1.Evaluation of non-human primate anatomical operation risk assessment and control measures in high-level biosafety laboratories
Xiaoqi ZHENG ; Senren XUE ; Xianyu ZHANG ; Jiaxin YANG ; Yuyu CHEN ; Xiaobo LI ; Jingwen LIN ; Yabin ZHANG ; Jianbao HAN
Chinese Journal of Comparative Medicine 2025;35(10):69-78
Non-human primate animal models are core tools for the study of highly pathogenic microorganisms and are irreplaceable in the fields of pathology and drug discovery.However,anatomical sampling of non-human primate infection models in high-level biosafety laboratories carries potential risk and related risk assessment and control measures require clarification.Based on biosafety regulations and practical experience,we systematically discuss the risk control strategies of anatomical operations with respect to personal protection,instrument selection,anatomical specifications,documentation,and personnel training.Our review will help to improve the management of high-level biosafety laboratories,reduce the risk of pathogen escape and human infection,and provide support for the safe research of highly pathogenic microorganisms.
2.A clinical comparative study on three surgical approaches for the removal of impacted supernumerary teeth in the midline ar-ea of the anterior maxilla
Xu CHENG ; Xianyu ZHENG ; Ding DING ; Shanshan HUANG ; Xiaoting WU ; Hengguo ZHANG
STOMATOLOGY 2025;45(5):342-346,354
Objective To evaluate the efficacy and safety of different surgical approaches for extracting high-positioned supernumerary teeth in the maxillary anterior midline region.Three surgical methods,the labial approach,the palatal approach,and a longitudinal incision beside the upper lip frenum were compared.Methods A total of 102 patients were recruited from the Department of Oral and Maxillofacial Surgery at the Affiliated Stomatological Hospital of Anhui Medical University between January and September 2024.They were randomly assigned via a random-digit table to three groups:the labial approach group(n=32),the palatal approach group(n=34),and the longitudinal incision beside the upper lip frenum group(n=36).Operation time,bone removal volume,post-operative midfacial swelling,degree of pain,and patient satisfaction across the three groups were recorded and compared.Results The average operation time in the labial approach group((20.50±3.02)min)and the longitudinal incision group((21.66±2.31)min)were both significantly shorter than that in the palatal approach group((29.19±3.40)min).In contrast,the palatal approach group demonstrated markedly lower postoperative swelling and pain scores(P<0.05),along with the highest patient satisfaction,as reflected in the OHIP-14 scale.However,the palatal approach required the greatest bone removal volume,measuring(91.19±9.86)mm3.Conclusion Despite the palatal approach yielding superior outcomes in terms of postoperative pain control,swelling reduction,and patient satisfaction,it necessitated longer operation time and involved greater bone removal.Meanwhile,the labial approach and the longitudinal incision beside the upper lip frenum were comparable in all measured parameters,showing no statistically significant differences.Therefore,when extracting high midline impacted teeth in the maxillary anterior region,the choice of surgical approach should balance safety,minimal invasiveness,and patient satisfaction.
3.Preoperative short-course radiotherapy followed by chemotherapy and PD-1 inhibitor administration for locally advanced rectal cancer: the initial results of a randomized controlled clinical trial (STELLAR II)
Haoyue LI ; Haitao ZHOU ; Lichun WEI ; Yinggang CHEN ; Wenjue ZHANG ; Feiyan DENG ; Ning LI ; Zheng JIANG ; Zheng LIU ; Jianwei LIANG ; Zhaoxu ZHENG ; Xianyu MENG ; Yufei LU ; Zifa LEI ; Xiaoge SUN ; Gong LI ; Yingjie WANG ; Yongwen SONG ; Shunan QI ; Hao JING ; Yirui ZHAI ; Shulian WANG ; Yexiong LI ; Yuan TANG ; Jing JIN
Chinese Journal of Oncology 2025;47(9):913-921
Objectives:To explore whether short-course radiotherapy (SCRT)-based total neoadjuvant therapy (TNT) combined with PD-1 inhibitors could further promote tumor regression and improve the prognosis.Methods:This is a prospective, multicenter, two-arm randomized controlled, seamless phase Ⅱ/Ⅲ trial for proficient mismatch repair or microsatellite stable (pMMR/MSS) locally advanced rectal cancer (LARC). Eligible patients were randomly assigned to the iTNT (TNT+PD-1) group or the TNT group. Patients in the TNT group received SCRT (5 Gy×5) followed by 4 cycles of CAPOX or 6 cycles of mFOLFOX chemotherapy, with the iTNT group receiving SCRT followed by the same regime in combination with 4 cycles of Sintilimab. Total mesorectal excision (TME) surgery or watch and wait (W&W) was performed after neoadjuvant therapy and then 2 cycles of same regimen as before were recommended. The primary endpoints are the complete response (CR) rate for phase Ⅱ trial and 3-year disease-free survival (DFS) for phase Ⅲ trial. A total of 588 patients will be enrolled for the phase Ⅱ/Ⅲ trial. Short-term efficacy and safety data from the initial 100 treated patients were analyzed as planned.Results:From 2022-8-31 to 2023-5-24 the initial 100 patients were enrolled from 10 hospitals in China, 76.0%(76/100) patients were male, and the median age was 61 years (21-74 years). More patients had tumors located in the lower rectum (78.0%, 78/100), staged T3-4 (97.0%, 97/100) and N1-2 (93.0%, 93/100), and about half of the tumors invaded the mesorectal fascia (52.0%, 52/100) and with extramural vascular invasion (51.0%, 51/100). Analyses were performed according to the per-protocal (PP) set. All patients in the iTNT group ( n=52) and the TNT group ( n=48) completed SCRT; The 4-cycle chemotherapy±Sintilimab completion rates were 86.5% and 100.0% in the iTNT and TNT groups, respectively. In the iTNT group, 82.7% (43/52), 11.5% (6/52), and 5.8% (3/52) of the patients received 4, 3, and 2 cycles of PD-1 inhibitor. After TNT, 68 patients underwent radical surgery and 15 patients achieved cCR and adopted W&W. The pathological complete response (pCR) rates were 48.5% (16/33) and 17.1% (6/35) in the iTNT and TNT groups, with CR rates of 50.0% (25/50) and 26.1% (12/46), respectively. The incidence of treatment-related grade 3-4 adverse events was 26.9% (14/52, iTNT group) and 18.8% (9/48, TNT group), with thrombocytopenia and leukopenia being the most common. Among patients receiving immunotherapy, grade 3 immunotherapy-related adverse events occurred in 2 (3.8%, 2/52) patients: one case was pancreatitis, another case was hepatitis combined with myositis and myocarditis. Conclusion:The preliminary results show that SCRT-based TNT combined with PD-1 inhibitors could further improve the CR rate for LARC without unexpected serious adverse events.
4.Preoperative short-course radiotherapy followed by chemotherapy and PD-1 inhibitor administration for locally advanced rectal cancer: the initial results of a randomized controlled clinical trial (STELLAR II)
Haoyue LI ; Haitao ZHOU ; Lichun WEI ; Yinggang CHEN ; Wenjue ZHANG ; Feiyan DENG ; Ning LI ; Zheng JIANG ; Zheng LIU ; Jianwei LIANG ; Zhaoxu ZHENG ; Xianyu MENG ; Yufei LU ; Zifa LEI ; Xiaoge SUN ; Gong LI ; Yingjie WANG ; Yongwen SONG ; Shunan QI ; Hao JING ; Yirui ZHAI ; Shulian WANG ; Yexiong LI ; Yuan TANG ; Jing JIN
Chinese Journal of Oncology 2025;47(9):913-921
Objectives:To explore whether short-course radiotherapy (SCRT)-based total neoadjuvant therapy (TNT) combined with PD-1 inhibitors could further promote tumor regression and improve the prognosis.Methods:This is a prospective, multicenter, two-arm randomized controlled, seamless phase Ⅱ/Ⅲ trial for proficient mismatch repair or microsatellite stable (pMMR/MSS) locally advanced rectal cancer (LARC). Eligible patients were randomly assigned to the iTNT (TNT+PD-1) group or the TNT group. Patients in the TNT group received SCRT (5 Gy×5) followed by 4 cycles of CAPOX or 6 cycles of mFOLFOX chemotherapy, with the iTNT group receiving SCRT followed by the same regime in combination with 4 cycles of Sintilimab. Total mesorectal excision (TME) surgery or watch and wait (W&W) was performed after neoadjuvant therapy and then 2 cycles of same regimen as before were recommended. The primary endpoints are the complete response (CR) rate for phase Ⅱ trial and 3-year disease-free survival (DFS) for phase Ⅲ trial. A total of 588 patients will be enrolled for the phase Ⅱ/Ⅲ trial. Short-term efficacy and safety data from the initial 100 treated patients were analyzed as planned.Results:From 2022-8-31 to 2023-5-24 the initial 100 patients were enrolled from 10 hospitals in China, 76.0%(76/100) patients were male, and the median age was 61 years (21-74 years). More patients had tumors located in the lower rectum (78.0%, 78/100), staged T3-4 (97.0%, 97/100) and N1-2 (93.0%, 93/100), and about half of the tumors invaded the mesorectal fascia (52.0%, 52/100) and with extramural vascular invasion (51.0%, 51/100). Analyses were performed according to the per-protocal (PP) set. All patients in the iTNT group ( n=52) and the TNT group ( n=48) completed SCRT; The 4-cycle chemotherapy±Sintilimab completion rates were 86.5% and 100.0% in the iTNT and TNT groups, respectively. In the iTNT group, 82.7% (43/52), 11.5% (6/52), and 5.8% (3/52) of the patients received 4, 3, and 2 cycles of PD-1 inhibitor. After TNT, 68 patients underwent radical surgery and 15 patients achieved cCR and adopted W&W. The pathological complete response (pCR) rates were 48.5% (16/33) and 17.1% (6/35) in the iTNT and TNT groups, with CR rates of 50.0% (25/50) and 26.1% (12/46), respectively. The incidence of treatment-related grade 3-4 adverse events was 26.9% (14/52, iTNT group) and 18.8% (9/48, TNT group), with thrombocytopenia and leukopenia being the most common. Among patients receiving immunotherapy, grade 3 immunotherapy-related adverse events occurred in 2 (3.8%, 2/52) patients: one case was pancreatitis, another case was hepatitis combined with myositis and myocarditis. Conclusion:The preliminary results show that SCRT-based TNT combined with PD-1 inhibitors could further improve the CR rate for LARC without unexpected serious adverse events.
5.Evaluation of non-human primate anatomical operation risk assessment and control measures in high-level biosafety laboratories
Xiaoqi ZHENG ; Senren XUE ; Xianyu ZHANG ; Jiaxin YANG ; Yuyu CHEN ; Xiaobo LI ; Jingwen LIN ; Yabin ZHANG ; Jianbao HAN
Chinese Journal of Comparative Medicine 2025;35(10):69-78
Non-human primate animal models are core tools for the study of highly pathogenic microorganisms and are irreplaceable in the fields of pathology and drug discovery.However,anatomical sampling of non-human primate infection models in high-level biosafety laboratories carries potential risk and related risk assessment and control measures require clarification.Based on biosafety regulations and practical experience,we systematically discuss the risk control strategies of anatomical operations with respect to personal protection,instrument selection,anatomical specifications,documentation,and personnel training.Our review will help to improve the management of high-level biosafety laboratories,reduce the risk of pathogen escape and human infection,and provide support for the safe research of highly pathogenic microorganisms.
6.A clinical comparative study on three surgical approaches for the removal of impacted supernumerary teeth in the midline ar-ea of the anterior maxilla
Xu CHENG ; Xianyu ZHENG ; Ding DING ; Shanshan HUANG ; Xiaoting WU ; Hengguo ZHANG
STOMATOLOGY 2025;45(5):342-346,354
Objective To evaluate the efficacy and safety of different surgical approaches for extracting high-positioned supernumerary teeth in the maxillary anterior midline region.Three surgical methods,the labial approach,the palatal approach,and a longitudinal incision beside the upper lip frenum were compared.Methods A total of 102 patients were recruited from the Department of Oral and Maxillofacial Surgery at the Affiliated Stomatological Hospital of Anhui Medical University between January and September 2024.They were randomly assigned via a random-digit table to three groups:the labial approach group(n=32),the palatal approach group(n=34),and the longitudinal incision beside the upper lip frenum group(n=36).Operation time,bone removal volume,post-operative midfacial swelling,degree of pain,and patient satisfaction across the three groups were recorded and compared.Results The average operation time in the labial approach group((20.50±3.02)min)and the longitudinal incision group((21.66±2.31)min)were both significantly shorter than that in the palatal approach group((29.19±3.40)min).In contrast,the palatal approach group demonstrated markedly lower postoperative swelling and pain scores(P<0.05),along with the highest patient satisfaction,as reflected in the OHIP-14 scale.However,the palatal approach required the greatest bone removal volume,measuring(91.19±9.86)mm3.Conclusion Despite the palatal approach yielding superior outcomes in terms of postoperative pain control,swelling reduction,and patient satisfaction,it necessitated longer operation time and involved greater bone removal.Meanwhile,the labial approach and the longitudinal incision beside the upper lip frenum were comparable in all measured parameters,showing no statistically significant differences.Therefore,when extracting high midline impacted teeth in the maxillary anterior region,the choice of surgical approach should balance safety,minimal invasiveness,and patient satisfaction.
7.Expression and pathological diagnostic value of extracellular matrix metalloproteinase inducer,ma-trix metalloproteinase-9 and lysine demethylase 6B in invasive breast cancer
Huang JIANG ; Lihua ZHENG ; Xiaoyan XU ; Jianjun WANG ; Xianwei XU ; Na WANG ; Chenju XING ; Xianyu LU
Journal of Xinxiang Medical College 2024;41(2):143-150
Objective To investigate the expressions of extracellular matrix metalloproteinase inducer(EMMPRIN),matrix metalloproteinase-9(MMP-9),lysine demethylase 6B(KDM6B)proteins and their correlation with clinicopathologic features in invasive breast cancer,and analyze the correlation among the three proteins and their value in pathological diagnosis of invasive breast cancer.Methods The surgical biopsy specimens of 124 patients with invasive breast cancer who were admitted to the Department of Pathology,the Fifth Clinical Medical College of Henan University of Chinese Medicine/People's Hospital of Zhengzhou from January 2014 to December 2017 were selected as research subjects,and 20 low-grade intraductal carcinoma tissue specimens,27 high-grade intraductal carcinoma tissue specimens,and 22 adjacent tissue specimens>1 cm away from the invasive breast cancer were selected as controls.The expressions of EMMPRIN,MMP-9 and KDM6B proteins in cancer-adjacent tissues,low-grade intraductal carcinoma tissues,high-grade intraductal carcinoma tissues and invasive breast cancer tissues were detected by immunohistochemistry.The relationship between the relative expressions of EMMPRIN,MMP-9 and KDM6B proteins and clinicopathologic features of invasive breast cancer was analyzed,Spearman correlation analysis was used to evaluate the correlation of EMMPRIN,MMP-9 and KDM6B proteins in breast cancer tissues,and receiver operating characteristic(ROC)curve was adopted to evaluate the diagnostic value of EMMPRIN,MMP-9 and KDM6B for invasive breast cancer.Results The relative expressions of EMMPRIN and MMP-9 proteins in high-grade intraductal carcinoma and invasive breast cancer tissues were significantly higher those in cancer-adjacent tissues and low-grade intraductal carcinoma tissues,and the relative expression of KDM6B protein was significantly lower than those in cancer-adjacent tissues and low-grade intraductal carcinoma tissues(P<0.05);the relative expressions of EMMPRIN and MMP-9 proteins in invasive breast cancer tissues were significantly higher those in high-grade intraductal carcinoma tissues,and the relative expression of KDM6B protein was significantly lower than that in high-grade intraductal carcinoma tissues(P<0.05);there was no statistically significant difference in the relative expressions of EMMPRIN,MMP-9 and KDM6B proteins between cancer-adjacent tissues and low-grade intraductal carcinoma tissues(P>0.05).The relative expressions of EMMPRIN and KDM6B proteins were not related to the age,tumor location and tumor diameter of patients with invasive breast cancer(P>0.05),and the relative expression of MMP-9 protein was not related to the age and tumor location of patients with invasive breast cancer(P>0.05).Relative expressions of EMMPRIN,MMP-9 and KDM6B proteins were correlated with WHO grading,lymph node metastasis,and tumor,node and metastasis(TNM)staging of invasive breast cancer(P<0.05),and the relative expression of MMP-9 protein was correlated with the tumor diameter(P<0.05).In the WHO grades Ⅰ,Ⅱ,and Ⅲ of invasive breast cancer,the relative expressions of EMMPRIN and MMP-9 proteins increased sequentially,while the relative expression of KDM6B protein decreased sequentially(P<0.05);the relative expressions of EMMPRIN and MMP-9 proteins in the lymph node metastasis group were significantly higher than those in the non-lymph node metastasis group,and the relative expression of KDM6B protein was significantly lower than that in the non-lymph node metastasis group(P<0.05);the relative expressions of EMMPRIN and MMP-9 proteins in TNM stages Ⅲ-Ⅳ were significantly higher than those in stages Ⅰ-Ⅱ(P<0.05),while the relative expression of KDM6B protein was significantly lower than that in stages Ⅰ-Ⅱ(P<0.05).In the group of invasive breast cancer with diameter≤2 cm,2 to 5 cm,and>5 cm,the relative expression of MMP-9 protein increased sequentially(P<0.05).Spearman correlation analysis showed that the expression of EMMPRIN was positively correlated with MMP-9 protein in invasive breast cancer tissues(r=0.990,P=0.000),the expression of EMMPRIN was negatively correlated with KDM6B protein(r=-0.606,P=0.000),and the expression of MMP-9 was negatively correlated with KDM6B protein(r=-0.612,P=0.000).ROC curve analysis showed that the area under the curve(AUC)of EMMPRIN protein for diagnosing invasive breast cancer was 0.875[95%confidence interval(CI):0.823-0.926,P<0.05],with an optimal threshold of 10.043,sensitivity of 79.0%,and specificity of 76.8%;the AUC of MMP-9 protein in diagnosing invasive breast cancer was 0.863(95%CI:0.808-0.917,P<0.05),with an optimal threshold of 10.070,sensitivity of 74.2%,and specificity of 76.8%;the AUC of KDM6B protein in diagnosing invasive breast cancer was 0.267(95%CI:0.196-0.338,P<0.05),with an optimal threshold of 11.003,sensitivity of 71.0%,and specificity of 98.6%.Conclusion EMMPRIN,MMP-9 and KDM6B are related to the occurrence and development of invasive breast cancer.Detection of the expressions of EMMPRIN,MMP-9 and KDM6B is helpful to the pathological diagnosis of invasive breast cancer and clinical judgment of invasion and metastasis of breast cancer.
8.Expert consensus on limb management of patients with transvenous temporary cardiac pacing
Radioactive Interventional Nursing Professional Committee of Chinese Nursing Association ; Huafen LIU ; Jiali ZHOU ; Zheng HUANG ; Zhixia ZHANG ; Jingyu LIANG ; Zhongxiang CAI ; Fuhong CHEN ; Yunying ZHOU ; Yunyan XIANYU ; Lin YAN ; Huidan YU ; Huizhen PENG ; Jian ZHU ; Yuan TIAN ; Yan ZHANG ; Hejun JIANG ; Su ZHANG
Chinese Journal of Nursing 2024;59(13):1581-1583
Objective To form the expert consensus on the limb management of patients with transvenous temporary cardiac pacing,standardize the limb management of patients with transvenous temporary cardiac pacing,and reduce complications related to the limb.Methods Using evidence-based methods,the evidence in this field was searched,evaluated and summarized,and relevant recommendations and research conclusions were extracted and classified by the level of evidence quality,and then the first draft of the consensus was formed.From December 2023 to January 2024,through 2 rounds of expert consultation and 4 rounds of expert meetings,the content was adjusted and the consensus was reached.Results Totally 16 experts participated in the consultation.The positive coefficient is 100%;the authoritative coefficient is 0.847 and 0.836;the average value of each index is more than>3.8;the coefficient of variation is less than 0.21.The Kendall's harmony coefficient of the 2 rounds of expert consultation is 0.372 and 0.314,respectively,which were statistically significant.The consensus covers the preoperative,intraoperative and postoperative on limb management of patients with transvenous temporary cardiac pacing.Totally 11 themes were involved,including the preoperative preparation,position and catheter fixation in operation,position and catheter fixation in postoperative,activity,turn and transfer,duty shift on limb,nursing care after withdrawal of the catheter,prevention of deep vein thrombosis of the operative limb and prevent infection.Conclusion The consensus is highly scientific,and it is helpful to standardize the limb management of patients with transvenous temporary cardiac pacing.
9.Analysis of clinical implementation of nursing group standard for oxygen therapy in adult patients
Xiaojiu QI ; Huiting WANG ; Yu XU ; Zheng HUANG ; Zhixia ZHANG ; Hongwen MA ; Yunyan XIANYU ; Su ZHANG
Chinese Journal of Nursing 2024;59(14):1726-1731
Objective To understand the implementation of the nursing group standards for oxygen inhalation therapy in clinical practice,and to provide a reference for improving the nursing practice of oxygen therapy.Methods A convenience sampling method was used to investigate nurses from 902 hospitals in 24 provinces and municipalities directly under the central government using a self-designed questionnaire from December 15th,2022,to January 14th,2023.The content of questionnaire included whether they had implemented the recommendations of the oxygen therapy standards,the knowledge of safety related to oxygen therapy,and the components of oxygen therapy prescriptions,the indications used for patients receiving oxygen therapy and practice status of oxygen therapy.Results A total of 10481 questionnaires were returned,of which 10447 were valid,with a valid questionnaire recovery rate of 99.68%.63.14%of the nurses indicated that the hospital had organized training on oxygen therapy standards.Only 47.82%of nurses know the correct use of the Venturi mask.41.90%of nurses could indicate the correct indicator of flow adjustment.31.88%of the nurses stated that they will adjust the oxygen flow rate based on the oxygenation status of carbon dioxide storage patients.Only 19.56%of nurses indicated that humidification is applied in oxygen therapy based on the oxygen flow and duration.Conclusion Even though nurses had received training related to oxygen therapy standards,the level of knowledge of oxygen therapy standards was still low;therefore continuous systematic training was needed,and the implementation of the content of oxygen therapy standards needed to be further standardized.Healthcare institutions would focus on organizing systematic training and maintaining the training effect,enhancing infrastructure and providing support for implementation.Recommendation to the nursing administration is to explore how to comprehensively and continuously implementing the oxygen therapy nursing standards with the ultimate goal of providing patients safer and more accurate oxygen therapy.
10.Construction of post competency model of human organ donation coordinators based on onion model
Jianquan WU ; Manman SHANG ; Guifang ZHENG ; Qin WEI ; Xianyu XIE ; Yueping LI
Organ Transplantation 2023;14(5):714-722
Objective To construct a scientific and rational post competency model of human organ donation coordinators. Methods Based on the onion model, the index pool was initially constructed by literature research and behavioral event interview. The index system was screened, modified and improved using Delphi method. The weight of indexes at all levels was determined by analytic hierarchy process. Results The effective response rates of two rounds of Delphi expert inquiries were both 100%, indicating that the expert opinions were highly dependable. The experts' judgment coefficient (Ca), familiarity (Cs) and authoritative coefficient (Cr) were all above 0.7, indicating that the experts' opinions were highly reliable. The expert coordination coefficients (W) were 0.294 and 0.342 (both P<0.001), indicating that experts delivered coordinated opinions and yielded slight difference in understanding the importance of indexes. Finally, according to the "onion model" theory and experts' opinions, a set of coordinator's post competency model including 6 first-level and 55 second-level indexes was established, which comprised an index surface layer, a middle layer and a core layer. Among them, the core layer represented core professional values, the middle layer was personal quality and professional ethics and quality, and the surface layer was interpersonal communication capability, organizational cooperation capability and professional knowledge and lifelong learning capability. Conclusions The post competency model of organ donation coordinators established in this study consists of 6 first-level and 55 second-level indexes, which is highly effective and reliable.

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