ObjectiveTo evaluate the effects and safety of the optimized new Shengmai Powder （优化新生脉散方） on exercise tolerance in patients with chronic heart failure （CHF） of qi deficiency， blood stasis， and fluid retention syndrome. MethodsA randomized， double-blind， placebo-controlled trial was conducted. A total of 78 CHF patients with qi deficiency， blood stasis， and fluid retention syndrome were recruited and randomly assigned to a treatment group （39 cases） and a control group （39 cases）. On the basis of conventional western medical therapy， patients in the treatment group additionally received the optimized new Shengmai Powder granules， while the control group was given an oral placebo of optimized new Shengmai Powder granules. Patients in both groups took 30.6 g each time， twice a day， mixed with water for administration， with a total treatment course of 4 weeks. The primary outcomes were 6-minute walk distance （6MWD） and peak oxygen uptake （Peak VO₂） measured by cardiopulmonary exercise testing. Secondary outcomes included New York Heart Association （NYHA） functional classification， B-type natriuretic peptide （BNP） levels， cardiac function indexes including left ventricular ejection fraction （LVEF）， left ventri-cular end-systolic diameter （LVESD） and left ventricular end-diastolic diameter （LVEDD）， Minnesota Living with Heart Failure Questionnaire （MLHFQ） scores， and scores of four diagnostic information of traditional Chinese medicine （TCM）. All indicators were assessed once before and after treatment respectively. Safety indicators were evaluated， and adverse events during the trial were recorded. ResultsAll patients in both groups were included in the full ana-lysis set （FAS） and safety set （SS）. Compared with baseline， the 6MWD and Peak VO₂ of cardiopulmonary exercise test in the treatment group significantly increased after treatment， while the MLHFQ scores， serum BNP levels and scores of TCM four diagnostic information significantly decreased， and the NYHA cardiac function grade significantly improved （P＜0.01）. After treatment， the 6MWD and Peak VO₂ of cardiopulmonary exercise test， as well as their changes from baseline in the treatment group were higher than those in the control group； the MLHFQ scores， serum BNP levels and scores of TCM four diagnostic information in the treatment group were lower than those in the control group； and the improvement of NYHA cardiac function grade in the treatment group was superior to that in the control group （P＜0.01）. There was no statistically significant differences in all indicators after treatment in the control group （P＞0.05）. The incidence of adverse events was 5.1% （2/39） in the treatment group and 2.6% （1/39） in the control group， with no statistically significant difference between groups （P＞0.05）. ConclusionOn the basis of conventional western medicine treatment， the addition of the optimized new Shengmai Powder can further improve exercise tolerance， cardiac function and quality of life in patients with CHF of qi deficiency， blood stasis and fluid retention syndrome， and show good safety.

Objective To investigate the clinical factors affecting the risk of distant metastasis in patients with gallbladder carcinoma(GBC)and to construct a predictive model for metastasis risk.Methods Retrospective analysis was conducted on 4979 GBC patients from the surveillance,epidemiology,and end results(SEER)database from January 2000 to December 2021,which were divided into a training set(n=3485)and an internal validation set(n=1494)in a 7∶3 ratio.Additionally,47 GBC patients from Hefei First People's Hospital from January 2009 to December 2024 were collected as an external validation set.In the training set,univariate and multivariate analyses were performed to identify independent predictors of distant metastasis in GBC and to construct a predictive model.The predictive ability of the model was assessed by using area under the receiver operating characteristic curve.The model's calibration and clinical utility were evaluated through calibration curves and decision curve analysis.Results The results of univariate and multivariate analyses revealed that Caucasian,tumor size,T stage,and N stage were independent risk factors for distant metastasis in patients with GBC(P＜0.05).The predictive model constructed based on these factors had an AUC of 0.727,indicating good predictive performance.In the training set,internal validation set,and external validation set,the predictive results of this model showed good consistency with the actual situation.Conclusion The nomogram established by using SEER database can accurately predict the distant metastasis status in patients with GBC and demonstrates good clinical applicability.It assists clinicians in intuitively assessing the distant metastasis rate in GBC patients,thereby facilitating the formulation of personalized treatment plans.

AIM:To elucidate the mechanism by which Polygonatum sibiricum polysaccharides(PSP)miti-gate high-sugar diet-induced neuroinflammation through the gut microbiota-serum metabolome axis.METHODS:Fifty male ICR mice were divided into 5 groups:control group,model group,low-dose(250 mg/kg)PSP group,high-dose(500 mg/kg)PSP group,and donepezil hydrochloride(3 mg/kg)group.The neuroinflammation model was established through administration of high-sugar chow and 10%sucrose water for 12 weeks.Cognitive function assessment was per-formed utilizing the Morris water maze.Hippocampal histopathology was examined by hematoxylin-eosin(HE)staining,activated microglia were assessed via immunofluorescence,and neuronal apoptosis was evaluated by TUNEL assay.Serum and hippocampal levels of interleukin-6(IL-6),IL-1β,tumor necrosis factor-α(TNF-α)and nitric oxide(NO)were quantified using ELISA and Western blot.Gut microbiota diversity and serum untargeted metabolomics analyses were car-ried out employing 16S rRNA sequencing and LC-MS/GC-MS,respectively.Differential metabolites were screened,and key metabolic pathways were enriched using MetaboAnalyst 6.0.Spearman correlation analysis established relationships between gut microbiota,metabolites,and inflammatory factors.RESULTS:Model mice demonstrated increased escape latency(P<0.05 or P<0.01)and decreased platform crossings(P<0.01)compared with controls,which were reversed by PSP treatment(P<0.05 or P<0.01).Treatment with PSP substantially reduced IL-6,IL-1β,TNF-α and NO levels in se-rum and hippocampus(P<0.05 or P<0.01),diminished inflammatory infiltration,inhibited microglial activation,and re-duced neuronal damage.Gut microbiota analysis demonstrated that PSP increased Lactobacillus and Bacteroides abun-dance while reducing Alistipes(P<0.05).Metabolomics identified 15 differential metabolites(including betaine,kyotor-phin and ε-caprolactam)and highlighted the significance of alanine,aspartate and glutamate metabolism pathways.Spear-man analysis revealed that abundance of Alistipes and Bacteroides were positively correlated with IL-1β(P<0.05),while abundance of Lactobacillus was negatively correlated with inflammatory factors(P<0.05 or P<0.01).Key metabolites(be-taine,kyotorphin,ε-caprolactam,trans-cinnamate,cis-zeatin and galactitol)showed strong associations with inflamma-tion factors(P<0.05 or P<0.01).CONCLUSION:Treatment with PSP attenuates neuroinflammation through modula-tion of gut microbiota(Lactobacillus,Bacteroides and Alistipes),regulation of metabolites(betaine,kyotorphin and so on),and targeting amino acid metabolism pathways.

Organ fibrosis is a chronic tissue injury caused by multiple causes,and the continuous dynamic progression will lead to abnormal organ structure and function.Recent studies have shown that Chinese materia medica can inhibit organ fibrosis by regulating the PI3K/Akt pathway,which holds potential significance for developing anti-fibrosis strategies.This article systematically reviewed the role of the PI3K/Akt signaling pathway in the entire process of fibrosis,and summarized the potential mechanisms of Chinese materia medica monomers,drug pairs and compounds that can target and intervene in PI3K/Akt signaling transduction in preventing and treating organ fibrosis,in order to provide reference for the intervention of Chinese materia medica in the PI3K/Akt pathway for the treatment of organ fibrosis.

Objective:To explore the application value of pterygium excision(PE)combined with autologous limbal stem cell transplantation(LSCT)in the treatment of pterygium.Methods:The clinical data of 125 patients with pterygium admitted to Yucheng County People's Hospital from Feb 2021 to Feb 2023 were retrospectively analyzed.The patients were divided into two groups according to the surgical method,with 58 patients undergoing PE combined with amniotic membrane transplantation as the control group and 67 patients undergoing PE combined with LSCT as the observation group.The surgical-related indicators and postoperative complications were compared between the two groups,as well as the pre-and post-operative visual acuity,corneal parameters[corneal astigmatism,corneal fluorescein staining(FL)score],tear secretion function[tear film breakup time(BUT),Schirmer test].Results:The operation time,corneal wound healing time,regression time of hyperemia and edema,and suture removal time in the observation group were shorter than those in the control group(P＜0.01).The visual acuity level in the observation group was higher than that in the control group at 7 days,1 month,and 3 months after surgery(P＜0.05).The corneal astigmatism degree and FL score in the observation group were lower than those in the control group at 1 month and 3 months after surgery,while BUT and Schirmer test were higher than those in the control group(P＜0.05).There was no significant difference in the total incidence of complications between the two groups after surgery(P＞0.05).Conclusion:The combined treatment of PE and LSCT for pterygium is effective,which can accelerate the recovery process after surgery,improve corneal morphology and tear secretion function,enhance visual acuity,and ensure surgical safety.

Objective To summarize and analyze the CT or MRI imaging signs of ovarian torsion in children.Methods The CT or MRI data of 24 children surgically confirmed ovarian torsion were analyzed retrospectively,focusing on imaging signs such as ovarian position,size,the relationship with surrounding appendages and uterus.Results In this group of cases,8 cases underwent CT examination and 16 cases underwent MRI examination.Among the age of children,12 cases were in newborns,and 6 cases were in school-age and adolescent children respectively.It was more common in newborns and children aged 10-12 years old.Among the 24 patients,3 cases(12.5％)had primary ovarian torsion,all of which were adolescent children;21 cases(87.5％)had secondary ovarian torsion,with all torsions in the neonatal period were secondary ovarian torsion.Among secondary ovarian torsion,there were 7 cases(33.3％)of ovarian teratoma with torsion,12 cases(57.1％)of simple ovarian cysts,1 case(4.7％)of ovarian serous cystadenoma,and 1 case(4.7％)of ovarian mucinous cyst.Torsion occurred in 9 cases(37.5％)of the left ovary and 15 cases(62.5％)of the right ovary,with right ovarian torsion being more common.Imaging signs included varying degrees of enlargement of the ovaries on the ipsilateral side of the torsion,with 14 cases(58.3％)of ovarian masses had a maximum diameter≥5 cm,and 3-5 cm being more common in the neonatal period.There were 11 cases(45.8％)with the pedicle sign/vortex sign on the ipsilateral side of the torsion,9 cases(37.5％)with mass and hemorrhage,4 cases(16.7％)with mass displacement to the midline or uterine displacement to the ipsilateral side,and 3 cases(12.5％)of the ovarian follicle outward migration showed fruit bowl sign.Conclusion Secondary ovarian torsion is relatively common in children,with distinctive imaging manifestations.Especially when neonatal ovarian cysts show hemorrhagic signals should be alert to the risk of ovarian torsion.CT and MRI examinations can provide a powerful reference for the clinical diagnosis of ovarian torsion in children.

Objective In this paper,the ethnic patent medicines(EPMs)in the Chinese Pharmacopeia,National Basic Medical Insurance,Employment Injury Insurance and Maternity Insurance Medicine List,and National Essential Medicine List(re-ferred to as"one pharmacopeia and two lists")were counted and analyzed.Methods The EPMs in"one pharmacopeia and two lists"were summarized,and the information of manufacturers,medicinal materials used in EPMs,and their current quality standards were collated,and their indicative function,adverse reactions,contraindications,and precautions were analyzed.The modern research level of the above EPMs was analyzed by searching relevant literature on CNKI and PubMed.Results A total of 142 EPMs in"one pharmacopeia and two lists"were included,and 68 of the EPMs had exclusive manufacturers and 98.75％of the medicinal materials had provincial-level or higher quality standards.There were issues such as the expression of indicative function in the instruction being mixed between medical terms,91.55％ of the EPMs lacking sufficient information on adverse re-actions,contraindications,and precautions,and modern basic research was weak.Conclusions In the development of EPMs,it is important to improve information on adverse reactions,contraindications,and precautions in the instructions.In expressing indic-ative function,it is necessary to avoid mixing medical terms,which is more conducive to the clinical promotion of EPMs.

Objective:? To summarize the achievements in improving the consistency of clinical liquid chromatography-tandem mass spectrometry (LC-MS/MS) testing results.Methods:? From 2021 to 2024, Zhongshan Hospital Affiliated to Fudan University recruited laboratories voluntarily participating in the MSHP (Clinical LC-MS/MS Testing Consistency Program). As of Batch 202404, a total of 76 laboratories had enrolled, including 60 medical institutions (all tertiary hospitals) and 16 third-party laboratories. Test items were established, and comparative samples were distributed regularly-each item′s samples covered three concentrations (high, medium, and low). Samples were shipped via cold chain and tested within one week. Our laboratory′s measurements served as the target, with participating labs′ results within ±25% of the target deemed qualified. Passing-Bablok regression and Bland-Altman analysis were used to assess consistency.Results:Taking 3-MT (3-methoxytyramine) as an example, the coefficients of variation (CVs) for the project′s three concentration levels improved from 17.00%, 47.18%, and 4.88% in the first comparative batch to 9.59%, 9.59%, and 6.1% in Batch 202404. Passing-Bablok regression results for the 5 units participating in 3-MT testing showed that Laboratory A had proportional bias but no systematic bias (regression slope [95% CI]: 0.903 [0.862-0.952]; intercept [95% CI]: 0.912 [-1.921-6.073]). The remaining laboratories exhibited no proportional or systematic bias with the target (Laboratory B: slope 1.031 [0.961-1.147], intercept-0.733 [-4.641-8.272]; Laboratory C: slope 0.982 [0.940-1.009], intercept-0.576 [-2.675-1.891]; Laboratory D: slope 0.973 [0.939-1.066], intercept-1.168 [-6.108-1.649]; Laboratory E: slope 0.999 [0.905-1.051], intercept-1.876 [-6.111-3.508]). Bland-Altman analysis indicated that all 5 laboratories′ results generally showed good consistency with the target. Through quality feedback and optimizing sample preparation concentrations, result consistency was enhanced.? Conclusion:? Clinical LC-MS/MS testing consistency programs contribute to improving the comparability of test results.

Objective To establish and validate a method for simultaneous analysis of fluconazole,linezolid,voriconazole and cont-ezolid by liquid chromatography-tandem mass spectrometry,and conduct preliminary assessment its value of application value in clinical therapeutic drug monitoring.Methods Using an isotopic internal standard method,the serum samples were pretreated with protein precipitation.The supernatant was diluted after centrifugation,and detected by liquid chromatography-tandem mass spectrometer.Refer-ring to the Recommendations for Clinical Application of Liquid Chromatography-Mass Spectrometry(LC-MS)and Clinical and Labora-tory Standards Instituhe(CLSI)C62A,the performance of the LC-MS method was verified,including quantitation limits,linearity,trueness,precision,matrix effect,carry-over,interference,dilution consistency and stability.The blood samples from patients who were treated with fluconazole,linezolid,voriconazole,and contezolid were collected and measured for trough or peak concentrations.Results The quantitation limits of fluconazole,linezolid,voriconazole and contezolid by this method were 1 μg/mL,0.25 μg/mL,0.25 μg/mL and 0.1 μg/mL,respectively.The linear ranges were 1-100 μg/mL,0.25-25 μg/mL,0.25-25 μg/mL,and 0.1-10μg/mL,respectively.The recovery rates were 103.0％-105.7％,103.1％-108％,102.4％-106.2％and 101.0％-109.9％,respectively.The precisions,expressed as coefficient of variation(CV),were 1.7％-3.4％,2.1％-4.8％,1.9％-3.1％,and 3.1％-6.8％,respective-ly.No obvious matrix effect,carry-over contamination and interference were found.The dilution consistency and stability were satisfac-tory.The concentrations of fluconazole,linezolid and voriconazole within the reference interval accounted for 49.1％,52.5％and 80.7％of the total samples,respectively.The peak concentration of contezolamide was(14.02±4.94)μg/mL(n=4),and the trough concen-tration was(0.34±0.20)μg/mL(n=5).Conclusion In this study,a method for simultaneous analysis of the concentrations of flu-conazole,linezolid,voriconazole and contezolid was successfully established and verified by liquid chromatography-tandem mass spec-trometry.This method is simple,rapid,and suitable for therapeutic drug monitoring,and providing a basis for the optimization of drug regimens.

Objective To explore the effect and mechanism of Sechang Zhixie Powder(SCZXS)on mice with acute diarrhea caused by castor oil.Methods The mice were randomly divided into blank control group,model control group,montmorillonite powder group(1.4 g·kg-1),SCZXS-L group(0.9 g·kg-1),SCZXS-M group(1.8 g·kg-1)and SCZXS-H group(3.6 g·kg-1),10 mice in each group.After continuous administration of 7 days,the acute diarrhea model of mice was prepared by oral administration of castor oil(0.01 mL·g-1).The diarrhea of mice was observed within 4 hours of castor oil administration,and the rate of loose stool,degree of loose stool,and diarrhea index were calculated;the levels of DAO,D-LDH,VIP,and SS in the colon were determined by enzyme-linked immunosorbent assay;The morphological changes in the colon tissue of mice were observed after HE staining and the thicknesses of the mucosal and muscular layers of the colon were quantified;AB-PAS staining was performed to observe the effect on mucin in the colon;and the expression of AQP3,Occludin,and ZO-1 in the colon were quantified by immunohistochemistry.Results Compared with the model control group,the rate of loose stool,degree of loose stool,and diarrhea index of the mice in the SCZXS groups tended to decrease,but the difference was not statistically significant.Compared with the model control group,the flat luminal surface of the mice in the SCZXS-M and SCZXS-H group were significantly thickened(P<0.01),and the amount of VIP in the colon was significantly decreased(P<0.05,P<0.01),and that of DAO in the colon was significantly decreased(P<0.01),Occludin and ZO-1 expression were significantly increased(P<0.01),the mucin area ratio was significantly increased(P<0.05)in the SCZXS-M group,and AQP3 expression was significantly increased(P<0.05)in the SCZXS groups.Conclusions SCZXS can improve acute diarrhea induced by castor oil in mice.and its mechanism may be related to the regulation of gastrointestinal hormones and AQP3.In addition,SCZXS improves intestinal damage caused by diarrhea and protects the intestinal barrier.