Access to the clinical application of medical technology is one of the core institutional contents of medical quality management， involving medical quality assurance， the achievement of patient safety goals， and medical service satisfaction. Medical technology is only permitted for clinical use after its safety and effectiveness have been verified through clinical research， as well as evaluated and reviewed by the medical technology clinical application management committee and ethics committee of this medical and health institution. Based on the relevant laws， regulations， and ethical principles， combined with the experience of ethical review in the clinical application of medical technology from some medical and health institutions， a thematic discussion was held to formulate ethical review guidelines for the clinical application of medical technology for references. These guidelines elaborated on the management system for access to the clinical application of medical technology in medical and health institutions， the system of ethics committees and the requirements of review norms， technical plans and their review points， key points for the implementation of informed consent， technical teams and conditions， and other aspects.

Objective To explore the predictive efficacy of several multimodal MRI-based machine learning models for the promoter methylation states of O6-methylguanine-DNA methyltransferase(MGMT)of glioblastoma muliforme(GBM)patients in terms of the GBM heterogeneity and the complexity of the tumor microenvironment.Methods Firstly,the multimodal MRI images of 317 GBM patients from The University of Pennsylvania Glioblastoma(UPENN-GBM)dataset were pre-processed,with four sequences involved in including T1-weighted imaging(T1WI)sequence,T1-weighted contrast-enhanced imaging(T1CE)sequence,T2-weighted imaging(T2WI)sequence and fluid-attenuated inversion recovery(FLAIR)sequence,and the radiomics features were extracted for two regions of interest(ROIs)such as the tumor core region and the tumor edema region.Secondly,the data of the 317 GBM patients were randomly divided into a training set(254 cases)and a test set(63 cases),which underwent normalization with Z-scores and feature selection and dimensionality reduction with Lasso regression.Finally,three models were established respectively with particle swarm optimization-support vector machine(PSO-SVM),C-support vector classification(C-SVC)and adaptive boosting(adaptive boosting(Adaboost)algorithms,and the predictive efficacy of the three models for glioblastoma multiforme MGMT promoter methylation states were evaluated in terms of accuracy and AUC.Results The Adaboost model based on T2WI sequence and radiomics features of the tumor core region had the highest predictive efficacy with accuracy and AUC values of 67％and 0.74,respectively,higher than those of other combinations of sequences,models and regions of interest.Conclusion The multimodal MRI-based machine learning models can be used for the prediction of glioblastoma multiforme MGMT promoter methylation states,which provides powerful support for personalized treatment and prognostic assessment of GBM.[Chinese Medical Equipment Journal,2025,46(6):7-13]

OBJECTIVE: To evaluate the immediate effect of Kuanxiong Aerosol (KXA) on perioperative coronary microcirculation in patients with unstable angina (UA) suffering from elective percutaneous coronary intervention (PCI). METHODS: From February 2021 to July 2023, UA inpatients who underwent PCI alone in the left anterior descending (LAD) branch were included. Random numbers were generated to divide patients into the trial group and the control group at a ratio of 1:1. The index of coronary microcirculation resistance (IMR) was measured before PCI, and the trial group was given two sprays of KXA, while the control group was not given. IMR was measured again after PCI, cardiac troponin I (cTnI) and creatine kinase isoenzyme-MB (CK-MB) were detected before and 24 h after surgery, and major cardiovascular adverse events (MACEs) were recorded for 30 days. The data statistics and analysis personnel were blinded. RESULTS: Totally 859 patients were screened, and 62 of them were involved into this study. Finally, 1 patient in the trial group failed to complete the post-PCI IMR and was excluded, 30 patients were included for data analysis, while 31 patients in the control group were enrolled in data analysis. There was no significant difference in baseline data (age, gender, risk factors, previous history, biochemical index, and drug therapy, etc.) between the two groups. In addition, differences in IMR, cTnI and CK-MB were not statistically significant between the two groups before surgery. After PCI, the IMR level of the trial group was significantly lower than that of the control group (19.56 ± 14.37 vs. 27.15 ± 15.03, P=0.048). Besides, the incidence of perioperative myocardial injury (PMI) was lower in the trial group, but the difference was not statistically significant (6.67% vs. 16.13%, P=0.425). No MACEs were reported in either group. CONCLUSIONS KXA has the potential of improving coronary microvascular dysfunction. This study provides reference for the application of KXA in UA patients undergoing elective PCI. (Registration No. ChiCTR2300069831).
Humans ; Percutaneous Coronary Intervention ; Male ; Microcirculation/drug effects* ; Female ; Angina, Unstable/physiopathology* ; Pilot Projects ; Middle Aged ; Aged ; Drugs, Chinese Herbal/pharmacology* ; Aerosols ; Troponin I/blood* ; Coronary Circulation/drug effects* ; Elective Surgical Procedures

Mutations in the cyclin-dependent kinase-like 5 gene (CDKL5) cause a severe neurodevelopmental disorder, yet the impact of truncating mutations remains unclear. Here, we introduce the Cdkl5^492stop mouse model, mimicking C-terminal truncating mutations in patients. 492stop/Y mice exhibit altered dendritic spine morphology and spontaneous seizure-like behaviors, alongside other behavioral deficits. After creating cell lines with various Cdkl5 truncating mutations, we found that these mutations are regulated by the nonsense-mediated RNA decay pathway. Most truncating mutations result in CDKL5 protein loss, leading to multiple disease phenotypes, and offering new insights into the pathogenesis of CDKL5 disorder.
Animals ; Disease Models, Animal ; Mice ; Protein Serine-Threonine Kinases/deficiency* ; Mutation/genetics* ; Epileptic Syndromes/genetics* ; Humans ; Dendritic Spines/pathology* ; Spasms, Infantile/genetics* ; Male ; Seizures/genetics* ; Mice, Inbred C57BL

Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards* ; Humans ; Consensus ; Drugs, Chinese Herbal/therapeutic use* ; Surveys and Questionnaires

Primary ciliary dyskinesia (PCD) is a genetically heterogeneous disorder characterized by impaired motility of cilia and flagella. Mutations in cilia- and flagella-associated protein 300 ( CFAP300 ) are associated with human PCD and male infertility; however, the underlying pathogenic mechanisms remain poorly understood. In a consanguineous Chinese family, we identified a homozygous CFAP300 loss-of-function variant (c.304delC) in a proband presenting with classical PCD symptoms and severe sperm abnormalities, including dynein arm deficiency and acrosomal malformation, as confirmed by transmission electron microscopy (TEM). Histological analysis revealed multiple morphological abnormalities of the sperm flagella in CFAP300 -mutant individual, whereas immunofluorescence demonstrated markedly reduced CFAP300 expression in the spermatozoa of the proband. Furthermore, tandem mass tag (TMT)-based quantitative proteomics showed that the CFAP300 mutation reduced key spermatogenesis proteins (e.g., sperm flagellar 2 [SPEF2], solute carrier family 25 member 31 [SLC25A31], and A-kinase anchoring protein 3 [AKAP3]) and mitochondrial ATP synthesis factors (e.g., SLC25A31, cation channel sperm-associated 3 [CATSPER3]). It also triggered abnormal increases in autophagy-related proteins and signaling mediator phosphorylation. These molecular alterations are likely to contribute to progressive deterioration of sperm ultrastructure and function. Notably, successful pregnancy was achieved via intracytoplasmic sperm injection (ICSI) using the proband's sperm. Overall, this study expands the known CFAP300 mutational spectrum and offers novel mechanistic insights into its role in spermatogenesis.
Humans ; Male ; Infertility, Male/pathology* ; Acrosome/pathology* ; Sperm Tail/pathology* ; Pedigree ; Spermatozoa ; Adult ; Loss of Function Mutation ; Ciliary Motility Disorders/genetics* ; Spermatogenesis/genetics* ; Female

Aim To investigate the promotive effects and mechanisms of the combined use of brucine(Bru)and lumbrokinase(LK),active ingredient derived from Longma formula,in promoting chondrocyte proliferation via the Wnt/β-catenin signaling pathway.Methods The extracted primary rat chondrocytes were divided in-to the following groups:Control group,Bru,LK alone group,and Bro+LK combination group.The optimal drug concentration and intervention time were deter-mined using CCK-8 assay,followed by cell proliferation validation through EdU and phalloidin staining.The expression levels of collagen Ⅱ,aggrecan and SRY-re-lated high-mobility group box gene 9(SOX9)in chon-drocytes following intervention with the combination of Bru and LK were detected by Western blotting.Addi-tionally,the regulatory effects of these proteins on the Wnt/β-catenin signaling pathway were also investiga-ted.Results The optimal combination concentration of Longma formula active ingredients(Bru 0.025 mg·L-1+LK 5 mg·L-1)significantly enhanced chondro-cyte viability compared to control,Bru,or LK alone at 48 h.This combination increased the S-phase ratio,promoted the aggregation of intracellular actin fila-ments,and upregulated the expression of collagen Ⅱ and aggrecan.Furthermore,it activated the Wnt/β-catenin pathway,leading to increased SOX9 expres-sion.Conclusions The optimal combination of Bru and LK(Bru 0.025 mg·L-1+LK 5 mg·L-1)de-rived from Longma formula significantly maintains chondrocyte phenotype and promotes cellular prolifera-tion through the activation of the Wnt/β-catenin signa-ling pathway,which subsequently upregulates the downstream target SOX9.

Objective To explore the predictive efficacy of several multimodal MRI-based machine learning models for the promoter methylation states of O6-methylguanine-DNA methyltransferase(MGMT)of glioblastoma muliforme(GBM)patients in terms of the GBM heterogeneity and the complexity of the tumor microenvironment.Methods Firstly,the multimodal MRI images of 317 GBM patients from The University of Pennsylvania Glioblastoma(UPENN-GBM)dataset were pre-processed,with four sequences involved in including T1-weighted imaging(T1WI)sequence,T1-weighted contrast-enhanced imaging(T1CE)sequence,T2-weighted imaging(T2WI)sequence and fluid-attenuated inversion recovery(FLAIR)sequence,and the radiomics features were extracted for two regions of interest(ROIs)such as the tumor core region and the tumor edema region.Secondly,the data of the 317 GBM patients were randomly divided into a training set(254 cases)and a test set(63 cases),which underwent normalization with Z-scores and feature selection and dimensionality reduction with Lasso regression.Finally,three models were established respectively with particle swarm optimization-support vector machine(PSO-SVM),C-support vector classification(C-SVC)and adaptive boosting(adaptive boosting(Adaboost)algorithms,and the predictive efficacy of the three models for glioblastoma multiforme MGMT promoter methylation states were evaluated in terms of accuracy and AUC.Results The Adaboost model based on T2WI sequence and radiomics features of the tumor core region had the highest predictive efficacy with accuracy and AUC values of 67％and 0.74,respectively,higher than those of other combinations of sequences,models and regions of interest.Conclusion The multimodal MRI-based machine learning models can be used for the prediction of glioblastoma multiforme MGMT promoter methylation states,which provides powerful support for personalized treatment and prognostic assessment of GBM.[Chinese Medical Equipment Journal,2025,46(6):7-13]

Aim To investigate the promotive effects and mechanisms of the combined use of brucine(Bru)and lumbrokinase(LK),active ingredient derived from Longma formula,in promoting chondrocyte proliferation via the Wnt/β-catenin signaling pathway.Methods The extracted primary rat chondrocytes were divided in-to the following groups:Control group,Bru,LK alone group,and Bro+LK combination group.The optimal drug concentration and intervention time were deter-mined using CCK-8 assay,followed by cell proliferation validation through EdU and phalloidin staining.The expression levels of collagen Ⅱ,aggrecan and SRY-re-lated high-mobility group box gene 9(SOX9)in chon-drocytes following intervention with the combination of Bru and LK were detected by Western blotting.Addi-tionally,the regulatory effects of these proteins on the Wnt/β-catenin signaling pathway were also investiga-ted.Results The optimal combination concentration of Longma formula active ingredients(Bru 0.025 mg·L-1+LK 5 mg·L-1)significantly enhanced chondro-cyte viability compared to control,Bru,or LK alone at 48 h.This combination increased the S-phase ratio,promoted the aggregation of intracellular actin fila-ments,and upregulated the expression of collagen Ⅱ and aggrecan.Furthermore,it activated the Wnt/β-catenin pathway,leading to increased SOX9 expres-sion.Conclusions The optimal combination of Bru and LK(Bru 0.025 mg·L-1+LK 5 mg·L-1)de-rived from Longma formula significantly maintains chondrocyte phenotype and promotes cellular prolifera-tion through the activation of the Wnt/β-catenin signa-ling pathway,which subsequently upregulates the downstream target SOX9.

Objective:To study the changes in skeletal muscle and serum nutritional indicators during concurrent chemoradiotherapy in cervical cancer patients,and to evaluate their correlation with short-term efficacy and long-term prognosis. Methods:A retrospective analysis was conducted on 114 patients with cervical cancer who underwent radical concurrent chemoradiotherapy in the Department of Oncology,Nanjing Drum Tower Hospital from February 2019 to February 2023. All patients underwent a treatment regimen comprising external beam radiation (EBRT),internal radiation,and concurrent chemotherapy. Serum nutritional data of the patients were collected before radiotherapy,one week,two weeks and five weeks after the onset of radiotherapy. CT images of the patients at the time of simulation and about five weeks after the onset of radiotherapy were imported into the Pinnacle 39.10 planning system,and the skeletal muscle index (SMI) of the third lumbar vertebra (L3) were calculated for each patients. The changes of the serum nutritional indicators of the patients prior to and post EBRT were analyzed statistically. The patients are categorized into two groups according to the baseline SMI:a sarcopenic group consisting of 35 cases and a non-sarcopenic group comprising 79 cases. The therapeutic outcomes between the two groups were compared,and logistic analysis of the relevant factors affecting the occurrence of sarcopenia during radiotherapy was conducted. The survival curves were drawn using Kaplan-Meier method and disease-free survival (DFS) between the two groups was compared using Log Rank test. We used Cox univariate and multivariate regression analysis to identify prognostic factors related to DFS. Results:The serum nutritional indicators of the patient at one week,two weeks,and five weeks after the beginning of EBRT were significantly lower than those before radiotherapy (P<0.05). The SMI from the CT images of simulation at five weeks after the onset of radiotherapy was significantly lower than that before radiotherapy (P<0.001). There was a significant correlation between hemoglobin levels prior to radiotherapy and incidence of sarcopenia during radiotherapy (P=0.046). There was no significant difference in efficacy between the two groups at the end of EBRT (P>0.05). At the end of radiotherapy,the complete response (CR) rate of the non-sarcopenia group was significantly higher than that of the sarcopenia group (P=0.040). However,the objective response rate (ORR) and disease control rate (DCR) of both groups at the end of radiotherapy were 100％. The 2-year DFS of the sarcopenia group and the non-sarcopenia group were 66.7％ and 85.5％,respectively,and the difference was statistically significant (P=0.016). Only four patients died during the 2-year follow-up,so OS was not reached. Baseline SMI,serum squamous cell antigen levels prior to radiotherapy,and degree of bone marrow suppression were three independent prognostic factors affecting DFS in the patients. Conclusion:Cervical cancer patients experience significant nutritional loss during chemoradiotherapy,and baseline SMI is significantly correlated with short-term efficacy and long-term prognosis and can serve as a predictive marker for patients with cervical cancer receiving chemoradiotherapy.