Establishing a comprehensive mechanism for the initiation and review of investigator-initiated trial(IIT) plays an important role in ensuring the scientific validity of clinical research and improving research quality.Since 2021, Zhongshan Hospital affiliated to Fudan University had actively explored improvements in the project management of IIT. The hospital had established a standardized grading review management process, developed an integrated clinical research management system, established a three-level clinical research training system, built a methodological support platform, and formulated research plan templates, gradually formed a standardized grading project approval review management mode. As of February 2024, the hospital had completed 400 quick reviews and more than 400 expert letter reviews based on the integrated clinical research management system. The efficiency and quality of IIT project approval had been improved. At the same time, over 40 academic salons and forums had been held, cultivating a group of young clinical research talents, providing data management training for more than 30 clinical departments, and promoting the improvement of the quality of research protocol. In the future, hospitals should further optimize their information systems, expand the influence of their training systems, enhance the capabilities of their methodological support platforms, and improve the efficiency of the application of clinical research protocol templates, so as to escort the establishment and implementation of high-quality clinical research projects and provide references for other hospitals′ IIT project management.

Objective To clarify the understanding of types of laboratories and manufacturers for GB 9706.1-2020 Medical electrical equipment-Part 1:General requirements for basic safety and essential performance by laboratory proficiency testing for creepage distance and electrical clearance test.Methods An operation guide was formed according to the testing program in GB 9706.1-2020,and the homogeneity and stability of the samples were evaluated according to CNAS-GL003:2018 Guidance on Evaluating the Homogenneity and Stability of Samples Used for Proficiency Testing.Robust statistic methods were used to assess the quantitative parameters of the test results of the participating laboratories according to the requirements in GB/T 28043-2019 Statistical methods for use in proficiency testing by interlaboratory comparison;the results reported by the expert laboratories were used as the specified values of the qualitative parameters.SPSS 25.0 statistical software was used for data analysis.Results All the results of the crreepage distance and electrical clearance tests met the requirements for homogeneity and stability.Of the 46 laboratories involved in,37 ones did have comprehensive satisfactory determinations while the remained 9 ones not.Conclusion Some laboratories don't behave well in understanding the standard,which have to be reformed accordingly to enhance their proficiencies.[Chinese Medical Equipment Journal,2024,45(10):54-59]

Objective:To analyze the current status of the global burden of stroke disease from 1990 to 2019,to predict the development trend of stroke disease burden in the 30 years from 2020 to 2049,and to provide a basis for formulating national health policies on stroke diseases.Methods:The Global Burden of Disease Study 2019(GBD 2019)database was searched to extract global stroke disease incidence,prevalence,case fatality,and disability-adjusted life years(DALYs)disease burden indicators from 1990-2019,the trends over time were modeled using linear,Poisson,and exponential regressions,prediction and study of the relationship between stroke and sociodemographic index(SDI)based on per capita gross domestic product(GDP)were conducted.Results:The global burden of stroke disease increased significantly from 1990-2019 and is predicted to continue to rise over the next 30 years(2020-2049).In 2049,the global stroke incidence,prevalence,case fatality,and DALYs will increase by 8.53 million(63％),119.83 million(109％),7.79 million(118％)and 118.92 million person-years(79％),respectively,compared with 2019,with a significant increase in the burden of stroke in the elderly population.In the next 30 years,the age-standardized incidence rates of stroke in men and women will be similar,while the age-standardized rates of prevalence in women will be relatively higher,and age-standardized case fatality rates and DALYs in men will be relatively higher.The disease burden of stroke was negatively correlated with SDI.The burden of stroke disease was significantly higher in regions with a low SDI than in regions with a high SDI.Conclusion:The global burden of stroke will increase in the next 30 years,which may be related to the aging of population and closely related to the development of economy.It is necessary to strengthen the prevention of stroke and formulate targeted strategies targeted strategies according to different SDI regions.

Objective To investigate the diagnostic value of CT radiomics features in pulmonary alveolar proteinosis(PAP).Methods The general data and clinical characteristics of 24 patients with PAP in the Chinese PLA General Hospital from November 2008 to August 2022 were retrospectively collected and analyzed.Another 53 patients with other diffuse lung diseases except for PAP during the same period served as control group.The differences in the 10 conventional CT signs(semantic features)and 107 radiomics features between the two groups were compared.All patients were randomly divided into the training group(n=53)and the validation group(n=24)at a ratio of 7:3.CT semantic feature model,radiomics model and combined model to diagnose PAP were constructed in training group,and the diagnostic efficacy of models was compared using the receiver operating characteristic(ROC)curve in validation group.Decision curve analysis(DCA)was used to assess the value of models for practical clinical application.Radscore was calculated for the model with the highest diagnostic efficacy.Results A total of 24 patients with pathologically confirmed PAP were enrolled,with a male to female ratio of 3:1 and an average age of(44.6±15.2)years.The main clinical symptoms of patients with PAP included shortness of breath,cough,sputum and chest tightness.Compared with control group,the incidence of pleural effusion in PAP group was significantly lower(P＜0.05),while no significant differences were observed in other CT features(P＞0.05).The areas under the curve(AUC)of the semantic feature model for diagnosing PAP in training and validation group were 0.590 and 0.594,respectively,and in validation group,the accuracy,sensitivity,and specificity for diagnosis of PAP were 0.188,1.000,and 0.188,respectively.The AUCs of the radiomics model in training group and validation group were 0.845 and 0.867,respectively,and in validation group,the accuracy,sensitivity,and specificity were 0.641,0.938,and 0.703,respectively.The AUCs of the combined model in training group and validation group were 0.850 and 0.883,respectively,and in validation group,the accuracy,sensitivity,and specificity were 0.688,0.750,and 0.938,respectively.The AUCs of the radiomics model and the combined model were significantly greater than that of the semantic feature model,but there was no significant difference in the AUCs between the first two models.The decision curve analysis showed that both the radiomics model and the combined model had high application value for predicting PAP.Conclusion CT radiomics shows higher clinical value in the diagnosis of PAP compared with conventional CT features.

Objective To evaluate the short-term efficacy and safety of catheter-directed thrombolysis(CDT)via femoral vein access and via anterior tibial vein access for lower extremity deep vein thrombosis(LEDVT).Methods The clinical data of 86 LEDVT patients,who were treated with CDT via healthy-side femoral vein access or via affected-side anterior tibial vein access at the Second Affiliated Hospital of Nanjing Medical University of China between January 2019 and December 2021,were retrospectively analyzed.Of the 86 patients,via femoral vein access was adopted in 40(FV group)and via anterior tibial vein access was adopted in 46(ATV group).The primary endpoints were the technical success rate and the thrombus removal rate.The secondary endpoints included the operation time and the complications.Results In the FV group and ATV group,the technical success rates were 92.5％and 100％respectively(P=0.097),the thrombus removal rates were(68.9+25.9)％and(78.3±21.0)％respectively(P=0.067),and the differences between the two groups were not statistically significant.The operation time in the FV group and ATV group was(64.1±14.8)min and(72.0±19.9)min respectively(P=0.037),and the difference between the two groups was statistically significant.The incidence of complications in the FV group and ATV group was 22.5％and 10.9％respectively(P=0.145),and the difference between the two groups was not statistically significant.Conclusion CDT therapy,regardless of via femoral vein access or via anterior tibial vein access,can effectively treat LEDVT with quite same clinical short-term efficacy and safety.

Objective: To evaluate the efficacy and safety of thermal ablation in treating solitary low-risk T2N0M0 papillary thyroid cancer (PTC) and compare the outcomes of microwave ablation (MWA) and radiofrequency ablation (RFA). Materials and Methods: This retrospective, single center study involved 34 patients (age: 40.0 ± 13.9 years; 28 female) who had low-risk T2N0M0 PTC with a maximum diameter >2 cm and ≤4 cm and underwent MWA (n = 15) or RFA (n = 19) from November 2016 to April 2023. The primary outcomes were the cumulative rate of disease progression and delayed surgery rates.In contrast, the secondary outcomes included changes in tumor size, cumulative rate of complete tumor disappearance, and complication rates. Results: The median follow-up period was 18.0 months (interquartile range [IQR]: 9.0–40.0 months). At 12 months, the median volume reduction rate of the ablation zone was 74.2% (IQR: 53.7%–86.0%). Disease progression was noted in two patients within 1 year, including one patient with local tumor progression post-RFA and one with a new tumor post-MWA, resulting in a constant cumulative disease progression rate of 8.8% (95% confidence interval [CI]: 0%–19.8%) throughout the remaining follow-up period. Both patients were subsequently treated with additional ablation and did not require surgery. The cumulative rates of complete tumor disappearance at 1, 3, and 5 years were 4.0% (95% CI: 0%–11.4%), 26.8% (95% CI: 2.7%– 44.9%), and 51.2% (95% CI: 0%–79.1%), respectively. No significant differences were observed in the disease progression (P = 0.829) or complete tumor disappearance (P = 0.633) rates between the MWA and RFA groups. Complications occurred in 14.7% (5/34) of patients presenting with transient hoarseness. RFA had a higher but not statistically significant complication rate than MWA did (21.1% [4/19] vs. 6.7% [1/15]; P = 0.355). Conclusion Both MWA and RFA demonstrated promising short-term outcomes in terms of efficacy and safety in treating solitary low-risk T2N0M0 PTC, with no significant differences.

OBJECTIVE: To investigate the effect of baicalin on the growth of extranodal NK/T cell lymphoma (ENKTCL) cells and its related mechanism. METHODS: Normal NK cells and human ENKTCL cells lines SNK-6 and YTS were cultured, then SNK-6 and YTS cells were treated with 5, 10, 20 μmol/L baicalin and set control. Cell proliferation and apoptosis was detected by Edu method and FCM method, respectively, and expressions of BCL-2, Bax, FOXO3 and CCL22 proteins were detected by Western blot. Interference plasmids were designed and synthesized. FOXO3 siRNA interference plasmids and CCL22 pcDNA overexpression plasmids were transfected with PEI transfection reagent. Furthermore, animal models were established for validation. RESULTS: In control group and 5, 10, 20 μmol/L baicalin group, the proliferation rate of SNK-6 cells was (56.17±2.96)%, (51.92±4.63)%, (36.42±1.58)%, and (14.60±2.81)%, respectively, while that of YTS cells was (58.85±2.98)%, (51.38±1.32)%, (34.75±1.09)%, and (15.45±1.10)%, respectively. In control group and 5, 10, 20 μmol/L baicalin group, the apoptosis rate of SNK-6 cells was (5.93±0.74)%, (11.78±0.34)%, (28.46±0.44)%, and (32.40±0.37)%, respectively, while that of YTS cells was (7.93±0.69)%, (16.29±1.35)%, (33.91±1.56)%, and (36.27±1.06)%, respectively. Compared with control group, the expression of BCL-2 protein both in SNK-6 and YTS cells decreased significantly (P<0.001), and the expression of Bax protein increased in SNK-6 cells only when the concentration of baicalin was 20 μmol/L (P<0.001), while that in YTS cells increased in all three concentrations(5, 10, 20 μmol/L) of baicalin (P<0.001). The expression of FOXO3 protein decreased while CCL22 protein increased in ENKTCL cell lines compared with human NK cells (P<0.001), but the expression of FOXO3 protein increased (P<0.01) and CCL22 protein decreased after baicalin treatment (P<0.001). Animal experiments showed that baicalin treatment could inhibit tumor growth. The expression of CCL22 protein in ENKTCL tissue of nude mice treated with baicalin decreased compared with control group (P<0.01), while the FOXO3 protein increased (P<0.05). In addition, FOXO3 silencing resulted in the decrease of FOXO3 protein expression and increase of CCL22 protein expression (P<0.01, P<0.001). CONCLUSION Baicalin can inhibit proliferation and promote apoptosis of ENKTCL cell lines SNK-6 and YTS, up-regulate the expression of Bax protein, down-regulate the expression of BCL-2 protein, and down-regulate the expression of CCL22 protein mediated by FOXO3. Animal experiment shown that the baicalin can inhibit tumor growth. Baicalin can inhibit the growth and induce apoptosis of ENKTCL cells through FOXO3/CCL22 signaling pathway.
Animals ; Mice ; Humans ; Lymphoma, Extranodal NK-T-Cell/pathology* ; Forkhead Box Protein O3/metabolism* ; bcl-2-Associated X Protein/pharmacology* ; Mice, Nude ; Signal Transduction ; Apoptosis ; Proto-Oncogene Proteins c-bcl-2/metabolism* ; Chemokine CCL22/pharmacology*

Humans ; Infant ; Female ; Dandy-Walker Syndrome/diagnosis* ; Tomography, X-Ray Computed ; Craniocerebral Trauma/complications*

OBJECTIVE: To analysis and determine MR signs of Harris score ARCO stages 2-4 in osteonecrosis of femoral head (ONFH). METHODS: Thirty-four patients with ONFH of ARCO stages 2 to 4 who underwent routine MR, T2 mapping, 3D-SPACE sequence examination and Harris score were retrospectively collected from January 2019 to June 2020, and 3 patients were excluded, and 31 patients were finally included, including 23 males and 8 females, aged from 18 to 62 years old with an average of(40.0±10.8) years old. Among them 21 patients with bilateral femoral head necrosis, totally 52 cases, including 17 with ARCO stage 2 patients, 24 ARCO stage 3, and 11 ARCO stage 4. MR imaging signs (femoral head collapse depth, ONFH index, bone marrow edema, hyperplasia, grade and T2 value of cartilage injury, and joint effusion) were scored and measured on the picture archiving and communication system (PACS) workstation, and the cartilage quantitative parameter T2 value was calculated and measured on Siemens postprocessing workstation. Pearson correlation analysis was used to evaluate the correlation between various MR signs and Harris score, and then multiple linear regression analysis was used to examine impact of MR signs on Harris hip score. RESULTS: Femoral head collapse depth(r=-0.563, P=0.000), grade of cartilage injury(r=-0.500, P=0.000), and joint effusion (r=-0.535, P=0.000) were negatively correlated with Harris score by Pearson correlation analysis. Multiple linear regression analysis showed that joint effusion(β=-6.198, P=0.001) and femoral head collapse depth(β=-4.085, P=0.014) had a significant negative impact on Harris hip score. CONCLUSION Femoral head collapse depth and joint effusion both had significant negative relationship with Harris hip score. It is recommended to routinely evaluate femoral head collapse depth and joint effusion quantitatively and gradedly, so as to efficiently and accurately assist clinical diagnosis and treatment.
Male ; Female ; Humans ; Adolescent ; Young Adult ; Adult ; Middle Aged ; Femur Head Necrosis/diagnostic imaging* ; Retrospective Studies ; Femur Head/diagnostic imaging* ; Bone Transplantation/methods* ; Magnetic Resonance Imaging ; Treatment Outcome

OBJECTIVE: To investigate the effect of Baicalin on the proliferation and pyroptosis of diffuse large B-cell lymphoma cell line DB and its mechanism. METHODS: DB cells were treated with baicalin at different concentrations (0, 5, 10, 20, 40 μmol/L). Cell proliferation was detected by CCK-8 assay and half maximal inhibitory concentration (IC₅₀) was calculated. The morphology of pyroptosis was observed under an inverted microscope, the integrity of the cell membrane was verified by LDH content release assay, and the expressions of pyroptosis-related mRNA and protein (NLRP3, GSDMD, GSDME, N-GSDMD, N-GSDME) were detected by real-time fluorescence quantitative PCR and Western blot. In order to further clarify the relationship between baicalin-induced pyroptosis and ROS production in DB cells, DB cells were divided into control group, baicalin group, NAC group and NAC combined with baicalin group. DB cells in the NAC group were pretreated with ROS inhibitor N-acetylcysteine (NAC) 2 mmol/L for 2 h. Baicalin was added to the combined treatment group after pretreatment, and the content of reactive oxygen species (ROS) in the cells was detected by DCFH-DA method after 48 hours of culture. RESULTS: Baicalin inhibited the proliferation of DB cells in a dose-dependent manner (r=-0.99), and the IC₅₀ was 20.56 μmol/L at 48 h. The morphological changes of pyroptosis in DB cells were observed under inverted microscope. Compared with the control group, the release of LDH in the baicalin group was significantly increased (P<0.01), indicating the loss of cell membrane integrity. Baicalin dose-dependently increased the expression levels of NLRP3, N-GSDMD, and N-GSDME mRNA and protein in the pyroptosis pathway (P<0.05). Compared with the control group, the level of ROS in the baicalin group was significantly increased (P<0.05), and the content of ROS in the NAC group was significantly decreased (P<0.05). Compared with the NAC group, the content of ROS in the NAC + baicalin group was increased. Baicalin significantly attenuated the inhibitory effect of NAC on ROS production (P<0.05). Similarly, Western blot results showed that compared with the control group, the expression levels of pyroptosis-related proteins was increased in the baicalin group (P<0.05). NAC inhibited the expression of NLRP3 and reduced the cleavage of N-GSDMD and N-GSDME (P<0.05). Compared with the NAC group, the NAC + baicalin group had significantly increased expression of pyroptosis-related proteins. These results indicate that baicalin can effectively induce pyroptosis in DB cells and reverse the inhibitory effect of NAC on ROS production. CONCLUSION Baicalin can inhibit the proliferation of DLBCL cell line DB, and its mechanism may be through regulating ROS production to affect the pyroptosis pathway.
Humans ; NLR Family, Pyrin Domain-Containing 3 Protein/metabolism* ; Reactive Oxygen Species/pharmacology* ; Pyroptosis ; Cell Line ; RNA, Messenger ; Lymphoma, Large B-Cell, Diffuse