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.GDF-15 promotes collateral circulation and improves cardiac function in rats with acute myocardial infarction by activating the NO/cGMP/PKG signaling pathway
Xiaosen SHANG ; Yichun YANG ; Jianan HOU ; Linhua FAN ; Xiaoping CHEN ; Bingyan WEI ; Zhaoyang CHEN
Chinese Journal of Comparative Medicine 2025;35(5):60-70
Objective To observe the effects of growth differentiation factor-15(GDF-15)on collateral circulation and cardiac function in rats with acute myocardial infarction(AMI)in relation to the nitric oxide(NO)/cyclic guanosine monophosphate(cGMP)/protein kinase G(PKG)signaling pathway.Methods An AMI rat model was constructed by ligating the left anterior descending coronary artery.After modeling,the rats were divided randomly into Sham,Model,and GDF-15 groups(n=12 rats per group).Rats in the GDF-15 group were injected intraperitoneally with recombinant GDF-15 protein,and the other two groups were injected with the same amount of normal saline twice a week for 8 consecutive weeks.Cardiac function was detected by echocardiography.Pathological damage to rat myocardial tissue was detected by hematoxylin and eosin staining and the collateral circulation was observed by CD31 immunohistochemical staining.Vascular endothelial growth factor(VEGF)mRNA expression was detected by quantitative polymerase chain reaction.Transcriptomic sequencing of heart tissues in the model and GDF-15 groups was performed and differentially expressed genes(DEGs)were screened.Pathway enrichment analysis of the DEGS was carried out according to the Kyoto Encyclopedia of Genes and Genomes(KEGG).Nitric oxide(NO),reactive oxygen species(ROS),and cGMP were detected using kits,and VEGF,endothelial nitric oxide synthase(eNOS)monomer,p-eNOSser1177monomer,eNOS dimer,and PKG protein were detected by Western blot.Results Left ventricular end-systolic diameter(LVEDs)and left ventricular end-diastolic diameter(LVEDd)were increased(P<0.001),and left ventricular ejection fraction(LVEF)and the short-axis shortening rate(FS)were decreased in the Model group compared with the Sham group(P<0.001).Myocardial cell necrosis was more severe,vascular density in the infarcted area was decreased(P<0.05),but VEGF mRNA and protein levels were no change(P>0.05),and levels of NO,eNOS dimer,cGMP,and PKG protein were decreased(P<0.05),and expression levels of ROS,eNOS monomer,and p-eNOSser1177 monomer were increased(P<0.05).LVEDs and LVEDd decreased(P<0.05),LVEF and FS increased(P<0.01),myocardial cell necrosis was relieved,vascular density in the infarcted area increased significantly(P<0.0001),and VEGF mRNA levels increased(P<0.0001),compared with the Model group.Transcriptomic sequencing identified 324 DEGs,including 230 up-regulated and 94 down-regulated genes.According to KEGG enrichment analysis,the cGMP-PKG signaling pathway showed the most significant difference in the T20 pathway.VEGF,NO,eNOS dimer,cGMP,and PKG protein levels were all increased(P<0.05),while ROS,eNOS monomer,and p-eNOSser1177 monomer were decreased in the GDF-15 group(P<0.05).Conclusions GDF-15 can promote collateral circulation in ischemic myocardium and improve cardiac function by inhibiting eNOS decoupling and activating the NO/cGMP/PKG pathway.
4.GDF-15 promotes collateral circulation and improves cardiac function in rats with acute myocardial infarction by activating the NO/cGMP/PKG signaling pathway
Xiaosen SHANG ; Yichun YANG ; Jianan HOU ; Linhua FAN ; Xiaoping CHEN ; Bingyan WEI ; Zhaoyang CHEN
Chinese Journal of Comparative Medicine 2025;35(5):60-70
Objective To observe the effects of growth differentiation factor-15(GDF-15)on collateral circulation and cardiac function in rats with acute myocardial infarction(AMI)in relation to the nitric oxide(NO)/cyclic guanosine monophosphate(cGMP)/protein kinase G(PKG)signaling pathway.Methods An AMI rat model was constructed by ligating the left anterior descending coronary artery.After modeling,the rats were divided randomly into Sham,Model,and GDF-15 groups(n=12 rats per group).Rats in the GDF-15 group were injected intraperitoneally with recombinant GDF-15 protein,and the other two groups were injected with the same amount of normal saline twice a week for 8 consecutive weeks.Cardiac function was detected by echocardiography.Pathological damage to rat myocardial tissue was detected by hematoxylin and eosin staining and the collateral circulation was observed by CD31 immunohistochemical staining.Vascular endothelial growth factor(VEGF)mRNA expression was detected by quantitative polymerase chain reaction.Transcriptomic sequencing of heart tissues in the model and GDF-15 groups was performed and differentially expressed genes(DEGs)were screened.Pathway enrichment analysis of the DEGS was carried out according to the Kyoto Encyclopedia of Genes and Genomes(KEGG).Nitric oxide(NO),reactive oxygen species(ROS),and cGMP were detected using kits,and VEGF,endothelial nitric oxide synthase(eNOS)monomer,p-eNOSser1177monomer,eNOS dimer,and PKG protein were detected by Western blot.Results Left ventricular end-systolic diameter(LVEDs)and left ventricular end-diastolic diameter(LVEDd)were increased(P<0.001),and left ventricular ejection fraction(LVEF)and the short-axis shortening rate(FS)were decreased in the Model group compared with the Sham group(P<0.001).Myocardial cell necrosis was more severe,vascular density in the infarcted area was decreased(P<0.05),but VEGF mRNA and protein levels were no change(P>0.05),and levels of NO,eNOS dimer,cGMP,and PKG protein were decreased(P<0.05),and expression levels of ROS,eNOS monomer,and p-eNOSser1177 monomer were increased(P<0.05).LVEDs and LVEDd decreased(P<0.05),LVEF and FS increased(P<0.01),myocardial cell necrosis was relieved,vascular density in the infarcted area increased significantly(P<0.0001),and VEGF mRNA levels increased(P<0.0001),compared with the Model group.Transcriptomic sequencing identified 324 DEGs,including 230 up-regulated and 94 down-regulated genes.According to KEGG enrichment analysis,the cGMP-PKG signaling pathway showed the most significant difference in the T20 pathway.VEGF,NO,eNOS dimer,cGMP,and PKG protein levels were all increased(P<0.05),while ROS,eNOS monomer,and p-eNOSser1177 monomer were decreased in the GDF-15 group(P<0.05).Conclusions GDF-15 can promote collateral circulation in ischemic myocardium and improve cardiac function by inhibiting eNOS decoupling and activating the NO/cGMP/PKG pathway.
5.Predictive value of Cys C,HMGB1,GDF-15 levels for early infection after flap reconstruction for diabetic foot ulcer
Hongtao FENG ; Xiaoping JIAO ; Wenxuan SHANG ; Hongpu LI
The Journal of Practical Medicine 2024;40(23):3331-3336
Objective To explore the predictive value of cystatin C(Cys C),high mobility group box 1(HMGB1),and growth differentiation factor-15(GDF-15)levels for early infection after flap reconstruction for diabetic foot ulcer(DFU).Methods From July 2021 to March 2024,155 DFU patients treated in our hospital were included in DFU group.DFU patients were assigned into non-infection group(104 cases)and infection group(51 cases)according to whether there was infection at the operation site within one week after flap reconstruction.Control group included 85 patients with diabetes but without foot ulcer.Latex immunoturbidimetry was applied to detect serum Cys C level;enzyme linked immunosorbent assay to detect serum levels of HMGB1 and GDF-15;multivariate logistic regression to analyze the factors affecting early infection after flap reconstructionfor DFU,and receiver operating characteristic(ROC)curve to analyze the predictive value of serum Cys C,HMGB1,and GDF-15 levels for early infection after flap reconstruction for DFU.Results The expression levels of serum Cys C,HMGB1,and GDF-15 were obviously higher in the DFU group(P<0.05)when compared with those in the control group.The expression levels of FPG,CRP,Cys C,HMGB1,and GDF-15 were obviously higher in the infection group(P<0.05)when compared with those in the non-infection group.Cys C,HMGB1,GDF-15,FPG,and CRP were all inde-pendent risk factors for early infection after flap reconstruction for DFU(P<0.05).The AUC predicted by serum Cys C,HMGB1,and GDF-15 alone for early infection after flap reconstruction for DFU was 0.810,0.850,and 0.828,respectively.The AUC predicted by the combination of these three markers was 0.930,which was better than that predicted by the three markers alone(ZCysC-three combination=3.381,ZHMGB1-three combination=2.588,ZGDF-15-three combination=2.857,all P<0.05).Conclusions Cys C,HMGB1,and GDF-15 are upregulated in the serum of DFU patients,and all the three are factors affecting early infection after flap reconstruction for DFU.The combination of the three has high predictive value for early infection after DFU flap repair.
6.Predictive value of Cys C,HMGB1,GDF-15 levels for early infection after flap reconstruction for diabetic foot ulcer
Hongtao FENG ; Xiaoping JIAO ; Wenxuan SHANG ; Hongpu LI
The Journal of Practical Medicine 2024;40(23):3331-3336
Objective To explore the predictive value of cystatin C(Cys C),high mobility group box 1(HMGB1),and growth differentiation factor-15(GDF-15)levels for early infection after flap reconstruction for diabetic foot ulcer(DFU).Methods From July 2021 to March 2024,155 DFU patients treated in our hospital were included in DFU group.DFU patients were assigned into non-infection group(104 cases)and infection group(51 cases)according to whether there was infection at the operation site within one week after flap reconstruction.Control group included 85 patients with diabetes but without foot ulcer.Latex immunoturbidimetry was applied to detect serum Cys C level;enzyme linked immunosorbent assay to detect serum levels of HMGB1 and GDF-15;multivariate logistic regression to analyze the factors affecting early infection after flap reconstructionfor DFU,and receiver operating characteristic(ROC)curve to analyze the predictive value of serum Cys C,HMGB1,and GDF-15 levels for early infection after flap reconstruction for DFU.Results The expression levels of serum Cys C,HMGB1,and GDF-15 were obviously higher in the DFU group(P<0.05)when compared with those in the control group.The expression levels of FPG,CRP,Cys C,HMGB1,and GDF-15 were obviously higher in the infection group(P<0.05)when compared with those in the non-infection group.Cys C,HMGB1,GDF-15,FPG,and CRP were all inde-pendent risk factors for early infection after flap reconstruction for DFU(P<0.05).The AUC predicted by serum Cys C,HMGB1,and GDF-15 alone for early infection after flap reconstruction for DFU was 0.810,0.850,and 0.828,respectively.The AUC predicted by the combination of these three markers was 0.930,which was better than that predicted by the three markers alone(ZCysC-three combination=3.381,ZHMGB1-three combination=2.588,ZGDF-15-three combination=2.857,all P<0.05).Conclusions Cys C,HMGB1,and GDF-15 are upregulated in the serum of DFU patients,and all the three are factors affecting early infection after flap reconstruction for DFU.The combination of the three has high predictive value for early infection after DFU flap repair.
7.Current status of surgery for portal hypertension in China: a national multi-center survey analysis
Lei ZHENG ; Haiyang LI ; Jizhou WANG ; Xiao LIANG ; Jian DOU ; Jitao WANG ; Qiang FAN ; Xiong DING ; Wenlong ZHAI ; Yun JIN ; Bo LI ; Songqing HE ; Tao LI ; Jun LIU ; Kui WANG ; Zhiwei LI ; Yongyi ZENG ; Yingmei SHAO ; Yang BU ; Dong SHANG ; Yong MA ; Cheng LOU ; Xinmin YIN ; Jiefeng HE ; Haihong ZHU ; Jincai WU ; Zhidan XU ; Dunzhu BASANG ; Jianguo LU ; Liting ZHANG ; Jianguo ZHAO ; Ling LYU ; Guoyue LYU ; Nim CHOI ; To Tan CHEUNG ; Meng LUO ; Wanguang ZHANG ; Xiaolong QI ; Xiaoping CHEN
Chinese Journal of Organ Transplantation 2023;44(3):152-159
Objective:To explore the current status of surgery for portal hypertension to grasp current status and future development of surgery in China.Methods:This study is jointly sponsored by China Hepatobiliary & Pancreatic Specialist Alliance & Portal Hypertension Alliance in China (CHESS).Comprehensive surveying is conducted for basic domestic situations of surgery for portal hypertension, including case load, surgical approaches, management of postoperative complications, primary effects, existing confusion and obstacles, liver transplantation(LT), laparoscopic procedures and transjugular intrahepatic portosystemic shunt(TIPS), etc.Results:A total of 8 512 cases of portal hypertension surgery are performed at 378 hospitals nationwide in 2021.Splenectomy plus devascularization predominated(53.0%)and laparoscopy accounted for 76.1%.Primary goal is preventing rebleeding(67.0%) and 72.8% of hospitals used preventive anticoagulants after conventional surgery.And 80.7% of teams believe that the formation of postoperative portal vein thrombosis is a surgical dilemma and 65.3% of hospitals practiced both laparoscopy and TIPS.The major reasons for patients with portal hypertension not receiving LT are due to a lack of qualifications for LT(69.3%)and economic factors(69.0%).Conclusions:Surgery is an integral part of management of portal hypertension in China.However, it is imperative to further standardize the grasp of surgical indications, the handling of surgical operation and the management of postoperative complications.Moreover, prospective, multi-center randomized controlled clinical studies should be performed.
8.Analysis of related factors of emotional and behavioral abnormalities in children with overactivity of bladder
Wenjuan WANG ; Guowei SI ; Yakai LIU ; Ru JIA ; Songyang WANG ; Jing YANG ; Lei LYU ; Yanping ZHANG ; Xiaoping SHANG ; Jianguo WEN
Journal of Modern Urology 2023;28(4):313-317
【Objective】 To analyze the related factors of emotional and behavioral abnormalities in children with overactive bladder (OAB). 【Methods】 OAB children (aged 6 to 16 years) in a survey of 5 032 children from a county in Henan Province during Sep.2022 and Dec.2022 were identified and surveyed with Overactive Bladder Symptom Score (OABSS), Strength and Difficulties Questionnaire (SDQ) and Pediatric Sleep Questionnaire (PSQ). According to the SDQ score, they were divided into abnormal group (SDQ≥20) and normal group. 【Results】 There were 35.7%(137/385) cases in the abnormal group and 64.3% (248/385) in the normal group. Gender, education level of caregivers, body mass index (BMI), age, constipation, enuresis and severity of OAB were significantly associated with emotional and behavioral abnormalities (P<0.05). Children in the abnormal group showed significant differences in emotional symptoms, conduct problems, hyperactivity symptoms, peer interaction and sleep (P<0.001). Multivariate regression analysis revealed significant differences in gender, educational level of caregi-vers, BMI, age, constipation, enuresis, severity of OAB and PSQI between the two groups (P<0.05). 【Conclusion】 The prevalence of emotional and behavioral abnormalities is high in children with OAB, which is related to female gender, high BMI, puberty, constipation, enuresis and severity of OAB.
9.Study on knowledge, attitudes and practices of pulse oximetry among pediatric healthcare providers in China and their influencing factors
Fengxia XUE ; Yuejie ZHENG ; Adong SHEN ; Hanmin LIU ; Xing CHEN ; Lili ZHONG ; Guangmin NONG ; Xin SUN ; Gen LU ; Shenggang DING ; Yuanxun FANG ; Jiahua PAN ; Zhiying HAN ; Yun SUN ; Qiang CHEN ; Yi JIANG ; Xiaoping ZHU ; Suping TANG ; Xiufang WANG ; Changshan LIU ; Shaomin REN ; Zhimin CHEN ; Deyu ZHAO ; Yong YIN ; Rongfang ZHANG ; Ming LI ; Yunxiao SHANG ; Yaping MU ; Shuhua AN ; Yangzom YESHE ; Peiru XU ; Yan XING ; Baoping XU ; Jing ZHAO ; Shi CHEN ; Wei XIANG ; Lihong LI ; Enmei LIU ; Yuxin SONG ; Yonghong YANG ; Kunling SHEN
Chinese Journal of Applied Clinical Pediatrics 2022;37(23):1807-1812
Objective:To investigate the knowledge, attitudes, and practices (KAP) of pulse oximetry among pediatric healthcare providers in China and analyze the factor influencing the KAP.Methods:A self-developed questionnaire was used for an online research on the KAP of 11 849 pediatric healthcare providers from 31 provinces, autonomous regions, and municipalities of China from March 11 to 14, 2022.The factors influencing the KAP of pulse oximetry among pediatric healthcare providers were examined by Logistic regression. Results:The scores of KAP, of pulse oximetry were 5.57±0.96, 11.24±1.25 and 11.19±4.54, respectively.The corresponding scoring rates were 69.61%, 74.95%, and 55.99%, respectively. Logistic regression results showed that the gender and working years of pediatric healthcare providers, the region they were located, and whether their medical institution was equipped with pulse oximeters were the main factors affecting the knowledge score (all P<0.05). Main factors influencing the attitude score of pediatric healthcare providers included their knowledge score, gender, educational background, working years, region, medical institution level, and whether the medical institution was equipped with pulse oximeters (all P<0.05). For the practice score, the main influencing factors were the knowledge score, gender, age, and whether the medi-cal institution was equipped with pulse oximeters (all P<0.05). Conclusions:Chinese pediatric healthcare providers need to further improve their knowledge about and attitudes towards pulse oximetry.Pulse oximeters are evidently under-used.It is urgent to formulate policies or guidelines, strengthen education and training, improve knowledge and attitudes, equip more institutions with pulse oximeters, and popularize their application in medical institutions.
10.Expert consensus on prevention and management of enteral nutrition therapy complications for critically ill patients in China (2021 edition)
Yuanyuan MI ; Haiyan HUANG ; You SHANG ; Xiaoping SHAO ; Peipei HUANG ; Chenglin XIANG ; Shuhua WANG ; Lei BAO ; Lanping ZHENG ; Su GU ; Yun XU ; Chuansheng LI ; Shiying YUAN
Chinese Critical Care Medicine 2021;33(8):903-918
Enteral nutrition plays an irreplaceable role in the nutritional treatment of critically ill patients. In order to help clinical medical staff to manage the common complications during the implementations of enteral nutrition for critically ill patients, the consensus writing team carried out literature retrieval, literature quality evaluation, evidence synthesis. Several topics such as diarrhea, aspiration, high gastric residual volume, abdominal distension, etc. were assessed by evidence-based methodology and Delphi method. After two rounds of expert investigations, Expert consensus on prevention and management of enteral nutrition therapy complications for critically ill patients in China (2021 edition) developed, and provided guidance for clinical medical staff.

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