Background: Adrenocortical hormones, particularly 11-oxygenated androgens, are pivotal in female reproductive health and fertility. Standardized detection kits and population-specific reference intervals are lacking in China, hindering related clinical applications. Methods: A HPLC-tandem mass spectrometry (HPLC-MS/MS) pipeline was developed, rigorously validated, and applied to simultaneously quantify corticosterone, cortisone, cortisol, 18-OH cortisol, androstenedione (A4), 11β-hydroxyandrostenedione (11-OH A4), dehydroepiandrosterone, and dehydroepiandrosterone sulfate in serum samples from 455 reproductive-aged women (18–45 yrs) in Guangxi, China. Age-dependent concentration trends were analyzed, and reference intervals stratified by age (2.5th to 97.5th percentiles) were established. Correlations with body-composition metrics, ethnicity, and the menstrual cycle were investigated. Results: The HPLC-MS/MS method demonstrated high precision (intra- and inter-assay CVs < 15%), accuracy, and sensitivity. All eight hormones exhibited significant age-related declines (P < 0.001 for seven hormones; P = 0.001 for 11-OH A4). Notably, 11-OH A4 levels were significantly lower in the 35–45-yr (3.05 nmol/L) and 25–34-yr (3.09 nmol/L) age groups than in the 18–24-yr (3.57 nmol/L) age group, whereas no significant difference was observed between the 35–45-yr and 25–34-yr age groups. Weak negative correlations were observed between the body mass index and corticosterone and cortisone levels, whereas ethnicity and the menstrual cycle showed no significant associations with hormone levels. Conclusions We developed an HPLC-MS/MS-based method for simultaneously quantifying eight adrenocortical hormones, including 11-OH A4, and defined age-specific reference intervals for reproductive-aged Chinese women. These findings advance the clinical utility of adrenocortical hormones in diagnosing and managing reproductive disorders.

Objective To explore the safety and feasibility of 5G remote robot-assisted thoracoscopic anatomic lobectomy and segmentectomy. Methods A retrospective analysis was conducted on patients who underwent 5G remote robot-assisted thoracoscopic anatomic lobectomy or segmentectomy between July and September 2024. The surgeries were performed collaboratively by Shanghai Chest Hospital, Affiliated Hospital of Yangzhou University, and The First Affiliated Hospital of Nanchang University. Perioperative outcomes were recorded and analyzed. Results Ten patients were included, comprising 4 anatomic lobectomies and 6 segmentectomies. The median age was 61.0 (56.0, 72.0) years. The median intraoperative bi-directional network latency was 52.5 (39.0, 54.0) ms. There were no instances of network interruption, robot-related adverse events, or conversions to open thoracotomy. The median postoperative chest tube drainage volume was 500.0 (375.0, 600.0) mL, and the median hospital stay was 5.5 (4.0, 6.0) days. No complications of Clavien-Dindo grade Ⅱor higher occurred. All patients were recurrence-free and alive during the 6-month postoperative follow-up period. Conclusion 5G remote robot-assisted thoracoscopic surgery demonstrates high safety and operational stability. This technology shows promising potential for clinical application and is worthy of further development and utilization.

Objective:To screen inflammatory markers that can be used for the diagnosis and intervention evaluation of patients with chronic kidney disease(CKD)with depression,and to systematically study the therapeutic effect and safety of modified Chaihu Longgu Muli decoction in patients with CKD with depression.Methods:This study was a prospective study,a total of 120 patients with CKD who were diagnosed and treated in the Department of Nephrology,Chongqing Traditional Chinese Medicine Hospital from April 2023 to October 2024 were included.They were divided into CKD with depression(CKD-D)group and CKD without depression(CKD-N)group according to the diagnostic criteria by random number table method.The results of routine laboratory tests were collected,and the severity of depressive disorder was evaluated by Hamilton Depression Rating Scale-17(HAMD-17).The levels of interleukin-18(IL-18),interferon-γ(IFN-γ),β-thromboglobulin(β-TG),platlet factor-4(PF-4),eosinophil chemotactic factor(Eotaxin),soluble tumor necrosis factor receptor-2(sTNFR-2)and CD40 ligand(CD40L)in serum were quantitatively evaluated by liquid chip technology.Pearson correlation analysis was used to analyze the correlation between HAMD-17 scores and inflammatory markers with statistical differences in CKD patients with depression at different stages.The patients in CKD-D group were randomly divided into control group and treatment group.The control group was given basic treatment of CKD,while the treatment group was treated with modified Chaihu Longgu Muli decoction on the basis of the control group.After 8 weeks of continuous intervention,the clinical effective rate,the changes of effective inflammatory markers and the occurrence of adverse reactions were compared between the two groups.Results:In the CKD-D group and the CKD-N group,the difference of HAMD-17 score,serum phosphorus(P),serum creatinine(Scr),estimated glomerular filtration rate(eGFR),albumin(ALB),serum iron(Fe3+),C-reactive protein(CRP),IL-18,IFN-γ,sTNFR-2 indicators were statistically significant(P＜0.05).Multivariate Logistic regression analysis showed that in addition to HAMD-17 score(OR=1.259,P=0.006),SCr(OR=1.748,P=0.003),eGFR(OR=1.354,P=0.005),serum IL-18(OR=0.924,P=0.011)and IFN-γ(OR=0.859,P=0.031)levels were also independent influencing factors for CKD patients with depression.Pearson correlation analysis showed that there was a significant positive correlation between HAMD-17 score and IL-18,IFN-γ,sTNFR-2 and CD40L.The total clinical effective rate of the treatment group was higher than that of the control group,and the serum levels of IL-18 and IFN-γ in the treatment group were lower than those in the control group,the differences were statistically significant(P＜0.05),and no significant difference in the incidence of adverse reactions between the two groups(P＞0.05).Conclusion:IL-18 and IFN-γ can be used as effective serum markers for the diagnosis and treatment of depressive disorders in CKD patients.At the same time,the changes of serum levels of IL-18 and IFN-γ can be used to evaluate the severity of symptoms in CKD patients with depression at different stages to a certain extent.Modified Chaihu Longgu Muli decoction may improve CKD combined with depressive symptoms and improve the quality of life of patients by down-regulating the level of inflammatory factors.

Objective:To explore the application strategies and clinical effects of superior gluteal artery perforator tissue flaps in repairing stage Ⅳ pressure ulcers in the sacrococcygeal region.Methods:This study was a retrospective observational study. From July 2019 to April 2024, 89 patients with stage Ⅳ pressure ulcers in the sacrococcygeal region who met the inclusion criteria were admitted to the First Affiliated Hospital of Nanchang University, including 59 males and 30 females, aged 21 to 84 years. There were 89 sacrococcygeal pressure ulcers, with an area of 5.0 cm×4.0 cm-21.0 cm×21.0 cm after debridement. According to the shape, size, and depth of the wounds after debridement, combined with the elasticity and texture of the skin around the wounds, and the principle of minimizing damage to the donor area, the appropriate forms of superior gluteal artery perforator tissue flaps were cut for wound repair in the following three conditions. (1) For wounds with a round shape, an area of 5.0 cm×5.0 cm-21.0 cm×21.0 cm, and a depth of 1.0-3.5 cm, the superior gluteal artery perforator propeller flap or myocutaneous flap, bilobed superior gluteal artery perforator relay flap, and bilateral superior gluteal artery perforator rotational flap were used. (2) For wounds with an oval shape, an area of 5.0 cm×4.0 cm-18.5 cm×10.5 cm, and a depth of 1.0-3.0 cm, the superior gluteal artery perforator propeller flap or myocutaneous flap, unilateral superior gluteal artery perforator propeller flap combined with contralateral superior gluteal artery perforator V-Y advanced flap or keystone flap were used. (3) For wounds with a fusiformis shape, an area of 7.0 cm×4.0 cm-17.5 cm×6.0 cm, and a depth of 1.5-5.0 cm, the unilateral or bilateral superior gluteal artery perforator V-Y advanced flap, superior gluteal artery perforator keystone flap, or superior gluteal artery perforator keystone flap combined with gluteus maximus muscle flap were used. In this group of patients, a total of 40 superior gluteal artery perforator propeller flaps (with an resection area of 11.0 cm×6.0 cm-17.0 cm×11.0 cm), 22 superior gluteal artery perforator propeller myocutaneous flaps (with an resection area of 10.0 cm×5.0 cm-14.0 cm×8.0 cm), 7 bilobed superior gluteal artery perforator relay flaps (with a main flap resection area of 5.5 cm×5.5 cm-18.0 cm×11.5 cm and a side flap resection area of 4.5 cm×3.0 cm-11.0 cm×6.5 cm), 5 bilateral superior gluteal artery perforator rotational flaps (with a total resection area of 20.0 cm×16.0 cm-26.0 cm×21.0 cm on both sides), 14 superior gluteal artery perforator V-Y advanced flaps (with an resection area of 12.0 cm×10.0 cm-18.0 cm×18.0 cm), 13 superior gluteal artery perforator keystone flaps (with an resection area of 13.0 cm×6.5 cm-19.0 cm×18.0 cm), and 3 gluteus maximus muscle flaps (with an resection area of 8.0 cm×3.0 cm-15.0 cm×4.5 cm). The donor area wounds were all directly sutured. The survival of tissue flaps was observed and the incidence rate of delayed wound healing in the reception area was calculated, and wound healing in the donor area was observed. The appearance and texture of tissue flaps and recurrence of pressure ulcers were followed up.Results:After surgery, all bilateral superior gluteal artery perforator rotational flaps, superior gluteal artery perforator V-Y advanced flaps, superior gluteal artery perforator keystone flaps, and gluteus maximus muscle flaps survived well. There were 6 cases of delayed wound healing in the reception area after surgery, with an incidence rate of 6.7% (6/89). Two patients had incision dehiscence in the donor area wounds due to postoperative bleeding, the wounds healed after debridement, vacuum sealing drainage, and dressing change. The wounds in the donor area of the remaining patients healed well. Six patients were lost to follow-up. Eighty-three patients were followed up for 3-48 months, of whom 4 patients died. Among the remaining 79 patients, 3 cases had pressure ulcers recur due to improper nursing, while the rest of the patients had tissue flaps with good appearance and soft texture and no recurrence of pressure ulcers.Conclusions:Based on the characteristics of wound shape, size, and depth after debridement of stage Ⅳ pressure ulcers in the sacrococcygeal region, individualized selection of flap, myocutaneous flap, or a combination of flap and gluteus maximus muscle flap based on the perforating branch of the superior gluteal artery perforator can achieve good clinical repair results. The postoperative tissue flap survived well, with a good appearance, soft texture, and less recurrence of pressure ulcers.

Objective:To investigate the feasibility and clinical outcomes of using the deep inferior epigastric perforator flap to repair stage Ⅳ pressure ulcers in elderly patients with the femoral trochanter.Methods:Retrospective analysis of clinical data of elderly patients with stage Ⅳ pressure ulcers of the femoral trochanter treated at the Medical Center of Burn Plastic and Wound Repair, the First Affiliated Hospital of Nanchang University from May 2018 to May 2023 using the deep inferior epigastric perforator flap.The deep inferior epigastric perforator flap was designed on the same side of the abdomen based on the preoperative detection of the paraumbilical perforating branch.The axis of the inferior epigastric artery was determined by the line connecting the femoral artery pulsation point at the inguinal ligament and the obvious paraumbilical perforating branch point. The axis of the skin flap was determined by the line connecting the obvious paraumbilical perforating branch point and the subscapular angle. Combined with the situation of the sinus after pressure ulcer debridement and the range of skin and soft tissue defects, the inferior epigastric artery perforating branch skin flap was cut and repaired. The pedicle of the inferior epigastric artery was freed to the required length according to the location of the pressure ulcer, and the wound was transferred and repaired through a subcutaneous tunnel. The donor area was directly pulled and sutured. The survival of the skin flap and the healing of the donor site wound after surgery were observed, and the recurrence of pressure ulcers, the appearance and texture of the skin flap, and the recovery of the donor site were followed up regularly.Results:A total of 11 patients were included, including 7 males and 4 females; age ranged from 66 to 83 years old, with an average of 72.1 years old. There were total of 11 pressure ulcers in the femoral trochanter, with an area of 5.0 cm × 3.0 cm-13.0 cm ×6.0 cm before debridement and an area of 8.0 cm × 5.0 cm-16.0 cm × 8.0 cm after debridement. The deep inferior epigastric perforator flap was used to repair the wound. The flap was cut with an area of 10.0 cm × 6.0 cm-18.0 cm × 9.0 cm, and the length of the blood vessels in the flap pedicle was 12-16 cm, with an average of 14 cm. After surgery, 9 of the 11 flaps survived completely. One skin flap developed purplish discoloration at the distal end 24 hours after surgery, which was relieved by removing the suture at the site with high tension at the wound edge. One skin flap also showed slight necrosis at the distal end. The flap was removed under local anesthesia at the bedside of the ward, and the surgical wound was directly sutured. After dressing change, it healed. The wounds in the donor area all healed well. Follow up for 3-15 months postoperatively, with an average of 11 months, showed no recurrence of pressure ulcers in all patients. The skin flap had a soft texture, and its color and appearance were similar to those of the surrounding skin. No abdominal wall hernia was observed in the inferior epigastric donor area.Conclusion:The deep inferior epigastric perforator flap has a long vascular pedicle, reliable blood supply, sufficient tissue volume for cutting, no recurrence of pressure ulcers after surgery, good appearance and texture of the affected area, and no secondary abdominal wall hernia in the donor site. It is an effective method for repairing stage Ⅳ pressure ulcers of the femoral trochanter in elderly patients.

Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

Objective To evaluate the safety and efficacy of valve-in-valve transcatheter mitral valve replacement(ViV-TMVR)in patients with bioprosthetic valve degeneration who are at high surgical risk.Methods This study is a multi-center,retrospective cohort analysis of 20 consecutive patients who underwent transseptal ViV-TMVR using the Edwards SAPIEN 3 transcatheter heart valve(THV).The primary endpoints include technical success and procedural success,both defined according to the Mitral Valve Academic Research Consortium(MVARC)criteria,as well as mortality and functional change assessed based on New York Heart Association(NYHA)classification at 30-days and six months post-procedure.Clinical follow-up assessments are conducted at 30-days and six months.Results From February 2021 to October 2022,a total of 20 patients with symptoms of bioprosthetic valve degeneration were enrolled across nine sites in China.The patients had a mean age of(73.5±5.5)years,with 85.0％being females and 70.0％classified as NYHA class Ⅲ/Ⅳ.The study achieved a 100.0％technical success rate and a 90.0％procedural success rate finally.All patients remained alive during the 30-day follow-up period.However,six months post-intervention,two patients(10.0％)were re-hospitalized due to heart failure,and sadly,one of them(5.0％)died.None of the patients reported any adverse events related to ViV-TMVR during the follow-up period.Notably,there was a significant improvement in NYHA class compared to baseline(P=0.0004)at six-month follow-ups.Conclusions The transseptal ViV-TMVR technique proved to be highly successful and was associated with significant improvement in NYHA class function.These findings strongly suggest that it serves as a safe and efficient treatment alternative for high-risk patients suffering from bioprosthetic valve degeneration.

Objective To evaluate the safety and efficacy of valve-in-valve transcatheter mitral valve replacement(ViV-TMVR)in patients with bioprosthetic valve degeneration who are at high surgical risk.Methods This study is a multi-center,retrospective cohort analysis of 20 consecutive patients who underwent transseptal ViV-TMVR using the Edwards SAPIEN 3 transcatheter heart valve(THV).The primary endpoints include technical success and procedural success,both defined according to the Mitral Valve Academic Research Consortium(MVARC)criteria,as well as mortality and functional change assessed based on New York Heart Association(NYHA)classification at 30-days and six months post-procedure.Clinical follow-up assessments are conducted at 30-days and six months.Results From February 2021 to October 2022,a total of 20 patients with symptoms of bioprosthetic valve degeneration were enrolled across nine sites in China.The patients had a mean age of(73.5±5.5)years,with 85.0％being females and 70.0％classified as NYHA class Ⅲ/Ⅳ.The study achieved a 100.0％technical success rate and a 90.0％procedural success rate finally.All patients remained alive during the 30-day follow-up period.However,six months post-intervention,two patients(10.0％)were re-hospitalized due to heart failure,and sadly,one of them(5.0％)died.None of the patients reported any adverse events related to ViV-TMVR during the follow-up period.Notably,there was a significant improvement in NYHA class compared to baseline(P=0.0004)at six-month follow-ups.Conclusions The transseptal ViV-TMVR technique proved to be highly successful and was associated with significant improvement in NYHA class function.These findings strongly suggest that it serves as a safe and efficient treatment alternative for high-risk patients suffering from bioprosthetic valve degeneration.

Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

Objective:To screen inflammatory markers that can be used for the diagnosis and intervention evaluation of patients with chronic kidney disease(CKD)with depression,and to systematically study the therapeutic effect and safety of modified Chaihu Longgu Muli decoction in patients with CKD with depression.Methods:This study was a prospective study,a total of 120 patients with CKD who were diagnosed and treated in the Department of Nephrology,Chongqing Traditional Chinese Medicine Hospital from April 2023 to October 2024 were included.They were divided into CKD with depression(CKD-D)group and CKD without depression(CKD-N)group according to the diagnostic criteria by random number table method.The results of routine laboratory tests were collected,and the severity of depressive disorder was evaluated by Hamilton Depression Rating Scale-17(HAMD-17).The levels of interleukin-18(IL-18),interferon-γ(IFN-γ),β-thromboglobulin(β-TG),platlet factor-4(PF-4),eosinophil chemotactic factor(Eotaxin),soluble tumor necrosis factor receptor-2(sTNFR-2)and CD40 ligand(CD40L)in serum were quantitatively evaluated by liquid chip technology.Pearson correlation analysis was used to analyze the correlation between HAMD-17 scores and inflammatory markers with statistical differences in CKD patients with depression at different stages.The patients in CKD-D group were randomly divided into control group and treatment group.The control group was given basic treatment of CKD,while the treatment group was treated with modified Chaihu Longgu Muli decoction on the basis of the control group.After 8 weeks of continuous intervention,the clinical effective rate,the changes of effective inflammatory markers and the occurrence of adverse reactions were compared between the two groups.Results:In the CKD-D group and the CKD-N group,the difference of HAMD-17 score,serum phosphorus(P),serum creatinine(Scr),estimated glomerular filtration rate(eGFR),albumin(ALB),serum iron(Fe3+),C-reactive protein(CRP),IL-18,IFN-γ,sTNFR-2 indicators were statistically significant(P＜0.05).Multivariate Logistic regression analysis showed that in addition to HAMD-17 score(OR=1.259,P=0.006),SCr(OR=1.748,P=0.003),eGFR(OR=1.354,P=0.005),serum IL-18(OR=0.924,P=0.011)and IFN-γ(OR=0.859,P=0.031)levels were also independent influencing factors for CKD patients with depression.Pearson correlation analysis showed that there was a significant positive correlation between HAMD-17 score and IL-18,IFN-γ,sTNFR-2 and CD40L.The total clinical effective rate of the treatment group was higher than that of the control group,and the serum levels of IL-18 and IFN-γ in the treatment group were lower than those in the control group,the differences were statistically significant(P＜0.05),and no significant difference in the incidence of adverse reactions between the two groups(P＞0.05).Conclusion:IL-18 and IFN-γ can be used as effective serum markers for the diagnosis and treatment of depressive disorders in CKD patients.At the same time,the changes of serum levels of IL-18 and IFN-γ can be used to evaluate the severity of symptoms in CKD patients with depression at different stages to a certain extent.Modified Chaihu Longgu Muli decoction may improve CKD combined with depressive symptoms and improve the quality of life of patients by down-regulating the level of inflammatory factors.