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

In recent years, the high temperature and heatwaves have seriously affected the health of Chinese residents, and there is an important need for public health protection guidelines for high temperature and heatwaves in China. The National Bureau of Disease Control and Prevention has organized experts to fully investigate the evidence from epidemiological research on the health of populations in high temperature and heatwaves globally and in China, analyze the health hazards and protection needs of different populations, and put forward practical and effective individual protection measures and health recommendations. For this reason, the "Guideline for Public Health Protection against High Temperature and Heatwaves" (referred to as the "Guideline") was officially issued in June 2023. This article interprets the background and significance of the Guideline, the principles of compilation, the main considerations, the main contents, the implementations and promotions and other aspects, to improve the understanding of the content of the Guideline and strengthen the publicity and implementations.

Background::There is a need for effective and safe therapies for psoriasis that provide sustained benefits. The aim of this study was to assess the efficacy and safety of tildrakizumab, an anti-interleukin-23p19 monoclonal antibody, for treating moderate-to-severe plaque psoriasis in Chinese patients.Methods::In this multi-center, double-blind, phase III trial, patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned (1:1) to receive subcutaneous tildrakizumab 100 mg or placebo at weeks 0 and 4. Patients initially assigned to placebo were switched to receive tildrakizumab at weeks 12, 16, and every 12 weeks thereafter. Patients in the tildrakizumab group continued with tildrakizumab at week 16, and every 12 weeks until week 52. The primary endpoint was the Psoriasis Area and Severity Index (PASI 75) response rate at week 12.Results::At week 12, tildrakizumab demonstrated significantly higher PASI 75 response rates (66.4% [73/110] vs. 12.7% [14/110]; difference, 51.4% [95% confidence interval (CI), 40.72, 62.13]; P <0.001) and Physician’s Global Assessment (60.9% [67/110] vs. 10.0% [11/110]; difference, 49.1% [95% CI, 38.64, 59.62]; P <0.001) compared to placebo. PASI 75 response continued to improve over time in both tildrakizumab and placebo-switching to tildrakizumab groups, reaching maximal efficacy after 28 weeks (86.8% [92/106] vs. 82.4% [89/108]) and maintained up to 52 weeks (91.3% [95/104] vs. 87.4% [90/103]). Most treatment-emergent adverse events were mild and not related to tildrakizumab. Conclusion::Tildrakizumab demonstrated durable efficacy through week 52 and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.Trial registration::ClinicalTrials.gov, NCT05108766.

In recent years, the high temperature and heatwaves have seriously affected the health of Chinese residents, and there is an important need for public health protection guidelines for high temperature and heatwaves in China. The National Bureau of Disease Control and Prevention has organized experts to fully investigate the evidence from epidemiological research on the health of populations in high temperature and heatwaves globally and in China, analyze the health hazards and protection needs of different populations, and put forward practical and effective individual protection measures and health recommendations. For this reason, the "Guideline for Public Health Protection against High Temperature and Heatwaves" (referred to as the "Guideline") was officially issued in June 2023. This article interprets the background and significance of the Guideline, the principles of compilation, the main considerations, the main contents, the implementations and promotions and other aspects, to improve the understanding of the content of the Guideline and strengthen the publicity and implementations.

Due to the limited reliability of traditional self-completed questionnaire, the accuracy of measurement of physical behaviors (physical activity, sedentary behavior and sleep) is not high. With the development of technology, wearable devices (e.g. accelerometer) can be used for more accurate measurement of physical behaviors and have great application potential in large-scale research. However, the data of objective measurement of physical behaviors from large-scale cohort research in Asian populations is still limited. Between August 2020 and December 2021, the 3 rd resurvey of China Kadoorie Biobank (CKB) project used Axivity AX3 wrist triaxial accelerometer to collect the data of participants' daily activity and sleep status. A total of 20 370 participants from 10 study areas were included in the study, in whom 65.2% were women, and the age was (65.4±9.1) years. The participants' physical activity level varied greatly in different study areas. The objective measurement of participants' physical behaviors in CKB project has provided valuable resources for the description of 24-hour patterns of physical behaviors and evaluation of the health effect of physical activity, sedentary behavior and sleep as well as their association with diseases in the elderly in China.

BACKGROUND:microRNA-26b(miR-26b)plays an important regulatory role in a variety of stem cell functions,but its effects on the biological properties of stem cells from human exfoliated deciduous teeth and human umbilical cord mesenchymal stem cells are unknown. OBJECTIVE:To investigate the effects of miR-26b on the proliferation,migration and osteogenic differentiation of stem cells from human exfoliated deciduous teeth and human umbilical cord mesenchymal stem cells. METHODS:Stem cells from human exfoliated deciduous teeth and human umbilical cord mesenchymal stem cells were cultured and identified.miR-26 mimics(experimental group)and miRNAs mimics control(control group)were used to transfect above mentioned two kinds of cells and construct overexpressed models for subsequent experiments.CCK-8 assay was applied to detect the proliferation ability of overexpressed miR-26b cells.Transwell and scratch assay were employed to analyze the migration ability of overexpressed miR-26b cells.RT-qPCR was utilized to examine the expression of osteogenic markers after osteogenic induction of overexpressed miR-26b cells. RESULTS AND CONCLUSION:(1)Transfection of miR-26b mimics increased miR-26b expression in the two kinds of cells and promoted the proliferation of stem cells from human exfoliated deciduous teeth,with no significant effect on the amplification of human umbilical cord mesenchymal stem cells.(2)Compared with the control group,the migration ability was enhanced after two types of cells overexpressing miR-26b.(3)miR-26b expression decreased during osteogenic differentiation of the two kinds of cells.(4)Compared with the control group,the levels of osteogenesis-related genes osteocalcin,osteopontin,alkaline phosphatase,and human type I collagen mRNA were downregulated after overexpression of miR-26b in the two kinds of cells.The results showed that overexpression of miR-26b promoted the proliferation and migration of stem cells from human exfoliated deciduous teeth and inhibited their osteogenic differentiation;it promoted the migration of human umbilical cord mesenchymal stem cells and inhibited their osteogenic differentiation,but had no significant effects on their proliferation.

Objective To observe the effects of Jianpi Qutan Huayu Prescription on oxidative stress and inflammatory response in mini-pigs with atherosclerosis(AS);To explore its mechanism based on the NOX5-ERK1/2 signaling pathway.Methods Twelve Bama mini-pigs were randomly divided into control group,model group,and Jianpi Qutan Huayu Prescription low-and high-dosage groups,with 3 pigs in each group.A high-fat diet was used to feed for 24 weeks to construct an AS model,and the treatment group was also supplemented with Jianpi Qutan Huayu Prescription in the feed.The general condition of mini-pigs(body length,abdominal circumference,body mass,food intake,and fecal water content)was measured at week 0,16,and 24 of administration,HE staining was used to observe the morphology of aortic tissue,while oil red O staining was used to observe lipid deposition in aortic and myocardial tissue,transmission electron microscopy was used to observe the ultrastructure of aortic tissue,and a fully automated biochemical analyzer was used to detect serum contents of TC,HDL-C,and LDL-C.ELISA was used to detect the contents of serum reactive oxygen species(ROS),interleukin(IL)-6,IL-10,tumor necrosis factor(TNF)-α,hypersensitivity-C-reactive protein(hs-CRP),vascular cell adhesion molecule-1(VCAM-1),and intercellular adhesion molecule-1(ICAM-1).Western blot was used to detect the expressions of NADPH oxidase 5(NOX5),extracellular signal regulated kinase 1/2(ERK1/2),p-ERK1/2,VCAM-1,and proliferating cell nuclear antigen(PCNA)proteins.Results Compared with the control group,the abdominal circumference,body mass,and food intake of mini-pigs in the model group increased at 16 and 24 weeks(P<0.01),there was significant thickening of the inner membrane of aorta,destruction of endothelial cells,lipid deposition,edema of smooth muscle cells,and significant swelling of mitochondria,serum TC,LDL-C contents and the contents of ROS,IL-6,IL-10,TNF-α,hs-CRP,VCAM-1,and ICAM-1 increased,while the content of HDL-C decreased(P<0.01);the expressions of NOX5,p-ERK1/2,VCAM-1,and PCNA proteins in aortic tissue increased(P<0.01).Compared with the model group,Jianpi Qutan Huayu Prescription low-and high-dosage groups showed a decrease in abdominal circumference,body mass,and food intake at 16 and 24 weeks(P<0.05,P<0.01),the plaque area and lipid deposition were reduced,and the damage to endothelial cells was alleviated,serum TC,LDL-C contents and the contents of ROS,IL-6,IL-10,TNF-α,hs-CRP,ICAM-1,and VCAM-1 decreased,and the content of HDL-C increased(P<0.01,P<0.05);the expressiond of NOX5,p-ERK1/2,VCAM-1,and PCNA proteins in aortic tissue decreased(P<0.01,P<0.05).Conclusion Jianpi Qutan Huayu Prescription can effectively alleviate AS in mini-pigs,and its mechanism may be related to inhibiting the activation of the NOX5-ERK1/2 signaling pathway and alleviating oxidative stress-induced inflammatory response.

Objectives:Present study aimed to use quantitative flow ratio based on Murray's law to analyze the risk factors of impaired side branches perfusion without naked eye visible slowing of blood flow in branches after interventional treatment of true bifurcation lesions of the coronary arteries. Methods:A total of 211 patients with non-left main coronary artery true bifurcation coronary artery disease who underwent percutaneous coronary intervention(PCI)in Hunan Provincial People's Hospital from June 2022 to September 2023 were continuously enrolled,with a total of 234 bifurcation lesions.The general clinical indicators,anatomical characteristics of coronary artery bifurcation lesions,branch protection methods,postoperative branch TIMI blood flow and other data were collected,and quantitative flow ratio(μQFR)was measured for postoperative branch blood vessels.Post-PCI μQFR<0.8 was considered as impaired branch perfusion and was included in the postoperative impaired branch perfusion group(n=51,53 branch lesions).Patients with μQFR≥0.8 were included in the postoperative normal branch perfusion group(n=160,181 branch lesions).Multivariate Logistic regression analysis was used to evaluate the effects of various clinical and anatomical factors on branch perfusion after PCI. Results:The post-PCI branch flow grading of all patients was TIMI grade Ⅲ.The postoperative branch μQFR of 53 vessels(22.6％)in the group with impaired postoperative branch perfusion was 0.70±0.10,and 0.93±0.05 in the group with normal postoperative branch perfusion,and the difference between the two groups was statistically significant(P<0.001).Compared with the postoperative group with normal branch perfusion,the postoperative group with impaired branch perfusion was featured with an elevated branch lesion length,branch reference diameter,postoperative branch opening diameter stenosis rate,postoperative branch narrowest lumen diameter stenosis rate,and a lower main branch-to-branch diameter ratio,preoperative branch narrowest lumen diameter stenosis rate,and preoperative main branch μQFR,all of which were statistically significant(all P<0.05).The postoperative branch opening diameter stenosis rate(r=-0.490,P<0.001),postoperative branch narrowest lumen diameter stenosis rate(r=-0.788,P<0.001),preoperative branch narrowest lumen diameter stenosis rate(r=-0.280,P<0.001),branch narrowest lumen diameter(r=-0.469,P<0.001),branch lesion length(r=-0.157,P=0.016)were negatively correlated with postoperative branch μQFR,and branch reference diameter(r=0.173,P=0.008),main branch/side branch diameter ratio(r=0.194,P=0.003),and branch opening diameter(r=0.328,P<0.001)were positively correlated with postoperative branch μQFR,and none of them were significantly correlated with clinical baseline data(all P>0.05).Multifactorial logistic regression analysis showed that following four factors were independent risk factors for impaired branch perfusion:postoperative stenosis of the narrowest branch lumen diameter(OR=1.228,95％CI:1.144-1.318,P<0.001),postoperative stenosis of the branch opening diameter(OR=1.110,95％CI:1.055-1.168,P<0.001),postoperative stenosis of the narrowest lumen diameter of the main branch(OR=1.115,95％CI:1.042-1.192,P=0.001),and length of the branch lesion(OR=1.121,95％CI:1.021-1.231,P=0016). Conclusions:Some of the patients whose branch flow reached TIMI grade Ⅲ after PCI are still faced the risk of hemodynamical impairment and should be functionally evaluated after PCI.The postoperative stenosis rate of the narrowest branch lumen diameter,postoperative stenosis rate of the branch opening diameter,postoperative stenosis rate of the narrowest lumen diameter of the main branch,and branch lesion length are the risk factors of branch perfusion impairment after PCI for coronary bifurcation lesions.