Objective To investigate the predictive value of pre-transfer serum fibroblast growth factor 21(FGF-21),anti-Müllerian hormone(AMH),and neuropilin-1(NRP-1)for early pregnancy loss at 6 weeks following in vitro fertilization-embryo transfer(IVF-ET),and to establish an early predictive model based on serum biochemical markers.Methods This prospective study consecutively enrolled 322 women who achieved clinical pregnancy after IVF-ET at our center between September 2022 and September 2024.Participants were randomly divided into a modeling cohort(n=225)and a validation cohort(n=97)at a 7:3 ratio.According to ultrasound findings at 6 weeks of gestation,patients in the modeling cohort were classified into an early pregnancy loss group(n=59)and an ongoing pregnancy group(n=166).Baseline clinical characteristics and pre-transfer serum levels of FGF-21,AMH,and NRP-1 were collected.Multivariate logistic regression was applied to identify inde-pendent risk factors for early pregnancy loss and to construct a predictive model.Model discrimination,calibra-tion,and stability were evaluated using receiver operating characteristic(ROC)curves,the Hosmer-Lemeshow goodness-of-fit test,and bootstrap resampling in both cohorts.Results Univariate analysis revealed that the FSH/LH ratio,antral follicle count,and number of retrieved oocytes were significantly associated with early pregnancy loss(P<0.001).Compared with the ongoing pregnancy group,women with early loss showed significantly elevated pre-transfer serum FGF-21 levels,whereas AMH and NRP-1 levels were markedly reduced(P<0.001).Multivariate logistic regression demonstrated that an FSH/LH ratio<1.8(OR=1.629,P=0.002)and higher FGF-21 levels(OR=1.338,P=0.002)were independent risk factors,while higher AMH(OR=0.741,P=0.010)and NRP-1 levels(OR=0.874,P=0.007)were protective.Stratified analysis indicated that among patients with FSH/LH≥1.8,FGF-21 levels were significantly higher and AMH and NRP-1 levels significantly lower(all P<0.001).Interaction analysis further suggested that the FSH/LH ratio significantly modified the associations between these biomarkers and pregnancy loss risk(P for interaction<0.05).Specifically,in the higher FSH/LH subgroup,the risk effect of FGF-21 was amplified,while the protective effects of AMH and NRP-1 were more pronounced.The combined predictive model achieved C-indices of 0.869(95%CI:0.826～0.926)in the modeling cohort and 0.835(95%CI:0.811～0.907)in the validation cohort.Its AUC for predicting early pregnancy loss was 0.934 in the modeling co-hort and 0.909 in the validation cohort,both significantly outperforming individual markers(AUCs:FGF-21=0.867,AMH=0.881,NRP-1=0.853;Z=2.024,1.831;P<0.001).Decision curve analysis showed that the model provided consistent net clinical benefit across threshold probabilities of 0.1～0.4,underscoring its clinical utility.Conclusions Elevated pre-transfer serum FGF-21 and reduced AMH and NRP-1 levels are strongly associ-ated with early pregnancy loss at 6 weeks after IVF-ET.The predictive model developed in this study demonstrates robust accuracy and stability,offering substantial clinical application value for early risk stratification.

OBJECTIVE To analyze the levels of NOD like receptor thermal protein domain associated protein 3(NLRP3),nuclear factor κB(NF-κB)and Caspase-1 in peripheral blood mononuclear cells in patients with recur-rent spontaneous abortion(RSA)and reproductive tract infection(RTI),and the relationship between above inde-xes and pregnancy outcome.METHODS A total of 136 patients with RSA and RTI who were admitted to Nanyang First People's Hospital from Mar.2021 to Apr.2024 were selected as the study group,70 patients with RSA but without RTI during the same period were selected as the control group,and those patients with RSA and RTI who were pregnant again were divided into the continued pregnancy group and the abortion group based on their preg-nancy outcomes.The levels of NLRP,NF-κB and caspase-1 in peripheral blood mononuclear cells were compared between the study group and the control group,Multivariate logistic regression analysis was used to identify risk factors for adverse pregnancy outcomes in patients with RSA and RTI.Receiver's operating characteristic(ROC)curves were used to evaluate the value of NLRP,NF-κB,and Caspase-1 in peripheral blood mononuclear cells in predicting pregnancy outcomes of patients with RSA and RTI.RESULTS The levels of NLRP,NF-κB and caspase-1 in the study group were(1.93±0.49),(1.82±0.41)and(2.23±0.41)respectively,which were higher than those in the control group(P＜0.05).The proportion of abortion in the study group was 39.79％,which was higher than that in the control group(P=0.036).Pre-pregnancy body mass index(BMI)and the levels of glycated hemoglobin,triacylglycerol,NLRP,NF-κB and Caspase-1 in the abortion group were higher than those in the continued pregnancy group.Multivariate logistic regression analysis showed that NLRP3(OR=4.721,95％CI:1.336-16.680,P=0.016),NF-κB(OR=4.669,95％CI:1.495-14.58,P=0.008),caspase-1(OR=4.358,95％CI:1.260-15.070,P=0.023)and pre-pregnancy BMI(OR=2.927,95％CI:1.280-6.693,P=0.011)were risk factors affecting pregnancy outcomes of patients with RSA and RTI(P＜0.05).ROC curves indicated that the area under the curve(AUC)of NLRP,NF-κB and Caspase-1 for pregnancy outcome in patients with RSA combined with RTI was 0.846,0.885 and 0.938.CONCLUSION The NLRP,NF-κB and Caspase-1 in peripheral blood mononuclear cells is highly expressed in patients with RSA and RTI,and the high expression of the above indicators is closely related to the adverse pregnancy of patients,which can be used as a predictor of pregnancy outcomes in patients with RSA and RTI.

Objective To investigate the predictive value of pre-transfer serum fibroblast growth factor 21(FGF-21),anti-Müllerian hormone(AMH),and neuropilin-1(NRP-1)for early pregnancy loss at 6 weeks following in vitro fertilization-embryo transfer(IVF-ET),and to establish an early predictive model based on serum biochemical markers.Methods This prospective study consecutively enrolled 322 women who achieved clinical pregnancy after IVF-ET at our center between September 2022 and September 2024.Participants were randomly divided into a modeling cohort(n=225)and a validation cohort(n=97)at a 7:3 ratio.According to ultrasound findings at 6 weeks of gestation,patients in the modeling cohort were classified into an early pregnancy loss group(n=59)and an ongoing pregnancy group(n=166).Baseline clinical characteristics and pre-transfer serum levels of FGF-21,AMH,and NRP-1 were collected.Multivariate logistic regression was applied to identify inde-pendent risk factors for early pregnancy loss and to construct a predictive model.Model discrimination,calibra-tion,and stability were evaluated using receiver operating characteristic(ROC)curves,the Hosmer-Lemeshow goodness-of-fit test,and bootstrap resampling in both cohorts.Results Univariate analysis revealed that the FSH/LH ratio,antral follicle count,and number of retrieved oocytes were significantly associated with early pregnancy loss(P<0.001).Compared with the ongoing pregnancy group,women with early loss showed significantly elevated pre-transfer serum FGF-21 levels,whereas AMH and NRP-1 levels were markedly reduced(P<0.001).Multivariate logistic regression demonstrated that an FSH/LH ratio<1.8(OR=1.629,P=0.002)and higher FGF-21 levels(OR=1.338,P=0.002)were independent risk factors,while higher AMH(OR=0.741,P=0.010)and NRP-1 levels(OR=0.874,P=0.007)were protective.Stratified analysis indicated that among patients with FSH/LH≥1.8,FGF-21 levels were significantly higher and AMH and NRP-1 levels significantly lower(all P<0.001).Interaction analysis further suggested that the FSH/LH ratio significantly modified the associations between these biomarkers and pregnancy loss risk(P for interaction<0.05).Specifically,in the higher FSH/LH subgroup,the risk effect of FGF-21 was amplified,while the protective effects of AMH and NRP-1 were more pronounced.The combined predictive model achieved C-indices of 0.869(95%CI:0.826～0.926)in the modeling cohort and 0.835(95%CI:0.811～0.907)in the validation cohort.Its AUC for predicting early pregnancy loss was 0.934 in the modeling co-hort and 0.909 in the validation cohort,both significantly outperforming individual markers(AUCs:FGF-21=0.867,AMH=0.881,NRP-1=0.853;Z=2.024,1.831;P<0.001).Decision curve analysis showed that the model provided consistent net clinical benefit across threshold probabilities of 0.1～0.4,underscoring its clinical utility.Conclusions Elevated pre-transfer serum FGF-21 and reduced AMH and NRP-1 levels are strongly associ-ated with early pregnancy loss at 6 weeks after IVF-ET.The predictive model developed in this study demonstrates robust accuracy and stability,offering substantial clinical application value for early risk stratification.

OBJECTIVE To analyze the levels of NOD like receptor thermal protein domain associated protein 3(NLRP3),nuclear factor κB(NF-κB)and Caspase-1 in peripheral blood mononuclear cells in patients with recur-rent spontaneous abortion(RSA)and reproductive tract infection(RTI),and the relationship between above inde-xes and pregnancy outcome.METHODS A total of 136 patients with RSA and RTI who were admitted to Nanyang First People's Hospital from Mar.2021 to Apr.2024 were selected as the study group,70 patients with RSA but without RTI during the same period were selected as the control group,and those patients with RSA and RTI who were pregnant again were divided into the continued pregnancy group and the abortion group based on their preg-nancy outcomes.The levels of NLRP,NF-κB and caspase-1 in peripheral blood mononuclear cells were compared between the study group and the control group,Multivariate logistic regression analysis was used to identify risk factors for adverse pregnancy outcomes in patients with RSA and RTI.Receiver's operating characteristic(ROC)curves were used to evaluate the value of NLRP,NF-κB,and Caspase-1 in peripheral blood mononuclear cells in predicting pregnancy outcomes of patients with RSA and RTI.RESULTS The levels of NLRP,NF-κB and caspase-1 in the study group were(1.93±0.49),(1.82±0.41)and(2.23±0.41)respectively,which were higher than those in the control group(P＜0.05).The proportion of abortion in the study group was 39.79％,which was higher than that in the control group(P=0.036).Pre-pregnancy body mass index(BMI)and the levels of glycated hemoglobin,triacylglycerol,NLRP,NF-κB and Caspase-1 in the abortion group were higher than those in the continued pregnancy group.Multivariate logistic regression analysis showed that NLRP3(OR=4.721,95％CI:1.336-16.680,P=0.016),NF-κB(OR=4.669,95％CI:1.495-14.58,P=0.008),caspase-1(OR=4.358,95％CI:1.260-15.070,P=0.023)and pre-pregnancy BMI(OR=2.927,95％CI:1.280-6.693,P=0.011)were risk factors affecting pregnancy outcomes of patients with RSA and RTI(P＜0.05).ROC curves indicated that the area under the curve(AUC)of NLRP,NF-κB and Caspase-1 for pregnancy outcome in patients with RSA combined with RTI was 0.846,0.885 and 0.938.CONCLUSION The NLRP,NF-κB and Caspase-1 in peripheral blood mononuclear cells is highly expressed in patients with RSA and RTI,and the high expression of the above indicators is closely related to the adverse pregnancy of patients,which can be used as a predictor of pregnancy outcomes in patients with RSA and RTI.

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Objective To discuss the tympanic membrane puncture or tympanostomy tube under endotoscope combined with adenoidectomy under nasal endoscopy on the influence of invalid conservative treatment of pediatric secretory otitis media.Methods A total of 112 cases of secretory otitis media with invalid conservative treatment were selected in the department of otorhinolaryngology of children′s hospital of Nanjing Medical University from July 2013 to August 2015.They were divided into three groups,the group A of 38 cases(68 ears)underwent transnasal endoscopic pure adenoidectomy;the group B of 37 cases(60 ears)underwent transnasal endoscopic adenoidectomy combined with tympanocentesis;the group C of 37 cases(59 ears)underwent tympanostomy tube insertion.The clinical treatment effect,the period of middle ear effusion,postoperative recurrence and complication were observed and compared.Results The total effective rate of the 3 groups was improved after 3 months(P<0.05);the total effective rate in group B and group C at one week and 3 months after operation were higher than those of group A(P<0.05);and the total effective rate in group C at 3 months after operation was significantly higher than that of group B(P<0.05).The level of auditory brainstem evoked potential(ABR)and the latency of ABR wave Ⅰ latency were decreased at 1 year after operation(P<0.05);the ABR changes in group B and group C at 1 week and 1 year after operation were lower than those in group A(P<0.05).The incidence of recurrence rate and the period of middle ear effusion in group C were lower than those in group A and B(P<0.05).The incidence of complication of group A was lower than those of group B and group C(P<0.05).Conclusion Using tympanostomy tube combined with adenoidectomy under endoscope can improve the children with hearing,which not only can shorten the time of the middle ear effusion,but also effectively reduce the recurrence rate.

The results of different interventions administered in 118 cases with impaired fasting glucose (IFG) for 3 years were investigated. The rates of transformation of IFG to diabetes mellitus in metformin treatment groups and rosiglitazone treatment groups were significantly lower than that in life style intervention group. This study suggested that metformin or rosiglitazone treatment could effectively reduce transformation of IFG to diabetes as compared with life style intervention.

Objective To develop and evaluate a porcine model for training the single needle running suture method of laparoscopie urethrovesical anastomosis(LUA). Methods Twenty minipigs with mean weight of 30kg were general anaesthetized with Sumianxin solution 0. 1 ml/kg intramuscularly. Pneumoperitoneum was created by insufflation of carbon dioxide by a veress needle inserted through the umbilicus. One 10mm port and two 5mm ports were positioned after the establishment of pneumoperitoneum. The intestine was used as "bladder". The procedures were completed with the single needle running suture method of laparoscopic urethrovesical anastomosis. Six trainees performed the LUA procedure based on the models during a laparoscopic training course, following the technique used in the operation room. The learning curve was analyzed by operative time. Results The porcine model for laparoscopic training was established successfully and 3 LUAs could be performed on each pig. Each trainee performed 10 LUAs based on the models during the training course of laparoscopic urology. The operative time declined from (55.3±10. 4)min initially to (22.4±4.8)min (P＜0. 01) after the training course. At the end of training, all trainees could accomplish a watertight LUR procedure on the model. Conclusions The establishment of the training model is feasible. The trainees could acquire the skills necessary to perform LUA in vivo based on this model. The model provides a platform for training the basic techniques of LUA procedures.

Objective To describe the single needle running suture method for the urethrovesi-cal anastomosis during laparoscopic radical prostatectomy(LRP). Methods Forty-five patients of prostate cancer underwent LRP with the single needle running suture method. The technique was initi-ated by performing a fixing suture at the posterior lip of bladder neck at 4 o' clock and tying the first knot. Another suture at the nearby position of the first suture was performed to leave the first knot outside. From 5 o' clock to 8 o' clock, sutures were performed every one o' clock to secure posterior approximation, then every two o'clock a suture. To avoid a loose anastomosis, lock sutures were per-formed every 3 sutures. After completing the full circumference, the needle was drawn at the 2 o' clock for the second knot. The needle was always driven full-thickness outside-in in the bladder neck and inside-out on the urethra. Any remaining leakage could be closed with additional interrupted su-tures. Results All urethrovesical anastomosis were completed successfully. The mean anastomosis time was 16 rain(from 12 to 25 min), and mean operative time was 132 rain (112 to 185 rain). The mean catheterization time was 9 d(7 to 14 d). Three temporal urinary leaks requiring prolonged cathe-terization were identified. Forty-four patients had total urinary control in 1 year postoperatively and no other short-term or persistent complication was found with a mean follow-up of 21 months. Conclu- sion The single needle running suture method could be a simple and safe method for urethrovesical anastomosis during LRP.

Objective To develop a staged laparoscopic training program for performing the ana-tomic retroperitoneoscopic adrenalectomy(ARA), and to determine its safety and feasibility. Me-thods Five young urological doctors without previous experience in open adrenalectomy were selected third period, trainees acted as camera holder first, then performed simple operations such as laparo-scopic renal cyst unroofing. Finally, they performed 30 ARA independently under the mentor's super-vision. Pheochromocytoma was ruled out for its large tumor size and potential cardiovascular risk. The patient selection criteria were the same as those of the initial 30 cases performed by the tutor. Preope-rative data of the initial 30 ARA performed by each trainee and tutor which included gender, age, body mass index, tumor size, tumor location and pathological diagnosis of tumor were compared between trainees and the tutor. The intraoperative and postoperative data of 150 ARA in the trainees were compared with the initial 30 ARA of the tutor. These included mean operative time, estimated blood loss, length of hospital stay, conversion rate, complication rate. Qualitative and quantitative data were compared between the groups using x2 and t test statistics methods by SPSS 12.0 for Windows, except operative time, which was from a nonnormal distribution. A P value less than 0.05 was consi-dered to be statistically significant. Results Preoperative data of the initial 30 ARA performed by each trainee were marched to those of the mentor (all P>0.05). All ARA were completed successful-ly. No procedure converted to open surgery. The median operative time of the trainees was 82 min (range 59-133 min), which was less than that of the tutor [132 min (range 73-230 min), P< 0.01]. And the trainees' learning curve was flatter than their tutor's. Estimated blood loss and length of hospital stay for the 5 trainees and the tutor were 62.2±22.0 ml, 4.8±1.3 d and 63.9±21.1 ml, 4.5±1.4 d respectively. There was no significant difference between these results (both P>0.05). No major complication was observed. Though the total perioperative complication rates were no diffe-rence between the trainees and their tutor (8.0% versus 13.3%, P>0.05), intraoperative minor complication rates of the trainees (1.3%) was less than that of the tutor (10.0%, P<0.05). Con-clusion The staged laparoscopic training is safe and feasible for young urological doctor to study in performing ARA.