Investigator initiated trial （IIT） represents a primary format for clinical research in traditional Chinese medicine （TCM）. As key implementation sites for TCM-based IIT targeting malignant tumors， western medicine institutions often face unique challenges in conducting such studies， which limit their feasibility and standardization. This paper reviews the registration status of TCM-based IIT for malignancies conducted in western medical institutions and analyzes key difficulties， including complex project initiation and management processes， limited TCM knowledge and skills among western medicine physicians， and relatively low patient acceptance of TCM. From a practical perspective， the study proposes several optimization strategies. These include improving the review and management mechanisms of TCM-related IIT within western medical institutions， establishing multidisciplinary clinical research teams that integrate TCM and western medicine， and enhancing investigators' training in TCM theory and clinical skills. Additionally， the study suggests standardizing IIT operational procedures， objectifying the collection of TCM diagnostic information， refining subject recruitment methods， and increasing TCM involvement in patient follow-up and management. These investigator-oriented， TCM-featured， and operable strategies aim to promote the high-quality development of TCM-based IIT in western medicine institutions and enhance the clinical application of TCM.

Objective: To develop a modified calculation formula for renal tumor volume and tumor contact surface area (CSA) based on the modeling results of 3D Slicer software, and to create a webpage of the calculation formula for use. Methods: The general information and tumor anatomical data of 98 patients who underwent partial nephrectomy during Jan.2021 and Jul.2023 in the Second Affiliated Hospital of Xi'an Jiaotong University were retrospectively analyzed.The imaging data were input into 3D Slicer software in the form of Dicom files for tumor and ipsilateral kidney modeling to obtain tumor anatomical data.The relationship between tumor anatomical parameters and tumor volume and CSA was analyzed using multifactorial linear regression.The initial modified formulas (V2, C2) and the optimized modified formulas (V3, C3) for tumor volume over CSA were established, respectively, after insignificant variables were eliminated.The mean square error (MSE) and Akaike information criterion (AIC) of the modified and traditional formulas (V1, C1) were compared, and the formula with the smallest MSE and AIC was selected as the optimal tumor volume and CSA calculation formula.The median tumor volume and CSA obtained from 3D modeling were used as the cutoff values.The optimal formula and conventional formula were applied to calculate tumor volume and CSA for all patients, and risk stratification was performed for all patients based on these cutoff values, and the perioperative indicators of patients in the upper and lower groups were compared.Finally, an online calculation tool was developed based on HTML. Results: Based on multifactorial linear regression analysis, we obtained the modified tumor volume calculation formula: V=0.382abc+2.488a+2.372b－4.146c+1.948（V2）, V=0.469abc－4.586c+13.816（V3）; the modified tumor CSA calculation formula CSA=2.469a －2.262L －19.23a+6.206b+1.212c+18.017L+1.616h－3.97h －2.185h/h －0.388（C2）, CSA=2.376a －2.144L －20.157a+5.024b+1.128c+17.578L+2.525h－2.634（C3）.Both of the modified volume formula (MSE=151.298 vs. 127.807 vs. 104.106) and modified CSA formula (MSE=309.878 vs.23.556 vs.30.388) had smaller errors compared to the conventional formula.The modified volume calculation formula showed that bleeding was more and thermal ischemia time was longer in patients with larger tumor volumes than in patients with smaller tumor volumes (P<0.05); and the modified CSA calculation formula showed that bleeding was more, surgery and thermal ischemia time were longer in patients with high CSA than in patients with low CSA (P＜0.05).Finally, V3 and C3 are selected as the best calculation formula, and a web page (https://lizihao-bot.github.io/RCC-Calculate/) was established for easy use. Conclusion: This study combined data from a medical information technology platform with numerical modeling methods to provide a faster and more accurate method to calculate the renal tumor volume and CSA.Meanwhile, a webpage version of the tool was developed to enhance its practicability.

In recent years, with the continuous development and increasing maturity of interventional techniques, interventional treatment for congenital heart disease (CHD) has been progressively disseminated to county- and city-level hospitals in China. Concurrently, the standardized management of adult CHD (particularly patent foramen ovale) and the lifelong management of complex CHD are gaining increasing clinical attention, while the emergence of new techniques and products continuously advances the discipline. This article aims to review the new progress made in the field of interventional treatment for congenital heart disease in China during 2024. It specifically reviews and analyzes the following key aspects: (1) annual statistics on interventional closure procedures for CHD; (2) recent insights into patent foramen ovale closure; (3) advances in transcatheter pulmonary valve replacement; (4) interventional treatment and lifelong management strategies for complex CHD; (5) new interventional techniques for acquired heart disease; and (6) the application of artificial intelligence in CHD management. Through the synthesis and discussion of these topics, this article seeks to provide a detailed analysis of the current landscape of interventional treatment for CHD in China and project its future development trends.

Objective:To analyze the clinic effects of arthroscopic partial trapeziectomy and suture button suspensionplasty in the treatment of first carpometacarpal joint (CMCJ) Eaton stage II/III arthrosis.Methods:A retrospective study was conducted on a total of 15 cases (16 hands) of patients including 5 males (1 bilateral) and 10 females with CMCJ stage II/III arthrosis who underwent surgical treatment at the first affiliated hospital of Shenzhen university from January 2020 to June 2022, with mean age of 56.7±6.4 years (range, 46-75 years). The duration from pain to treatment was 7.8±3.2 months (range, 4-14 months). X-ray showed narrowing of CMCJ with osteophytes and distal radial subluxation. All the patients were treated with arthroscopic partial trapeziectomy and suture button suspensionplasty. The preoperative and last postoperative follow-up radiographs, visual analogue scale (VAS), thumb's Kapandji scores, disabilies of the arm, shoulder, and hand (DASH) scores, grip and pinch strength and time to return to work were compared.Results:All cases were followed up for 19.6±6.3 months (range, 11-36 months). The postoperative X-ray showed all the CMCJs were reduced with a normal height of first metacarpal. The mean time for patients to return to their daily activities was 18.69±3.70 d and the mean time to return to work was 24.63±4.91 d. The average VAS score decreased from 6.56±1.15 preoperatively to 1.00 (0.75, 1.25). The preoperative Kapandji's score was 8.00±0.82 and the postoperative Kapandji's score was 8.00 (7.25, 9.00). The average DASH values improved from 24.06±3.19 to 4.00 (3.00, 5.00). The were significant differences except for Kapandji score ( Z=-4.905, P<0.001; Z=-0.121, P=0.905; Z=-4.846, P<0.001). The mean grip and pinch strength showed improvement from an average of 16.4 (14.13, 18.68) kg and 1.70±0.35 kg to 26.14±3.27 kg and 3.58±0.91 kg with significant difference ( Z=-4.617, P<0.001; t=-7.669, P<0.001). Conclusion:Arthroscopic partial trapeziectomy and suture button suspensionplasty is a minimally invasive surgery for the treatment of first CMCJ Eaton stage II/III arthrosis. By this technique, the patients' existing instability and pain problems can be solved.

Objective:To report the results of national surveillance on the distribution and antimicrobial resistance profile of clinical Gram-negative bacteria isolates from bloodstream infections in China in 2022.Methods:The clinical isolates of Gram-negative bacteria from blood cultures in member hospitals of national bloodstream infection Bacterial Resistant Investigation Collaborative System（BRICS）were collected during January 2022 to December 2022. Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by Clinical and Laboratory Standards Institute（CLSI）. WHONET 5.6 and SPSS 25.0 software were used to analyze the data.Results:During the study period，9 035 strains of Gram-negative bacteria were collected from 51 hospitals，of which 7 895（87.4%）were Enterobacteriaceae and 1 140（12.6%）were non-fermenting bacteria. The top 5 bacterial species were Escherichia coli（ n=4 510，49.9%）， Klebsiella pneumoniae（ n=2 340，25.9%）， Pseudomonas aeruginosa（ n=534，5.9%）， Acinetobacter baumannii complex（ n=405，4.5%）and Enterobacter cloacae（ n=327，3.6%）. The ESBLs-producing rates in Escherichia coli， Klebsiella pneumoniae and Proteus spp. were 47.1%（2 095/4 452），21.0%（427/2 033）and 41.1%（58/141），respectively. The prevalence of carbapenem-resistant Escherichia coli（CREC）and carbapenem-resistant Klebsiella pneumoniae（CRKP）were 1.3%（58/4 510）and 13.1%（307/2 340）；62.1%（36/58）and 9.8%（30/307）of CREC and CRKP were resistant to ceftazidime/avibactam combination，respectively. The prevalence of carbapenem-resistant Acinetobacter baumannii（CRAB）complex was 59.5%（241/405），while less than 5% of Acinetobacter baumannii complex was resistant to tigecycline and polymyxin B. The prevalence of carbapenem-resistant Pseudomonas aeruginosa（CRPA）was 18.4%（98/534）. There were differences in the composition ratio of Gram-negative bacteria in bloodstream infections and the prevalence of main Gram-negative bacteria resistance among different regions，with statistically significant differences in the prevalence of CRKP and CRPA（ χ2=20.489 and 20.252， P<0.001）. The prevalence of CREC，CRKP，CRPA，CRAB，ESBLs-producing Escherichia coli and Klebsiella pneumoniae were higher in provinicial hospitals than those in municipal hospitals（ χ2=11.953，81.183，10.404，5.915，12.415 and 6.459， P<0.01 or <0.05），while the prevalence of CRPA was higher in economically developed regions（per capita GDP ≥ 92 059 Yuan）than that in economically less-developed regions（per capita GDP <92 059 Yuan）（ χ2=6.240， P=0.012）. Conclusions:The proportion of Gram-negative bacteria in bloodstream infections shows an increasing trend，and Escherichia coli is ranked in the top，while the trend of CRKP decreases continuously with time. Decreasing trends are noted in ESBLs-producing Escherichia coli and Klebsiella pneumoniae. Low prevalence of carbapenem resistance in Escherichia coli and high prevalence in CRAB complex have been observed. The composition ratio and antibacterial spectrum of bloodstream infections in different regions of China are slightly different，and the proportion of main drug resistant bacteria in provincial hospitals is higher than those in municipal hospitals.

For the past few years, the indocyanine green fluorescence imaging has been widely used in the diagnosis and treatment of biliary tract diseases. Fluorescence visualization of the biliary system by indocyanine green accurately localize the diseased tissue and identify the biliary structures precisely, which effectively avoids the damage to the natural biliary structure and greatly improves the accuracy and safety of biliary surgery. However, the application of this new technology in biliary surgery is still at the exploratory stage, showing great potential for application while also exposing many problems and controversies. It is believed that with the continuous development and improvement, the indocyanine green fluorescence cholangiography will play a more important role in the diagnosis and treatment of biliary tract diseases in the future, and bring more benefits to patients.

Objective:To investigate the influencing factors for early tumor recurrence and the efficacy of adjuvant chemotherapy in gallbladder carcinoma (GBC) patients after curative-intent resection.Methods:The retrospective case-control study was conducted. The clinicopathological data of 506 patients with GBC in 11 medical centers, including The First Affiliated Hospital of Xi'an Jiaotong University et al, from January 2016 to December 2020 were collected. There were 168 males and 338 females, aged (62±11)years. All patients underwent curative-intent resection of GBC, and they were divided into patients with and without early recurrence based on time to postoperative recurrence. Observation indicators: (1) treatment; (2) follow-up and survival of patients; (3) analysis of influencing factors for early tumor recurrence after curative-intent resection of GBC; (4) efficacy of postoperative adjuvant chemotherapy. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M(range). Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test. Comparison of ordinal data was conducted using the Mann-Whitney U test. Univariate analysis was conducted using the corresponding statistical methods based on data type. Multivariate analysis was conducted using the Logistic regression model with forward method. The Kaplan-Meier method was used to draw survival curve and calculate survival rate, and Log-Rank test was used for survival analysis. Results:(1) Treatment. Of 506 patients, there were 112 cases with postoperative adjuvant chemotherapy, and 394 cases without postopera-tive adjuvant chemotherapy. They underwent 5(range, 3-9)cycles of postoperative adjuvant chemo-therapy. (2) Follow-up and survival of patients. All 506 patients underwent postoperative follow-up, with the follow-up time of 55(range, 34-93)months. During the follow-up, there were 248 patients with tumor recurrence, including 158 cases of early recurrence and 90 cases of late recurrence, and there were 258 patients without tumor recurrence. Of 506 patients, 275 cases survived, and 231 cases died of multiple organ failure caused by tumor recurrence and metastasis. The postoperative recurr-ence-free survival time, overall survival time were 52(range,1-93)months, 62(range, 2-93)months. The 1-, 3-, 5-year disease-free survival rates and 1-, 3-, 5-year overall survival rates of the 506 pati-ents were 68.8%, 53.8%, 47.9% and 78.3%, 58.7%, 51.6%, respectively. Results of survival analysis showed that the median overall survival time of 158 patients with postoperative early recurrence and 348 patients without postoperative early recurrence (including 90 cases of late recurrence and 258 cases of no tumor recurrence) were 9(range, 2-73)months and unreached, showing a significant difference between them ( χ2=456.15, P<0.05). (3) Analysis of influencing factors for early tumor recurrence after curative-intent resection of GBC. Results of multivariate analysis showed that carcinoembryonic antigen (CEA) >5.0 μg/L, poorly differentiated tumor, liver invasion, and tumor N staging as stage N1-N2 were independent risk factors influencing early tumor recurrence after cura-tive-intent resection of GBC ( odds ratio=2.74, 6.20, 1.81, 2.93, 4.82, 95% confidence interval as 1.62-4.64, 1.82-21.12, 1.15-3.08, 1.68-5.09, 1.91-12.18, P<0.05), while postoperative adjuvant chemo-therapy was an independent protect factor ( odds ratio=0.39, 95% confidence interval as 0.21-0.71, P<0.05). (4) Efficacy of postoperative adjuvant chemotherapy. The median overall survival time of 394 patients without postoperative adjuvant chemotherapy and 112 patients with postoperative adjuvant chemotherapy were 57(range, 2-93)months and unreached, showing a significant differ-ence between them ( χ2=9.38, P<0.05). Of the 158 patients with postoperative early recurrence after curative-intent resection of GBC, 135 cases didn't receive adjuvant chemotherapy and 23 cases received adjuvant chemotherapy, with the overall survival time of 8(range, 2-73)months and 17(range, 8-61)months, respectively, showing a significant difference between them ( χ2=7.68, P<0.05). Conclusions:CEA >5.0 μg/L, poorly differentiated tumor, liver invasion, and tumor N staging as stage N1-N2 are independent risk factors influencing early tumor recurrence after curative-intent resection of GBC, while postoperative adjuvant chemotherapy is an independent protect factor. Postoperative adjuvant chemotherapy can prolong the overall survival time of patients with post-operative tumor early recurrence.

Pancreatobiliary maljunction(PBM)represents a congenital anatomical abnormality of the pancreaticobiliary ductal system,frequently predisposing individuals to recurrent cholangitis and pancreatitis.Accumulating evidence indicates that PBM is a precancerous lesion,and PBM plays an important role in the development and progression of gallbladder cancer(GBC).GBC arising from PBM is designated as PBM-associated GBC.Consequently,early diagnosis and treatment of PBM is paramount in mitigating the risk of GBC.This review outlined the epidemiology and advancements in the diagnosis and management of PBM,along with the clinical features,underlying mechanisms,and therapeutic progressions pertaining to PBM-associated GBC,in order to underscore the clinical significance of early intervention in PBM,so as to reduce the incidence of PBM-associated GBC.

Objective:To investigate the efficacy of liver wedge resection and liver Ⅳb and Ⅴ segmentectomy for T2 gallbladder carcinoma (GBC).Methods:The retrospective cohort study was conducted. The clinicopathological data of 168 patients who underwent radical resection of T2 GBC in The First Affiliated Hospital of Xi′an Jiaotong University from January 2011 to December 2021 were collected. There were 59 males and 109 females, aged (65±10)years. Of 168 patients, there were 112 cases in T2a stage and 56 cases in T2b stage. Of 112 patients in T2a stage, 73 cases underwent liver wedge resection and 39 cases underwent liver Ⅳb and Ⅴ segmentectomy. Of 56 patients in T2b stage, 27 cases underwent liver wedge resection and 29 cases underwent liver Ⅳb and Ⅴ segmen-tectomy. Measurement data with normal distribution were represented as Mean± SD, and measure-ment data with skewed distribution were represented as M(range). Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Comparison of ordinal data was conducted using the Mann-Whitney U test. The Kaplan-Meier method was used to calculate survival rate and draw survival curve, and the Log-rank test was used for survival analysis. The COX proportional risk model was used for univariate and multivariate analyses. Results:(1) Clinical data analysis of patients undergoing different extent of hepatic resection for T2 GBC. There was no significant difference in gender, age, cholecystoli-thiasis, preoperative total bilirubin, carcinoembryonic antigen, CA19-9, CA125, incidental GBC, perineural invasion, microvascular invasion, pathological differentiation, histopathological subtypes, N staging, TNM staging between patients with T2a and T2b GBC who underwent different extent of hepatic resection ( P>0.05). (2) Prognostic analysis of T2 GBC patients undergoing different extent of hepatic resection. The 1-, 3- and 5-year cumulative disease-free survival rates of T2 GBC patients undergoing liver wedge resection were 78.0%, 60.1% and 51.4%, respectively, versus 86.8%, 80.0% and 68.0% of T2 GBC patients undergoing liver Ⅳb and Ⅴ segmentectomy, showing a significant difference between them ( χ2 =5.205, P<0.05). The 1-, 3-, and 5-year cumulative overall survival rates of T2 GBC patients undergoing liver wedge resection were 85.0%, 62.5%, and 55.1%, respectively, versus 92.6%, 81.6%, and 68.8% for T2 GBC patients undergoing liver Ⅳb and Ⅴ segmentectomy, showing a significant difference in cumulative overall survival rate between them ( χ2=4.351, P<0.05). The 1-, 3-, and 5-year cumulative disease-free survival rates of T2b GBC patients undergoing liver wedge resection were 70.4%, 45.9% and 39.2%, respectively, versus 89.7%, 71.3% and 54.0% of T2b GBC patients undergoing liver Ⅳb and Ⅴ segmentectomy, showing a significant difference between them ( χ2=5.047, P<0.05). The 1-, 3-, and 5-year cumulative overall survival rates of T2b GBC patients undergoing liver wedge resection were 81.5%, 53.2%, and 41.0%, respectively, versus 89.7%, 77.0%, and 60.7% of T2b GBC patients undergoing liver Ⅳb and Ⅴ segmentectomy, showing no significant difference in cumulative overall survival rate between them ( χ2=4.014, P<0.05). (3) Analysis of factors influencing prognosis of patients undergoing radical resection for T2 GBC. Results of multivariate analysis showed that CA19-9>39.0 U/mL, perineural invasion, N1 and N2 stage were independent risk factors influencing disease-free survival time of patients undergoing radical resection for T2 GBC ( hazard ratio=2.736, 3.496, 2.638, 17.440, 95% confidence interval as 1.195-6.266, 1.213-10.073, 1.429-4.869, 8.362-36.374, P<0.05). Liver Ⅳb and Ⅴ segmentectomy was an independent protective factor influencing disease-free survival time of patients undergoing radical resection for T2 GBC ( hazard ratio=0.418, 95% confidence interval as 0.230-0.759, P<0.05). CA19-9 >39.0 U/mL, perineural invasion, ⅡB stage, ⅢB stage and ⅣB stage of TNM staging were independent risk factors influencing overall survival time of patients undergoing radical resection for T2 GBC ( hazard ratio=2.740, 3.210, 2.037, 3.439, 24.466, 95% confidence interval as 1.127-6.664, 1.049-9.819, 1.004-4.125, 1.730-6.846, 10.733-55.842, P<0.05). Liver Ⅳb and Ⅴ segmentectomy was an independent protective factor influencing overall survival time of patients undergoing radical resec-tion for T2 GBC ( hazard ratio=0.476, 95% confidence interval as 0.261-0.867, P<0.05). (4) Analysis of postoperative complications in patients undergoing different extent of hepatic resection for T2 GBC. There was no significant difference in postoperative complications of patients with T2a and T2b GBC undergoing liver wedge resection or liver Ⅳb and Ⅴ segmentectomy ( P>0.05). Conclusions:Compared to liver wedge resection, liver Ⅳb and Ⅴ segmentectomy can effectively prolong the disease-free survival overall survival time of T2b GBC patients. There is no significant difference in the major complications. Liver Ⅳb and Ⅴ segmentectomy is an independent protective factor for prognosis of patients undergoing radical resection for T2 GBC.

Objective To mine valid information in public databases through bioinformatics analysis and machine learning models and to identify candidate genes related to preeclampsia,so as to improve the accuracy of early diagnosis and provide targets for pathogenesis,diagnosis and treatment research.Methods The RNA-seq datasets of placental tissue samples of preeclampsia patients and healthy pregnant women were retrieved from the Gene Expression Omnibus,and the gene expression matrix was obtained after data download,quality control,comparison and quantification through bioinformation analysis.The differentially expressed genes were screened by DESeq2 1.38.3,the enrichment pathway was determined using Gene Ontology and Kyoto Encyclopedia of Genes and Genomes,the co-expression network was constructed using weighted gene co-expression network analysis(WGCNA),and the machine learning prediction model was established by random forest algorithm.Results A total of 49 common differentially expressed genes were screened from placental tissue samples of 156 pregnant women(70 preeclampsia patients and 86 healthy pregnant women)in 4 datasets and they were significantly enriched in extracellular regions,positive regulation pathway of follicle-stimulating hormone secretion,hormone activity pathway,and cytokine-cytokine receptor interaction pathway,etc.The 49 differentially expressed genes were categorized into 7 co-expression modules by WGCNA,and key modules highly related to preeclampsia were identified.Six candidate key genes(fms related receptor tyrosine kinase 1[FLT1],pappalysin 2[PAPPA2],protein phosphatase 1 regulatory inhibitor subunit 1C[PPP1R1C],myosin ⅦB[MYO7B],long intergenic non-protein coding RNA 2009[LINC02009],and inhibin subunit α[INHA])were screened.The random forest model based on these 6 key genes had good predictive value for preeclampsia(area under curve was 0.978).Conclusion Preeclampsia may be associated with genes for hormone secretion,immune response,angiogenic factors,pregnancy-associated plasma proteins,and inhibin,and these genes may be candidate diagnostic markers of preeclampsia.