In recent years, with the development of big data application technology, the real-world data and the corresponding generated real-world evidence have attracted the attention of healthcare regulatory authorities around the world. Regulators recognize that real-world research with specific purposes using real-world data can provide important evidence for regulatory decisions. A total of 90 instances of publicly released on the application of real-world evidence to support regulatory decisions of U. S. Food and Drug Administration are explored, and the positioning and value of real-world evidence in U. S. Food and Drug Administration regulatory decisions are summarized and analyzed, providing references for the use of real-world data and real-world evidence to promote medical devices whole cycle regulation in China.
United States ; United States Food and Drug Administration ; Equipment and Supplies ; Device Approval ; China

OBJECTIVES: In recent years, the incidence and detection rate of pancreatic cystic lesions (PCLs) have increased significantly. Endoscopic ultrasound (EUS) plays an indispensable role in the diagnosis and differential diagnosis of PCLs. However, evidence comparing the diagnostic performance of EUS-guided fine-needle aspiration (EUS-FNA) and fine-needle biopsy (FNB) remains limited. This study aims to compare the diagnostic yield, adequacy of tissue acquisition, and safety between EUS-FNA and EUS-FNB in evaluating PCLs to inform clinical practice. METHODS: A retrospective review was conducted on patients with PCLs who underwent either EUS-FNA or EUS-FNB between January 2014 and August 2021. The diagnostic yield, tissue acquisition adequacy, and incidence of adverse events were compared between the 2 groups. RESULTS: A total of 90 patients with PCLs were included (52 in the FNA group and 38 in the FNB group). The diagnostic yield was similar between the FNA and FNB groups (94.2% vs 94.7%, P>0.05). The adequacy of tissue acquisition was 71.2% in the FNA group and 81.6% in the FNB group (P>0.05). No statistically significant difference was observed in the incidence of adverse events between the 2 groups (P>0.05). CONCLUSIONS Both EUS-FNA and EUS-FNB demonstrate equally high diagnostic yields and tissue adequacy in PCLs, with excellent safety profiles. Both methods are safe and effective diagnostic tools for evaluating PCLs.
Humans ; Endoscopic Ultrasound-Guided Fine Needle Aspiration/adverse effects* ; Retrospective Studies ; Female ; Male ; Pancreatic Cyst/diagnostic imaging* ; Middle Aged ; Biopsy, Fine-Needle/adverse effects* ; Aged ; Pancreatic Neoplasms/diagnosis* ; Adult ; Endosonography/methods* ; Pancreas/pathology* ; Diagnosis, Differential

Patients with periodontal disease often require combined periodontal-orthodontic interventions to restore periodontal health, function, and aesthetics, ensuring both patient satisfaction and long-term stability. Managing these patients involving orthodontic tooth movement can be particularly challenging due to compromised periodontal soft and hard tissues, especially in severe cases. Therefore, close collaboration between orthodontists and periodontists for comprehensive diagnosis and sequential treatment, along with diligent patient compliance throughout the entire process, is crucial for achieving favorable treatment outcomes. Moreover, long-term orthodontic retention and periodontal follow-up are essential to sustain treatment success. This expert consensus, informed by the latest clinical research and practical experience, addresses clinical considerations for orthodontic treatment of periodontal patients, delineating indications, objectives, procedures, and principles with the aim of providing clear and practical guidance for clinical practitioners.
Humans ; Consensus ; Orthodontics, Corrective/standards* ; Periodontal Diseases/complications* ; Tooth Movement Techniques/methods* ; Practice Guidelines as Topic

Objective To explore the barriers to postoperative self-management behaviors in patients with pituitary adenoma and provide a theoretical basis for developing nursing intervention strategies.Methods Using a purposive sampling method,16 postoperative pituitary adenoma patients admitted to a tertiary hospital in Zhengzhou from July 2024 to January 2025 were selected for semi-structured interviews.The interview data were analyzed and refined through Colaizzi's phenomenological analysis method.Results A total of 4 themes and 12 subthemes were extracted,including postoperative physiological dysfunction(sensory dysfunction,difficulty in managing diabetes insipidus,fatigue syndrome),psychosocial adaptation barriers(self-image distress,fear of disease recurrence,restricted information delivery),challenges in maintaining health behaviors(environment-behavior conflicts,insufficient adherence to medication and activity guidelines,inadequate complication management),deficiencies in support systems(non-specific postoperative guidance,poor communication channels,insufficient coordination of medical resources).Conclusion Postoperative self-management behaviors in pituitary adenoma patients are influenced by multidimensional factors,necessitating comprehensive intervention strategies addressing physiological,psychological,behavioral,and systemic support levels.

Objective:To assess the clinical value of digital PCR (dPCR) for the prenatal diagnosis of common fetal aneuploidies.Methods:A dPCR-based assay was developed for detecting trisomies 21, 18, and 13. A retrospective analysis was carried out on 173 amniotic fluid samples collected by the Prenatal Diagnosis Center of Taizhou Hospital between January 2017 and December 2023. By using chromosomal karyotyping as the gold standard, the diagnostic performance of the multiplex dPCR system was evaluated in a double-blind manner. This study has been approved by the Ethics Committee of Taizhou Hospital (Ethics No. K20250339).Results:Chromosomal karyotyping has identified 59 cases of trisomy 21, 5 cases of trisomy 18, 2 cases of trisomy 13, 6 cases with chromosomal structural abnormalities or mosaicisms, and 101 cases with a normal karyotype. The dPCR results ( Z-score cutoff = 4.0, CI = 99.997%) showed full concordance with karyotyping (sensitivity = 100%, specificity = 100%, Kappa = 1). Among the 6 structurally abnormal or mosaicism samples, dPCR has accurately detected 4 cases, but mis-classified 2 cases of trisomy 21 with very low-level mosaicisms (3.3%, 6.9%, respectively) as normal. Conclusion:The established multiplex dPCR system demonstrated high diagnostic accuracy for common chromosomal aneuploidies, with results available within 24 hours. It can serve as an efficient supplementary tool to conventional chromosomal karyotyping, providing reliable support for time-sensitive clinical decision-making in prenatal diagnosis.

Objective To explore the medication law of Professor Zhao Jinxi in the treatment of diabetic kidney disease(DKD).Methods The outpatient prescriptions of Professor Zhao Jinxi from Dongzhimen Hospital of Beijing University of Chinese Medicine in the treatment of DKD were collected from Jan 2021 to May 2024.The Ancient and Modern Medical Case Cloud Platform 2.3.9,Origin 2024,R 4.4.2,SPSS Modeler 18.0,SPSS Statistics 26.0 and Cytoscape 3.10.2 were used to count the frequency,property and taste,meridian tropism,efficacy and dosage of drugs.Association rules,complex networks and clustering analysis were carried out.Results Totally 1 168 prescriptions were included,involving 237 kinds of Chinese materia medica.The high-frequency drugs were Astragali Radix,Salviea Miltiorrhizae Radix et Rhizoma,Dioscoreae Spongiosae Rhizoma,Smilacis Glabrae Rhizoma,etc.The medicinal properties were mostly warm,neutral and cold.The medicinal tastes were mainly bitter,sweet and pungent.They mainly belonged to the liver meridian,spleen meridian and lung meridian.The efficacy was mainly heat-clearing drugs,tonic drugs,and water-clearing and dampness-percolating drugs.18 and 12 drug combinations were obtained by association rules and cluster analysis,respectively.Conclusion Professor Zhao Jinxi's treatment of DKD pays attention to the formation of pathogenesis of"micro abdominal mass",emphasizes"treatment from wind",commonly uses"five methods of kidney treatment"such as tonifying qi,activating blood circulation,dispelling wind,promoting qi and detoxification,and attaches importance to the treatment idea of"three-dimension maintenance kidney",which can provide references for clinical treatment of DKD.

Objective:To study the cardiac morphology and function of fetuses with different types of complete transposition of the great arteries（cTGA）by using fetal heart quantification（fetal HQ）.Methods:A retrospective study was conducted on 50 fetuses diagnosed with cTGA through fetal echocardiography at Sir Run Run Shaw Hospital，Zhejiang University School of Medicine from July 2020 to December 2024. These cases were categorized into simple cTGA group（ n=31）and complex cTGA group（ n=19）based on the presence of concomitant cardiac anomalies. A control group of 160 normal fetuses with matched gestational ages was selected for comparison. Utilizing fetal HQ technology，the cardiac longitudinal diameter，transverse diameter，area，global sphericity index（GSI），left and right ventricular end-diastolic area（LVEDA，RVEDA），left and right ventricular fractional area change（LVFAC，RVFAC），left and right ventricular global longitudinal strain（LVGLS，RVGLS），and segmental sphericity index of 24 segments for both left and right ventricles（LVSI，RVSI）were measured. The analysis focused on comparing the differences among the simple cTGA group，complex cTGA group，and the control group. Results:Compared to the control group，the simple cTGA group exhibited significantly lower fetal GSI，LVEDA，RVFAC，and RVGLS（all P<0.05）. Statistically significant differences were observed in LVSI segments 1-4 and 10-17，as well as RVSI segments 1-7，9，and 15-23 compared to the control group（all P<0.05）. In comparison with the control group，the complex cTGA group demonstrated significantly reduced fetal GSI，LVFAC，LVGLS，RVFAC，and RVGLS（all P<0.05）. Significant differences were noted in LVSI segments 5-8 and 10-14，along with RVSI segments 1-14 and 24 compared to the control group（all P<0.05）. When compared to the simple cTGA group，the complex cTGA group showed significantly lower LVFAC，LVGLS，RVFAC，and RVGLS（all P<0.05），while GSI and LVEDA were significantly higher（all P<0.05）. Statistically significant differences were observed in LVSI segments 3-4，6-8，and 17，as well as RVSI segments 10-19 between the complex cTGA group and the simple cTGA group（all P<0.05）. Conclusions:The comprehensive parameters provided by Fetal HQ facilitate the assessment of cardiac morphology and function in cTGA fetuses，enabling a deeper understanding of the alterations in cardiac structure and function across different types of cTGA. This advanced analysis offers valuable reference information for clinical guidance during pregnancy.

Objective To investigate the correlation between cognitive impairment and depression in elderly patients with type 2 diabetes mellitus(T2DM).Methods Based on China Health and Retirement Longitudinal Study in 2011,totally 521 elderly T2DM patients were enrolled,and according to the results of minimum mental state examination(MMSE)and their education lev-els,they were divided into a cognitively impaired group(437 cases)and a cognitively normal group(84 cases).Center for ED Epidemiological Survey Depression Scale was used to assess the depression symptoms.The correlation between cognitive impairment and depression was analyzed.Results Compared with the cognitively normal group,the cognitively impaired group had signifi-cantly advanced age(71.98±5.29 year vs 69.42±3.98 year,P=0.000),larger proportion of de-pression(60.6％vs 35.7％,P=0.000),and higher C-reactive protein level(5.09±12.80 mg/L vs 2.25±2.43 mg/L,P=0.000),and obviously lower ratios of being married(72.1％vs 86.9％,P=0.001)and having cardiovascular disease(20.1％vs 32.1％,P=0.010),and decreased estimated glomerular filtration rate[77.15±15.88 ml/(min·1.73 m2)vs 81.91±13.55 ml/(min·1.73 m2),P=0.001].Multivariate logistic regression analysis showed that cognitive impairment was an independent risk factor for the development of depression in elderly T2DM patients(OR=3.44,95％CI:1.89-6.27,P＜0.01).ROC curve analysis indicated that the AUC value of MMSE score in predicting depression in elderly T2DM patients was 0.669(95％CI:0.626-0.709,P＜0.01).The direct effect of cognitive impairment and the mediating effect of loneliness on depression in elderly T2DM patients accounted for 72.22％and 27.78％of the total effect,respectively.Conclu-sion Cognitive impairment is associated with the presence of depression in elderly T2DM pa-tients,and loneliness plays a mediating role.

The incidence rate of coronary atherosclerotic heart disease(commonly referred to as coronary heart disease)remains high in China.In clinical practice,drug therapy,percutaneous coronary intervention(PCI),and coronary artery bypass grafting(CABG)are commonly employed.For patients with multi-vessel coronary artery stenosis,minimally invasive interventional therapy is often the preferred option.However,for those with multi-vessel disease complicated by comorbidities,CABG is generally recommended.Despite its advantages,PCI carries risks such as vascular restenosis,thrombosis,and other adverse events.Consequently,hybrid coronary revascularization(HCR)has emerged as an alternative approach.This paper provides an overview of coronary heart disease and re-views the advantages,applications,and patient selection criteria for HCR.

Objective To analyze the effect of Callicarpa nudiflora on wound healing and phos-phatidylinositol-3-kinase/protein kinase B/mammalian target of rapamycin(PI3K/AKT/mTOR)path-way by regulating M2 macrophage polarization in rats with diabetic foot ulcer.Methods A total of 40 rats were selected,with 10 rats in control group(topical application of saline),and the remaining 30 were used to establish rat model of diabetic foot ulcer.Ultimately,27 rats were successfully mod-eled and divided into model group(topical application of saline),Callicarpa nudiflora group(topi-cal application of Callicarpa nudiflora),and Callicarpa nudiflora combined with inhibitor group(topical application of Callicarpa nudiflora combined with CD206 inhibitor,a marker protein of M2 macrophages),with 9 rats in each group.The wound healing rate,levels of basic fibroblast growth factor(bFGF)and vascular endothelial growth factor(VEGF),relative expression levels of induc-ible nitric oxide synthase(iNOS),CD16/32,CD206,PI3K,AKT and mTOR as well as mRNA ex-pression levels of PI3K,AKT and mTOR were compared among groups.Results On the 3rd,7th and 14th days after intervention,compared with the control group,the wound healing rate,VEGF,bFGF,relative expression level of CD206,relative expression of PI3K,AKT and mTOR at mRNA and protein levels were significantly decreased while the relative expression levels of iNOS and CD16/32 were significantly increased in all other groups(P＜0.05);compared with the model group,the Callicarpa nudiflora group and the Callicarpa nudiflora combined with inhibitor group showed significant increased wound healing rate,VEGF,bFGF,relative expression level of CD206,and relative expression of PI3K,AKT and mTOR at mRNA and protein levels,and significant de-creased relative expression levels of iNOS and CD16/32(P＜0.05);compared with the Callicarpa nudiflora group,the Callicarpa nudiflora combined with inhibitor group showed significant decreased wound healing rate,VEGF,bFGF,relative expression level of CD206,and relative expression of PI3K,AKT and mTOR at mRNA and protein levels,and significant increased relative expression levels of iNOS and CD16/32(P＜0.05).Conclusion Callicarpa nudiflora can promote M2 mac-rophage polarization,increase wound healing rate and levels of VEGF and bFGF in rats with diabetic foot ulcer,and activate the PI3K/AKT/mTOR signaling pathway.