OBJECTIVE To optimize the management model of drugs used in investigator-initiated trial （IIT）. METHODS With benchmarking analysis， based on the practical work experience of a tertiary specialized hospital in the field of IIT drug management in Shanghai， a thorough review was conducted， involving relevant laws， regulations， and academic literature to establish benchmark criteria and the evaluation standards. Starting from the initiation of IIT projects， a detailed comparative analysis of key processes was carried out， such as the receipt， storage， distribution， use and recycling of drugs for trial. The deficiencies in the current management of IIT drugs were reviewed in detail and a series of optimization suggestions were put forward. RESULTS It was found that the authorized records of drug management were missing， the training before project implementation was insufficient， and the records of receipt and acceptance of IIT drugs were incomplete. In light of these existing problems， improvement measures were put forward， including strengthening the training of drug administrators and stipulating that only drug administrators with pharmacist qualifications be eligible to inspect and accept drugs， etc. The related systems were improved， and 17 key points of quality control for the management of IIT drugs were developed. CONCLUSIONS A preliminary IIT drug management system for medical institutions has been established， which helps to improve the institutional X2023076） framework of medical institutions in this field.

In order to further standardize the vaccination of kidney transplant candidates and recipients in China, the Branch of Organ Transplantation of Chinese Medical Association has organized experts in kidney transplantation and infectious diseases. Based on the "Vaccination of Solid Organ Transplant Candidates and Recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice", and in combination with the clinical reality of infectious diseases and vaccination after organ transplantation in China, as well as referring to relevant recommendations from home and abroad in recent years, these guidelines are formulated from aspects such as epidemiology, types of vaccines, vaccination principles, target population, and specific vaccine administration. The "Guidelines for Vaccination of Kidney Transplant Candidates and Recipients in China" aims to provide theoretical reference for medical workers in the field of kidney transplantation in China, regarding the vaccination of kidney transplant candidates and recipients. It is expected to better guide the vaccination of kidney transplant candidates and recipients, reduce the risk of postoperative infection, and improve survival outcomes.

The chemical constituents of the petroleum ether extract derived from the 90% ethanol extract of Elephantopus scaber were investigated. By silica gel column chromatography, C_(18), MCI column chromatography and semi-preparative high performance liquid chromatography, ten compounds were isolated. Their structures were identified as 3β-hydroxy-6β,7β-epoxytaraxeran-14-ene(1), 3β-hydroxyolean-12-en-28-oic acid(2), D-friedoolean-14-ene-3β,7α-diol(3), 3β-hydroxy-11α-methoxyolean-12-ene(4), 3β-hydroxyolean-11,13(18)-diene(5), 11α-hydroxy-β-amyrin(6), betulinic acid(7), 3β-hydroxy-30-norlupan-20-one(8), 6-acetonylchelerythrine(9), and 4',5'-dehydrodiodictyonema A(10) by analysis of the 1D NMR, 2D NMR, MS, and IR spectral data. Among them, compound 1 was a new triterpene and other compounds except compounds 2 and 7 were isolated from this plant for the first time.
Triterpenes/isolation & purification* ; Drugs, Chinese Herbal/isolation & purification* ; Molecular Structure ; Asteraceae/chemistry* ; Chromatography, High Pressure Liquid ; Magnetic Resonance Spectroscopy

OBJECTIVE: To explore the neuroprotective effects of Xuefu Zhuyu Decoction (XFZYD) based on in vivo and metabolomics experiments. METHODS: Traumatic brain injury (TBI) was induced via a controlled cortical impact (CCI) method. Thirty rats were randomly divided into 3 groups (10 for each): sham, CCI and XFZYD groups (9 g/kg). The administration was performed by intragastric administration for 3 days. Neurological functions tests, histology staining, coagulation and haemorheology assays, and Western blot were examined. Untargeted metabolomics was employed to identify metabolites. The key metabolite was validated by enzyme-linked immunosorbent assay and immunofluorescence. RESULTS: XFZYD significantly alleviated neurological dysfunction in CCI model rats (P<0.01) but had no impact on coagulation function. As evidenced by Evans blue and IgG staining, XFZYD effectively prevented blood-brain barrier (BBB) disruption (P<0.05, P<0.01). Moreover, XFZYD not only increased the expression of collagen IV, occludin and zona occludens 1 but also decreased matrix metalloproteinase-9 (MMP-9) and cyclooxygenase-2 (COX-2), which protected BBB integrity (all P<0.05). Nine potential metabolites were identified, and all of them were reversed by XFZYD. Adenosine was the most significantly altered metabolite related to BBB repair. XFZYD significantly reduced the level of equilibrative nucleoside transporter 2 (ENT2) and increased adenosine (P<0.01), which may improve BBB integrity. CONCLUSIONS XFZYD ameliorates BBB disruption after TBI by decreasing the levels of MMP-9 and COX-2. Through further exploration via metabolomics, we found that XFZYD may exert a protective effect on BBB by regulating adenosine metabolism via ENT2.
Animals ; Drugs, Chinese Herbal/therapeutic use* ; Blood-Brain Barrier/metabolism* ; Brain Injuries, Traumatic/metabolism* ; Adenosine/metabolism* ; Male ; Rats, Sprague-Dawley ; Rats

Cemental tear is a rare and indetectable condition unless obvious clinical signs present with the involvement of surrounding periodontal and periapical tissues. Due to its clinical manifestations similar to common dental issues, such as vertical root fracture, primary endodontic diseases, and periodontal diseases, as well as the low awareness of cemental tear for clinicians, misdiagnosis often occurs. The critical principle for cemental tear treatment is to remove torn fragments, and overlooking fragments leads to futile therapy, which could deteriorate the conditions of the affected teeth. Therefore, accurate diagnosis and subsequent appropriate interventions are vital for managing cemental tear. Novel diagnostic tools, including cone-beam computed tomography (CBCT), microscopes, and enamel matrix derivatives, have improved early detection and management, enhancing tooth retention. The implementation of standardized diagnostic criteria and treatment protocols, combined with improved clinical awareness among dental professionals, serves to mitigate risks of diagnostic errors and suboptimal therapeutic interventions. This expert consensus reviewed the epidemiology, pathogenesis, potential predisposing factors, clinical manifestations, diagnosis, differential diagnosis, treatment, and prognosis of cemental tear, aiming to provide a clinical guideline and facilitate clinicians to have a better understanding of cemental tear.
Humans ; Dental Cementum/injuries* ; Consensus ; Diagnosis, Differential ; Cone-Beam Computed Tomography ; Tooth Fractures/therapy*

Objective To establish a liquid chromatography-tandem mass spectrometry(LC-MS/MS)method for the determination of ginsenoside Rh2(GRh2)in plasma of mice,so as to provide preclinical data support for the pharmacokinetic study and application of GRh2.Methods C57BL16 mice were given 7.5 mg/kg GRh2 by gavage.After administration,0.03 mL of whole blood was collected at 5 min,10 min,15 min,30 min,1 h,2 h,4 h,and 8 h.Then,the whole blood was centrifuged and the serum was treated with 0.1％formic acid acetonitrile,dried by nitrogen(40℃),and redissolved with 50.0 pL 50％methanol solution containing 100 ng/mL diclofenac sodium.After vortex mixing for 5 min at room temperature,it was put into the automatic sampler for sampling analysis.The chromatographic column was Waters BEHC18(2.1 mm × 50.0 mm,1.7 pm),the mobile phase was aqueous solution containing 0.1％formic acid and acetonitrile solution containing 0.1％formic acid at a flow rate of 0.60 mL/min,the column temperature was 40℃,and the injection volume was 1.00 pL.The electric spray ion source,positive ion mode and multiple reaction monitoring mode were performed.A standard curve was established to calculate blood drug concentration.The blood drug concentration-time curve was established according to the blood drug concentration,and the main pharmacokinetic parameters were calculated.Results The linear range of the standard curve of drug containing plasma was 100-40 000 ng/mL,and the correlation coefficient(r)was 0.996 0.After internal standard normalization,the matrix effect factors of GRh2 were 1.09,1.06,and 1.00(between 0.8 and 1.2),indicating no significant matrix effect.The precision and accuracy results showed that the average measured concentration of GRh2 samples at each concentration level was 103,333,23 800 and 35 000 ng/mL,the inter batch standard deviation was 6.47-1 120 ng/mL,the inter batch relative standard deviation was 1.5％-8.3％,and the inter batch accuracy deviation was 93.3％-111.1％.The long-term stability,short-term stability,repeated freeze-thaw property,and extraction recovery rate of GRh2 were all good.The pharmacokinetic parameters Tmax and Cmax of GRh2 in mice were(1.42±1.01)h and(1 251±495)ng/mL,respectively,indicating that the absorption and utilization rate of GRh2 in vivo was high and GRh2 had good drug performance.Conclusion The established LC-MS/MS method is accurate and reliable,and can be used to determine the concentration of GRh2 in mouse plasma and study its pharmacokinetic.

AIM To investigate the effects of Xinyue Capsules on the expression of glycerophospholipid metabolizing enzymes in isoproterenol(ISO)-induced rat heart tissue and primary myocardial cells of neonatal rats.METHODS The SD rats were randomly divided into the normal group,the model group,the Xinyue Capsules intervention group and Xinyue Capsules control group,with 8 rats in each group.The rat model of cardiac hypertrophy was established by 14 days consecutive intraperitoneal injection of ISO(30 mg/kg).Prior to the modeling,once daily administration of 0.393 g/kg Xinyue Capsules was given by gavage from 3 days in advance to the end of the experiment.After the last administration,the procurement of blood from abdominal aorta,the left and right ventricles were processed.And the rats had their indices levels of the heart,the left ventricle and the right ventricle measured;their pathomorphological changes of myocardial tissue observed using HE staining;their expressions of cardiac hypertrophy-related myocardial embryonic genes ANP,β-MHC and α-SKA mRNA detected using RT-qPCR method;and their serum TC,TG,LDL-C and HDL-C levels detected by biochemical method.In in vitro experiment,the neonatal rat model of myocardial hypertrophy was induced by exposure to ISO 1 μmol/L for 24 h.The investigation of the effect of Xinyue Capsules 12.5 μg/mL on ISO-induced myocardial hypertrophy was conducted by detection of myocardial cell area,embryo genes related to cardiac hypertrophy and myocardial cells protein cuntent.The further anti-cardiac hypertrophy mechanism of Xinyue Capsules research was conducted using RT-qPCR and Western blot to detect the gene and protein expressions of phospholipase A2(PLA2G6),phospholipase A1 member A(PLA1A)and lecithin cholesterol acyltransferase(LCAT)in left ventricle tissue and myocardial cells of each group.RESULTS The in vivo experimental result showed that compared with the normal group,the model group displayed increased indices levels of the heart,the left ventricle and the right ventricle and cross-sectional area of left ventricular myocytes(P＜0.05);and up-regulated expressions of ANP,β-MHC,α-SKA mRNA and PLA2G6,PLA1A and LCAT mRNA and proteins in the left ventricle(P＜0.05);and increased levels of serum TC,TG and LDL-C(P＜0.05);and decreased HDL-C level(P＜0.05).However,the intervention of Xinyue Capsules inhibited the changes of the aforementioned indices(P＜0.05).The in vitro experimental result revealed that Xinyue Capsules inhibited the ISO-induced increases of myocardial cell surface area and myocardial cell protein level,the up-regulation of ANP,β-MHC,α-SKA mRNA expressions and the PLA2G6,PLA1A,LCAT mRNA and protein expressions as well(P＜0.05).CONCLUSION Xinyue Capsules can improve the ISO-induced cardiac hypertrophy in rats,and its mechanism may be associated with its regulation upon the expressions of glycerophospholipid metabolism-related enzymes PLA2G6,PLA1A and LCAT.

The integrated management of multi-campus public hospitals is a mandate for national assessment and compul-sory requirement for high-quality advancement of public hospitals.A challenge in multi-campus hospital management is to accel-erate the standardization of various hospital campuses and facilitate the information sharing among them.Based on the manage-ment practices of multi-campus hospitals in Ningxia,this paper discussed the challenges encountered in the integrated manage-ment of multi-campus hospitals.It proposed strategies to enhance homogeneous management and inter-hospital coordination in multi-hospital and multi-campus hospital to provide valuable references.

The integrated use of health insurance funds and public health funds is the driving force for promoting service integration and continuously advancing the construction of a"Healthy China".Based on the synergistic advantage theory and the PCIC theory,this paper proposes three paths to promote the integrated use:rationalizing the functional position and service supply of the two parties,optimizing the payment and incentive mechanism,and strengthening the capacity building of service buyers.Based on the above path perspective,this paper finds that the current domestic exploration and practice of coordinated use has achieved certain results,but there are also problems such as unclear funding sources,unclear scope of purchased services,insufficient coordination of multi-subject assessment incentives,weak correlation with health outputs,insufficient cost accounting and health measurement assessment capabilities,and imperfect information system interconnection.It is recommended to improve the top-level design,establish an assessment and payment incentive mechanism related to health outcomes,and realize the dynamic construction of fund expansion and informatization.

Aim To investigate the effect of Huazhuo Jiedu Yikui decoction(HJYD)on Th1/Th2 balance,stress response and intestinal mucosal in rats with ul-cerative colitis.Methods Wistar rats of SPF grade were randomly divided into six groups:control group,model group,HJYD low,medium and high dose groups(1.25,2.5,5 kg·L-1),and positive me-salazine group(0.05 kg·L-1).Except for the con-trol group,the rats in other groups were established in-to ulcerative colitis animal models and were intragastri-cally administered with drug.TNF-α,IL-8,IL-13,IL-10,IFN-γ and IL-4 were detected by ELISA.The levels of SOD,MDA and GSH-Px were detected by re-lated kits.The pathological morphology of intestinal tissue was observed using HE staining and the score was calculate.The apoptosis rate of intestinal epithelial cells was detected by TUNEL method.The protein lev-els of NF-κB,TLR4,MyD88,Bcl-2 and Bax in intes-tinal tissue were detected by Western blot.Results Compared with the model group,the levels of TNF-α,IL-8,IL-13,MDA,IFN-γ,pathological score,intes-tinal epithelial cell apoptosis rate,NF-κB,TLR4,MyD88 and Bax in the HJYD groups were reduced(P＜0.05),and the levels of IL-10,IL-4,SOD,GSH-Px and Bcl-2 were raised(P＜0.05).Conclu-sions HJYD can significantly inhibit oxidative stress and inflammatory response in rats with ulcerative coli-tis,promote Th1/Th2 balance,and play a protective role in intestinal mucosa.The mechanism is related to the inhibition of NF-κB/TLR4/MyD88 signaling path-way.