1.Application of "balance-shaped sternal elevation device" in the subxiphoid uniportal video-assisted thoracoscopic surgery for anterior mediastinal masses resection
Jinlan ZHAO ; Weiyang CHEN ; Chunmei HE ; Yu XIONG ; Lei WANG ; Jie LI ; Lin LIN ; Yushang YANG ; Lin MA ; Longqi CHEN ; Dong TIAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(03):308-312
		                        		
		                        			
		                        			Objective To introduce an innovative technique, the "balance-shaped sternal elevation device" and its application in the subxiphoid uniportal video-assisted thoracoscopic surgery (VATS) for anterior mediastinal masses resection. Methods Patients who underwent single-port thoracoscopic assisted anterior mediastinal tumor resection through the xiphoid process at the Department of Thoracic Surgery, West China Hospital, Sichuan University from May to June 2024 were included, and their clinical data were analyzed. Results A total of 7 patients were included, with 3 males and 4 females, aged 28-72 years. The diameter of the tumor was 1.9-17.0 cm. The operation time was 62-308 min, intraoperative blood loss was 5-100 mL, postoperative chest drainage tube retention time was 0-9 days, pain score on the 7th day after surgery was 0-2 points, and postoperative hospital stay was 3-12 days. All patients underwent successful and complete resection of the masses and thymus, with favorable postoperative recovery. Conclusion The "balance-shaped sternal elevation device" effectively expands the retrosternal space, providing surgeons with satisfactory surgical views and operating space. This technique significantly enhances the efficacy and safety of minimally invasive surgery for anterior mediastinal masses, reduces trauma and postoperative pain, and accelerates patient recovery, demonstrating important clinical significance and application value.
		                        		
		                        		
		                        		
		                        	
2.Application of CRISPR/Cas System in Precision Medicine for Triple-negative Breast Cancer
Hui-Ling LIN ; Yu-Xin OUYANG ; Wan-Ying TANG ; Mi HU ; Mao PENG ; Ping-Ping HE ; Xin-Ping OUYANG
Progress in Biochemistry and Biophysics 2025;52(2):279-289
		                        		
		                        			
		                        			Triple-negative breast cancer (TNBC) represents a distinctive subtype, characterized by the absence of estrogen receptors, progesterone receptors, and human epidermal growth factor receptor 2 (HER2). Due to its high inter-tumor and intra-tumor heterogeneity, TNBC poses significant chanllenges for personalized diagnosis and treatment. The advant of clustered regular interspaced short palindromic repeats (CRISPR) technology has profoundly enhanced our understanding of the structure and function of the TNBC genome, providing a powerful tool for investigating the occurrence and development of diseases. This review focuses on the application of CRISPR/Cas technology in the personalized diagnosis and treatment of TNBC. We begin by discussing the unique attributes of TNBC and the limitations of current diagnostic and treatment approaches: conventional diagnostic methods provide limited insights into TNBC, while traditional chemotherapy drugs are often associated with low efficacy and severe side effects. The CRISPR/Cas system, which activates Cas enzymes through complementary guide RNAs (gRNAs) to selectively degrade specific nucleic acids, has emerged as a robust tool for TNBC research. This technology enables precise gene editing, allowing for a deeper understanding of TNBC heterogeneity by marking and tracking diverse cell clones. Additionally, CRISPR facilitates high-throughput screening to promptly identify genes involved in TNBC growth, metastasis, and drug resistance, thus revealing new therapeutic targets and strategies. In TNBC diagnostics, CRISPR/Cas was applied to develop molecular diagnostic systems based on Cas9, Cas12, and Cas13, each employing distinct detection principles. These systems can sensitively and specifically detect a variety of TNBC biomarkers, including cell-specific DNA/RNA and circulating tumor DNA (ctDNA). In the realm of precision therapy, CRISPR/Cas has been utilized to identify key genes implicated in TNBC progression and treatment resistance. CRISPR-based screening has uncovered potential therapeutic targets, while its gene-editing capabilities have facilitated the development of combination therapies with traditional chemotherapy drugs, enhancing their efficacy. Despite its promise, the clinical translation of CRISPR/Cas technology remains in its early stages. Several clinical trials are underway to assess its safety and efficacy in the treatment of various genetic diseases and cancers. Challenges such as off-target effects, editing efficiency, and delivery methods remain to be addressed. The integration of CRISPR/Cas with other technologies, such as 3D cell culture systems, human induced pluripotent stem cells (hiPSCs), and artificial intelligence (AI), is expected to further advance precision medicine for TNBC. These technological convergences can offer deeper insights into disease mechanisms and facilitate the development of personalized treatment strategies. In conclusion, the CRISPR/Cas system holds immense potential in the precise diagnosis and treatment of TNBC. As the technology progresses and becomes more costs-effective, its clinical relevance will grow, and the translation of CRISPR/Cas system data into clinical applications will pave the way for optimal diagnosis and treatment strategies for TNBC patients. However, technical hurdles and ethical considerations require ongoing research and regulation to ensure safety and efficacy. 
		                        		
		                        		
		                        		
		                        	
		                				4.Development of an in  vitro  screening method for idiosyncratic hepatotoxic components in traditional Chinese medicine: a case study with Epimedii Folium  and Psoraleae Fructus 
		                			
		                			Ying-ying LI ; Meng-meng LIN ; Bo CAO ; Ying LI ; Jing XU ; Xiao-he XIAO ; Guo-hui LI ; Chun-yu LI
Acta Pharmaceutica Sinica 2024;59(3):621-632
		                        		
		                        			
		                        			 Idiosyncratic drug-induced liver injury (IDILI) has long posed a challenging and pivotal concern in pharmaceutical research. The complex composition of traditional Chinese medicine (TCM) has introduced a bottleneck in current research, hindering the elucidation of the component basis associated with IDILI in TCM. Using 
		                        		
		                        	
5.Impact of parental divorce on psychological abuse and neglect among middle and high school students
REN Xiaohong, LIN Cen, CEN Yu, HE Ping, LUO Jiaming
Chinese Journal of School Health 2024;45(4):525-529
		                        		
		                        			Objective:
		                        			To investigate how parental divorce impacts psychological abuse and neglect among middle and high school students, so as to provide evidence for the development of family intervention strategies for mental health promotion.
		                        		
		                        			Methods:
		                        			A stratified random cluster sampling method was employed to select students from 23 middle and high schools in Nanchong, Neijiang, and Luzhou. Online questionnaires utilizing the General Data Questionnaire and the Child Psychological Abuse and Neglect Scale (CPANS) were administered. Propensity score matching (PSM) was used to compare individual characteristics between parent divorce and the control groups. The  χ 2 test was then employed to analyze differences in psychological abuse and neglect across variables, with Logistic regression used to treat psychological abuse and neglect as dependent variables.
		                        		
		                        			Results:
		                        			After PSM, there were 1 898 cases in both parent divorce and control groups. There was no significant difference in gender composition between the two groups ( χ 2=0.03,  P >0.05). Compared to the control group, after controlling for various factors including gender, phase of studying, parental education, whether to live in school, and long term caregivers of the student, the risk of experiencing psychological abuse ( OR=1.43, 95%CI =1.26-1.63) and neglect ( OR=1.53, 95%CI =1.33-1.75) was significantly higher in parentdivorce group ( P <0.05).
		                        		
		                        			Conclusions
		                        			Parental divorce significantly impacts psychological abuse and neglect experienced by middle and high school students. Therefore, support and intervention efforts should be intensified for students from divorced or unstable marriage families.
		                        		
		                        		
		                        		
		                        	
6.Analysis on Quality of Sojae Semen Praeparatum Based on Traditional Quality Evaluation
Yihan WANG ; Wangmin LIN ; Shuili ZHANG ; Bing YU ; Tiegui NAN ; Liping KANG ; Guofeng LI ; Xiyuan HE ; Zhilai ZHAN ; Luqi HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(1):31-42
		                        		
		                        			
		                        			ObjectiveBased on the quality evaluation experience of "it is better to have a fragrant and strong aroma" summarized by materia medica of past dynasties, the chemical components of Sojae Semen Nigrum(SSN) and Sojae Semen Praeparatum(SSP) were systematically compared and analyzed, and the main fermentation products in different fermentation time were quantitatively analyzed, so as to clarify the transformation law of internal components in the processing process and provide scientific basis for the modern quality control of SSP. MethodUltra performance liquid chromatography-quadrupole tandem time-of-flight mass spectrometry(UPLC-Q-TOF-MS) was used for the structural identification of the chemical constituents of SSN and SSP, and with the aid of Progenesis QI v2.3 software, the negative ion mode was employed for principal component analysis(PCA) pattern recognition, and the data were analyzed with the aid of orthogonal partial least squares-discriminant analysis(OPLS-DA) for two-dimensional data to obtain S-plot, and components with |P|>0.1 were selected as the differential constituents. The contents of isoflavonoids in SSP during fermentation was determined by UPLC, and the samples were taken every 8 h in the pre-fermentation period and every 2 d in the post-fermentation period, and the dynamic changes of isoflavonoid contents in different fermentation stages were analyzed. The contents of amino acids and nucleosides in SSP and SSN from different fermentation stages were quantitatively analyzed by phenyl isothiocyanate(PITC) pre-column derivatization and high performance liquid chromatography(HPLC) gradient elution, and the contribution of flavor substances to the "delicious" taste of SSP was discussed by taste intensity value(TAV). ResultA total of 19 kinds of differential components were screened out, mainly soybean saponins and isoflavones, and their contents decreased significantly or even disappeared after fermentation. In the pre-fermentation process of SSP, glycoside bond hydrolysis mainly occurred, and isoflavone glycosides in SSN were degraded and converted into the corresponding aglycones, the content of flavor substances such as amino acids increased gradually. In the post-fermentation process, protein degradation mainly occurred, after 8 d of post-fermentation, the content of isoflavones was basically stable, while the total content of amino acids increased by 8-40 times on average. Different amino acids form the special flavor of SSP, such as the TAV of glutamate is always ahead of other flavor substances, and sweet substances such as alanine and valine have made relatively great contributions to SSP. ConclusionBased on the law of constituent transformation, combined with the traditional evaluation index of "fragrant and strong", it is difficult to control the fermentation degree of SSP by the existing standards in the 2020 edition of Chinese Pharmacopoeia. It is suggested that description of the characteristics of SSP be refined and changed to "fragrant, delicious and slightly sweet", and at the same time, the post-fermentation index compounds such as glutamic acid, alanine and valine should be added as the quality control indicators of SSP, so as to standardize the production process and improve the quality of SSP. 
		                        		
		                        		
		                        		
		                        	
7.Action mechanism of gluteus medius width ratio in progression of non-traumatic femoral head necrosis by finite element analysis
Yingjia YUAN ; Yulai JIANG ; Jin LI ; Ke WANG ; Yu WANG ; Tianye LIN ; Qingwen ZHANG ; Wei HE ; Qiushi WEI
Chinese Journal of Tissue Engineering Research 2024;33(33):5276-5282
		                        		
		                        			
		                        			BACKGROUND:The gluteus medius not only abducts the hip joint,but also plays an important role in limiting the external movement of the femoral head.At present,there is a lack of research on the correlation between gluteus medius status and non-traumatic femoral head necrosis. OBJECTIVE:To investigate the relationship between the gluteus medius width ratio and the medial space ratio of the hip joint and the progression of non-traumatic femoral head necrosis,and to explore the effect of gluteus medius atrophy on the surface and necrotic zone stress of the femoral head necrosis through finite element analysis. METHODS:Retrospective analysis of unilateral non-traumatic femoral head necrosis patients admitted to Third Affiliated Hospital of Guangzhou University of Chinese Medicine was performed.All patients were followed up for an average of more than 2 years.They were divided into a collapsed group and a non-collapsed group based on whether there was collapse of the femoral head during the follow-up.Medial space ratio,gluteus medius width ratio,Sharp angle,gluteus medius length ratio,and gluteus medius activation angle were measured and calculated.The differences in these indicators were compared between the two groups.At the first visit and follow-up at 3,6,12,and 24 months,the medial space ratio and gluteus medius width ratio were measured and calculated to explore the changes of these two indicators in the course of non-traumatic femoral head necrosis.In addition,using three-dimensional finite element analysis,a Japanese Investigation Committee classification C1 type femoral head necrosis model was constructed based on CT data.At the same time,based on MRI data,a model of the gluteus medius muscle was constructed and divided into a gluteus medius muscle atrophy group(gluteus medius width ratio:74%-76%)and a gluteus medius muscle normal group(gluteus medius width ratio:94%-96%).Each group constructed 10 models,with 6 degrees of freedom of the distal femur constrained to zero.600 N pressures were applied along the Z-axis to the upper surface of the sacrum.The stress distribution,maximum stress values on the surface and necrotic area of the femoral head,and the maximum displacement of the necrotic area were compared between two groups of models. RESULTS AND CONCLUSION:(1)A total of 153 patients(67 males and 86 females)with 153 hips were included in this study.(2)At the 24-hour follow-up,the medial space ratio of the collapsed group was significantly higher than that of the non-collapsed group(P<0.05).The gluteus medius width ratio of the collapsed group was significantly lower than that of the non-collapsed group(P<0.05).There was no statistically significant difference in Sharp angle,gluteus medius activation angle,and gluteus medius length ratio between the two groups(P>0.05).(3)Since the follow-up time exceeded 3 months,the gluteus medius width ratio of the collapsed group was lower than that of the non-collapsed group(P<0.05).Since the follow-up time exceeded 12 months,the medial space ratio of the collapsed group was higher than that of the non-collapsed group(P<0.05).(4)Pearson correlation analysis showed a significant positive correlation between follow-up time and medial space ratio in the collapsed group(P<0.05),and a significant negative correlation between follow-up time and gluteus medius width ratio(P<0.05).The regression coefficient of gluteus medius width ratio was larger than that of medial space ratio.(5)The group with middle gluteal muscle atrophy showed significant stress concentration on the surface of the femoral head,and the stress zone was significantly located on the outside.The maximum stress on the surface of the femoral head in the group with middle gluteal muscle atrophy was significantly greater than that in the group with normal middle gluteal muscle(P<0.05).There was significant stress concentration in the necrotic area of the middle gluteal muscle atrophy group,and the maximum stress was located at the edge of the necrotic area.The maximum stress and maximum displacement in the necrotic area of the middle gluteal muscle atrophy group were significantly greater than those of the normal group(P<0.05).(6)It is indicated that gluteus medius width ratio is an effective indicator for evaluating changes in gluteal muscle atrophy.In the progression of non-traumatic femoral head necrosis,atrophy of the gluteus medius muscle first occurs,followed by widening of the medial hip joint space.The mechanical mechanism may be that the atrophy of the gluteus medius muscle affects the stability of the hip joint,leading to external displacement of the femoral head,and increasing stress and displacement on the surface and necrotic area of the femoral head.
		                        		
		                        		
		                        		
		                        	
8.Analysis of the distribution characteristics and antibiotic resistance of pathogen in children with hematological disorders and cancers complicated with sepsis in PICU
Liangliang KANG ; Yuhui WU ; Nannan HE ; Huabao CHEN ; Yucong ZHANG ; Bin YU ; Yizhou PIAN ; Jiayin LIN
Chinese Pediatric Emergency Medicine 2024;31(1):28-34
		                        		
		                        			
		                        			Objective:To explore the distribution characteristics and antibiotic resistance of pathogen in children with hematological disorders and cancers complicated with sepsis in pediatric intensive care unit (PICU).Methods:The clinical data of children with hematological disorders and cancers complicated with sepsis hospitalized at Shenzhen Children′s Hospital affiliated to China Medical University from January 2016 to August 2023 were retrospectively analyzed. Patients were divided into survival group and death group based on the outcome of sepsis on 28 days after diagnosis.Results:A total of 202 sepsis episodes occurred in 176 children were enrolled in this study. Among all, 144 (71.3%) cases of bloodstream infection, 59 (29.2%) cases of pulmonary infection, 21 (10.4%) cases of abdominal infection, 9 (4.5%) cases of soft tissue infection, 9 (4.5%) cases of nervous system infection, and 3 (1.5%) cases of urinary tract infection. A total of 244 pathogenic strains were identified, in which 74 (30.3%) cases were gram-positive bacteria. The top 3 pathogens isolated were Coagulase negative Staphylococcus (21 strains), Staphylococcus aureus (19 strains) and Streptococcus pneumoniae (13 strains). Gram-negative bacteria accounted for 122 (50.0%) strains, in which top 3 were Klebsiella pneumonia (33 strains), Escherichia coli (25 strains), and Pseudomonas aeruginosa (23 strains). Fungi comprised 48 (19.7%) strains:the top 3 were Candida tropicalis (14 strains), Candida albicans (10 strains), Aspergillus and Pneumocystis jirovecii (7 strains each). The incidence of Acinetobacter baumannii, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa were significantly higher in death group compared to survival group[9.0%(6/67)vs. 2.3%(4/177), χ2=3.971 ,P=0.046; 9.0%(6/67)vs. 1.1%(2/177), χ2=7.080 ,P=0.008;16.4%(11/67)vs. 6.8%(12/177), χ2=5.288 ,P=0.021]. The samples of 57 cases were simultaneously detected by both culture and metagenomic next-generation sequencing (mNGS). Pathogens were detected in 25 cases by both culture and mNGS. In 30 cases, pathogen detection were mNGS positive but culture negative. Two cases showed positive results only with culture. A total of 79 (46.8%) strains were multi-drug resistant bacteria, including 27 (34.2%) strains of gram-positive bacteria and 52 (65.8%) strains of gram-negative bacteria. A total of 174 (86.1%) children with sepsis received empirical anti-infective drugs within 24 hours of fever onset. A total of 124 (61.4%) cases were appropriately covered by the initial empirical antibiotics, while 40 (19.8%) cases were not adequately covered and 10 (5.0%) cases had incomplete coverage. Despite the inclusion of pathogenic in the coverage, resistance to initial antibiotics was observed in 22 (10.9%) cases. Fifty-one patients died. Conclusion:The predominant pathogens responsible for sepsis in PICU with hematological disorders and cancers is gram-negative bacteria, followed by gram-positive bacteria and fungi. In comparison to healthy children with sepsis, there is a higher incidence of fungal infections among hematological disorders and cancers. The proportion of multi-drug resistant bacteria infection is high. Early identification and combination of local etiological distribution and drug resistance, along with the empirical selection of appropriate anti-infection treatment strategies, can greatly enhance survival rate.
		                        		
		                        		
		                        		
		                        	
9.Prognosis and influencing factors analysis of patients with initially resectable gastric cancer liver metastasis who were treated by different modalities: a nationwide, multicenter clinical study
Li LI ; Yunhe GAO ; Liang SHANG ; Zhaoqing TANG ; Kan XUE ; Jiang YU ; Yanrui LIANG ; Zirui HE ; Bin KE ; Hualong ZHENG ; Hua HUANG ; Jianping XIONG ; Zhongyuan HE ; Jiyang LI ; Tingting LU ; Qiying SONG ; Shihe LIU ; Hongqing XI ; Yun TANG ; Zhi QIAO ; Han LIANG ; Jiafu JI ; Lin CHEN
Chinese Journal of Digestive Surgery 2024;23(1):114-124
		                        		
		                        			
		                        			Objective:To investigate the prognosis of patients with initially resectable gastric cancer liver metastasis (GCLM) who were treated by different modalities, and analyze the influencing factors for prognosis of patients.Methods:The retrospective cohort study was conducted. The clinicopathological data of 327 patients with initially resectable GCLM who were included in the database of a nationwide multicenter retrospective cohort study on GCLM based on real-world data from January 2010 to December 2019 were collected. There were 267 males and 60 females, aged 61(54,68)years. According to the specific situations of patients, treatment modalities included radical surgery combined with systemic treatment, palliative surgery combined with systemic treatment, and systemic treatment alone. Observation indicators: (1) clinical characteristics of patients who were treated by different modalities; (2) prognostic outcomes of patients who were treated by different modalities; (3) analysis of influencing factors for prognosis of patients with initially resectable GCLM; (4) screening of potential beneficiaries in patients who were treated by radical surgery plus systemic treatment and patients who were treated by palliative surgery plus systemic treatment. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M( Q1, Q3), and comparison between groups was conducted using the rank sum test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test. The Kaplan-Meier method was used to calculate survival rate and draw survival curve, and Log-Rank test was used for survival analysis. Univariate and multivariate analyses were conducted using the COX proportional hazard regression model. The propensity score matching was employed by the 1:1 nearest neighbor matching method with a caliper value of 0.1. The forest plots were utilized to evaluate potential benefits of diverse surgical combined with systemic treatments within the population. Results:(1) Clinical characteristics of patients who were treated by different modalities. Of 327 patients, there were 118 cases undergoing radical surgery plus systemic treatment, 164 cases undergoing palliative surgery plus systemic treatment, and 45 cases undergoing systemic treatment alone. There were significant differences in smoking, drinking, site of primary gastric tumor, diameter of primary gastric tumor, site of liver metastasis, and metastatic interval among the three groups of patients ( P<0.05). (2) Prognostic outcomes of patients who were treated by different modalities. The median overall survival time of the 327 pati-ents was 19.9 months (95% confidence interval as 14.9-24.9 months), with 1-, 3-year overall survival rate of 61.3%, 32.7%, respectively. The 1-year overall survival rates of patients undergoing radical surgery plus systemic treatment, palliative surgery plus systemic treatment and systemic treatment alone were 68.3%, 63.1%, 30.6%, and the 3-year overall survival rates were 41.1%, 29.9%, 11.9%, showing a significant difference in overall survival rate among the three groups of patients ( χ2=19.46, P<0.05). Results of further analysis showed that there was a significant difference in overall survival rate between patients undergoing radical surgery plus systemic treatment and patients undergoing systemic treatment alone ( hazard ratio=0.40, 95% confidence interval as 0.26-0.61, P<0.05), between patients undergoing palliative surgery plus systemic treatment and patients under-going systemic treatment alone ( hazard ratio=0.47, 95% confidence interval as 0.32-0.71, P<0.05). (3) Analysis of influencing factors for prognosis of patients with initially resectable GCLM. Results of multivariate analysis showed that the larger primary gastric tumor, poorly differentiated tumor, larger liver metastasis, multiple hepatic metastases were independent risk factors for prognosis of patients with initially resectable GCLM ( hazard ratio=1.20, 1.70, 1.20, 2.06, 95% confidence interval as 1.14-1.27, 1.25-2.31, 1.04-1.42, 1.45-2.92, P<0.05) and immunotherapy or targeted therapy, the treatment modality of radical or palliative surgery plus systemic therapy were independent protective factors for prognosis of patients with initially resectable GCLM ( hazard ratio=0.60, 0.39, 0.46, 95% confidence interval as 0.42-0.87, 0.25-0.60, 0.30-0.70, P<0.05). (4) Screening of potentinal beneficiaries in patients who were treated by radical surgery plus systemic treatment and patients who were treated by palliative surgery plus systemic treatment. Results of forest plots analysis showed that for patients with high-moderate differentiated GCLM and patients with liver metastasis located in the left liver, the overall survival rate of patients undergoing radical surgery plus systemic treatment was better than patients undergoing palliative surgery plus systemic treatment ( hazard ratio=0.21, 0.42, 95% confidence interval as 0.09-0.48, 0.23-0.78, P<0.05). Conclusions:Compared to systemic therapy alone, both radical and palliative surgery plus systemic therapy can improve the pro-gnosis of patients with initially resectable GCLM. The larger primary gastric tumor, poorly differen-tiated tumor, larger liver metastasis, multiple hepatic metastases are independent risk factors for prognosis of patients with initial resectable GCLM and immunotherapy or targeted therapy, the treatment modality of radical or palliative surgery plus systemic therapy are independent protective factors for prognosis of patients with initially resectable GCLM.
		                        		
		                        		
		                        		
		                        	
10.Clinical safety and validity analysis of retrograde new endo-scopic visual field in miniature pigs
Zhe KUANG ; Peng LI ; Da-Qing JIN ; Yong-Chao ZHANG ; Hui-Li GUO ; Yu-Fei ZHANG ; Guang-Lin HE ; Guo-Feng SUN ; Yuan HE
Chinese Journal of Current Advances in General Surgery 2024;27(1):14-18
		                        		
		                        			
		                        			Objective:To study the clinical safety and validity of retrograde new endoscopic field of vision in miniature pigs.Methods:6 live miniature pigs were selected as study subjects,En-doscopic Retrograde New View(ERNV)was selected.The performance,image quality and intraoper-ative and postoperative complications were evaluated.To evaluate whether all the experimental ani-mals could complete the relevant endoscopy.Verify ERNV's operating performance,including whether the duodenoscope can enter the biliary tract smoothly,and made sure whether the injection,suction,and instrument channels were unobstructed.Choledochoscope image clarity,color resolu-tion,image deformation and distortion,accurate evaluation of lumen conditions and clear observation of mucosal surface conditions were analyzed.Whether there were operant injuries such as bleeding and perforation,as well as adverse events such as respiratory depression and cardiac arrest.The sur-vival status and adverse reactions of all pigs were observed.Results:The choledochoscope was successfully inserted into the bile duct of 6 miniature pigs.The product had good operation perfor-mance and could enter the bile duct through the duodenoscope smoothly.The injection,suction and instrument channels were relatively smooth.In addition,the endoscopic images are clear,with better color resolution,and without image deformation and distortion,which can realize accurate evaluation of the conditions in the lumen and observe the mucosal surface conditions more clearly.No bile duct stenosis or dilatation occurred in all miniature pigs,and the bile duct mucosa was smooth,without hyperemia and edema,and no abnormal thickening or bending of mucous vessels.During the exami-nation,there were no operational injuries such as bleeding and perforation,and no adverse events such as respiratory depression and cardiac arrest occurred.The vital signs of all miniature pigs tended to be stable after operation,and the survival state was good,and there were no complications such as cholangitis,bleeding and perforation.Conclusion:ERNV has good clinical safety and efficacy,ex-cellent operation performance and excellent image quality,and is worthy of clinical application.
		                        		
		                        		
		                        		
		                        	
            

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