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 design a performance testing platform to evaluate the working status and performance characteristics of the ventilator proportional solenoid valve.Methods The performance testing platform had its hardware including a high-pressure gas source,a pressure regulating valve,sensors and etc,and its software designed based on PyQt5 and composed of several modules for data acquisition,parameter setting,image display,indicator computation,result output and etc.Two kinds of proportional solenoid valves(Valve 1、Valve2)were selected for static and dynamic tests to verify the performance of the platform.Results The platform developed facilitated the proportional solenoid valve to carry out accurate computation of static and dynamic indicators at real time and time domain and waveform feature extraction of sensor data by precision control and data acquisition for the proportional solenoid valve.Static tests showed that Valve 1 gained advantages over Valve 2 in static flow characteristics involving in lowered repeatability,return error and offset while enhanced stability;dynamic tests indicated Valve 2 had rapid flow variations and significant flow fluctuation impacts,Valve 1 showed smooth dynamic response changes,and Valve 2 behaved better than Valve 1 in dynamic performance.Conclusion The testing platform developed comprehensively demonstrates the performance characteristics and working performance of the ventilator proportional solenoid valve,which is of great significance to enhance the reliability and safety of the ventilator.[Chinese Medical Equipment Journal,2025,46(1):13-19]

Aim To evaluate the bioequivalence of two oral preparations of rivaroxaban tablets(test preparation T and refe-rence preparation R)in fasting/postprandibular state in healthy Chinese subjects.Methods A randomized,open,single-dose,four-cycle,completely repeated crossover experiment was used in this study.A total of 70 healthy male and female subjects were enrolled,including 38 subjects in the fasting group and 32 sub-jects in the postprandial group.Rivaroxaban tablets(2.5 mg/tablet)were taken orally once per cycle and their reference preparations were tested.The plasma rivaroxaban concentration was determined by LC-MS/MS method.The pharmacokinetic parameters of rivaroxaban tablets were calculated by WinNonlin software,and the parameters were analyzed and processed.Re-sults The PK parameters of rivaroxaban tablets and reference preparations in fasting group were as follows:Cmax was(72.48±17.08)and(66.36±15.64)μg·L-1,respectively.AUC0-t were(383.49±101.06)and(370.43±102.16)h·ng·mL-1,and AUC0-inr were(389.58±102.28)and(375.84±103.01)h·μg·L-,respectively.Main PK parameters of subjects taking rivaroxaban tablets orally after meals:Cmax were(66.48±15.64 and 60.87±13.44)μg·L-1,AUC0-t were(404.44±72.58)and(381.80±79.93)h·μg·L-1,re-spectively.AUC0_inf was(410.88±73.55)and(393.64±69.71)h·μg·L-1,respectively.Under fasting and postmeal conditions,subjects took rivaroxaban test and reference prepara-tion orally,one tablet(2.5 mg/tablet)each time.The geometric mean of the main pharmacokinetic parameters of rivaroxaban in plasma(Cmax,AUC0-t,AUC0-inf)and their corresponding values had a 90％confidence interval ranging from 80.00％to 125.00％.No serious adverse events or unexpected adverse e-vents occurred in both groups.Conclusion Rivaroxaban tablets are bioequivalent and safe in vivo under fasting and postprandial conditions.

Aim To evaluate the bioequivalence of two oral preparations of rivaroxaban tablets(test preparation T and refe-rence preparation R)in fasting/postprandibular state in healthy Chinese subjects.Methods A randomized,open,single-dose,four-cycle,completely repeated crossover experiment was used in this study.A total of 70 healthy male and female subjects were enrolled,including 38 subjects in the fasting group and 32 sub-jects in the postprandial group.Rivaroxaban tablets(2.5 mg/tablet)were taken orally once per cycle and their reference preparations were tested.The plasma rivaroxaban concentration was determined by LC-MS/MS method.The pharmacokinetic parameters of rivaroxaban tablets were calculated by WinNonlin software,and the parameters were analyzed and processed.Re-sults The PK parameters of rivaroxaban tablets and reference preparations in fasting group were as follows:Cmax was(72.48±17.08)and(66.36±15.64)μg·L-1,respectively.AUC0-t were(383.49±101.06)and(370.43±102.16)h·ng·mL-1,and AUC0-inr were(389.58±102.28)and(375.84±103.01)h·μg·L-,respectively.Main PK parameters of subjects taking rivaroxaban tablets orally after meals:Cmax were(66.48±15.64 and 60.87±13.44)μg·L-1,AUC0-t were(404.44±72.58)and(381.80±79.93)h·μg·L-1,re-spectively.AUC0_inf was(410.88±73.55)and(393.64±69.71)h·μg·L-1,respectively.Under fasting and postmeal conditions,subjects took rivaroxaban test and reference prepara-tion orally,one tablet(2.5 mg/tablet)each time.The geometric mean of the main pharmacokinetic parameters of rivaroxaban in plasma(Cmax,AUC0-t,AUC0-inf)and their corresponding values had a 90％confidence interval ranging from 80.00％to 125.00％.No serious adverse events or unexpected adverse e-vents occurred in both groups.Conclusion Rivaroxaban tablets are bioequivalent and safe in vivo under fasting and postprandial conditions.

Diabetic nephropathy(DN)is a serious complication of diabetes mellitus and a leading cause of end-stage renal diseases.In DN patients,key pathological mechanisms include proteinuria,glomerulo-sclerosis,and fibrosis,largely driven by poor glycemic control and oxidative stress caused by prolonged hyperglycemia.This stress damages renal podocytes and triggers inflammatory mesenchymal infiltration of renal tubular cells,exacerbating the progression of proteinuria and fibrosis.Human umbilical cord-de-rived mesenchymal stem cells(hUC-MSCs)offer promising potential for treating DN due to their strong anti-oxidative properties.In this study,we developed a DN mouse model and treated the mouse via tail vein injections of hUC-MSCs(1×106 cells/mouse).The results indicated that hUC-MSCs significantly lowered fasting blood glucose levels(22.5±3.0 vs 14.7±1.1,P＜0.01)and improved glucose toler-ance,as shown by intraperitoneal glucose tolerance test(IPGTT)results(P＜0.05).Additionally,the renal function improved in hUC-MSCs-treated mice,with marked reductions in oxidative stress markers,including blood urea nitrogen(BUN),urinary creatinine(Ucr),urinary protein(PRO),superoxide dismutase(SOD),and malondialdehyde(MDA)(P＜0.05).Histological analyses through hematoxy-lin-eosin(H&E),Periodic Acid-Schiff(PAS),and Sirius red staining demonstrated alleviation of glo-merular mesangial hyperplasia,glomerular hypertrophy,and tubular inflammation.Furthermore,hUC-MSCs treatment downregulated the expression of oxidative stress-related proteins,such as NADPH oxi-dase 4(NOX4)and thioredoxin-interacting protein(TXNIP),and reduced reactive oxygen species(ROS)production(P＜0.05).Meanwhile,human renal cortical proximal tubule epithelial cells(HK-2 cells)were selected for validation in vitro experiments using high glucose treatment followed by super-natants of hUC-MSCs(MSC-CM),and Western blotting showed that the expression of both NOX4 and TXNIP was inhibited(P＜0.05)and ROS expression was reduced.In conclusion,hUC-MSC treatment effectively lowered blood glucose levels and improved renal function in DN mice,likely through the sup-pression of NOX4 expression and TXNIP-mediated oxidative stress.

This study aims to explore the scientific connotation of sinking Rehmanniae Radix has the best quality and compare the quality between floating and sinking fresh Rehmanniae Radix samples. Ultra-performance liquid chromatography tandem quadrupole electrostatic field Orbitrap high-resolution mass spectrometry(UHPLC-Q-Orbitrap HRMS) was employed to detect the chemical components in floating and sinking fresh Rehmanniae Radix samples. The fingerprint of fresh Rehmanniae Radix was established by high performance liquid chromatography(HPLC), and four index components were determined simultaneously. The cluster analysis, principal component analysis(PCA), and orthogonal partial least squares-discriminant analysis(OPLS-DA) were conducted to compare the quality of floating and sinking fresh Rehmanniae Radix samples. An evaporative light-scattering detector was used to compare the content of five sugars. The extract yield and drying rate were determined, and the quality connotation of sinking Rehmanniae Radix has the best quality was explained by multiple indicators. A total of 41 components were preliminarily identified from fresh Rehmanniae Radix by UHPLC-Q-Orbitrap HRMS, including 7 iridoid glycosides, 9 phenylethanol glycosides, 6 amino acids, 4 sugars, 3 phenolic acids, 5 nucleosides, 3 organic acids, 1 ionone, 1 furan, 1 coumarin, and 1 phenylpropanoid. The results showed that the main chemical components were consistent between floating and sinking fresh Rehmanniae Radix. Nine common peaks were identified in the fingerprints of 15 batches of floating and sinking fresh Rehmanniae Radix samples, and the similarity of fingerprints was greater than 0.9. The cluster analysis, PCA, and OPLS-DA classified floating and sinking fresh Rehmanniae Radix sasmples into two categories, indicating differences in the quality between them. The total content of catalpol, rehmannioside D, ajugol, and verbascoside in sinking fresh Rehmanniae Radix samples was higher than that in floating samples of the same batch and specification, and the main differential component was catalpol. The total content of fructose, glucose, sucrose, raffinose, and stachyose in sinking fresh Rehmanniae Radix samples was higher than that in floating samples of the same batch and specification, and the main differential component was stachyose. The extract yield and drying rate of the sinking samples were higher than those of floating samples. This study preliminarily showed that floating and sinking fresh Rehmanniae Radix samples had the same components but great differences in the content of medicinal substance basis. The total content of four glycosides and five sugars, extract yield, and drying rate of sinking fresh Rehmanniae Radix samples is higher than that of floating samples of the same batch and specification. These findings, to a certain extent, explains the scientificity of sinking Rehmanniae Radix has the best quality recorded in ancient books and provide a reference for the quality control and clinical application of fresh Rehmanniae Radix.
Chromatography, High Pressure Liquid/methods* ; Drugs, Chinese Herbal/chemistry* ; Rehmannia/chemistry* ; Chemometrics ; Mass Spectrometry/methods* ; Quality Control ; Principal Component Analysis ; Plant Extracts

Glucocorticoid-induced osteoporosis(GIOP) is a serious metabolic bone disease caused by long-term application of glucocorticoids(GCs). Traditional Chinese medicine(TCM) has unique advantages in improving bone microstructure and antagonizing hormone toxicity. This paper systematically reviews the theoretical research, clinical application, and basic research progress of TCM intervention in GIOP. In terms of theoretical research, the theory of "kidney governing bone and generating marrow" indicates that the kidney is closely related to bone development, revealing that core pathogenesis of GIOP is Yin-Yang disharmony, which can be discussed using the theories of "Yin fire", "ministerial fire", and "Yang pathogen damaging Yin". Thus, regulating Yin and Yang is the basic principle to treat GIOP. In terms of clinical application, effective empirical prescriptions(such as Bushen Zhuanggu Decoction, Bushen Jiangu Decoction, and Zibu Ganshen Formula) and Chinese patent medicines(Gushukang Capsules, Hugu Capsules, Xianling Gubao Capsules, etc.) can effectively increase bone mineral density(BMD) and improve calcium and phosphorus metabolism. The combination of traditional Chinese and western medicine can reduce the risk of fracture and play an anti-GIOP role. In terms of basic research, it has been clarified that active ingredients of TCM(such as fraxetin, ginsenoside Rg_1, and salidroside) reduce bone loss and promote bone formation by inhibiting oxidative stress, ferroptosis, and other pathways, effectively improving bone homeostasis. Additionally, classical prescriptions(Modified Yiguan Decoction, Modified Qing'e Pills, Zuogui Pills, etc.) and Chinese patent medicines(Gushukang Granules, Lurong Jiangu Dropping Pills, Gubao Capsules, etc.) can improve bone marrow microcirculation, promote osteoblast differentiation, and inhibit bone cell apoptosis through multiple pathways, multiple targets, and multiple mechanisms. Through the above three aspects, the TCM research status on GIOP is elucidated in the expectation of providing reference for its diagnosis and treatment using traditional Chinese and western medicine treatment programs.
Osteoporosis/physiopathology* ; Humans ; Glucocorticoids/adverse effects* ; Drugs, Chinese Herbal/administration & dosage* ; Animals ; Medicine, Chinese Traditional ; Bone Density/drug effects*

Inflammatory diseases (IDs) are a general term of diseases characterized by chronic inflammation as the primary pathogenetic mechanism, which seriously affect the quality of patient′s life and cause significant social and medical burden. Current drugs for IDs include nonsteroidal anti-inflammatory drugs, corticosteroids, immunomodulators, biologics, and antioxidants, but these drugs may cause gastrointestinal side effects, induce or worsen infections, and cause non-response or intolerance. Given the outstanding performance of metal polyphenol network (MPN) in the fields of drug delivery, biomedical imaging, and catalytic therapy, its application in the diagnosis and treatment of IDs has attracted much attention and significant progress has been made. In this paper, we first provide an overview of the types of IDs and their generating mechanisms, then sort out and summarize the different forms of MPN in recent years, and finally discuss in detail the characteristics of MPN and their latest research progress in the diagnosis and treatment of IDs. This research may provide useful references for scientific research and clinical practice in the related fields.

BACKGROUND: Blood glucose and serum albumin have been associated with cardiovascular disease prognosis, but the impact of admission-blood-glucose-to-albumin ratio (AAR) on adverse outcomes in critical ill coronary artery disease (CAD) patients was not investigated. METHODS: Patients diagnosed with CAD were non-consecutively selected from the MIMIC-IV database and categorized into quartiles based on their AAR. The primary outcome was 1-year mortality, and secondary endpoints were in-hospital mortality, acute kidney injury (AKI), and renal replacement therapy (RRT). A restricted cubic splines model and Cox proportional hazard models assessed the association between AAR and adverse outcomes in CAD patients. Kaplan-Meier survival analysis determined differences in endpoints across subgroups. RESULTS: A total of 8360 patients were included. There were 726 patients (8.7%) died in the hospital and 1944 patients (23%) died at 1 year. The incidence of AKI and RRT was 63% and 4.3%, respectively. High AAR was markedly associated with in-hospital mortality (HR = 1.587, P = 0.003), 1-year mortality (HR = 1.502, P < 0.001), AKI incidence (HR = 1.579, P < 0.001), and RRT (HR = 1.640, P < 0.016) in CAD patients in the completely adjusted Cox proportional hazard model. Kaplan-Meier survival analysis noted substantial differences in all endpoints based on AAR quartiles. Stratified analysis and interaction test demonstrated stable correlations between AAR and outcomes. CONCLUSIONS The results highlight that AAR may be a potential indicator for assessing in-hospital mortality, 1-year mortality, and adverse renal prognosis in critical CAD patients.

Objective:This study aims to explore the predictive value of the ratio of caliceal pelvic height to infundibular length（CPH/IL）for the stone-free rate（SFR）in the treatment of lower calyx stones using flexible ureteroscopic lithotripsy（FURL）combined with a distally bendable negative pressure suction sheath.Methods:A retrospective analysis was conducted on the clinical data and anatomical parameters of 312 patients with lower calyx stones or combined lower calyx stones admitted to the Third Xiangya Hospital of Central South University from September 2022 to December 2023，all of whom were treated with FURL combined with a distally bendable negative pressure suction sheath. Stone clearance was defined as no residual stones or residual stones with a diameter of ≤3 mm without any symptoms. Patients were divided into the clearance group（265 cases，84.90%）and the non-clearance group（47 cases，15.10%）. There were no significant differences in gender（male/female：173/92 cases vs. 29/18 cases），age［（44.69 ± 13.14）years vs.（42.60 ± 10.93）years］，degree of hydronephrosis（no hydronephrosis/mild hydronephrosis/moderate to severe hydronephrosis：122/85/58 cases vs. 21/12/14 cases），side of lower calyx stones（left/right：157/108 cases vs. 31/16 cases），maximum diameter of stones（MDS）［（19.23 ± 6.41）mm vs.（17.77 ± 6.18）mm］，and CT value of stones［（993.46 ± 249.12）Hu vs.（1013.43 ± 300.90）Hu］between the two groups（ P > 0.05），indicating comparability between groups. There was no significant difference in the distance from the midpoint of the lower lip of the renal pelvis to the ureter at the lowest plane of the lower calyx（K-A line）between the clearance and non-clearance groups［（26.16 ± 5.18）mm vs.（25.70 ± 8.66）mm， P > 0.05］. However，significant differences were observed in the infundibulopelvic angle（IPA）［（53.97 ± 15.72）° vs.（37.43 ± 15.39）°］，infundibular length（IL）［（27.26 ± 5.11）mm vs.（33.04 ± 7.38）mm］，infundibular width（IW）［（8.27 ± 2.82）mm vs.（7.09 ± 3.20）mm］，caliceal pelvic height（CPH）［（19.96 ± 4.63）mm vs.（30.32 ± 7.56）mm］，ureter-lower calyx distance（ULD）［（23.00 ± 5.59）mm vs.（18.78 ± 6.31）mm］，CPH/IL ratio［（0.73 ± 0.11）vs.（0.92 ± 0.09）］，and curvature of the lower calyx of the renal pelvis［（0.06 ± 0.01）mm -1 vs.（0.08 ± 0.03）mm -1］between the two groups（ P <0.05）. Univariate and logistic multivariate regression analyses were used to identify the independent risk factors affecting the postoperative SFR of FURL-treated lower calyx stones and to assess the value of CPH/IL for SFR in the treatment of lower calyx stones using FURL combined with a distally bendable negative pressure suction sheath. A logistic multivariate regression model and a corresponding nomogram were constructed，and the predictive ability of the model for SFR was evaluated using the receiver operating characteristic（ROC）curve. The calibration curve and the Hosmer -Lemeshow test were used to assess the consistency and accuracy of the model. The clinical utility of the model was evaluated using decision curve analysis（DCA）. Results:Univariate analysis revealed that seven anatomical parameters differed significantly between the clearance and non-clearance groups（all P < 0.05）：infundibulopelvic angle（IPA， OR = 0.27，95% CI 0.17-0.42， P < 0.01），infundibular length（IL， OR = 2.52，95% CI 1.83-3.47， P < 0.01），infundibular width（IW， OR = 0.64，95% CI 0.45-0.90， P = 0.011），caliceal pelvic height（CPH， OR = 5.78，95% CI 3.67-9.10， P < 0.01），ureter-lower calyx distance（ULD， OR = 0.43，95% CI 0.30-0.63， P < 0.01），CPH/IL ratio（ OR = 13.62，95% CI 6.86-27.03， P < 0.01），and curvature of the lower calyx of the renal pelvis（ O = 3.15，95% CI 2.08-4.78， P < 0.01）. Multivariate logistic regression further identified CPH/IL（ OR = 9.87，95% CI 4.92-19.79， P < 0.01），IPA（ OR = 0.41，95% CI 0.23-0.71， P = 0.001），and ULD（ OR = 0.50，95% CI 0.29-0.87， P = 0.014）as independent risk factors influencing the stone-free rate after flexible ureteroscopic lithotripsy combined with a distally bendable negative-pressure suction sheath. The area under the ROC curve（AUC）of the univariate regression model showed that for IPA，the AUC was 0.788（95% CI 0.711-0.864）；for IL，it was 0.731（95% CI 0.643-0.819）；for ULD，it was 0.677（95% CI 0.586-0.767）；for CPH，it was 0.867（95% CI 0.804-0.929）；for IW，it was 0.628（95% CI 0.535-0.721）；for CPH/IL，it was 0.906（95% CI 0.850-0.961）with an optimal cutoff value of 0.882，corresponding to a sensitivity of 83.02% and a specificity of 92.08%；and for curvature of the lower calyx of the renal pelvis，it was 0.744（95% CI 0.662-0.827）. The AUC of the multivariate regression model was 0.929（95% CI 0.884-0.974）with an optimal cutoff value of 0.364，corresponding to a sensitivity of 82.98% and a specificity of 95.09%. Calibration curves demonstrated close agreement between the predicted and actual stone-free rates after FURL（C-index = 0.921）. The Hosmer-Lemeshow goodness-of-fit test indicated no significant discrepancy between predicted and observed probabilities（ P = 0.135，>0.05）. Decision-curve analysis further revealed that basing clinical decisions on the model ，s predicted probability yields a higher net clinical benefit than either withholding FURL for all patients or treating all patients regardless of risk，and it also outperforms strategies guided by any single independent predictor alone. Conclusions:IPA，IL，IW，CPH，ULD，CPH/IL ratio，and curvature of the lower calyx of the renal pelvis can all predict the postoperative SFR of FURL combined with a distally bendable negative pressure suction sheath for the treatment of lower calyx stones to varying degrees. Among them，CPH/IL has the highest predictive value. When CPH/IL >0.88，it may be difficult to use FURL to treat lower calyx stones.