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.Study on correlation between preoperative ultrasound parameters and serum albumin levels,and maturation of arteriovenous fistula
Ning ZHANG ; Yujuan XIE ; Shengjiang CHEN
China Medical Equipment 2025;22(1):58-62,67
Objective:To investigate the correlation between preoperative ultrasound parameters,serum albumin (ALB),low-density lipoprotein (LDL) levels and the maturation of radial-cephalic fistula (RCF) in patients with end-stage renal disease (ESRD). Methods:A total of 130 ESRD patients who admitted to the First Affiliated Hospital of Henan University of Science and Technology from January 2022 to September 2023 and established RCF access for the first time were selected as the study subjects. All patients underwent ultrasound examinations on upper limb blood vessels and heart before fistula surgery,and serum ALB and LDL levels of them also were measured. According to the postoperative fistula maturation,the patients were divided into the fistula maturation group (102 cases) and the poor fistula maturation group (28 cases). And then,the correlations between the preoperative ultrasound parameters,serum ALB level,serum LDL level,and the fistula maturation in the two groups were compared and analyzed. Results:The cephalic vein dilation,radial artery diameter and serum ALB levels in the RCF maturation group were higher than those in the poor fistula maturation group,and the serum LDL level was lower than that in the poor fistula maturation group (t=3.810,3.401,3.405,-2.846,P<0.05),respectively. The area under curve (AUC) value of receiver operating characteristic (ROC) curve of laboratory dual indicators (LDL+ALB) was 0.745 (95%CI:0.647-0.842) in predicting RCF maturation,and the sensitivity and specificity of that were respectively 77.50% and 67.90%. The AUC value of ultrasound dual parameters (cephalic vein dilation+radial artery diameter) was 0.809 (95%CI:0.728~0.891) in predicting RCF maturation,and the sensitivity and specificity of that were respectively 68.60% and 82.10%. The AUC value of ultrasound dual parameters combined with laboratory dual indicators was 0.905 (95%CI:0.847~0.962) in predicting RCF maturation,and the sensitivity and specificity of that were respectively 76.50% and 92.90%. The Delong test showed that the AUC value of ultrasound dual parameters combined with laboratory dual indicators was better than that of single ultrasound dual parameters and single laboratory dual indicators in predicting RCF maturation (Z=-2.899,-3.609,P<0.05). Conclusion:The combination of cephalic vein dilation,radial artery diameter,serum ALB and LDL has higher predictive value for fistula maturation in ESRD patients.
3.Study on correlation between preoperative ultrasound parameters and serum albumin levels,and maturation of arteriovenous fistula
Ning ZHANG ; Yujuan XIE ; Shengjiang CHEN
China Medical Equipment 2025;22(1):58-62,67
Objective:To investigate the correlation between preoperative ultrasound parameters,serum albumin (ALB),low-density lipoprotein (LDL) levels and the maturation of radial-cephalic fistula (RCF) in patients with end-stage renal disease (ESRD). Methods:A total of 130 ESRD patients who admitted to the First Affiliated Hospital of Henan University of Science and Technology from January 2022 to September 2023 and established RCF access for the first time were selected as the study subjects. All patients underwent ultrasound examinations on upper limb blood vessels and heart before fistula surgery,and serum ALB and LDL levels of them also were measured. According to the postoperative fistula maturation,the patients were divided into the fistula maturation group (102 cases) and the poor fistula maturation group (28 cases). And then,the correlations between the preoperative ultrasound parameters,serum ALB level,serum LDL level,and the fistula maturation in the two groups were compared and analyzed. Results:The cephalic vein dilation,radial artery diameter and serum ALB levels in the RCF maturation group were higher than those in the poor fistula maturation group,and the serum LDL level was lower than that in the poor fistula maturation group (t=3.810,3.401,3.405,-2.846,P<0.05),respectively. The area under curve (AUC) value of receiver operating characteristic (ROC) curve of laboratory dual indicators (LDL+ALB) was 0.745 (95%CI:0.647-0.842) in predicting RCF maturation,and the sensitivity and specificity of that were respectively 77.50% and 67.90%. The AUC value of ultrasound dual parameters (cephalic vein dilation+radial artery diameter) was 0.809 (95%CI:0.728~0.891) in predicting RCF maturation,and the sensitivity and specificity of that were respectively 68.60% and 82.10%. The AUC value of ultrasound dual parameters combined with laboratory dual indicators was 0.905 (95%CI:0.847~0.962) in predicting RCF maturation,and the sensitivity and specificity of that were respectively 76.50% and 92.90%. The Delong test showed that the AUC value of ultrasound dual parameters combined with laboratory dual indicators was better than that of single ultrasound dual parameters and single laboratory dual indicators in predicting RCF maturation (Z=-2.899,-3.609,P<0.05). Conclusion:The combination of cephalic vein dilation,radial artery diameter,serum ALB and LDL has higher predictive value for fistula maturation in ESRD patients.
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.Clinical management of thrombocytopenia in cirrhosis
Jianping LI ; Ying TAN ; Hang SUN ; Ganqiu LIN ; Binbin CHEN ; Yue WU ; Zhiwei XIE ; Yaping WANG ; Aiqi LU ; Yujuan GUAN
Chinese Journal of Hepatology 2024;32(6):489-492
Thrombocytopenia is one of the common complications of cirrhotic patients, which can induce an increasing bleeding risk and closely correlate with bleeding following invasive procedures. Consequently, how to respond to thrombocytopenia is crucial for improving the prognosis of patients with cirrhosis. This article reviews the main mechanisms of cirrhosis concurrent with thrombocytopenia, as well as the corresponding clinical management strategies.
6.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
7.Efficacy of unilateral biportal endoscopic surgery versus percutaneous transforaminal endoscopic discectomy in treating lumbar spinal stenosis
Zemin WANG ; Jiongwen LU ; Zhongbin CAI ; Yujuan XIE ; Xianglin XU ; Haixin LIU ; Jianqi LU
Journal of Navy Medicine 2024;45(7):710-714
Objective To compare the efficacies of unilateral biportal endoscopic(UBE)technique and percutaneous transforaminal endoscopic discectomy(PTED)in the treatment of lumbar spinal stenosis.Methods Forty patients who were diagnosed with lumbar spinal stenosis in Chashan Hospital of Dongguan from January 2019 to January 2023 were enrolled in this retrospective study.They were divided into PTED group(n=20)and UBE group(n=20).Perioperative data(operation time,intraoperative bleeding,postoperative hospital stay,degree of decompression and complications)were compared between the two groups.Visual analogue scale(VAS)score and Oswestry dysfunction index(ODI)were collected before surgery and on 3 days,1 month and 6 months after surgery.Results There were no significant differences in the operation time,intraoperative bleeding,or hospitalization time between the two groups(all P>0.05).The incidence of postoperative complications in the UBE group was significantly lower than that in the PTED group(P=0.001).VAS score and ODI of the low back and leg pains in the UBE group were superior to the PTED group at each postoperative time point(all P<0.05).One month after surgery,the UBE group had a more significant increase in the dural sac cross-sectional area and intervertebral foramen area than the PTED group(t=3.842,P=0.003;t=2.469,P=0.006).Conclusion Compared with PTED,UBE has better clinical outcomes,higher degree of decompression,and lower incidence of complications.UBE is a safe and feasible surgical method for the treatment of lumbar spinal stenosis.
8.Effects of high intensity interval training in cardiac rehabilitation of patients after heart transplantation: a Meta-analysis
Xiangying XIE ; Zhongxiang CAI ; Ting SUN ; Xin CAI ; Yujuan SONG ; Huijun LENG ; Yao ZHENG ; Ting FANG ; Yinglin LI
Chinese Journal of Modern Nursing 2023;29(12):1548-1555
Objective:To explore the effect of high intensity interval training (HIIT) on cardiac rehabilitation in patients after heart transplantation.Methods:According to the search terms, the search was conducted on China National Knowledge Infrastructure, VIP, WanFang Data, China Biology Medicine disc, Web of Science, PubMed, Cochrane Library, Embase, and EBSCO. The search time limit was from the establishment of the database to January 31, 2022. After 2 researchers screened the article, extracted information, and evaluated the quality, a Meta-analysis was conducted using RevMan 5.4 software.Results:According to the inclusion and exclusion criteria, 10 English articles were selected, including 191 patients in the intervention group and 212 patients in the control group, with a total of 403 patients. Meta-analysis showed that during cardiac rehabilitation exercise in patients after heart transplantation, HIIT could improve peak oxygen uptake in cardiopulmonary function exercise testing [ MD=1.98, 95% confidence interval ( CI) (0.55, 3.41), P=0.007], peak heart rate in chronotropic responses [ MD=6.93, 95% CI (2.62, 11.24), P=0.002], and muscle exercise ability [ MD=337.18, 95% CI (12.02, 62.35), P=0.04]. There was no statistically significant difference in systolic blood pressure, diastolic blood pressure, peak systolic blood pressure, peak diastolic blood pressure, resting heart rate and respiratory exchange rate between the two groups ( P>0.05). A subgroup analysis of peak oxygen uptake was conducted based on the intervention period and the start time of rehabilitation exercise after heart transplantation. The results showed that there were statistically significant differences in peak oxygen uptake between the intervention group and the control group when the intervention period was ≤ 12 weeks or the start time was > 6 weeks ( P<0.01) . Conclusions:HIIT effectively improves the peak oxygen uptake, peak heart rate, and muscle exercise activity of patients after heart transplantation. HIIT has a significant impact on peak oxygen uptake when the rehabilitation exercise start time after heart transplantation is > 6 weeks or the intervention period is ≤ 12 weeks.
9.The mediating effect of loneliness between social support and mobile social media dependence
Yujuan WANG ; Shanshan QI ; Juan XIE
Chinese Journal of Behavioral Medicine and Brain Science 2023;32(5):426-430
Objective:To explore the mediating effect of loneliness between social support and mobile social media dependence.Methods:From May to June 2021, a survey was conducted on 559 college students selected from a cluster by mobile social media dependence questionnaire, multidimensional scale of perceived social support and loneliness scale.SPSS 21.0 statistical software and PROCESS v3.5 program were used to test the mediating effect.Results:The total score of college students' dependence on mobile social media was (3.27±0.56), the saliency score was (3.51±0.60), the social gain score was (3.02±0.69), the compulsive score was (3.33±0.74), the conflicting score was (3.35±0.68), and the withdrawal score was (3.13±0.72). The mediating effect test found that loneliness played a complete mediating effect between social support and mobile social media dependence.The Bootstrap 95% CI interval corrected for the deviation of the indirect effect was -0.176--0.090, which did not contain 0 value.Similarly, loneliness also played a complete mediating role between social support and social gain, compulsive, conflict and withdrawal. Conclusion:Social support can affect mobile social media dependence through loneliness.It is suggested to reduce excessive loneliness as much as possible by cultivating students' ability to establish and maintain social support system, so as to use mobile social media rationally.
10.Efficacy of elbasvir/grazoprevir in treatment of genotype 1 chronic hepatitis C: A real-world study
Yang XIA ; Jing HUANG ; Shuduo WU ; Jianping LI ; Wenli CHEN ; Zhiwei XIE ; Yujuan GUAN
Journal of Clinical Hepatology 2020;36(12):2700-2704
ObjectiveTo investigate the efficacy and safety of elbasvir/grazoprevir in patients with genotype 1 hepatitis C in the real world. MethodsA total of 35 patients with hepatitis C who received elbasvir/grazoprevir treatment in Guangzhou Eighth People’s Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, and Guangdong General Hospital from August 2018 to March 2019 were enrolled, treated for 12 weeks, and then followed up for 12 weeks after drug withdrawal. The patients were observed in terms of sustained virologic response at week 12 after drug withdrawal (SVR12), biochemical response, and incidence rate of adverse events during treatment and follow-up. The Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data between groups, and the Mann-Whitney U test was used for further comparison between two groups; the chi-square test was used for comparison of categorical data between groups. A logistic regression analysis was used to investigate the risk factors for virologic response in patients with hepatitis C. ResultsAmong the 35 patients with HCV infection, 97.1% (34/35) had genotype 1b HCV and 2.9% (1/35) had genotype 1a HCV; of all patients, 28 (80%) were non-cirrhotic patients with chronic hepatitis C and 7 (20%) had compensated liver cirrhosis. At the end of treatment, the virologic response rate of 100% (28/28) and SVR12 was 94.74% (18/19). In addition, age, sex, baseline HCV RNA load, previous treatment history, presence or absence of liver cirrhosis, renal function, and presence or absence of other diseases did not affect the treatment outcome (all P>0.05). There were significant changes in the levels of alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, and albumin from baseline to the end of 12-week treatment (Z=-7.131, -6.797, -3.060, and -2.875, all P<0.05). No patient experienced drug withdrawal during treatment. ConclusionThis study confirms that elbasvir/grazoprevir has good efficacy and safety in the treatment of hepatitis C in domestic real-world studies.

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