OBJECTIVE: To investigate the safety and prognostic factors influencing the treatment of upper urinary tract urothelial carcinoma (UTUC) combined with bladder cancer (BCa) by laparoscopic simultaneous radical cystectomy and nephroureterectomy (RCNU). METHODS: The clinical data of patients admitted to Peking University Third Hospital for laparoscopic RCNU surgery from January 2009 to September 2023 were analyzed retrospectively. Based on the same gender, age (±5 years), history of uroepithelial tumors, underlying diseases, T-stage, N-stage, M-stage, American Society of Anesthesiologists (ASA) score, Charlson comorbidity index, and body mass index (BMI) (±5), 34 patients with RCNU were matched 1 ∶1 with patients with bladder cancer who underwent laparoscopic radical cystectomy (RC) alone. Kaplan-Meier survival analysis was used to calculate patient survival, and Cox proportional regression risk model was used to analyze clinical factors affecting prognosis. RESULTS: Of the 68 patients enrolled, the follow-up rate was 100% with a median follow-up time of 27.0 (11.7, 60.2) months. Comparison of intraoperative conditions (including operation time, estimated intraoperative bleeding, intra-operative blood transfusion, etc.) between the two groups of patients showed no significant difference (P>0.05). Comparison of preoperative creatinine and postoperative creatinine between the two groups of patients showed significant differences (P < 0.05). The perioperative Clavien grade Ⅲ-Ⅳ complication rates were 2.9% (1/34) in the RC group and 5.9% (2/34) in the RCNU group. There was no significant difference in terms of perioperative complications between the two groups. Overall survival was significantly lower in the patients receiving RCNU compared with the matched group receiving RC alone (P < 0.05). Cox regression analysis suggested that two factors, high N stage and high postoperative creatinine, were independent risk factors affecting the prognosis of patients in the 2 groups (P < 0.05). CONCLUSION The overall survival prognosis of patients undergoing RCNU surgery was worse compared with laparoscopic RC surgery alone during the same period. There was no clinically significant difference between the two groups in terms of operation time, intraoperative bleeding, and perioperative complications, and there were clinically significant differences in preoperative renal function and post-operative renal function.
Humans ; Laparoscopy/methods* ; Nephroureterectomy/methods* ; Cystectomy/methods* ; Prognosis ; Male ; Retrospective Studies ; Female ; Urinary Bladder Neoplasms/mortality* ; Middle Aged ; Aged

Cleaning process validation is an important guarantee for implantable medical devices to ensure product cleanliness. In the manufacturing process, implantable devices usually need to control pollution through cleaning process to achieve a certain cleanliness to ensure the effectiveness of sterilization and product safety. This paper discusses the cleaning process validation of the manufacturing process of the implantable devices based on relevant regulations and technical standards, and proposes the influencing factors and principles to be considered in the cleaning process validation, so as to provide technical reference for the design of the cleaning process validation.
Prostheses and Implants ; Sterilization ; Equipment and Supplies

Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C₀), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage* ; Drug Monitoring/methods* ; Humans ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

Objective:To investigate the value of quantitative parameters of dual-layer detector spectral CT (DLCT) in preoperative prediction of lymphovascular invasion (LVI) in invasive lung adenocarcinoma.Methods:This study employed a cross-sectional design. The data of 91 patients with primary lung adenocarcinoma confirmed by postoperative pathology who underwent DLCT enhanced scanning in the First Affiliated Hospital of Zhengzhou University from March 2022 to July 2024 were retrospectively collected. The patients were divided into LVI positive group and LVI negative group according to the postoperative pathology. Gender, age, smoking status, and lesion location were recorded,the clinical T-stage and N-stage were evaluated. Spectral base data images were generated based on the spectral reconstruction algorithm. Conventional CT features such as the size and density of the lesions were analyzed. The DLCT quantitative parameters such as 40 keV single-energy CT value (CT 40 keV), iodine density (ID), standardized iodine density (NID), and effective atomic number (Z eff) were measured. The differences of parameters between the two groups were compared using t-test, Mann-Whitney U test, or χ2 test. Multivariate logistic regression analysis was used to identify independent factors for predicting invasive lung adenocarcinoma LVI. The predictive performance of individual parameters and their combinations for LVI in invasive lung adenocarcinoma was evaluated using receiver operating characteristic curve analysis and area under the curve (AUC) measurements. Results:There were significant differences in age, T stage, N stage, maximum diameter, focal density, and arteriovenous stage NID and Z eff between the LVI positive group and the LVI negative group ( P<0.05). Multiple logistic regression analysis showed that age ( OR=0.890, 95% CI 0.821-0.966), N stage( OR=12.721, 95% CI 2.676-60.473) and venous stage Z eff( OR=0.012,95% CI 0-0.668) were independent factors for predicting invasive lung adenocarcinoma LVI ( P<0.05). The combination of age, N stage, and venous-phase Z eff values demonstrated the highest predictive efficacy for LVI in invasive lung adenocarcinoma, with an AUC of 0.916. Conclusions:The quantitative parameters of DLCT are helpful for preoperative prediction of LVI status of invasive lung adenocarcinoma. The Z eff in the venous stage is an independent predictor, the combination of multiple parameters can further improve the diagnostic efficiency.

Acute lateral ankle sprain (ALAS) is one of the most common sport injuries, with high incidence, recurrence and disability rates. Currently, exercise rehabilitation-based non-surgical treatment is the primary management approach for ALAS. However, there remain improper practices such as excessive immobilization or uncontrolled activity, which contribute to recurrent sprains and chronic ankle instability, significantly impairing patients′ athletic function and quality of life. To standardize the non-surgical management of ALAS, improve the cure rates, and reduce the recurrence and disability rates, Chinese Sports Rehabilitation Medicine Training Project of Chinese Medical Association, Foot and Ankle Basics and Orthopedics Group, Orthopedic Branch of Chinese Medical Doctor Association, and Sports Medicine Branch of Jiangsu Medical Association organized relevant experts to formulate Expert consensus on non-surgical treatment for acute lateral ankle sprain ( version 2025), following the principles of scientific vigor, practicality, and innovation. Thirteen recommendations were proposed for standardized treatment protocols across different healing phases, aiming to provide references for standard management of ALAS and improve the therapeutic outcomes.

To improve the understanding of L?effler endocarditis, we retrospectively analyzed six patients with eosinophilia, predominantly characterized by L?effler endocarditis, who were treated at the First Affiliated Hospital of Soochow University from January 2019 to October 2024. Among the 6 patients, 5 were male, with a median age of 45.5 years (31–77 years). All patients demonstrated increased white blood cell count and eosinophil count in peripheral blood. Clinical symptoms and imaging examination were considered as L?effler endocarditis, and two cases were complicated by cerebral infarction. Fusion gene testing was completed in five patients, with cases 4 and 5 demonstrating FIP1L1::PDGFRA fusion gene positivity, and case 6 with TLS::ERG (+) acute myeloid leukemia. Two patients with FIP1L1::PDGFRA positivity achieved rapid remission after imatinib treatment. Case 6 experienced symptom relief after glucocorticoids and hydroxyurea treatment, followed by complete remission after chemotherapy with the cytarabine (20 mg q12 h × 14 days), idarubicin (5 mg on days 2–12 every other day), and G-CSF (adjusted based on blood counts) regimen. After 8 months, the patient underwent allogeneic hematopoietic stem cell transplantation but died 1 year post-transplantation due to disease relapse complicated by infection. The remaining three patients demonstrated improvement after glucocorticoid treatment. Except for case 6, the other patients were still alive, with case 4 relapsing at 28 months after imatinib discontinuation and relieved after treatment re-initiation.

Objective: To analyze the correlation between ABO blood group compatibility and the risk of early complications after liver transplantation, and to identify risk factors for clinical intervention. Methods: Clinical data of 404 liver transplant recipients and donors were collected. Based on donor-recipient ABO matching, patients were divided into three groups: ABO-Identical (ABO-Id, n=313), ABO-compatible (ABO-c, n=68), ABO-incompatible (ABO-i, n=23). Clinical data, early complications, and associated risk factors were compared. Results: Compared with the ABO-Id, ABO-c and ABO-i recipients were younger, had a higher proportion of primary biliary atresia, and more frequently received living-donor transplantation from relatives (P<0.05). Overall complication rates were: ABO-c 47.1% (32/68), ABO-i 43.5% (10/23), ABO-Id 39.3% (123/313), with no significant intergroup difference (P>0.05). Infection was the most common complication [ABO-c 30.9% (21/68), ABO-i 21.7% (5/23), ABO-Id 17.9% (56/313)]. No significant differences were found in infection, vascular/biliary or acute kidney injury/renal failure among the three groups (P>0.05). However, ABO-c group had significantly higher rates of ascites/abscess (20.6% vs 8.9%, P<0.05) and pleural effusion (14.7% vs 7.0%, P<0.05) than ABO-Id group. There was no significant difference in the incidence of complications and ABO blood group between ABO non-Identical (ABO-c and ABO-i) and Identical groups. Logistic regression analysis showed that the risk of ascites/abscess in ABO non-Identical was higher than that in ABO-Id liver transplantation (P<0.05), and the risk of ascites/abscess after ABO-c liver transplantation was 2.246 times higher than that of ABO-Id liver transplantation. The primary biliary atresia were a risk factor for postoperative ascites/abscess. Conclusion: Enhanced postoperative management is critical for ABO-nonidentical (especially ABO-compatible) recipients, and those with biliary atresia to reduce complication risks.

Objective:To review the clinicopathological features of TFE3-rearranged renal cell carcino-ma(TFE3-RCC)with venous tumor thrombus(VT)(TFE3-VT),to explore treatment strategies and to prognostic characteristics,and to provide diagnostic and therapeutic references for TFE3-VT patients.Methods:Patients who underwent surgery at Department of Urology,Peking University Third Hospital from January 2013 to January 2024 were enrolled,including three cohorts:Pathologically confirmed TFE3-VT patients,TFE3-RCC patients without VT(TFE3-non-VT),and non-TFE3-rearranged renal cell carcinoma patients with VT(non-TFE3-VT).Clinical history,imaging data,pathological data,and follow-up records were collected.Primary and secondary endpoints were progression-free survival(PFS)and overall survival(OS),respectively.(1)Baseline characteristics were compared between the TFE3-VT and TFE3-non-VT patients.Normally distributed continuous variables were expressed as mean±SD and compared using Student's t-test;non-normally distributed variables were expressed as M(P25,P75)and analyzed with Mann-Whitney U test;categorical variables were described as frequency and percentage[n(％)]and compared by x2 test or Fisher's exact test.(2)Clinical history,radiological presenta-tions,surgical data,and histopathological features of the TFE3-VT patients were comprehensively charac-terized.(3)Survival analysis was performed for the TFE3-VT patients.Follow-up data of the TFE3-VT patients were described in detail,and their survival outcomes were compared with the TFE3-non-VT and non-TFE3-VT patients.When compared with the TFE3-non-VT counterparts,Kaplan-Meier method was used to generate PFS and OS curves among:(1)the TFE3-RCC patients across clinical stages Ⅰ-Ⅳ;(2)TFE3-VT versus TFE3-non-VT cohorts;(3)stage Ⅲ subgroups of the TFE3-VT and TFE3-non-VT patients.Intergroup survival differences were statistically evaluated using Log-rank tests.For comparisons with the non-TFE3-VT patients,a 1∶1 propensity score matching(PSM)was implemented to balance baseline characteristics between the two cohorts.Post-matching Kaplan-Meier curves were generated to compare PFS and OS between the matched groups,with Log-rank tests employed to determine statistical significance of survival disparities.All statistical analyses were conducted with R software(v 4.2.3),and two-tailed P＜0.05 was considered statistically significant.Results:The study included 45 TFE3-RCC patients:13 TFE3-VT and 32 TFE3-non-VT cases.Additionally,523 non-TFE3-VT patients were enrolled.Among the 13 TFE3-VT patients,9 were female(69.2％)and 4 male(30.8％),with a mean age of(37.9±14.4)years,mean BMI of(22.2±3.5)kg/m2,median age-adjusted Charlson comorbidity index(aCCI)of 1.0(0.0,1.0),and preoperative creatinine level of(75.3±15.9)μmol/L;tumors were located in the left kidney in 7 patients(53.8％)and right kidney in 6(46.2％);preoperative distant metastasis(M1 stage)was present in 6 patients(46.2％),while 7(53.8％)showed no metastasis;VT distribution by Mayo level comprised 7 cases(53.8％)at level 0,1 case each at levels Ⅰ and Ⅳ(7.7％respectively),and 2 cases each at levels Ⅱ and Ⅲ(15.4％respectively);surgical approaches comprised open surgery(n=2,15.4％),laparoscopic surgery(n=6,46.1％),and robot-assisted laparoscopic surgery(n=5,38.5％);mean operative time was(273±79)min,and intraoperative blood loss was(722±570)mL;mean maximum tumor diameter was(10.8±2.4)cm.All the 13 patients underwent TFE3 protein immunohistochemistry(IHC)staining,with 7 confirmed by fluorescence in situ hybridization(FISH).Tumor recurrence or metastasis occurred in 11 patients(84.6％),and 9(69.2％)patients died during follow-up.Median PFS was 4 months(1 year PFS rate:31％),and median OS was 13 months(1 year OS rate:54％).Survival analysis of 45 TFE3-RCC pa-tients revealed statistically significant differences in PFS and OS across all the clinical stages(P＜0.001).The TFE3-VT patients exhibited significantly worse PFS and OS than the TFE3-non-VT patients(P＜0.001),with persistent significance in stage Ⅲ subgroup analysis(P＜0.05).After PSM,TFE3-VT pa-tients showed significantly inferior PFS compared with non-TFE3-VT(P=0.01),though no significant difference was shown between the OS curves(P=0.11).Conclusion:TFE3-VT predominantly occurs in young females with frequent preoperative metastases.Strongly-positive staining of TFE3 protein in IHC stai-ning and red-green split signals in FISH tests are reliable diagnostic markers.TFE3-VT patients exhibit in-ferior survival compared with TFE3-non-VT patients and earlier progression than non-TFE3-VT patients.

Objective:To review and summarize the experience of robot-assisted laparoscopic trans-plant nephrectomy,share the surgical steps and technical key points,and provide a reference for clinical practice.Methods:A retrospective analysis was conducted on the perioperative data of 5 patients who underwent robot-assisted laparoscopic donor nephrectomy at Peking University Third Hospital from August 2023 to December 2024.The surgical steps and key points were summarized.The continuous variables were described by medians(ranges).Results:A total of 5 patients were included in the analysis,of whom 2 were male and 3 were female.The median age of the patients was 37(31-68)years.The me-dian time from kidney transplantation to donor nephrectomy was 10(3-22)years.The indications for donor nephrectomy included recurrent hematuria,abdominal pain,malignant tumor of the transplanted kidney,and recurrent infection with hydronephrosis of the transplanted kidney.The excised transplanted kidneys from all the 5 patients had a single renal artery and a single renal vein.The median operation time was 212(145-351)min,the median blood loss was 300(20-500)mL,and the median post-operative hospital stay was 7(4-25)days.Only 1 patient experienced intraoperative complications,who experienced an external iliac artery injury during the operation and underwent suture repair.No pa-tient died during the perioperative period.Postoperative pathological results showed that 3 patients had end-stage non-functional kidneys,1 patient had BK virus-associated urothelial carcinoma,and 1 patient had chronic pyelonephritis with renal parenchymal atrophy.Conclusion:Robot-assisted laparoscopic transplant nephrectomy as a new surgical approach is feasible and safe.Compared with traditional open transplant nephrectomy,its advantage lies in the ability to directly observe and prioritize the management of the renal pedicle of the transplanted kidney,while completely freeing and removing the transplanted kidney outside the renal capsule.With the continuous accumulation of experience,this surgical technique is expected to become a powerful alternative to traditional open transplant nephrectomy.

Objective To investigate the role of lupeol in mitigating chondrocyte senescence in osteoarthritis(OA)by regulating autophagy through the sirtuin 3(SIRT3)/mechanistic target of rapamycin kinase(mTOR)pathway.Methods Knee articular chondrocytes from primary-generation mice were isolated and divided into different groups,including a control group,a lupeol group(given 2.5,5,10,20,and 40 μmol/L lupeol),a tert-butyl hydrogen peroxide(TBHP)group(receiving 50 μmol/L TBHP),TBHP+lupeol group,TBHP+lupeol+chloroquine(CQ)group(receiving 20 μmol/L CQ,an autophagy inhibitor),TBHP+lupeol+si-NC group,and TBHP+lupeol+si-SIRT3 group.Cell proliferation,reactive oxygen species(ROS)levels,and apoptosis were determined by CCK-8,DCFH-DA probe,and flow cytometry.Cell senescence was evaluated by β-gal staining.Western blot was used to determine the expressions of SIRT3,mTOR,senescence marker proteins(p21 and p16),extracellular matrix(ECM)degradation-related proteins(aggrecan,collagen Ⅱ,ADAMTS5,and MMP13),and autophagy-related proteins(LC3B Ⅰ,LC3BⅡ,and P62).RT-qPCR was used to determine the mRNA levels of senescence-associated secretory phenotypes(SASP),including IL-6,Cxcl10,MCP1,and MMP3.The expression of LC3 was detected by immunofluorescence.Autophagosomes were observed by transmission electron microscopy.A total of 30 male wild-type C57BL/6 mice were divided into different groups(n=10),including a Sham group,an OA group,and an OA+lupeol group receiving 50 mg/(kg·d)lupeol via gastric gavage.Cartilage damage was evaluated by safranin O-fast green staining.Results Based on the results of cell viability assay,20 μmol/L lupeol treatment for 24 h was identified as the optimal intervention concentration and duration.Compared with that in the TBHP group,cell viability was elevated in the TBHP+lupeol group(P＜0.05);ROS production,the proportion of β-gal-positive cells,the protein expression levels of p21 and p16,and the mRNA levels of SASP were decreased(P＜0.05);the protein levels of aggrecan and collagen Ⅱ were elevated and the protein levels of ADAMTS5 and MMP13 were decreased(P＜0.05);apoptosis was reduced(P＜0.05);P62 protein levels were reduced and the LC3B Ⅱ/LC3B Ⅰ ratio,the intensity of LC3B fluorescence spots,and the number of autophagosomes were increased(P＜0.05);the expression level of SIRT3 was elevated and the level of mTOR phosphorylation was reduced(P＜0.05)in the TBHP+Lupeol group.CQ treatment effectively abolished the promotion effects of lupeol on cell viability and autophagy,and the inhibitory effects of lupeol on ROS level,cell senescence,ECM degradation,and apoptosis(P＜0.05).Silencing of SIRT3 reversed the inhibitory effect of lupeol on mTOR phosphorylation level and the promotion effect of lupeol on autophagy(P＜0.05).In the in vivo experiment,compared with the OA group,the OA+lupeol group showed reduced cartilage degeneration and lower scores for the Osteoarthritis Research Society International grading system(P＜0.05).The OA+lupeol group also showed up-regulated SIRT3 expression,reduced mTOR phosphorylation level,increased LC3B Ⅱ/LC3B Ⅰ ratio,reduced MMP13 protein level,and reduced mRNA level of SASP(P＜0.05).Conclusion Lupeol alleviates chondrocyte senescence in osteoarthritis by regulating autophagy through the SIRT3/mTOR pathway.