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The medical artificial intelligence(AI)social experiment aims to more comprehensively understand the comprehensive impact of medical AI technologies and products on society,with the characteristics of wide application scenarios,complex research types and methods,multi-dimensional evaluation indicators,cross-disciplinary,and diverse subjects.To ensure the quality of ethical review in medical AI social experiment,it is urgent for relevant parties such as government authorities,research initiators,medical and health institutions,universities,scientific research institutions,enterprises,and research teams to shoulder their respective responsibilities,establish a technology product access mechanism for medical AI social experiments,improve the ethical review ability of the ethical review committee,and construct a whole cycle regulatory system.
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With the development of more and more multi-center and cross-field cooperative medical research,the establishment of high-quality and efficient ethical collaborative review and mutual recognition systems is an inevitable demand for multi-institutional research,and an inevitable move to implement relevant national policies.Based on the work practice of ethical collaborative review and mutual recognition in Shenzhen,by analyzing the practical challenges of ethical collaborative review and mutual recognition in China,this paper proposed that to ensure the homogeneity and efficiency of review.Government departments need to take the lead,establish an ethical review alliance,and clarify responsibilities and rights.Based on actual needs,system first,and effective communication,ethical collaborative review and mutual recognition of results could be jointly promoted,aiming to provide a reference for our counterparts in China to promote ethical collaborative review and mutual recognition of cross-institutional research.
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Based on the characteristics of qualitative research, such as openness, flexibility, interaction and subjectivity, this paper discussed the related ethical challenges and responsibilities faced by institutional ethics committees and researchers in ethical review, informed consent, privacy protection and researchers’ influence in the application of medical and health fields. Ethics committees need to adopt review standards suitable for qualitative research characteristics and improve their review ability. Researchers need to consider from the perspective of research participants, improve their scientific ability and ethical awareness in the whole process of design, data collection, analysis and reporting, truly respect and protect the rights and interests of research participants, and finally produce valuable research evidence.
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Objective·To construct an mRNA vaccine encoding hemagglutinin(HA)of influenza A H1N1 virus,and explore the protective effects of different booster vaccination strategies.Methods·Firefly luciferase(Fluc)was used as the reporter gene to construct Fluc mRNA vaccine enveloped in lipid nanoparticles(LNP).The in vivo expression of Fluc mRNA-LNP after intramuscular injection was determined by live imaging assay in mice.Furthermore,M15-HA mRNA-LNP derived from H1N1 subtype(A/Michigan/45/2015)was constructed.Mice were immunized with 20,10,5,or 1 μg doses of M15-HA mRNA-LNP twice(with an interval of 3 weeks)through intramuscular injection.Serum antibody titers were measured by enzyme-linked immunosorbent assay(ELISA)at 2 weeks and 4 weeks after the second immunization,and functional antibody levels were detected by hemagglutination inhibition test.The third booster vaccination was performed 40 d after the second immunization in 1 μg dose group with 1 μg M15-HA mRNA-LNP or 10 μg HA subunit vaccine.The levels of specific antibody and functional antibody were detected by ELISA and hemagglutination inhibition test,respectively 2 weeks and 4 weeks later.Results·Live imaging assay showed that luciferase activity could be detected in mice 1 d after injection of Fluc mRNA-LNP.At 2 weeks and 4 weeks after the second immunization of M1 5-HA mRNA-LNP,HA-specific antibodies were significantly higher than those before the immunization in all vaccination groups at different doses(P=0.000).The hemagglutination inhibition test showed that the levels of functional antibodies in the 20 μg dose and 10 μg dose groups were significantly higher than those in the PBS control group(P<0.05).After 1 μg dose group mice were immunized with HA protein or M15-HA mRNA-LNP,higher levels of HA-specific antibody and functional antibody were induced and maintained for a long time.There was no significant difference between the two different booster immunization strategies.Conclusion·M15-HA mRNA-LNP vaccine is constructed with immunogenicity and antibody neutralization activity.Low-dose mRNA priming vaccination followed by both homologous mRNA vaccine and heterologous protein subunit vaccine booster vaccination can induce stronger immune recall responses.
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Objective:To discuss the necessity and possible difficulties faced in the implementation of commissioned ethics review in China, propose preliminary operational suggestions for the implementation of ethical review.Methods:Systematically review the relevant provisions on commissioned ethics review. Analyze possible problems and related reasons in the implementation of commissioned ethics review, taking into account the current status of entrusted review and the author's practical experience.Results:The commissioned ethics review is an important supplement to the ethical review system, however, there may be many difficulties, such as unclear ″indications″ and operating procedures, unclear standards and paths for the commissioned ethics committees, unclear responsibilities for ethical review, and low level of enthusiasm for the entrusted review.Conclusions:Commissioned ethics review is a strategy worth exploring. Refining the guidelines for commissioned ethics review, exploiting regional advantages of ethical resources, strengthening the capacity building of ethics committees, promoting the evaluation of the ethics committees, establishing an ethics review network with complementary advantages, building information systems, and constructing governance systems are important foundations for promoting the smooth implementation of entrusted review.
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BACKGROUND@#It is not clear whether sacubitril/valsartan is beneficial for patients with heart failure (HF) with reduced ejection fraction (HFrEF) and low systolic blood pressure (SBP). This study aimed to investigate the efficacy and tolerability of sacubitril/valsartan in HFrEF patients with SBP < 100 mmHg.@*METHODS & RESULTS@#An observational study was conducted on 117 patients, 40.2% of whom had SBP < 100 mmHg without symptomatic hypotension, and 59.8% of whom had SBP ≥ 100 mmHg in an optimized HF follow-up management system. At the 6-month follow-up, 52.4% of patients with SBP < 100 mmHg and 70.0% of those with SBP ≥ 100 mmHg successfully reached the target dosages of sacubitril/valsartan. A reduction in the concentration of N-terminal pro-B-type natriuretic peptide was similar between patients with SBP < 100 mmHg and SBP ≥ 100 mmHg (1627.5 pg/mL and 1340.1 pg/mL, respectively; P = 0.75). The effect of sacubitril/valsartan on left ventricular ejection fraction was observed in both SBP categories, with a 10.8% increase in patients with SBP < 100 mmHg (P < 0.001) and a 14.0% increase in patients with SBP ≥ 100 mmHg (P < 0.001). The effects of sacubitril/valsartan on SBP were statistically significant and inverse across both SBP categories (P = 0.001), with an increase of 7.5 mmHg in patients with SBP < 100 mmHg and a decrease of 11.5 mmHg in patients with SBP ≥ 100 mmHg. No statistically significant differences were observed between the two groups in terms of the occurrence of symptomatic hypotension, deteriorating renal function, hyperkalemia, angioedema, or stroke.@*CONCLUSIONS@#Within an optimized HF follow-up management system, sacubitril/valsartan exhibited excellent tolerability and prompted left ventricular reverse remodeling in patients with HFrEF who presented asymptomatic hypotension.
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Objective:This paper introduces the concepts of " patient-centered cell therapy research management model", to provide reference for domestic medical institutions which conduct cell therapy clinical trials.Methods:We reviewed and summarized the experiences of conducting cell therapy at Peking University Shenzhen Hospital, including challenges and response plans regarding to the technology assessment, ethical evaluation risks and regulatory compliance. According to which, this paper aims to explore the reflections and practical experience of establishing a patient-centered, multi-stakeholder shared decision-making research management system.Results:The " patient-centered cell therapy research management model" ensures the reliability of research results through multi-stakeholder engagement in decision-making and management, adequate technical evaluation, effective ethical review and harmonized scientific research management, which not only meets the urgent health needs of the patient, but also promotes the standardized development of emerging technologies.Conclusions:The " patient-centered cell therapy research management model" is tailored for the cell therapy research, it is important to promote its further assessment and applications.
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OBJECTIVE@#To analyze the composition, incidence and clinical characteristics of oral and maxillofacial infections in oral emergency.@*METHODS@#A retrospective study on patients with oral and maxillofacial infections who visited the Department of Oral Emergency in Peking University School and Hospital of Stomatology from January 2017 to December 2019 was conducted. General characteristics, such as disease composition, gender, age distribution and position of involved teeth were analyzed.@*RESULTS@#A total of 8 277 patients with oral and maxillofacial infections were finally collected, including 4 378 male patients (52.9%) and 3 899 female patients (47.1%), with gender ratio of 1.12:1. The common diseases were periodontal abscess (3 826 cases, 46.2%), alveolar abscess (3 537 cases, 42.7%), maxillofacial space infection (740 cases, 9.0%), sialadenitis (108 cases, 1.3%), furuncle & carbuncle (56 cases, 0.7%) and osteomyelitis (10 cases, 0.1%). Male patients were more easily affected by periodontal abscess, space infection and furuncle & carbuncle than female patients with the gender ratios 1.24:1, 1.26:1, 2.50:1 individually, while the incidence of alveolar abscess, sialadenitis, furuncle & carbuncle had no significant gender difference. Different diseases were prone to occur at different ages. The peak ages of alveolar abscess were 5-9 and 27-67 years, while the peak age of periodontal abscess was 30-64 years. Space infection tended to occur between 21-67 years. There were 7 363 patients with oral abscess (3 826 patients with periodontal abscess and 3 537 patients with alveolar abscess), accounting for 88.9% of all the patients with oral and maxillofacial infections, involving 7 999 teeth, including 717 deciduous teeth and 7 282 permanent teeth. Periodontal abscess usually occurred in permanent teeth, especially the molar teeth. Alveolar abscess may occur in both primary teeth and permanent teeth. In primary teeth, the most vulnerable sites were primary molar teeth and maxillary central incisors while in permanent teeth the most vulnerable sites were first molar teeth.@*CONCLUSION@#Understanding the incidence of oral and maxillofacial infection was conducive to the correct diagnosis and effective treatment of clinical diseases, as well as targeted education for patients of different ages and genders to prevent the occurrence of diseases.
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Humanos , Masculino , Feminino , Animais , Adulto , Pessoa de Meia-Idade , Abscesso , Estudos Retrospectivos , Abscesso Periodontal , Carbúnculo , Furunculose , Incisivo , Sialadenite/epidemiologiaRESUMO
Objective:To analyze the correlation between body mass index (BMI) and the graded expression, subcutaneous depth, and diameter of elbow veins (cephalic vein, median vein, basilic vein) in patients with metabolic syndrome, to provide a method and theoretical basis for precise puncture of peripheral veins in obese patients.Methods:From January to October 2021, a total of 767 patients with metabolic syndrome with gastric volume reduction were selected as the study subjects by retrospective cohort study from the first Affiliated Hospital of Nanjing Medical University. According to the quartile Q1, M and Q3 of BMI level, they were divided into four groups: group A, group B, group C and group D. The subcutaneous depth and diameter of the cephalic vein, median vein and basilic vein were measured by B-ultrasound, and the three veins were evaluated and graded according to the grading criteria of superficial veins.The correlation between BMI and the subcutaneous depth and diameter of the three elbow veins was analyzed, and collected data such as puncture method and puncture times. Results:There was no significant correlation between BMI and subcutaneous depth and vessel diameter of the basilic vein ( r = 0.041 and 0.046, both P>0.05), the level of BMI was positively correlated with the subcutaneous depth and diameter of cephalic vein ( r = 0.275 and 0.117, both P<0.05) and median vein ( r = 0.236 and 0.148, both P<0.05), and a linear regression relationship was found ( OR values were 1.013-1.031, all P<0.05). 187 cases had direct puncture conditions under direct vision, and the success rate of one puncture was 86.63%(162/187).Venipuncture was completed under the guidance of B-mode ultrasound for 25 cases with failure under direct vision and 580 cases without direct puncture conditions under direct vision, the success rate of one puncture was 98.51% (596/605). Conclusions:With the increase of BMI level in patients with metabolic syndrome, the depth and diameter of both cephalic vein and median vein increase, venous exposure is difficult to express. The visual vein puncture guided by B-ultrasound is more accurate and catheterization is more reliable.
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Objective:To investigate the characteristics of allergen component in dust mite(DM) -induced allergic rhinitis(AR) patients, and provide reference for the diagnosis and treatment of AR. Methods:DM-induced AR patients with or without allergic asthma(AA) who visited the Allergy Department of Tongji Hospital, Huazhong University of Science and Technology between 2021 and 2022 were enrolled. Patients'age, gender, and visual analog scale(VAS) for symptoms were recorded. sIgE and sIgG4 levels of allergen components such as Der f1, Der f2, Der p1, Der p2, Der p7, Der p10, Der p21, and Der p23 were detected using a protein chip method. The sensitization characteristics of the allergen components in the patients were observed, and the correlation between sIgE, sIgG of each component and VAS as well as the component differences between AR and AR with AA(AR&AA) were evaluated. Results:A total of 87 DM-induced AR patients were enrolled, with 42.5% of them were AR&AA, their VAS scores were significantly higher than those of AR patients(6.38±1.95 vs 5.25±1.85, P=0.009 8). The order of sensitization rates for DM components was as follows: Der p2(82.8%), Der f2(81.6%), Der p1(74.7%), Der f1(70.1%), and Der p23(35.6%). The order of positive rates for sIgG4 was: Der p2(21.8%), Der f2(13.8%), Der p21(8.0%), and Der p7(6.9%). There were no correlation between the sIgE, sIgG4 levels or positive numbers of components and VAS scores, but there were positive correlations between sIgE, sIgG4 concentrations of components. Compared with AR patients, AR&AA patients had higher levels of sIgE for Der p(60.5[7.2-91.1]vs 14.0[4.8-45.1], P=0.02), Der f(49.8[15.7-81.6]vs 21.3[7.0-50.2], P=0.04), Der p1(27.2[0.7-51.5]vs 2.6[0.2-24.9], P=0.02), Der p2(20.0[1.4-60.6]vs 5.5[0.6-19.1], P=0.004), and Der f2(58.9[16.0-89.2]vs 23.4[0.9-56.8], P=0.009), and a higher proportion of AR with AA patients had sIgE levels of Der p1(70.3% vs 48.0%, P=0.038) and Der p23(27.0% vs 14.0%, P=0.039) that were ≥3 grades. Conclusion:Der p1/f1, Der p2/f3, and Der p23 are the major components of DM sensitized AR patients. Multiple component sensitization and sIgE, sIgG4 levels of each component are not correlated with the severity of AR. The sIgE levels of the Der p1/f1, Der p2/f3, and Der p23 components in AR&AA patients are higher than AR.
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Animais , Humanos , Alérgenos , Piridinolcarbamato , Rinite Alérgica/terapia , Pyroglyphidae , Asma , Antígenos de DermatophagoidesRESUMO
A cluster is a special matter level above a single atom and between macroscopic and microscopic matter, and it is an important bridge to understanding the relationship between the structure and function of matter. Here, we perform a comprehensive theoretical study of 2D planar Aun (n = 1-12) clusters doped with both magnesium and germanium. Two interesting results are found, namely the rapid 3D "roll-up" structural growth of the GeMgAun (n = 1-12) cluster ground state isomers, and the relative "alienation" of the different sizes of the Aun (n = 1-12) cluster framework towards the Ge atom, and the relative "affinity" towards the Mg atom. This study will not only enrich the data on gold-based clusters but will also provide a simple and clear theoretical guide for the 3D structuring of planar clusters, i.e. the doping of different classes of "affinition" and "alienatation" atoms.
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Structure, stability, charge transfer, chemical bonding, and spectroscopic properties of Ga atom-doped neutral Mgn (n = 2-12) clusters have been systematically investigated by CALYPSO and density functional theory. All cluster structures are based on "tetrahedral" and "yurt-like" growth except for GaMg2. The ground state isomer of GaMg8 with high symmetry structure is predicted to be the best-fit candidate for the "magic" cluster because of its excellent stability. Natural bond orbital calculations reveal that Ga and Mg atoms play the role of electron acceptor and donor in all ground state isomers, while the orbitals in both Ga and Mg are sp-hybridized. Most importantly, chemical bonding studies based on atom-in-molecular theory have shown that the lowest-energy state of GaMg4 is so special, in that it has not only the critical size for the appearance of Mg-Mg covalent bonds, but also the only cluster that has both Ga-Mg covalent and non-covalent bonds. Finally, theoretical calculations of IR and Raman spectra of all ground state isomers indicate that the spectra of these clusters are observable in the low-frequency band, and thus they can be identified by spectroscopic experiments. Furthermore, the bond heterogeneity of the Ga-Mg in the GaMg4 ground state isomer has also been specifically investigated, including the fixed GaMg4 structure with Mg atoms added in different directions, as well as ab initio molecular dynamics sampling at different temperatures.
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Using CALYPSO crystal search software, the structural growth mechanism, relative stability, charge transfer, chemical bonding and optical properties of AuMgn (n = 2-12) nanoclusters were extensively investigated based on DFT. The shape development uncovers two interesting properties of AuMgn nanoclusters contrasted with other doped Mg-based clusters, in particular, the planar design of AuMg3 and the highly symmetrical cage-like of AuMg9. The relative stability study shows that AuMg10 has the robust local stability, followed by AuMg9. In all nanoclusters, the charge is transferred from the Mg atoms to the Au atoms. Chemical bonding properties were confirmed by ELF analysis that Mg-Mg formed covalent bonds in nanoclusters larger than AuMg3. Static polarizability and hyperpolarizability calculations strongly suggest that AuMg9 nanocluster possesses interesting nonlinear optical properties. Boltzmann distribution weighted average IR and Raman spectroscopy studies at room temperature verify that these nanoclusters are identifiable by spectroscopic experiments. Finally, the average bond distance and average nearest neighbor distance were fully investigated.
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Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is the causative agent of the coronavirus disease 2019 (COVID-19) pandemic. In this study, we conducted a comparative analysis of the structural genes of SARS-CoV-2 and other CoVs. We found that the sequence of the E gene was the most evolutionarily conserved across 200 SARS-CoV-2 isolates. The E gene and M gene sequences of SARS-CoV-2 and NC014470 CoV were closely related and fell within the same branch of a phylogenetic tree. The absolute diversity of E gene and M gene sequences of SARS-CoV-2 isolates was similar to that of common CoVs (C-CoVs) infecting other organisms. The absolute diversity of the M gene sequence of the KJ481931 CoV that can infect humans was similar to that of SARS-CoV-2 and C-CoVs infecting other organisms. The M gene sequence of KJ481931 CoV (infecting humans), SARS-CoV-2 and NC014470 CoV (infecting other organisms) were closely related, falling within the same branch of a phylogenetic tree. Patterns of variation and evolutionary characteristics of the N gene and S gene were very similar. These data may be of value for understanding the origins and intermediate hosts of SARS-CoV-2.
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Based on the characteristics of qualitative research, such as openness, flexibility, interaction and subjectivity, this paper discussed the related ethical challenges and responsibilities faced by institutional ethics committees and researchers in ethical review, informed consent, privacy protection and researchers’ influence in the application of medical and health fields. Ethics committees need to adopt review standards suitable for qualitative research characteristics and improve their review ability. Researchers need to consider from the perspective of research participants, improve their scientific ability and ethical awareness in the whole process of design, data collection, analysis and reporting, truly respect and protect the rights and interests of research participants, and finally produce valuable research evidence.
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Medical science and technology innovation activities should meet the latest requirements of Opinions Issued to Strengthen Governance over Ethics in Science and Technology. Thus, attention should paid on the challenges facing medical science and technology ethics governance. This study discussed the necessity, responsibilities and operational guarantee elements of establishing an independent and professional regional medical science and technology ethics center. On the one hand, promote the innovation and development of medical science and technology and ensure the compliance with ethical norms, On the other hand, the government needs to carry out top-level design and build a science and technology ethics system with equal emphasis on supervision and technical services.
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This paper retrospectively reported the ethical evaluation, discussion, review and decision made by the ethics committee of Peking University Shenzhen hospital on the first case study of TCR-T technology in the treatment of advanced pancreatic cancer. The issues discussed included the nature, risk-benefit assessment, informed consent and risk control of the case. Finally, three suggestions were put forward, including strengthen the supervision of innovative treatment research projects, implement full and effective informed consent by using doctor-patient joint decision-making mode, and improve the ability of ethical substance review, in order to provide reference for the ethics committee to review clinical research projects with cutting-edge technologies such as cell therapy.
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Purpose@#To identify more accurate predictors of upper urinary tract dilatation (UUTD) in neurogenic bladder (NB) children, we studied the relationship among urodynamic parameters at different bladder filling stages, detrusor leak point pressure (DLPP) and UUTD. @*Methods@#A total of 158 children (3–16 years) with NB were included and then divided into 2 groups according to whether their NB diagnosis was complicated with UUTD: the UUTD group (39 patients) and those without UUTD group (control group, 119 patients). The bladder filling phase was divided into 3 equal parts: the early, middle, and end filling stages. The bladder compliance (BC) and detrusor pressure (△Pdet) at each phase and DLPP at the end filling stage were recorded. @*Results@#A BC8 cm H2O in the early stage, 20 cm H2O in the middle stage and 25 cm H2O in the end stage are more sensitive than △Pdet >40 cm H2O in the end stage (82%, 85%, 85%, vs. 49%). A DLPP cutoff value of 20 cm H2O showed higher sensitivity for predicting UUTD than 40 cm H2O. @*Conclusions@#Low BC and a high △Pdet in the middle and end filling stages are more accurate factors than classic indicators for predicting UUTD. In addition, a DLPP value of >20 cm H2O in the end bladder filling stage shows high sensitivity.
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OBJECTIVE@#To analyze the etiological and clinical characteristics of oral emergency patients under 18 years with dental trauma, and to provide guidance on the prevention and treatment in children and adolescents.@*METHODS@#A retrospective study on the intact data of the dental trauma patients under 18 years from January 2016 to December 2018 in the Department of Oral Emergency in Peking University School of Stomatology was conducted, and the distribution of the patients' gender, age and visiting time, as well as the number and position of traumatic teeth, diagnostic classification, and multiple injury with dental trauma were analyzed.@*RESULTS@#During the period, 54.2% of the first visit dental trauma patients (10 164) were children or adolescents (5 506). The two peak ages were 3-4 and 7-9 years. The incidence of the male was higher than the female in every age group (Wilcoxon test, P < 0.001). From May to June and September to November, there were more cases of dental trauma. The peak time of daily dental trauma cases was from 19:00 to 20:00 (Jonckheere-Terpstra test, P < 0.001). The positions of traumatic teeth in both sides were approximate symmetrical, and maxillary central incisors were the most affected. 52.3% of the patients suffered multiple teeth injuries. Among the permanent teeth trauma, enamel and dentin fracture was the most common (24.7%), followed by concussion (20.5%), sub-luxation (17.9%) and complicated crown fracture (14.4%). And among the primary teeth trauma, subluxation was the most common (31.1%), followed by concussion (14.5%) and lateral luxation (9.5%). 19.7% of the children and adolescent dental trauma patients were also suffered maxillofacial soft or hard tissue injury.@*CONCLUSION@#The incidence of dental trauma in children and adolescents is higher than that in adults. There were two age peaks among the children and adolescents patients. Primary teeth and young permanent teeth were usually suffered. Clinical treatment should be considered along with the characteristics of child tooth growth. In order to prevent the occurrence of dental trauma, early orthodontic intervention should be carried out in children with severe overjet. Families, schools and nursery institutions should strengthen the protection against dental trauma.
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Adolescente , Adulto , Criança , Feminino , Humanos , Masculino , Incisivo , Sobremordida , Estudos Retrospectivos , Avulsão Dentária , Fraturas dos Dentes/epidemiologia , Traumatismos Dentários/epidemiologiaRESUMO
An increasing number of studies have recently indicated the important effects of gut microbes on various functions of the central nervous system.However, the underlying mechanisms by which gut microbiota regulate brain functions and behavioral phenotypes remain largely unknown. We therefore used isobaric tags for relative and absolute quantitation (iTRAQ)-based quantitative proteomic analysis to obtain proteomic profiles of the hippocampus in germ-free (GF), colonized GF, and specific pathogen-free (SPF) mice. We then integrated the resulting proteomic data with previously reported mRNA microarray data, to further explore the effects of gut microbes on host brain functions. We identified that 61 proteins were upregulated and 242 proteins were downregulated in GF mice compared with SPF mice. Of these, 124 proteins were significantly restored following gut microbiota colonization. Bioinformatic analysis of these significant proteins indicated that the glucocorticoid receptor signaling pathway and inflammation-related pathways were the most enriched disrupted pathways. This study provides new insights into the pathological mechanisms of gut microbiota-regulated diseases.