001).The predictive accuracy for Level 1 and Level 2 concerns was 0.89 and 0.90,respectively.Conclusion:The Adolescent Mental Health Computerized Adaptive Test(AMH-CAT)demonstrates excellent validity,reliability and assessment efficiency for evaluating adolescent psychological crises.
6.Application of cardiopulmonary arrest scenario simulation exercise combined with four-step disc method in the teaching practice of nurses in the department of anesthesiology
Lijuan GUO ; Yuange ZHANG ; Yueqiu SU ; Xi LUO ; Xiaorong YIN
Chinese Journal of Practical Nursing 2024;40(36):2864-2869
Objective:To explore the application effect of cardiac respiratory arrest scenario simulation exercise combined with four-step disk method in the teaching practice of standardized nurses in the department of anesthesiology, and to provide teaching plan and reference for the training of core competence of standardized nurses.Methods:A randomized controlled study was conducted to select 127 standardized trained nurses in rotation anesthesia and intoxication department of West China Hospital, Sichuan University from July 2020 to December 2023 by cluster sampling method. A total of 64 first-year standardized training nurses from three batches of rotation anesthesiology department from July 2020 to December 2021 were selected as the control group, and the conventional teaching method was applied to their teaching practice. A total of 63 first-year standardized training nurses from three batches of rotation anesthesiology department in 2022 and from July to December 2023 were selected as the observation group. On the basis of routine teaching, the cardio-respiratory arrest scenario simulation exercise combined with four-step review method was implemented to carry out teaching practice. One week before leaving the course, the theoretical test scores, skill operation scores (6 operations including anesthesia machine, intravenous induration needle infusion, open sputum aspiration, defibrillation apparatus, simple respiratory sac ventilation and single cardiopulmonary resuscitation), post competency scores and teaching satisfaction scores of the two groups of standardized training nurses were assessed and compared.Results:The control group included 11 males and 53 females, aged (23.25 ± 0.78) years. In the observation group, there were 12 males and 51 females, aged (23.29 ± 0.81) years. The average score of skill operation in the observation group was (93.54 ± 0.92) points, which was higher than that in the control group (91.02 ± 1.08) points, and the difference between the two groups was statistically significant ( t=-14.10, P<0.01). The total theoretical score of the observation group (81.32 ± 3.84) points was higher than that of the control group (61.86 ± 2.05) points, and the difference between the two groups was statistically significant ( t=-35.69, P<0.01). The scores of self-evaluation of post competence and other evaluation and teaching satisfaction of the observation group were (95.81 ± 2.69), (94.22 ± 2.57) and (96.81 ± 2.75) points, which were higher than those of the control group (88.47 ± 5.56), (91.64 ± 3.10) and (91.52 ± 3.50) points. The differences between the two groups were statistically significant ( t=-9.49, -5.10, -9.47, all P<0.01). Conclusions:The application of heart-respiratory arrest scenario simulation and GRAI repetition method in the teaching practice of standardized nurses can improve the theoretical mastery level of standardized nurses and their operational performance, enhance their post competency, improve their teaching satisfaction, enhance their self-confidence and self-awakening ability, improve their learning enthusiasm, and their theoretical connection with practice level. To promote the improvement of teaching program and teaching quality, it is worth applying and popularizing in teaching practice.
7.Bacterial culture and its clinical analysis of patients undergoing transnasal skull base surgery
Xiaorong ZHANG ; Xiuying GUO ; Linjuan ZHANG ; Na MEI ; Ruichun LI ; Ping MAO ; Ke GAO ; Li SONG
Journal of Xi'an Jiaotong University(Medical Sciences) 2024;45(4):645-649
Objective To analyze the status of the bacteria in the operative area of transnasal skull base surgery and its correlation with postoperative intracranial infection.Methods The procedure of transnasal skull base surgery was divided into three stages:nasal passage preparation(stage 1),tumor resection(stage 2),and skull base reconstruction(stage 3).Bacterial sampling was taken from the mucosa of the anterior wall of sphenoid sinus or clival recess of sellar floor at the beginning of each stage;and the positive rate of bacterial culture in different stages of operation and its correlation with postoperative intracranial infection were analyzed.Results A total of 105 patients were enrolled in this study,and 315 samples were taken.The average time point of sampling in the three stages was 20.3,45.1 and 131.3 min after the beginning of operation,respectively.The positive results were 9 cases(2.9%)in the stage 1,8 cases(2.5%)in the stage 2,and 23 cases(7.3%)in the stage 3,which were 24 cases of Staphylococcus epidermidis,7 cases of Staphylococcus aureus,3 cases of hemolytic streptococcus,2 cases of Klebsiella pneumonia,and 4 cases of Escherichia coli.There was no significant difference in the positive cases between stage 1 and stage 2(P=0.955),but there were significant differences between stage 1 or 2 and stage 3(P=0.013;P=0.007).There were 36(11.4%)patients with at least one positive result in the three stages,17(16.2%)with cerebrospinal fluid leakage,and 12(11.4%)with intracranial infection.The risk of intracranial infection was 3.1 times higher in patients with positive bacterial culture than patients with negative bacterial culture(OR=3.1,95%CI:0.9-10.6),which was not statistically significant;patients with CSF leakage were 61.4 times higher than those without CSF leakage(OR=61.4,95%CI:11.2-337.1),which was statistically significant(P<0.001).The consistency rate of bacteria in nasal cavity and postoperative cerebrospinal fluid culture was 57.1%.Conclusion The positive rate of bacterial culture in the operative area of transnasal skull base surgery increases significantly with the extension of operation time,which is a potential risk index of postoperative intracranial infection.
8.Mechanism of action and clinical research progress of iguratimod in connective tissue diseases
Xiaorong YANG ; Shuhong ZHOU ; Lijiang GUO ; Ying CHEN ; Yingying JI ; Lijie XU
China Pharmacy 2024;35(5):629-634
As a new type of immunosuppressant,iguratimod can mediate the anti-inflammatory signaling pathway by inhibiting the proliferation of inflammatory cells and reducing the release of inflammatory cytokines, and play the role of anti-inflammatory. It can affect the proliferation of immune cells and the expression of immune factors,reduce the production and deposition of immune complexes in the body,and play the role of immune regulation. It can regulate bone metabolism by mediating signaling pathways such as Wnt/β-catenin,Toll-like receptor 4/nuclear factor-κB and osteoprotegerin/nuclear factor-κB receptor activating factor ligand, and play a role in bone protection. It can inhibit pulmonary fibrosis by inhibiting the expression of transforming growth factor β1/ Smad2/3 signaling pathway,tumor necrosis factor-α,interleukin-1,interleukin-6,matrix metalloproteinase-9 and other inflammatory cytokines in lung tissue,and inhibiting the expression of collagen and fibronectin. Its efficacy and safety have been confirmed in the clinical application of rheumatoid arthritis and primary Sjogren syndrome and included in the diagnosis and treatment of the disease. It has also shown good efficacy in the clinical application of other connective tissue diseases such as systemic lupus erythematosus and ankylosing spondylitis,and no obvious safety risks have been found.
9.Analysis of the baseline investigation results of the conformity rate of bacterial culture examination records in a tertiary specialized hospital in 2022
Kexin GUO ; Jinying TONG ; Yang LUO ; Yuting LIU ; Xiaorong LI ; Xin ZHOU ; Lisi XU ; Junchen HUANG ; Qing'e TIAN
Modern Hospital 2024;24(5):733-736
Objective This paper aims to investigate and analyze the baseline conformity rate of bacterial culture exami-nation records in a tertiary specialized hospital.By doing this,this paper seeks to understand the current situation of medical re-cord writing of bacterial culture examination and explore the improvement path and relevant measures for enhancing the conformity rate of bacterial culture examination records.Methods According to the requirements of"Quality Control Index of Medical Re-cord Management(2021 Edition)",a retrospective analysis was conducted on 6 317 medical records that underwent bacterial culture examination in 2022.Results The execution rate of medical orders was 100.00%,the completeness rate of the report sheet was 100.00%,the record rate of medical records was 81.05%,the analysis rate of results was 33.07%,and the conformi-ty rate of bacterial culture examination records was 33.07%.Conclusion It is imperative to enhance the conformity rate of bac-terial culture examination records and improve the quality of medical records in terms of content.
10.Causal Relationship Between Components of Metabolic Syndrome and Endometrial Carcinoma
Min YANG ; Ying HU ; Weijie GUO ; Fan YANG ; Xiaorong QI ; Ying ZHENG
Journal of Sichuan University (Medical Sciences) 2024;55(6):1557-1566
Objective To investigate the causal associations between components of metabolic syndrome(MetS)and endometrial carcinoma using Mendelian randomization(MR).Methods Data mining of the Genome-Wide Association Studies(GWAS)database was performed,with the exposure factors being MetS components(lipids,blood pressure,blood glucose,and obesity)and the outcome factor being endometrial carcinoma.MR analyses were performed with the help of regression models,including MR-Egger method,weighted median method,and inverse variance weighted(IVW)method,and the causal relationship between MetS components and endometrial carcinoma was evaluated by odds ratio(OR).Reverse MR analysis was performed for the MetS components found to have a causal relationship with endometrial carcinoma in the forward MR analysis.Results After applying Benjamini-Hochberg correction,IVW results showed a causal relationship between multiple MetS components(obesity,lipids,blood pressure,and blood glucose)and endometrial carcinoma.Specifically,the three components of obesity,including body mass index,overweight,and percentage of body fat,were causally associated with an increased risk of endometrial carcinoma(P<0.001,OR>1).In blood lipids,high cholesterol levels(P<0.001,OR<1),high triglyceride levels,and high phospholipid levels were causally associated with a reduced risk of endometrial carcinoma(P<0.05,OR<1).Regarding blood pressure,heart disease,atherosclerosis,and stroke were causally associated with a reduced risk of endometrial carcinoma(P<0.05,OR<1).Regarding blood glucose,low fasting insulin levels,type 1 diabetes mellitus,insulin resistance,and high glycated hemoglobin levels were causally associated with a reduced risk of endometrial carcinoma(P<0.05,OR<1),while type 2 diabetes mellitus and high fasting insulin levels were causally associated with an increased risk of endometrial carcinoma(P<0.05,OR>1).Reverse MR analysis did not produce any evidence for a reverse causality between the above positive MetS components and endometrial carcinoma.Conclusion The MR study suggests that obesity and type 2 diabetes mellitus are risk factors for endometrial carcinoma,while other MetS components,including hyperlipidemia,cardiovascular diseases,insulin resistance,and complications of diabetes mellitus,are protective factors for endometrial carcinoma.Further research is needed to clarify the association between MetS and endometrial carcinoma and to further explore the underlying mechanisms involved.

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