1.Screening key genes of PANoptosis in hepatic ischemia-reperfusion injury based on bioinformatics
Lirong ZHU ; Qian GUO ; Jie YANG ; Qiuwen ZHANG ; Guining HE ; Yanqing YU ; Ning WEN ; Jianhui DONG ; Haibin LI ; Xuyong SUN
Organ Transplantation 2025;16(1):106-113
Objective To explore the relationship between PANoptosis and hepatic ischemia-reperfusion injury (HIRI), and to screen the key genes of PANoptosis in HIRI. Methods PANoptosis-related differentially expressed genes (PDG) were obtained through the Gene Expression Omnibus database and GeneCards database. Gene ontology (GO), Kyoto Encyclopedia of Genes and Genomes (KEGG), and Gene Set Enrichment Analysis (GSEA) were used to explore the biological pathways related to PDG. A protein-protein interaction network was constructed. Key genes were selected, and their diagnostic value was assessed and validated in the HIRI mice. Immune cell infiltration analysis was performed based on the cell-type identification by estimating relative subsets of RNA transcripts. Results A total of 16 PDG were identified. GO analysis showed that PDG were closely related to cellular metabolism. KEGG analysis indicated that PDG were mainly enriched in cellular death pathways such as apoptosis and immune-related signaling pathways such as the tumor necrosis factor signaling pathway. GSEA results showed that key genes were mainly enriched in immune-related signaling pathways such as the mitogen-activated protein kinase (MAPK) signaling pathway. Two key genes, DFFB and TNFSF10, were identified with high accuracy in diagnosing HIRI, with areas under the curve of 0.964 and 1.000, respectively. Immune infiltration analysis showed that the control group had more infiltration of resting natural killer cells, M2 macrophages, etc., while the HIRI group had more infiltration of M0 macrophages, neutrophils, and naive B cells. Real-time quantitative polymerase chain reaction results showed that compared with the Sham group, the relative expression of DFFB messenger RNA in liver tissue of HIRI group mice increased, and the relative expression of TNFSF10 messenger RNA decreased. Cibersort analysis showed that the infiltration abundance of naive B cells was positively correlated with DFFB expression (r=0.70, P=0.035), and the infiltration abundance of M2 macrophages was positively correlated with TNFSF10 expression (r=0.68, P=0.045). Conclusions PANoptosis-related genes DFFB and TNFSF10 may be potential biomarkers and therapeutic targets for HIRI.
2.Mechanism of post cardiac arrest syndrome based on animal models of cardiac arrest.
Halidan ABUDU ; Yiping WANG ; Kang HE ; Ziquan LIU ; Liqiong GUO ; Jinrui DONG ; Ailijiang KADEER ; Guowu XU ; Yanqing LIU ; Xiangyan MENG ; Jinxia CAI ; Yongmao LI ; Haojun FAN
Journal of Central South University(Medical Sciences) 2025;50(5):731-746
Cardiac arrest (CA) is a critical condition in the field of cardiovascular medicine. Despite successful resuscitation, patients continue to have a high mortality rate, largely due to post CA syndrome (PCAS). However, the injury and pathophysiological mechanisms underlying PCAS remain unclear. Experimental animal models are valuable tools for exploring the etiology, pathogenesis, and potential interventions for CA and PCAS. Current CA animal models include electrical induction of ventricular fibrillation (VF), myocardial infarction, high potassium, asphyxia, and hemorrhagic shock. Although these models do not fully replicate the complexity of clinical CA, the mechanistic insights they provide remain highly relevant, including post-CA brain injury (PCABI), post-CA myocardial dysfunction (PAMD), systemic ischaemia/reperfusion injury (IRI), and the persistent precipitating pathology. Summarizing the methods of establishing CA models, the challenges encountered in the modeling process, and the mechanisms of PCAS can provide a foundation for developing standardized CA modeling protocols.
Animals
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Disease Models, Animal
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Post-Cardiac Arrest Syndrome/physiopathology*
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Heart Arrest/physiopathology*
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Humans
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Ventricular Fibrillation/complications*
3.Clinical features and early warning of the sepsis in immunocompromised host sepsis.
Yanqing CHEN ; Runjing GUO ; Xiao HUANG ; Xiaoli LIU ; Huanhuan TIAN ; Bingjie LYU ; Fangyu NING ; Tao WANG ; Dong HAO
Chinese Critical Care Medicine 2025;37(3):245-250
OBJECTIVE:
To explore the clinical features of the sepsis in immunocompromised hosts and establish an early warning equation.
METHODS:
A retrospective study was conducted on sepsis patients admitted to the intensive care unit (ICU) of Binzhou Medical University Hospital from October 2011 to October 2022. General information, infection site, etiology results and drug susceptibility, clinical symptoms, inflammatory indicators, acute physiology and chronic health status evaluation II (APACHE II), sequential organ failure assessment (SOFA), incidence of immune paralysis, and outcome during hospitalization were collected. Based on whether they met the diagnostic criteria for immunocompromised hosts, patients were divided into immunocompromised group and immune normal group. The clinical information of the two groups were compared. Multivariate Logistic regression was used to analyze the risk factors of patients with immunocompromised sepsis and the regression equation model was initially established. Omnibus test and Hosmer-Lemeshow test were used to evaluate the model.
RESULTS:
A total of 169 patients with sepsis were included, including 61 in the immunocompromised group and 108 in the normal immune group. The top 3 infection sites in the immunocompromised group were bloodstream infection, pulmonary infection and abdominal infection. The top 3 infection sites in the normal immune group were pulmonary infection, bloodstream infection and abdominal infection. The infection rate of Gram-negative bacteria in the immunocompromised group was significantly lower than that in the normal group [49.2% (30/61) vs. 64.8% (70/108), P < 0.05]. The infection rate of Gram-positive bacteria [27.9% (17/61) vs. 13.9% (15/108)] and multidrug-resistant bacteria [54.1% (33/61) vs. 29.6% (32/108)] were significantly higher than those in normal immune group (both P < 0.05). In terms of clinical symptoms, the proportion of fever in the immunocompromised group was significantly lower than that in the immune normal group [49.2% (30/61) vs. 66.7% (72/108), P < 0.05]. Neutrophil count (NEU) and neutrophil percentage (NEU%) in the immunocompromised group were significantly lower than those in the normal immune group. Lymphocyte percentage (LYM%), neutrophil/lymphocyte ratio (NLR), C-reactive protein (CRP), procalcitonin (PCT), APACHE II score, combined shock rate, incidence of immune paralysis, and mortality during hospitalization in the immunocompromised group were significantly higher than those in the normal immune group. Logistic regression analysis showed that NLR, CRP and PCT were risk factors for patients with immunocompromised sepsis (all P < 0.05). The above indicators were used as covariables to construct a Logistic regression equation, that was, Logit (P) = 0.025X1+0.010X2+0.013X3-2.945, where X1, X2 and X3 represent NLR, CRP and PCT respectively. Omnibus test and Hosmer-Lemeshow test show that the model fits well and has certain early warning value.
CONCLUSIONS
Patients with immunocompromised sepsis have more intense inflammatory response, with Gram-negative bacteria being the predominant pathogen, and a higher incidence of Gram-positive bacterial infections and multi-drug resistant infections. The severity of the disease, in-hospital mortality, the incidence of shock and the incidence of immune paralysis after sepsis were significantly higher. NLR, CRP and PCT were independent risk factors for sepsis in immunocompromised hosts. The regression equation constructed based on this may have early warning significance for patients with immunocompromised sepsis.
Humans
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Sepsis/immunology*
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Immunocompromised Host
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Retrospective Studies
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Risk Factors
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Intensive Care Units
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Logistic Models
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Male
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APACHE
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Female
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Middle Aged
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Aged
4.Construction and validation of clinical prediction model of tongue base collapse under drug-induced sleep endoscopy in OSA patients
Shiming WANG ; Yinü DONG ; Yamin LIU ; Yanqing YE ; Jingmeng ZHOU ; Xiaoxing HUANG ; Huaihong CHEN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(8):837-843
Objective:To analyze the correlation between drug-induced sleep endoscopy (DISE), results, polysomnography (PSG) indicators, and clinical parameters in patients with obstructive sleep apnea (OSA), and to establish and validate a predictive model for tongue base plane obstruction.Methods:This retrospective study analyzed 117 OSA patients diagnosed via PSG and treated at the Department of Otolaryngology-Head and Neck Surgery, Nanfang Hospital, Southern Medical University, between October 2014 and March 2022. The cohort comprised of 114 males and 3 females, with an age range of 20 to 54 years (mean age 38.1±8.4 years). Data on DISE results, PSG results, and clinical indicators were collected for all 117 patients. Logistic regression analysis was performed to identify relevant indicators, and a predictive model for tongue base plane obstruction was constructed and internally validated using the R programming language.Results:Univariate logistic regression analysis identified four independent risk factors for predicting tongue root plane obstruction: tonsil grading, N2, N3, and rapid eye movement sleep(REM) stage [ OR:0.412(0.260~0.652),1.045(1.012~1.079),0.943(0.903~0.984),0.961(0.925~0.998), P <0.05]. Multivariate logistic regression analysis confirmed tonsil grading and N3 sleep stage (12.48±12.22%) as significant predictors. A nomogram model incorporating these factors demonstrated good predictive performance, with an area under curve(AUC) of 0.82 (95% CI: 0.548-1.000), an optimal cutoff of 0.519, a specificity of 80.0%, and a sensitivity of 86.7%. Internal validation of the model in the validation cohort yielded an AUC of 0.751 (95% CI: 0.625-0.876). Conclusions:Tongue base plane obstruction observed during DISE in OSA patients is associated with tonsil grading and N3 sleep stage duration. The predictive model developed for tongue base plane obstruction based on DISE demonstrates good efficacy, as evidenced by its internal validation.
5.An accurate diagnostic approach for urothelial carcinomas based on novel dual methylated DNA markers in small-volume urine.
Yucai WU ; Di CAI ; Jian FAN ; Chang MENG ; Shiming HE ; Zhihua LI ; Lianghao ZHANG ; Kunlin YANG ; Aixiang WANG ; Xinfei LI ; Yicong DU ; Shengwei XIONG ; Mancheng XIA ; Tingting LI ; Lanlan DONG ; Yanqing GONG ; Liqun ZHOU ; Xuesong LI
Chinese Medical Journal 2024;137(2):232-234
6.Study on the Expression of Tissue STAT3 and Serum STAT3 mRNA,IL-12p40 and IL-13R α 2 Levels in Children with Congenital Intestinal Atresia and Their Correlation with Prognosis
Yanqing DONG ; Huizhong NIU ; Pengju ZHANG ; Hui REN ; Pan CHEN ; Zhiguang ZHANG ; Bobo NIU
Journal of Modern Laboratory Medicine 2024;39(5):35-40,46
Objective To investigate the expression of tissue signal transducer and activator of transcription 3(STAT3)and serum STAT3 mRNA,IL-12p40 and IL-13R α 2 levels in children with congenital intestinal atresia and their correlation with prognosis.Methods From January 2020 to January 2023,100 cases of intestinal atresia lesion tissues,normal intestinal tissues and preoperative serum samples were collected from children with congenital intestinal atresia who underwent treatment in Hebei Children's Hospital.According to the Grosfeld typing criteria,these children were categorized into 39 cases of type Ⅰ,22 cases of type Ⅱ,30 cases of type Ⅲ and 9 cases of type Ⅳ.Based on the recovery situation at 6 months after surgery,these children were separated into a good prognosis group(n=78)and a poor prognosis group(n=22).Serum samples from 93 cases of healthy children undergoing medical examinations during the same period were regarded as control samples.Immunohistochemistry was applied to detect the positive expression and localization of STAT3 in tissues.Western blot was applied to detect the expression of STAT3 protein in tissues,and quantitative polymerase chain reaction(qPCR)was applied to detect the expression level of STAT3 mRNA in serum.Pearson correlation was applied to analyze the correlation between serum STAT3 and inflammatory factor levels in children with congenital intestinal atresia.Logistic regression was used to analyze the factors affecting the prognosis of children with congenital intestinal atresia.Receiver operating characteristic(ROC)curve was applied to analyze the predictive efficacy of serum STAT3 level on the prognosis of children with congenital intestinal atresia.Results Immunohistochemical results showed that STAT3 positive expression was mainly localized in the cytoplasm and nucleus.The positive expression rate in congenital intestinal atresia tissue(86%)was higher than that in normal intestinal tissue(18%),and the difference was significant(x2=92.628,P<0.05).Western blot results showed that the relative expression level of STAT3 in congenital intestinal atresia tissue(1.59±0.21)was higher than that in normal intestinal tissue(0.81±0.12),and the difference was significant(t=30.567,P<0.05).The results of qPCR showed that serum STAT3(2.13±0.56),IL-12p40(0.89±0.13 ng/ml),and IL-13R α 2 levels(6.42±1.86ng/ml)in the congenital intestinal atresia group were higher than those in the control groups(1.06±0.11,0.37±0.08ng/ml,1.35±0.41ng/ml),and the differences were significant(t=18.101,33.170,25.708,all P<0.05).The levels of STAT3 and IL-12p40,IL-13R α 2 were gradually increased with the increase of the children's subtypes,and the differences were significant(F=52.666,160.300,25.82,all P<0.05).Pearson correlation analysis showed a positive correlation between serum STAT3,IL-12p40,and IL-13R α 2 levels in children with congenital intestinal atresia(r=0.496,0.564,all P<0.001).The expression level of serum STAT3 in poor prognosis group(3.01±0.75)was higher than that in good prognosis group(1.88±0.51),and the differences was statistically significant(t=8.212,P<0.05).Logistic regression showed that STAT3,IL-12p40,IL-13R α 2,and low birth quality were all independent risk factors for poor prognosis in children with congenital intestinal atresia(all P<0.05).The ROC curve showed that the area under the curve(AUC)for evaluating the prognosis of children with congenital intestinal atresia by serum STAT3 expression was 0.916,with a sensitivity of 81.82%and a specificity of 88.46%,respectively.When the serum STAT3 mRNA level was higher than 2.47,children with congenital intestinal atresia had a higher probability of poor prognosis.Conclusion The expression of STAT3 is increased in the tissues and serum of children with congenital intestinal atresia.Serum STAT3 may have a predictive value for the prognosis of affected children.
7.Effects of small-group collaborative stratified teaching in standardized residency training in critical care medicine
Jun YANG ; Zhenhui DONG ; Fang LU ; Yanqing WANG ; Jinyan XING
Chinese Journal of Medical Education Research 2024;23(6):856-860
Objective:To explore the effects of small-group collaborative stratified teaching in critical care medicine training for professional postgraduate students.Methods:We randomly assigned 71 professional postgraduate students who entered the Intensive Care Unit of The Affiliated Hospital of Qingdao University for standardized training between June 2020 and November 2020 into experimental group and control group. An entrance examination was taken after one week of unified training. Then the experimental group adopted small-group collaborative stratified teaching, while the control group adopted traditional teaching for training. After two months of training, the Mini-Clinical Evaluation Exercise (Mini-CEX) assessment, post competency assessment, exit examination, and teaching satisfaction evaluation were conducted. SPSS 25.0 was used for the t test and chi-square test. Results:In the Mini-CEX assessment, the experimental group had significantly higher scores in history-taking skills [(7.42±0.60) vs. (7.00±0.55)], physical examination [(7.47±0.56) vs. (6.94±0.24)], communication skills [(7.56±0.50)vs.(7.24±0.49)], clinical dialectical thinking [(7.53±0.56) vs. (7.03±0.39)], clinical judgement [(7.50±0.51) vs.(6.90±0.42)], organization/efficiency [(7.58±0.50) vs. (7.15±0.44)], and overall clinical competence [(7.64±0.49) vs. (7.17±0.39); all P<0.05] than the control group. In the post competency assessment, the experimental group had significantly better performance in clinical basic competence [(89.15±9.12) vs. (86.24±10.23)], medical knowledge application [(48.37±5.87) vs. (46.98±3.68)], teamwork [(48.10±3.55) vs. (45.96±4.83)], information and management [(68.52±7.61) vs. (66.38±5.54)], and academic research [(22.18±0.95) vs. (20.87±1.22); all P<0.05] than the control group. The experimental group was also significantly superior to the control group in terms of the exit examination score and teaching satisfaction (both P<0.05). Conclusions:Small-group collaborative stratified teaching can improve the quality of critical care medicine training for professional postgraduate students, and strengthen their clinical comprehensive abilities and post competencies.
8.Surveillance of bacterial resistance in tertiary hospitals across China:results of CHINET Antimicrobial Resistance Surveillance Program in 2022
Yan GUO ; Fupin HU ; Demei ZHU ; Fu WANG ; Xiaofei JIANG ; Yingchun XU ; Xiaojiang ZHANG ; Fengbo ZHANG ; Ping JI ; Yi XIE ; Yuling XIAO ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Jingyong SUN ; Qing CHEN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yunmin XU ; Sufang GUO ; Yanyan WANG ; Lianhua WEI ; Keke LI ; Hong ZHANG ; Fen PAN ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Wei LI ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Qian SUN ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanqing ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Wenhui HUANG ; Juan LI ; Quangui SHI ; Juan YANG ; Abulimiti REZIWAGULI ; Lili HUANG ; Xuejun SHAO ; Xiaoyan REN ; Dong LI ; Qun ZHANG ; Xue CHEN ; Rihai LI ; Jieli XU ; Kaijie GAO ; Lu XU ; Lin LIN ; Zhuo ZHANG ; Jianlong LIU ; Min FU ; Yinghui GUO ; Wenchao ZHANG ; Zengguo WANG ; Kai JIA ; Yun XIA ; Shan SUN ; Huimin YANG ; Yan MIAO ; Mingming ZHOU ; Shihai ZHANG ; Hongjuan LIU ; Nan CHEN ; Chan LI ; Jilu SHEN ; Wanqi MEN ; Peng WANG ; Xiaowei ZHANG ; Yanyan LIU ; Yong AN
Chinese Journal of Infection and Chemotherapy 2024;24(3):277-286
Objective To monitor the susceptibility of clinical isolates to antimicrobial agents in tertiary hospitals in major regions of China in 2022.Methods Clinical isolates from 58 hospitals in China were tested for antimicrobial susceptibility using a unified protocol based on disc diffusion method or automated testing systems.Results were interpreted using the 2022 Clinical &Laboratory Standards Institute(CLSI)breakpoints.Results A total of 318 013 clinical isolates were collected from January 1,2022 to December 31,2022,of which 29.5%were gram-positive and 70.5%were gram-negative.The prevalence of methicillin-resistant strains in Staphylococcus aureus,Staphylococcus epidermidis and other coagulase-negative Staphylococcus species(excluding Staphylococcus pseudintermedius and Staphylococcus schleiferi)was 28.3%,76.7%and 77.9%,respectively.Overall,94.0%of MRSA strains were susceptible to trimethoprim-sulfamethoxazole and 90.8%of MRSE strains were susceptible to rifampicin.No vancomycin-resistant strains were found.Enterococcus faecalis showed significantly lower resistance rates to most antimicrobial agents tested than Enterococcus faecium.A few vancomycin-resistant strains were identified in both E.faecalis and E.faecium.The prevalence of penicillin-susceptible Streptococcus pneumoniae was 94.2%in the isolates from children and 95.7%in the isolates from adults.The resistance rate to carbapenems was lower than 13.1%in most Enterobacterales species except for Klebsiella,21.7%-23.1%of which were resistant to carbapenems.Most Enterobacterales isolates were highly susceptible to tigecycline,colistin and polymyxin B,with resistance rates ranging from 0.1%to 13.3%.The prevalence of meropenem-resistant strains decreased from 23.5%in 2019 to 18.0%in 2022 in Pseudomonas aeruginosa,and decreased from 79.0%in 2019 to 72.5%in 2022 in Acinetobacter baumannii.Conclusions The resistance of clinical isolates to the commonly used antimicrobial agents is still increasing in tertiary hospitals.However,the prevalence of important carbapenem-resistant organisms such as carbapenem-resistant K.pneumoniae,P.aeruginosa,and A.baumannii showed a downward trend in recent years.This finding suggests that the strategy of combining antimicrobial resistance surveillance with multidisciplinary concerted action works well in curbing the spread of resistant bacteria.
9.The efficacy and safety of irreversible electroporation in the treatment of localized prostate cancer
Baijun DONG ; Jun YANG ; Yanqing WANG ; Haifeng WANG ; Jiahua PAN ; Shaogang WANG ; Wei XUE
Chinese Journal of Urology 2024;45(8):603-607
Objective:To investigate the efficacy and safety of irreversible electroporation in focal ablation of localized prostate cancer.Methods:Clinical data of 128 patients with localized prostate cancer treated with irreversible electroporation from August 2019 to September 2023 at Renji Hospital of Shanghai Jiaotong University School of Medicine, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, and Dongfang Hospital of Tongji University, were retrospectively analyzed. The median age was 68 (62, 75) years. The median PSA was 8.64 (5.83, 12.57) ng/ml. Gleason score was 6 in 57 cases, 7 in 39 cases, and greater than 7 in 19 cases. There were 4 cases of T 1c, 69 cases of T 2a, 27 cases of T 2b, and 28 cases of T 2c. No lymph node or distant metastasis was seen in preoperative examination. All patients had no preoperative urinary retention or urinary incontinence. Irreversible electroporation treatment was administered under general anesthesia with patients in the lithotomy position. A transrectal ultrasound probe was used to measure prostate lesion size, determining the type and number of electrode needles. Electrode needles were strategically positioned around the targeted lesion. The distance between each pair of needles used for ablation ranged from 0.5 to 2.0 cm. The system automatically generated treatment parameters, including voltage, current, and the number of pulses, with each pulse cycle lasting approximately 5 minutes. After treatment, the needles were removed, gauze was applied for 1 minute. The urethra was then irrigated with a painless iodine solution diluted 1∶1 with 0.9% saline, followed by the insertion of a urinary catheter. Treatment efficacy and adverse reactions were documented. Biochemical recurrence was defined as a PSA increase of over 2 ng/ml from the post-treatment nadir; imaging recurrence was identified by abnormal lesions on MRI or contrast-enhanced ultrasound. Results:All 128 surgeries were successfully completed. At 6 months postoperatively, 116 cases were followed. Tne median PSA was 1.58 (0.56, .95) ng/ml, which was 82.22% (65.37%, 93.33%) lower than preoperative level( P<0.01). Five patients (4.31%) had biochemical recurrence, and MRI or contrast-enhanced ultrasound examinations were negative, 1 patient underwent radical prostatectomy with pathology of prostate cancer, and the remaining 4 were continued to be followed up. Ninety-eight patients underwent MRI or contrast-enhanced ultrasound review, including 6 patients (6.12%) detected imaging recurrence, of which 2 patients underwent radical prostatectomy with pathology of prostate cancer, and the remaining 4 underwent endocrine therapy. The postoperative continence rate was 98.28%, and 8 patients (6.89%) had complications of class II. Conclusions:Irreversible electroporation for focal treatment of localized prostate cancer has shown favorable results in terms of tumor control, safety and urinary continence.
10.Functional dyspepsia treated with WangShiBaoChiWan: a randomized, double-blind, parallel-controlled, multicenter clinical study
Huiyun ZHU ; Xiaoyang DONG ; Jianguo XIAO ; Xiangpeng HU ; Shengbao LI ; Jianlin REN ; Jianghong LING ; Guoxiong ZHOU ; Xi CHEN ; Xiaohua HOU ; Shengsheng ZHANG ; Jianting CAI ; Duowu ZOU ; Yanqing LI ; Bin CHENG ; Xiaoyan WANG ; Zhaoshen LI ; Yiqi DU
Chinese Journal of Digestion 2023;43(12):834-840
Objective:To compare the efficacy and safety between WangShiBaoChiWan and mosapride in the treatment of functional dyspepsia (FD).Methods:From September 2019 to September 2020, patients with postprandial fullness and early satiation who met the Rome Ⅳ criteria for FD diagnosis were enrolled from 15 hospitals, including the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical College. The subjects were randomly divided into WangShiBaoChiWan (experimental) group and mosapride (control) group in the ratio of 1∶1. The treatment regimens were WangShiBaoChiWan+ mosapride simulator, WangShiBaoChiWan simulator+ mosapride, respectively with a treatment period of 2 weeks. The primary efficacy outcome was the improvement rates of main symptoms before and after treatment, the secondary efficacy primary efficacy outcome was the total clinical effective rate and the change of the single symptom score. And the safety indicator included adverse events. Independent sample t-test, paired t-test and chi-square test were used for statistical analysis. Results:A total of 251 FD patients were enrolled in the full analysis set, including 124 in the experimental group and 127 in the control group; 241 FD patients were in the per-protocol analysis set, including 117 in the experimental group and 124 in the control group. The analysis of per-protocol analysis set showed that the improvement rates of the main symptoms of the experimental group and the control group were (66±29)% and (60±30)%, respectively, and the difference was not statistically significant ( P>0.05). The improvement rate of the main symptoms of the experimental group reached 117% of that of the control group, which exceeded the expected non-inferiority standard of 80%. The total clinical effective rates of the experimental group and the control group were 76.07% (89/117) and 75.81% (94/124), respectively, and the difference was not statistically significant ( P>0.05). The results of full analysis set showed that the incidence of adverse events of the experimental group and the control group was 1.62% (2/124) and 1.57% (2/127), respectively, and the difference was not statistically significant ( P>0.05). There were no serious adverse events in the two groups. Conclusion:The improvement rate of the main symptoms of WangShiBaoChiWan is not inferior to that of mosapride in the treatment of FD, and it has good safety.

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