To provide auxiliary decision-making support to improve incentive policies for pediatric drug development and approval, we systematically review the current status of research on and approval of anti-epileptic drugs (AEDs) for children at home and abroad, and comprehensively analyze the existing barriers in China’s pediatric AED development and market approval process. Findings reveal that China lags behind some countries and regions included in this comparative study (United State of America, European Union, Japan and Australia, etc.) in terms of research and development (R&D) capability and progress in pediatric AEDs, with significant disparity in the diversity of approved drugs, formulations, and dosage forms. It is recommended that China enhance its policy support for R&D, optimize the drug evaluation and approval system, strengthen the management of drug allocation and utilization, promote rational drug use, reinforce post-marketing incentive policies and help foster a more favorable policy environment for the development and approval of pediatric medications.

Inflammatory bowel disease (IBD) is an idiopathic intestinal inflammatory condition with chronic and relapsing manifestations and is characterized by a disturbance in the interplay between the intestinal microbiota, the gut, and the brain. The microbiota-gut-brain axis involves interactions among the nervous system, the neuroendocrine system, the gut microbiota, and the host immune system. Increasing published data indicate that psychological stress exacerbates the severity of IBD due to its negative effects on the microbiota-gut-brain axis, including alterations in the stress response of the hypothalamic-pituitary-adrenal (HPA) axis, the balance between the sympathetic nervous system and vagus nerves, the homeostasis of the intestinal flora and metabolites, and normal intestinal immunity and permeability. Although the current evidence is insufficient, psychotropic agents, psychotherapies, and interventions targeting the microbiota-gut-brain axis show the potential to improve symptoms and quality of life in IBD patients. Therefore, further studies that translate recent findings into therapeutic approaches that improve both physical and psychological well-being are needed.
Humans ; Inflammatory Bowel Diseases/metabolism* ; Stress, Psychological/microbiology* ; Gastrointestinal Microbiome/physiology* ; Brain/metabolism* ; Hypothalamo-Hypophyseal System ; Pituitary-Adrenal System ; Animals

Aim To investigate the association of triglyceride-glucose(TyG)index with microvascular obstruction(MVO)after percutaneous coronary intervention(PCI)in patients with ST-segment elevated myocardial infarction(STEMI).Methods Individual patient-data were pooled from 310 patients with STEMI underwent emergency PCI in Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School from June 2018 to June 2021 for a prospective analysis.A week following the operation,cardiac magnetic resonance imaging was used to evaluate the MVO region and the patients were divided into two groups based on whether MVO occured after PCI:the MVO group(n=183)and the non-MVO group(n=127).The clinical data of the two groups were compared,and the linear relationship between TyG index and MVO was described using restricted cubic splines(RCS).Univariate and multivariate Logistic regression analysis were used to correct for confounding factors and identify independent risk factors for MVO occurrence.Results After adjustment for confounding factors,TyG index was an independent risk factor for MVO after emergency PCI in STEMI patients,and every 1-unit increased in TyG index,the risk of MVO increased by 1.24 times(OR=2.24,95％CI:1.07～4.71,P=0.033).The RCS curve analysis results showed that there was a linear re-lationship between the TyG index and the occurrence of MVO after emergency PCI(non-linear correlation test P=0.47).When the TyG index was greater than 9.5,the risk of MVO after emergency PCI significantly increased.Conclusion An increased TyG index is postively associated with the incidence of MVO in STEMI patients who have undergone PCI,and has clinical significantce for early prevention and risk stratification of MVO in STEMI patients.

To explore the cultivation path of excellent physicians in regional medical universities, a horizontal integration of clinical courses was performed to construct a curriculum centered on systemic diseases. Clinical courses adopted bedside rotation teaching with small class (30-40 students, 3-4 students/group). A comprehensive approach was designed and implemented, covering overall framework, organizational guarantee, teaching arrangement, teaching method, and assessment system. The effectiveness of the reform was evaluated through the comprehensive exams during the basic stage and national clinical medicine proficiency test. Despite no significant differences in the basic stage, the national clinical medicine proficiency test scores of the C2E class with teaching reform increased continuously from 2017 to 2020. The theoretical examination score of the C2E class was higher than that of regular classes 1 in 2017, 2019, and 2020. With continuous optimization, the skill examination score of the C2E class was significantly higher than that of regular class 1 in 2020. These findings highlight the effectiveness of the teaching reform and provide a foundation for the teaching reform of large class in five-year clinical medicine programs.

Aim To investigate the association of triglyceride-glucose(TyG)index with microvascular obstruction(MVO)after percutaneous coronary intervention(PCI)in patients with ST-segment elevated myocardial infarction(STEMI).Methods Individual patient-data were pooled from 310 patients with STEMI underwent emergency PCI in Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School from June 2018 to June 2021 for a prospective analysis.A week following the operation,cardiac magnetic resonance imaging was used to evaluate the MVO region and the patients were divided into two groups based on whether MVO occured after PCI:the MVO group(n=183)and the non-MVO group(n=127).The clinical data of the two groups were compared,and the linear relationship between TyG index and MVO was described using restricted cubic splines(RCS).Univariate and multivariate Logistic regression analysis were used to correct for confounding factors and identify independent risk factors for MVO occurrence.Results After adjustment for confounding factors,TyG index was an independent risk factor for MVO after emergency PCI in STEMI patients,and every 1-unit increased in TyG index,the risk of MVO increased by 1.24 times(OR=2.24,95％CI:1.07～4.71,P=0.033).The RCS curve analysis results showed that there was a linear re-lationship between the TyG index and the occurrence of MVO after emergency PCI(non-linear correlation test P=0.47).When the TyG index was greater than 9.5,the risk of MVO after emergency PCI significantly increased.Conclusion An increased TyG index is postively associated with the incidence of MVO in STEMI patients who have undergone PCI,and has clinical significantce for early prevention and risk stratification of MVO in STEMI patients.

To explore the cultivation path of excellent physicians in regional medical universities, a horizontal integration of clinical courses was performed to construct a curriculum centered on systemic diseases. Clinical courses adopted bedside rotation teaching with small class (30-40 students, 3-4 students/group). A comprehensive approach was designed and implemented, covering overall framework, organizational guarantee, teaching arrangement, teaching method, and assessment system. The effectiveness of the reform was evaluated through the comprehensive exams during the basic stage and national clinical medicine proficiency test. Despite no significant differences in the basic stage, the national clinical medicine proficiency test scores of the C2E class with teaching reform increased continuously from 2017 to 2020. The theoretical examination score of the C2E class was higher than that of regular classes 1 in 2017, 2019, and 2020. With continuous optimization, the skill examination score of the C2E class was significantly higher than that of regular class 1 in 2020. These findings highlight the effectiveness of the teaching reform and provide a foundation for the teaching reform of large class in five-year clinical medicine programs.

Liver biopsy is an important means of clinical diagnosis and treatment of liver diseases, but it is not easily accepted by patients because of its invasiveness. The most commonly employed liver biopsy approaches are percutaneous or transjugular. Endoscopic ultrasound-guided liver biopsy (EUS-LB), a newly emerging transjugular technique, has been widely studied and applied in recent years, but its application in China is less common. The EUS-LB has the advantages of high safety and comfort, simultaneous sampling of both liver lobes, and adequate sampling volume; however, it also has the disadvantages of high requirements for hardware, operators, and cost. This article reviews the clinical application of EUS-LB in accordance with pertinent research findings from recent years and discusses its advantages, disadvantages, and implementation feasibility.

This article reports a case using China's self-developed HaloStitch? system to complete a percutaneous suture-mediated patent foramen ovale closure under ultrasound guidance alone,achieving outstanding clinical outcomes.This innovative method represents a new approach to patent foramen ovale treatment and is an ideal surgical technique.

Hereditary hemochromatosis is a rare autosomal genetic disorder that can cause multi-organ dysfunction in the liver,pancreas,spleen,heart and pituitary gland,with diverse clinical manifestations,make the diagnosis difficult.In recent years,with the deepening of clinical understanding and the development of genetic diagnosis tools,the diagnostic rate of this disease has increased significantly.In this paper,we report a case of hereditary hemochromatosis type 3 involving multiple organs and complicated by severe heart failure,aiming to improve the clinicians'understanding of this disease and reduce the leakage and misdiagnosis.

OBJECTIVE To provide a reference for strengthening the post-admission management of drugs on the medicare formulary in China. METHODS The basic situation， implementation process and effect of post-market reviews （PMR） were introduced after marketing approval of the Australian pharmaceutical benefits scheme （PBS） subsidized medicines. The suggestions were put forward for post-admission management of medicare formulary drugs in China. RESULTS & CONCLUSIONS PMR system exemplified Australia’s concept of life-cycle management of medicines on the PBS catalogue； as a mechanism for managing the admission and adjustment of PBS medicines， it provided a continuous evaluation of medicines in the PBS catalogue； the process mainly included two types： the pre-initiation process of PBS drug review and the PBS drug review process， involving steps such as drug selection， determination of review scope， and implementation management. Through PMR， Australia had completed the review of multiple medicines in nine treatment areas including diabetes， childhood asthma and Alzheimer’s disease in the PBS catalogue. The author suggests that China can improve the post-admission review of medicines at the institutional level （clarifying the selection criteria and methods of the review object， main procedures and responsible parties， and ensuring the transparency of the review process）； specify the National Healthcare Security Administration or the third-party organization until a special technical organization is established to take charge of this work； at the same time， further improve the construction of data collection and monitoring systems.