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.An experimental study of a novel suture instrument for endoscopic closure of full thickness defects of the gastric wall
Chunbo YU ; Mingxian CHEN ; Meihua CHEN ; Liang HUANG ; Yijing LIU ; Shufang TAO ; Yanhong HE ; Weizhong YAN ; Dong LI
Chinese Journal of Digestive Endoscopy 2025;42(1):47-52
Objective:To explore the feasibility, safety, and effectiveness of a novel suture instrument for closure of full thickness defects of the gastric wall under gastroscopy.Methods:Ten pigs were used as experimental animals. Perforation model (30 mm in long diameter) was created in the stomach of each pig. The perforations were then closed by the novel suture instrument under gastroscopy. The completion time and efficacy of each perforation repair were recorded. The pigs were euthanized 14 days after the procedure. The healing condition was observed under gastroscopy. A postmortem examination was performed to observe the abdominal infection and healing condition of perforation. Ascites sample was taken for bacterial culture.The stomach biopsy were taken for histopathologic examination.Results:All gastric perforation models in the 10 pigs were established successfully. Endoscopic closure for the stomach perforation was technically successful in all 10 pigs. The procedure time was 34.10±10.32 minutes. All animals survived. Gastroscopy and necropsy showed that the perforation healed well with local adhesion. One pig developed abdominal infection. Ascites culture were negative in 9 cases, 1 bacterial infection was caused by Arcanobacterium pyogenes and Escherichiacoli. The pathology results showed that the muscular layer of the gastric wall defect in the entire group was well repaired. Conclusion:The novel suture instrument is safe and effective in repairing full-thickness gastric wall defects under ordinary single clamp gastroscopy, providing an experimental basis for further clinical research.
3.Li Huilin's Experience in Treating Acne Through the Therapy of Unblocking Triple Energizer and Opening Xuanfu
Hongli WANG ; Yuxin YAN ; Xiaoxue YANG ; Shufang CHU ; Huilin LI
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(5):1250-1254
The triple energizer is the pathway for the transportation and metabolism of qi,blood and body fluid in the body,and the xuanfu(sweat pores)is the way for the ascending,descending,exiting,and entering of qi movement in the muscular striae and the exterior.Professor Li Huilin believes that the pathogenesis of acne is usually due to the dysfunction of triple energizer and the stagnation of depressed yang-heat,which result into the abnormal opening and closing of the xuanfu and the accumulation of heat-toxin in the muscular striae.For the treatment of acne with traditional Chinese medicine,it is necessary to pay attention to the regulation of triple energizer-xuanfu.The treatment should be based on unblocking therapy,and the therapeutic principle of unblocking triple energizer and opening xuanfu should be taken into account.In clinical practice,it is necessary to identify the syndromes of upper energizer,middle energizer and lower energizer.The syndrome of the upper energizer is often due to fire-heat,which results from the wind-heat in lung meridian or the exuberance of heart fire.The upper-energizer syndrome can be treated by the therapy of relieving and clearing the pathogens with light and mild drugs,expelling fire-heat to open sweat pores,and through the modified use of Mahuang Lianqiao Chixiaodou Decoction,Ma Xing Shi Gan Decoction,or Puji Xiaodu Decoction.The syndrome of the middle energizer is usually due to the qi stagnation,which results from intense stomach-heat,damp-heat in the spleen and stomach,liver depression and qi stagnation,or spleen deficiency with dampness accumulation.The middle-energizer syndrome can be treated by the therapy of regulating qi movement to relieve stagnation and open sweat pores,and through the modified use of Qingwei san,Sanren Decoction,Huanglian Wendan Decoction,Chaihu Shugan Powder,or Heqi Powder.The syndrome of the lower energizer is often due to healthy-qi deficiency,which results from yin deficiency of liver and kidney,or deficiency-cold in lower energizer.The lower-energizer syndrome can be treated by the therapy of cultivating the vital essence and consolidating vital base,supplementing deficiency to open sweat pores,and through the modified use of Liuwei Dihuang Pills or Yanghe Decoction.
4.Data Mining in the Medication Rules of Li Huilin in Treating Hashimoto's Thyroiditis Complicated with Hypothyroidism
Xiaoxue YANG ; Chenyang WANG ; Mengru YAN ; Hongli WANG ; Xueqi HU ; Shufang CHU ; Huilin LI
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(7):1779-1785
Objective To explore the medication rules of Professor Li Huilin in treating Hashimoto's thyroiditis(HT)complicated with hypothyroidism using data mining techniques based on the R language.Methods Prescription data of the patients with HT complicated with hypothyroidism treated by Professor Li Huilin in outpatient clinics from March 2023 to March 2024 were collected.A database was established using Microsoft Excel 2021,and R language was employed to analyze the frequency,efficacy,properties and flavors,and meridian tropism of the medicinals from Chinese herbal prescriptions.Additionally,correlation analysis,association rule analysis,and cluster analysis were performed on the medicines from Chinese herbal prescriptions.Results A total of 57 Chinese herbal prescriptions involving 125 medicinals with 782 medication frequencies were included.The top 10 frequently-used medicinals were Glycyrrhizae Radix et Rhizoma Praeparata cum Melle(Zhigancao),Angelicae Sinensis Radix(Danggui),Atractylodis Macrocephalae Rhizoma(Baizhu),Astragali Radix(Huangqi),Bupleuri Radix(Chaihu),Cinnamomi Ramulus(Guizhi),Leonuri Herba(Yimucao),Paeoniae Radix Alba(Baishao),Poria(Fuling),and Fici Simplicissimae Radix(Wuzhimaotao).Most of the medicinals had therapeutic action of tonifying deficiency.The analysis of properties and flavors showed that the majority of medicinals were mild or warm in nature,and sweet in flavor.The top three meridians having the tropism of medicinals were the liver,lung,and spleen meridians.Correlation analysis identified five strongly-correlated herbal combinations.Association rule mining revealed a core herbal combination consisting of seven medicinals of Zhigancao,Huangqi,Danggui,Chaihu,Codonopsis Radix(Dangshen),Baizhu,and Cyperi Rhizoma(Xiangfu).Cluster analysis of medicinals with a frequency of≥5 yielded five groups of herbal combination.Conclusion For the treatment of HT complicated with hypothyroidism,Professor Li Huilin follows the principle of addressing the root cause of the disease,and focuses on strengthening the spleen and replenishing qi.Moreover,attention is given to soothing the liver and regulating qi,harmonizing qi and blood simultaneously,and treating symptoms and root cause simultaneously.
5.miR-374c-5p reduces hydrogen peroxide induced apoptosis of human umbilical vein endothelial cells
Zonghu JIA ; Qun JIN ; Shufang HAN ; Yuhong HU ; Changzhen REN ; Yunping LI ; Wenyan LIU
Basic & Clinical Medicine 2025;45(11):1457-1462
Objective To explore the protective effect of miR-374c-5p on hydrogen peroxide(H2O2)-induced apoptosis of human umbilical vein endothelial cells(HUVECs).Methods HUVECs were cultured in vitro and the harvested cells were divided into four groups:control group,H2O2 group,H2O2+miR-374c-5p mimics trans-fection group,and H2O2+miR-374c-5p inhibitor transfection group.Cell activity was assessed by CCK-8 prolifer-ation rate assay,apoptosis was detected by TUNEL staining microscopy.Expression of miR-374c-5p and Fas mRNA by RT-qPCR,and Fas protein in HUVECs by was detected by Western blot.Results Proliferation of HUVECs was significantly inhibited(P<0.001);H2O2 was significantly increased as compared with the H2O2 in-tervention group(P<0.001);Proliferation in H2O2+miR-374c-5p inhibitor transfection group was significantly increased as compared to H2O2 intervention group(P<0.001).Conclusions miR-374c-5p protectes the HUVECs against apoptosis induced by H2O2.
6.Development and evaluation of nomogram prediction model for refractory chemotherapy-induced nausea and vomiting
Bo SUN ; Shufang LI ; Xun LIU ; Lu CHEN ; Erfeng ZHANG ; Huipin WANG
China Pharmacy 2025;36(9):1105-1110
OBJECTIVE To construct and evaluate nomogram prediction model for refractory chemotherapy-induced nausea and vomiting (CINV). METHODS The data of malignant tumor patients who received chemotherapy at the Third People’s Hospital of Zhengzhou from January 2017 to December 2023 were collected. These patients were categorized into the occurrence group and the non-occurrence group according to the occurrence of refractory CINV. Multivariate Logistic regression analysis was employed to screen predictive factors for refractory CINV and constructing a nomogram prediction model. Model performance was assessed via receiver operating characteristic curve analysis. Model calibration was evaluated using Bootstrap resampling. Decision curve analysis (DCA) was used to determine the clinical net benefit of three strategies under different risk thresholds. Clinical impact curves were utilized to assess the clinical value of the model at different risk thresholds. Shapley additive explanations (SHAP) analysis was performed to evaluate individual factor contributions to the predictive model. RESULTS A total of 388 patients were included, with 219 experiencing refractory CINV. Multivariate Logistic regression identified 11 predictive factors for refractory CINV, including gastrointestinal disease history, anticipated nausea and vomiting, chemotherapy-induced emetic risk classification, and electrolyte levels, etc. The model’s area under the curve was 0.80 [95% confidence interval (0.76, 0.84)], with a mean error of 0.036. DCA demonstrated the prediction model had higher clinical net benefit when the risk threshold was between 0.05 and 0.85. SHAP analysis revealed the top three predictive factors as gastrointestinal disease history (0.924), chemotherapy- induced emetic risk classification (0.866), and electrolyte levels (0.581). CONCLUSIONS Eleven factors, including gastrointestinal disease history, anticipated nausea and vomiting, chemotherapy-induced emetic risk classification, and electrolyte levels, are identified as predictors of refractory CINV. The model based on these factors has good predictive ability, which can be used to predict the risk of refractory CINV.
7.Antimicrobial resistance surveillance in the bacterial strains isolated from pediatric intensive care units in China:results from 2020 to 2022
Jing LIU ; Huiyuan YAN ; Gangfeng YAN ; Guoping LU ; Pan FU ; Chuanqing WANG ; Danqun JIN ; Wenjia TONG ; Chenyu ZHANG ; Jianli CHEN ; Yi LIN ; Jia LEI ; Yibing CHENG ; Qunqun ZHANG ; Kaijie GAO ; Yuanyuan CHEN ; Shufang XIAO ; Juan HE ; Li JIANG ; Huimin XU ; Yuxia LI ; Hanghai DING ; Hehe CHEN ; Yao ZHENG ; Qunying CHEN ; Ying WANG ; Hong REN ; Chenmei ZHANG ; Zhenjie CHEN ; Mingming ZHOU ; Yucai ZHANG ; Yiping ZHOU ; Zhenjiang BAI ; Saihu HUANG ; Lili HUANG ; Weiguo YANG ; Weike MA ; Qing MENG ; Pengwei ZHU ; Yong LI ; Yan XU ; Yi WANG ; Yanqiang DU ; Huijun CAI ; Bizhen ZHU ; Huixuan SHI ; Shaoxian HONG ; Yukun HUANG ; Meilian HUANG
Chinese Journal of Infection and Chemotherapy 2025;25(3):303-311
Objective This study aimed to investigate the antimicrobial resistance profiles of bacterial strains isolated from pediatric intensive care units(PICU)in China for better antimicrobial therapy.Methods Clinical isolates were collected from 17 institutions,including tertiary care children's hospitals and pediatric department of tertiary general hospitals in China from January 1,2020 to December 31,2022.Antimicrobial susceptibility testing was carried out according to a unified protocol using Kirby-Bauer method or automated systems.Results were interpreted according to the breakpoints released by the Clinical and Laboratory Standards Institute(CLSI)in 2020.Results A total of 10 688 isolates were collected,including gram-positive organisms(39.2%)and gram-negative organisms(60.8%).The top three organisms were S.aureus(13.6%,1 453/10 688),A.baumannii(10.0%,1 067/10 688),and coagulase-negative Staphylococcus(9.9%,1 058/10 688).Multi-drug resistant organisms(MDROs)were very common in children.The prevalence of methicillin-resistant Staphylococcus aureus(MRSA),carbapenem-resistant Enterobacterales(CRE),carbapenem-resistant E.coli,carbapenem-resistant K.pneumoniae(CRKP),carbapenem-resistant A.baumannii(CRAB),and carbapenem-resistant P.aeruginosa(CRPA)was 41.1%,19.4%,8.8%,30.9%,67.4%,and 28.8%,respectively.Overall,more than 50%of Enterobacteriales isolates were resistant to cephalosporins,while nearly 25%of Enterobacteriales isolates were resistant to carbapenems.MDROs were highly resistant to commonly used antibiotics.More than 80%of CRE and CRAB strains were resistant to all beta-lactam antibiotics.CRE and CRAB showed low resistance rates to tigecycline and polymyxin.CRPA showed lower resistance rates to piperacillin,beta-lactamase inhibitor combinations than the resistance rates to third and fourth generation cephalosporins.All of the Staphylococcus and Enterococcus isolates were susceptible to vancomycin and tigecycline.None of PRSP strains isolated from meningitis and nonmeningitis samples were resistant to rifampicin,vancomycin,or linezolid.The prevalence of β-lactamase-negative ampicillin-resistant(BLNAR)strains was 43.3%in Haemophilus influenzae.Conclusions MDROs were prevalent in PICU.It is necessary to establish an effective multidisciplinary team(MDT)to control the antimicrobial resistance.
8.RNF115 deficiency upregulates autophagy and inhibits hepatocellular carcinoma growth.
Zhaohui GU ; Jinqiu FENG ; Shufang YE ; Tao LI ; Yaxin LOU ; Pengli GUO ; Ping LV ; Zongming ZHANG ; Bin ZHU ; Yingyu CHEN
Chinese Medical Journal 2025;138(6):754-756
9.Guideline-driven clinical decision support for colonoscopy patients using the hierarchical multi-label deep learning method.
Junling WU ; Jun CHEN ; Hanwen ZHANG ; Zhe LUAN ; Yiming ZHAO ; Mengxuan SUN ; Shufang WANG ; Congyong LI ; Zhizhuang ZHAO ; Wei ZHANG ; Yi CHEN ; Jiaqi ZHANG ; Yansheng LI ; Kejia LIU ; Jinghao NIU ; Gang SUN
Chinese Medical Journal 2025;138(20):2631-2639
BACKGROUND:
Over 20 million colonoscopies are performed in China annually. An automatic clinical decision support system (CDSS) with accurate semantic recognition of colonoscopy reports and guideline-based is helpful to relieve the increasing medical burden and standardize the healthcare. In this study, the CDSS was built under a hierarchical-label interpretable classification framework, trained by a state-of-the-art transformer-based model, and validated in a multi-center style.
METHODS:
We conducted stratified sampling on a previously established dataset containing 302,965 electronic colonoscopy reports with pathology, identified 2041 patients' records representative of overall features, and randomly divided into the training and testing sets (7:3). A total of five main labels and 22 sublabels were applied to annotate each record on a network platform, and the data were trained respectively by three pre-training models on Chinese corpus website, including bidirectional encoder representations from transformers (BERT)-base-Chinese (BC), the BERT-wwm-ext-Chinese (BWEC), and ernie-3.0-base-zh (E3BZ). The performance of trained models was subsequently compared with a randomly initialized model, and the preferred model was selected. Model fine-tuning was applied to further enhance the capacity. The system was validated in five other hospitals with 3177 consecutive colonoscopy cases.
RESULTS:
The E3BZ pre-trained model exhibited the best performance, with a 90.18% accuracy and a 69.14% Macro-F1 score overall. The model achieved 100% accuracy in identifying cancer cases and 99.16% for normal cases. In external validation, the model exhibited favorable consistency and good performance among five hospitals.
CONCLUSIONS
The novel CDSS possesses high-level semantic recognition of colonoscopy reports, provides appropriate recommendations, and holds the potential to be a powerful tool for physicians and patients. The hierarchical multi-label strategy and pre-training method should be amendable to manage more medical text in the future.
Humans
;
Colonoscopy/methods*
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Deep Learning
;
Decision Support Systems, Clinical
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Female
;
Male
10.Current status of implementation of infection control core elements in grass-roots medical institutions under background of construction of"compact county-level medical communities"
Fangfang WANG ; Yuncui GUO ; Xiaoyan WU ; Haibo ZHANG ; Jing ZHOU ; Xu LIU ; Jia DI ; Shufang JIANG ; Chengyi FENG ; Xuemei LI
Chinese Journal of Nosocomiology 2025;35(18):2821-2825
OBJECTIVE To explore the implementation and standardized management of infection control core ele-ments in grass-roots medical institutions within county-level medical communities.METHODS From Mar.2024 to Apr.2024,the current status of implementation of infection control core elements in the grass-roots medical institu-tions within county-level medical communities was investigated by means of questionnaire survey and qualita-tive interview,and the implementation strategies were further explored.RESULTS The infection management or-ganizational system and functions of the two county-level medical institutions within the county medical communi-ties were completed,there is no independent hospital infection management department in the primary medical in-stitutions.The infection management personnel in the 16 grass-roots medical institutions were part-time person-nel,the personnel with the educational background below junior college accounted for 84.21%,the personnel with the professional background of nursing accounted for 100.00%,the personnel with less than 5 years of working experience accounted for 78.95%,none of them had an on-the-job training certificate.The monitoring programs of the county-level medical institutions within the county medical communities were completed,there was no infec-tion management monitoring information platform in the grass-roots medical institutions.The infection cases,hand hygiene,environmental health and occupational exposures were monitored by people.The grass-roots medi-cal institutions had the highest requirements for various professional trainings and increase of training contents of prevention and control of public health infectious diseases(100.00%).The county-level medical institutions had inadequate capabilities of professional examination of medical equipment replacement and construction of medi-cal architecture.CONCLUSION It is necessary for the country and local levels of governments to attach great importance to the implementation of the infection control core elements in the grass-roots medical institutions within the county-lev-el medical communities,establish the county-level regional information platform,formulate the corresponding surveil-lance indexes and homogenized management systems,complete the cultivation of talents,and offer financial support.

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