Objective:To compare the efficacy and clinical practicality of fluorescence in situ hybridization (FISH), thinprep cytology test (TCT), urine nuclear matrix protein 22 (NMP22) and urine cytology test in the diagnosis of upper tract urothelial carcinoma (UTUC). Methods:A retrospective analysis was conducted on the clinical data of 62 patients who underwent surgical treatment (biopsy or partial urothelial resection) for suspected UTUC in the Department of Urology, Peking University Third Hospital from January 2021 to December 2023, and received paraffin pathological diagnosis. Taking the pathological examination results as the diagnostic criteria, the sensitivity, specificity, Youden index, positive predictive value and negative predictive value of the four detection methods in the diagnosis of UTUC were calculated, and the cost-effectiveness analysis was performed. Combine the four detection methods in pairs, calculate the sensitivity, specificity and Youden index after the combination, and conduct a cost-effectiveness analysis. The comparison of sensitivity, specificity and Youden index of the four detection methods was conducted using Chi-test or Fisher exact probability method. The comparison between groups after pairwise combinations was also conducted using Chi-test or Fisher exact probability method. The receiver operating characteristic (ROC) curve was plotted and the area under the curve (AUC) was calculated.Results:The sensitivity (81.1%, 77.4%) and Youden index (0.700, 0.774) of FISH group and TCT group were significantly higher than those of NMP22 group and urine cytology group (39.6%, 43.4%; 0.174, 0.434), and the differences were statistically significant ( P<0.008 3). There were no statistically significant in the specificity (88.9%, 100.0%, 77.8%, 100.0%), positive predictive value (97.7%, 100.0%, 91.3%, 100.0%) and negative predictive value (44.4%, 42.9%, 17.9%, 23.1%) of the four groups ( P>0.008 3). The cost-effectiveness of the FISH group (3 256.4) was significantly higher than that of the TCT group (409.4), the NMP22 group (398.2) and the urine cytology group (627.9). After being combined in pairs, the net sensitivity of NMP22+ urine cytology (45.3%) was significantly lower than that of FISH+ TCT(88.7%), TCT+ NMP22(81.1%), FISH+ NMP22(86.8%), FISH + urine cytology (84.9%), TCT+ urine cytology (86.8%), and the difference was statistically significant ( P<0.008 3). The net specificities of the above combinations were 77.8%, 88.9%, 77.8%, 88.9%, 100.0%, respectively, and the differences were not statistically significant ( P>0.008 3). The cost-effectiveness was 1 008.0, 3 393.5, 632.8, 3 345.0, 3 513.5, and 737.3, respectively. Conclusions:In the diagnosis of UTUC, TCT has the highest diagnostic efficacy and relatively low cost, and is recommended for widespread promotion and application in clinical practice. If the patients economic conditions permit, it is recommended to combine TCT with urine cytology.

The expanded clinical trial system is designed to provide clinical trial drugs for patients suffering from serious or life-threatening diseases for which there is no effective treatment， essentially seeking a balance between the accessibility of drugs to patients and the soundness of the development of the pharmaceutical industry， as well as between the risk of expanding the use of clinical trial drugs and the need to safeguard the rights and interests of patients’ lives and health. Article 23 of China's Drug Administration Law provides only a principled description of the applicable standards and operating procedures for this system， with no implementing regulations， making it difficult for the system to function effectively in practice. The United States， Japan， and Canada have made detailed provisions on the conditions of application， applicants， review subjects and contents， and safeguards of the system through laws， regulations， and guidelines. Based on China's legislative environment and regulatory reality， and considering that the system is still in the initial stage in China， it is recommended that appropriate reference be made to the beneficial experience of foreign countries and that regulations and normative documents be promulgated as soon as possible to clarify the types of expanded clinical trials， applicants， review subjects etc.， and to determine the responsibilities of all the parties involved， to promote the standardization of China’s expanded clinical trial system， to promote the availability of medicines to patients， and to effectively safeguard the rights and interests of patients’ lives and health， and the soundness and safety of the development of the pharmaceutical industry.

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

Objectives:This study aims to evaluate the relationship between the triglyceride-glucose body mass index(TyG-BMI),the right pericoronary fat attenuation index(RCA-FAI),and prognosis in patients with coronary artery disease(CAD).Methods:This study included 513 CAD patients who underwent coronary computed tomography angiography(CCTA)and coronary angiography between April 2018 and June 2023.Data collection and parameter calculations were performed for all research variables.The patients were stratified into three groups based on TyG-BMI tertiles:T1 group(TyG-BMI≤207.02,n=171),T2 group(207.02

Objective This study aimed to investigate the relationship between malnutrition and coronary inflammation,and explore the interaction and mediating effects of coronary inflammation in the association between malnutrition and major adverse cardiovascular events(MACE).Methods A retrospective analysis was conducted on 428 patients diagnosed with coronary heart disease at the Central China Fuwai Hospital from May 2018 to July 2022.All patients underwent coronary angiography(CAG)and coronary computed tomography angiography(CCTA).The TCB index(triglycerides×total cholesterol×body weight)and the coronary fat attenuation index around the proximal right coronary artery(RCA-FAI)were used to assess patients' nutritional state and the degree of coronary inflammation,respectively.The study endpoint was MACE.We used linear regression models to analyze the correlation between TCBI and RCA-FAI,cox regression models to assess the correlation of TCBI and RCA-FAI with MACE,and mediation analysis to investigate whether RCA-FAI mediated the relationship between TCBI and MACE.Results A total of 428 patients were included in the study.There was a negative correlation between RCA-FAI and TCBI(r=-0.224,P<0.001).After adjusting for potential confounders,each standard deviation decrease in the TCBI index was associated with a 2.20 HU increase in RCA-FAI(95%CI:-3.40～-1.19,P<0.001).During a mean follow-up period of 2.15 years,51 MACE occurred.MACE risk in the low TCBI/high RCA-FAI group was 6.58 times higher than that in the high TCBI/low RCA-FAI group(adjusted HR=6.580,95%CI:2.237～19.360,P=0.001),and the interaction between TCBI and RCA-FAI was identified.Mediation analysis revealed that RCA-FAI mediated 37.5%of the associations between TCBI and MACE.Conclusions In patients with coronary artery disease,malnutrition is associated with increased coronary inflammation.There is a significant interaction between malnutrition and coronary inflammation in the risk of MACE,and coronary inflammation partially mediates the relationship between malnutrition and MACE.The combination of the TCBI index and RCA-FAI can help identify patients at high cardiovascular risk.Improving malnutrition and controlling coronary inflammation may provide addi-tional benefits for patients with coronary artery disease.

Objective This study aimed to investigate the relationship between malnutrition and coronary inflammation,and explore the interaction and mediating effects of coronary inflammation in the association between malnutrition and major adverse cardiovascular events(MACE).Methods A retrospective analysis was conducted on 428 patients diagnosed with coronary heart disease at the Central China Fuwai Hospital from May 2018 to July 2022.All patients underwent coronary angiography(CAG)and coronary computed tomography angiography(CCTA).The TCB index(triglycerides×total cholesterol×body weight)and the coronary fat attenuation index around the proximal right coronary artery(RCA-FAI)were used to assess patients' nutritional state and the degree of coronary inflammation,respectively.The study endpoint was MACE.We used linear regression models to analyze the correlation between TCBI and RCA-FAI,cox regression models to assess the correlation of TCBI and RCA-FAI with MACE,and mediation analysis to investigate whether RCA-FAI mediated the relationship between TCBI and MACE.Results A total of 428 patients were included in the study.There was a negative correlation between RCA-FAI and TCBI(r=-0.224,P<0.001).After adjusting for potential confounders,each standard deviation decrease in the TCBI index was associated with a 2.20 HU increase in RCA-FAI(95%CI:-3.40～-1.19,P<0.001).During a mean follow-up period of 2.15 years,51 MACE occurred.MACE risk in the low TCBI/high RCA-FAI group was 6.58 times higher than that in the high TCBI/low RCA-FAI group(adjusted HR=6.580,95%CI:2.237～19.360,P=0.001),and the interaction between TCBI and RCA-FAI was identified.Mediation analysis revealed that RCA-FAI mediated 37.5%of the associations between TCBI and MACE.Conclusions In patients with coronary artery disease,malnutrition is associated with increased coronary inflammation.There is a significant interaction between malnutrition and coronary inflammation in the risk of MACE,and coronary inflammation partially mediates the relationship between malnutrition and MACE.The combination of the TCBI index and RCA-FAI can help identify patients at high cardiovascular risk.Improving malnutrition and controlling coronary inflammation may provide addi-tional benefits for patients with coronary artery disease.

Objectives:This study aims to evaluate the relationship between the triglyceride-glucose body mass index(TyG-BMI),the right pericoronary fat attenuation index(RCA-FAI),and prognosis in patients with coronary artery disease(CAD).Methods:This study included 513 CAD patients who underwent coronary computed tomography angiography(CCTA)and coronary angiography between April 2018 and June 2023.Data collection and parameter calculations were performed for all research variables.The patients were stratified into three groups based on TyG-BMI tertiles:T1 group(TyG-BMI≤207.02,n=171),T2 group(207.02

Objective:To explore the clinical characteristics and prognostic factors of primary bladder adenocarcinoma（ACB）.Methods:The clinical data of 33 patients with primary ACB who underwent surgical treatment in the Department of Urology of Peking University Third Hospital from July 2003 to January 2024 were retrospectively analyzed. There were 5 females and 28 males，with an average age of（61.3 ± 11.5）years. Twelve patients had comorbidities（6 hypertension，2 coronary heart disease，5 diabetes mellitus，and 3 cerebrovascular diseases）and 12 had a smoking history. The mean body mass index（BMI）was（24.8 ± 3.2）kg/m 2. The maximum tumor diameter measured by enhanced computed tomography（CT）was（29.7 ± 12.7）mm. The preoperative neutrophil-to-lymphocyte ratio（NLR）was 3.4 ± 3.2，and the systemic immune-inflammation index（SII）was（582 ± 496）× 10 9/L.Patients were divided into two groups according to the surgical approach：the radical cystectomy group（ n = 23）and the bladder-sparing group（ n = 10）. For the radical cystectomy group，there were 19 males and 4 females，with a mean age of（59.9 ± 12.6）years. Five patients had comorbidities（3 hypertension，1 coronary heart disease，1 diabetes mellitus，and 2 cerebrovascular diseases）. Eight patients had a smoking history，with a mean BMI of（25.2 ± 3.5）kg/m 2. The maximum tumor diameter was（33.6 ± 10.9）mm，the preoperative NLR was 3.5 ± 3.5，and the SII was（618 ± 558）× 10 9/L. For the bladder-sparing group，there were 9 males and 1 female，with a mean age of（64.5 ± 8.2）years. Seven patients had comorbidities（3 hypertension，1 coronary heart disease，4 diabetes mellitus，and 1 cerebrovascular diseases）. Four patients had a smoking history，with a mean BMI of（23.5 ± 2.3）kg/m 2. The maximum tumor diameter was（20.7 ± 12.5）mm，the preoperative NLR was 3.1 ± 2.2，and the SII was（501 ± 323）× 10 9/L. Statistically significant differences were observed between the two groups in terms of comorbidities（ P = 0.008）and maximum tumor diameter（ P = 0.006），while no significant differences were found in other data（ P > 0.05）. The Kaplan-Meier survival curve was drawn，and Cox regression was used to analyze the prognostic factors of progression-free survival（PFS）and overall survival（OS）of patients. Results:Among the 33 patients，low-grade adenocarcinoma and high-grade adenocarcinoma accounted for 60.6% and 39.4% respectively according to the postoperative pathology，and 3 patients had positive surgical margins. There were 22 cases of muscle-invasive bladder adenocarcinoma，5 cases of lymph node metastasis，and 1 case of distant metastasis. The patients in tumor stages Ⅰ—Ⅳ were 9 cases（27.3%），8 cases（24.2%），7 cases（21.2%），and 9 cases（27.3%）respectively. Nine patients received postoperative adjuvant therapy，including 6 with adjuvant chemotherapy，2 with adjuvant chemotherapy combined with radiotherapy，and 1 with adjuvant immunotherapy. In the radical cystectomy group（ n = 23），there were 13 cases of low-grade and 10 cases of high-grade pathological grading，2 cases with positive margins，19 cases of muscle-invasive bladder adenocarcinoma，5 cases of lymph node metastasis，1 case of distant metastasis，and 5 patients received adjuvant therapy（4 cases of adjuvant chemotherapy，and 1 case of adjuvant immunotherapy）. In the bladder-sparing group（ n = 10），there were 7 cases of low-grade，3 cases of high-grade pathological grading，1 case with positive margins，3 cases of muscle-invasive bladder adenocarcinoma，zero lymph node or distant metastasis，and 4 patients received adjuvant therapy（2 cases of adjuvant chemotherapy，and 2 cases of combined adjuvant chemotherapy and radiotherapy）. A statistically significant difference was found in the proportion of muscle-invasive bladder adenocarcinoma between the two groups（ P = 0.006），while no significant differences were observed in other data（ P > 0.05）.The median follow-up duration of the patients was 28.0 months，the median PFS was 86.0 months，and the median OS was 90.0 months. The 2-year PFS and OS were 65.4% and 73.1% respectively. The 5-year PFS and OS were 54.2% and 56.5% respectively. The Kaplan-Meier survival analysis showed that there were no significant differences in PFS（ P = 0.777）and OS（ P = 0.585）between the radical cystectomy group and the bladder-preserving group. Female（ P = 0.011），BMI < 25 kg/m2（ P = 0.038），and positive surgical margins（ P < 0.01）were associated with poorer PFS. Aged ≥ 70 years（ P = 0.003），lymph node metastasis（ P = 0.041），and positive surgical margins（ P = 0.025）were associated with poorer OS，and patients in the adjuvant therapy group had better OS（ P = 0.005）. Multivariate Cox regression analysis indicated that positive surgical margins（HR 10.2， P = 0.012）were an independent impact factor for PFS，and positive surgical margins（HR 39.8， P = 0.001）and adjuvant therapy（HR 0.12， P = 0.021）were independent impact factors for OS. Conclusions:Positive surgical margins and adjuvant therapy are independent impact factors for the prognosis of patients with primary ACB.

Objective:To explore the clinical characteristics and prognostic factors of primary bladder adenocarcinoma（ACB）.Methods:The clinical data of 33 patients with primary ACB who underwent surgical treatment in the Department of Urology of Peking University Third Hospital from July 2003 to January 2024 were retrospectively analyzed. There were 5 females and 28 males，with an average age of（61.3 ± 11.5）years. Twelve patients had comorbidities（6 hypertension，2 coronary heart disease，5 diabetes mellitus，and 3 cerebrovascular diseases）and 12 had a smoking history. The mean body mass index（BMI）was（24.8 ± 3.2）kg/m 2. The maximum tumor diameter measured by enhanced computed tomography（CT）was（29.7 ± 12.7）mm. The preoperative neutrophil-to-lymphocyte ratio（NLR）was 3.4 ± 3.2，and the systemic immune-inflammation index（SII）was（582 ± 496）× 10 9/L.Patients were divided into two groups according to the surgical approach：the radical cystectomy group（ n = 23）and the bladder-sparing group（ n = 10）. For the radical cystectomy group，there were 19 males and 4 females，with a mean age of（59.9 ± 12.6）years. Five patients had comorbidities（3 hypertension，1 coronary heart disease，1 diabetes mellitus，and 2 cerebrovascular diseases）. Eight patients had a smoking history，with a mean BMI of（25.2 ± 3.5）kg/m 2. The maximum tumor diameter was（33.6 ± 10.9）mm，the preoperative NLR was 3.5 ± 3.5，and the SII was（618 ± 558）× 10 9/L. For the bladder-sparing group，there were 9 males and 1 female，with a mean age of（64.5 ± 8.2）years. Seven patients had comorbidities（3 hypertension，1 coronary heart disease，4 diabetes mellitus，and 1 cerebrovascular diseases）. Four patients had a smoking history，with a mean BMI of（23.5 ± 2.3）kg/m 2. The maximum tumor diameter was（20.7 ± 12.5）mm，the preoperative NLR was 3.1 ± 2.2，and the SII was（501 ± 323）× 10 9/L. Statistically significant differences were observed between the two groups in terms of comorbidities（ P = 0.008）and maximum tumor diameter（ P = 0.006），while no significant differences were found in other data（ P > 0.05）. The Kaplan-Meier survival curve was drawn，and Cox regression was used to analyze the prognostic factors of progression-free survival（PFS）and overall survival（OS）of patients. Results:Among the 33 patients，low-grade adenocarcinoma and high-grade adenocarcinoma accounted for 60.6% and 39.4% respectively according to the postoperative pathology，and 3 patients had positive surgical margins. There were 22 cases of muscle-invasive bladder adenocarcinoma，5 cases of lymph node metastasis，and 1 case of distant metastasis. The patients in tumor stages Ⅰ—Ⅳ were 9 cases（27.3%），8 cases（24.2%），7 cases（21.2%），and 9 cases（27.3%）respectively. Nine patients received postoperative adjuvant therapy，including 6 with adjuvant chemotherapy，2 with adjuvant chemotherapy combined with radiotherapy，and 1 with adjuvant immunotherapy. In the radical cystectomy group（ n = 23），there were 13 cases of low-grade and 10 cases of high-grade pathological grading，2 cases with positive margins，19 cases of muscle-invasive bladder adenocarcinoma，5 cases of lymph node metastasis，1 case of distant metastasis，and 5 patients received adjuvant therapy（4 cases of adjuvant chemotherapy，and 1 case of adjuvant immunotherapy）. In the bladder-sparing group（ n = 10），there were 7 cases of low-grade，3 cases of high-grade pathological grading，1 case with positive margins，3 cases of muscle-invasive bladder adenocarcinoma，zero lymph node or distant metastasis，and 4 patients received adjuvant therapy（2 cases of adjuvant chemotherapy，and 2 cases of combined adjuvant chemotherapy and radiotherapy）. A statistically significant difference was found in the proportion of muscle-invasive bladder adenocarcinoma between the two groups（ P = 0.006），while no significant differences were observed in other data（ P > 0.05）.The median follow-up duration of the patients was 28.0 months，the median PFS was 86.0 months，and the median OS was 90.0 months. The 2-year PFS and OS were 65.4% and 73.1% respectively. The 5-year PFS and OS were 54.2% and 56.5% respectively. The Kaplan-Meier survival analysis showed that there were no significant differences in PFS（ P = 0.777）and OS（ P = 0.585）between the radical cystectomy group and the bladder-preserving group. Female（ P = 0.011），BMI < 25 kg/m2（ P = 0.038），and positive surgical margins（ P < 0.01）were associated with poorer PFS. Aged ≥ 70 years（ P = 0.003），lymph node metastasis（ P = 0.041），and positive surgical margins（ P = 0.025）were associated with poorer OS，and patients in the adjuvant therapy group had better OS（ P = 0.005）. Multivariate Cox regression analysis indicated that positive surgical margins（HR 10.2， P = 0.012）were an independent impact factor for PFS，and positive surgical margins（HR 39.8， P = 0.001）and adjuvant therapy（HR 0.12， P = 0.021）were independent impact factors for OS. Conclusions:Positive surgical margins and adjuvant therapy are independent impact factors for the prognosis of patients with primary ACB.

【Objective】 To investigate the protective effects of aflexible sleeve penile protection device on reducing postoperative pain and wound edema in patients after circumcision. 【Methods】 A total of 54 patients who underwent circumcision at Yan’an Branch of Peking University Third Hospital during Feb.1 and May 31, 2023 were enrolled.The patients were randomly divided into the experimental group and control group, with 27 patients in either groups.Patients in the experimental group were treated with a flexible sleeve penis protection device after surgery, and patients in the control group were treated with traditional gauze bandage after surgery.Postoperative pain, wound edema and complications were compared between the two groups. 【Results】 In terms of pain, the visual analogue scale of the experimental group was significantly lower at 6 hours [(1.7±0.9) vs.(3.3±1.9), P<0.001] and 2 days [(2.0±1.3) vs.(3.3±1.3), P<0.001] after surgery than that of the control group, but there were no statistically significant differences between the two groups on the 4th and 7th postoperative days (P>0.05).In terms of edema, the edema score of the experimental group was significantly lower than that of the control group on the 2nd postoperative day [(2.0±1.0) vs.(4.0±0.8), P<0.001] , the 4th postoperative day [(1.5±1.2) vs.(2.6±0.9), P<0.001] , and the 7th postoperative day [(0.9±1.3) vs.(2.3±1.5), P<0.001] .There was no statistically significant difference in the incidence of complications between the two groups (P>0.05). 【Conclusion】 The flexible sleeve penile protection device has significant effects of reducing early postoperative pain and reducing edema in patients undergoing circumcision.