Through the voluntary participation of subjects,strictly designed clinical trials have generated new generalizable scientific knowledge to benefit more future populations.However,subjects participating in clinical trials often cannot distinguish between trials and clinical treatments,and they expect clinical trials to be able to treat their diseases.This phenomenon is called therapeutic misunderstanding,which needs to be prevented because it cannot meet the requirements of research ethics.With the advent of precision medicine,the scenario of clinical trials has changed significantly,manifested as the integration of trials and clinical treatments,and the prominent clinical benefits of subjects.The new treatment-oriented design scheme blurs the boundary between trial and treatment,giving subjects participating in clinical trials more opportunities for clinical treatment while increasing the risk of therapeutic misunderstanding,changing the connotation of therapeutic misunderstanding,and triggering more ethical thinking.Ethics committees should pay more attention to content related to the review of the design scheme of clinical trials,the opportunities for patients to participate in trials and enrollment of subjects,changes in communication and informed consent between researchers and subjects,the definition of roles for clinicians and researchers,and other aspects,to ensure that clinical trials better protect the rights,safety,and well-being of subjects while generating new knowledge.

Cryoablation therapy with explicit anti-tumor mechanisms and histopathological manifestations has a long history.A large number of clinical practice has shown that cryoablation therapy is safe and effective,making it an ideal tumor treatment method in theory.Previously,its efficacy and clinical application were constrained by the limitations of refrigerants and refrigeration equipment.With the development of the new generation of cryoablation equipment represented by argon helium knives,significant progress has been made in refrigeration efficien-cy,ablation range,and precise temperature measurement,greatly promoting the progression of tumor cryoablation technology.This consensus systematically summarizes the mechanism of cryoablation technology,indications for oral mucosal melanoma(OMM)cryotherapy,clinical treatment process,adverse reactions and management,cryotherapy combination therapy,etc.,aiming to provide reference for carrying out the standardized cryoablation therapy of OMM.

Objective To study the changes of blood glutathione peroxidase (GSH-px),superoxide dis-mutase (SOD),malondialdehyde (MDA) and pathological tissues in the rat contrast-induced nephropathy (CIN) model,and to determine the role of oxidation mechanism in CIN.Methods A total of 40 adult male SD rats were selected and divided into three big groups and five small groups.After constructing the model,six rats with good status were taken from each group for conducting the experiment.The serum GSH-px,SOD and MDA levels were measured,the renal tissue biopsy was performed and the morphological changes of kid-ney cells were compared.Results There was no statistically significant difference in the baseline data among the blank control group,the control group and the experimental group (P>0.05).There was no statistically significant difference in serum GSH-px,SOD and MDA levels before model construction,at 24,48 h after model construction between the blank control group and the control group (P>0.05).There were statistical-ly significant differences in serum GSH-px,SOD and MDA levels of the experimental group between before model construction and after model construction (P<0.05).There was no statistically significant difference in serum GSH-px,SOD and MDA level in the experimental group between at 24 h after modelling and 48 h af-ter modeling (P>0.05).There was no statistically significant difference in serum GSH-px,SOD and MDA levels at 24 h after modeling among the three groups (P>0.05).There were statistically significant differ-ences in serum GSH-px,SOD and MDA levels at 48 h after modeling among the three groups and their pairs (P<0.05).The pathological sections of the blank control group and control group showed no obvious abnor-mal changes in glomeruli,renal tubule and renal interstitium.Renal interstitial fibrosis and inflammatory cell infiltration were seen after 24 h in the experimental group,but there was no obvious change in the renal tu-bules.After 48 h,moderate focal-like atrophy of renal tubules,epithelial cell granule degeneration and vacuolar changes were obviously seen.Conclusion The oxidative stress mechanism plays a role in CIN.The contrast a-gent acute renal injury mainly acts on the renal tubules and renal interstitium,and there is no obvious damage to the glomeruli.

Objective:To construct a composite evaluation index of fourth-level surgical, for references for horizontal comparison of fourth-level surgical between clinical departments of hospital and hospital performance appraisal.Methods:The data were extracted from the medical record information system and disease diagnosis related group information system of a tertiary public hospital, including the number of surgical patients, the number of fourth-level surgical patients, the case mix index (CMI), and the average length of hospital stay for 23 surgical departments from 2019 to 2023. Based on disease diagnosis related groups, the average length of hospital stay for patients undergoing fourth-level surgery was standardized to obtain the time cost index; Multiply the CMI and time cost index by the fourth-level surgical ratio to obtain the quality coefficient. This coefficient was used to weight the number of fourth-level surgeries to establish the contribution degree of fourth-level surgeries, which was used for the comprehensive evaluation of fourth-level surgery quality and quantity for each surgical department.Results:A total of 329 177 surgical patients were included in this study, including 139 704 patients with fourth-level surgery. From 2019 to 2023, the top 3 departments in terms of the proportion of fourth-level surgery were department J, B and A, and the proportion of fourth-level surgery in departments with high surgical difficulty, such as C and I, ranked 8th and 16th. The top 3 departments with the contribution degree of fourth-level surgery were department A, B and C, I rosed to the 9th, and J felled to the 11th.Conclusions:The fourth-level surgery contribution degree combined the four factors of surgical composition, difficulty, cost and quantity, which could objectively evaluate fourth-level surgeries in different departments.

Objective:To study the distribution of species type, biotype and genotype of human Brucella isolated and identified in Nanjing. Methods:A total of 89 strains of human Brucella were collected from microbiology laboratories of three sentinel hospitals in Nanjing from 2017 to 2022. The species type was identified using biological methods and Brucella nucleic acid detection (BCSP31-PCR and AMOS-PCR). Further biotyping of Brucella melitensis isolates was conducted by serological results of A and M factors. Meanwhile, genotype analysis was performed using multiple-locus variable number tandem repeat analysis (MLVA), multilocus sequence typing (MLST) and single nucleotide polymorphism (SNP). Results:From 2017 to 2022, 89 strains of Brucella isolated and identified in Nanjing were all Brucella melitensis. Among them, Brucella melitensis biotype 3 accounted for 82.02% (73/89), and biotype 1 accounted for 17.98% (16/89). MLVA typing showed that 89 strains of Brucella melitensis belong to the "Eastern Mediterranean" cluster and could be divided into 50 MLVA genotypes; among which panel 1 had 3 genotypes, namely Type 42 (84.27%, 75/89), Type 63 (8.99%, 8/89) and Type 43 (6.74%, 6/89). The results of MLST-9 and MLST-21 were both ST8, and the core genome multilocus sequence typing (cgMLST) classified 89 strains into 11 genotypes. SNP analysis revealed a total of 4 013 SNP loci, with SNPs ranging from 0 to 409 across different strains, involving 59 SNP genotypes. Conclusions:The human Brucella strains isolated and identified in Nanjing are all Brucella melitensis, mainly biotype 3. The MLVA cluster is the "Eastern Mediterranean" cluster. The traditional MLST-9 and MLST-21 typing results are all ST8 type, while cgMLST divides all the strains into 11 genotypes with higher resolution.

Significant advancements have been made in the establishment of ethics committees within medical institu-tions.However,in order to achieve a high-quality development it is imperative to focus on such critical points as distinguishment between biomedical research and the clinical application of medical technologies,steadfast adherence to the fundamental princi-ples of ethical review,establishment of an ethics committee with independent administrative authority,establishing independent ethics review committees in large medical institutions based on specialty,and strengthening of ethical training for medical person-nel and biomedical researchers.

Objective:To investigate the clinical significance of intraoperative prepositioning of dual mediastinal drains in elderly patients developing anastomotic leakage(AL)after a total endoscopic Ivor-Lewis procedure.Methods:This retrospective case-control study analyzed the clinical data of 500 elderly patients who underwent total endoscopic Ivor-Lewis surgery for esophageal or cardia cancer from January 2020 to December 2022.In the control group, one mediastinal drainage tube was placed intraoperatively, while in the study group, two mediastinal drainage tubes were placed.Both groups had a chest tube placed conventionally.The study compared the incidence of anastomotic leak(AL)at 1 month postoperatively, inflammatory indexes in patients with AL, grading of AL, rate of nasal fistula placement, incision infection, anastomotic stenosis, and incidence of hoarseness.Additionally, it compared ICU occupancy, ventilator use, and ICU length of stay between the two groups.Results:The analysis included clinical data from 455 elderly patients.Among the patients who developed AL, the study group had significantly lower peak body temperature[(39.58±1.03)℃ vs.(38.05±0.56)℃, t=4.298, P<0.05], white blood cell count[(18.63±3.35)×10 9/L vs.(14.28±2.78)×10 9/L, t=3.450, P<0.05], and C-reactive protein(CRP)levels[(154.66±41.64)mg/L vs.(122.19±31.29)mg/L, t=2.131, P<0.05]. The study group also had a significantly lower grading of AL and rate of nasal fistula placement(82.4% vs.30.0%, P<0.05). In terms of ICU indicators, the study group had a significantly lower ICU admission rate(64.7% vs.10.0%, P<0.05), shorter period of ventilator use[(6.47±8.15)days vs.(0.90±2.23)days, t=2.62, P<0.05], and shorter ICU stay[(11.70±8.89)days vs.(4.70±6.27)days, t=2.184, P<0.05]. Conclusions:Double mediastinal drainage tubes, have been found to significantly alleviate inflammation, decrease the rate of nasal fistula placement and ICU admission, and shorten the length of ICU stay in elderly patients.Therefore, they are considered safe and deserving of clinical promotion.

Objective:To explore the pathogenesis of neuropsychiatric systemic lupus erythematosus (NPSLE) from imaging perspective by analyzing voxel-based morphology (VBM) and functional connectivity (FC) in resting state functional magnetic resonance imaging (rs-fMRI).Methods:Thirty-five patients with NPSLE and 30 patients with non-NPSLE admitted to Department of Rheumatology and Immunology, Taizhou People's Hospital Affiliated to Nanjing Medical University from June 2020 to March 2023 were enrolled; 31 healthy subjects were included as healthy control group during the same period. All subjects completed routine MRI and rs-fMRI, laboratory tests (C3, C4, IgA, IgM and IgG levels), mini-mental state examination (MMSE), hospital anxiety and depression scale (HADS), and fatigue scale for motor and cognitive functions (FSMC). Whole brain gray matter volume in subjects of the 3 groups was analyzed by VBM method, and the brain regions enjoying significant differences in gray matter volume between the NPSLE group and non-NPSLE group were selected as regions of interest (ROIs) for whole brain FC analysis. Partial correlation method was used to analyze the correlations of imaging indexes in brain regions enjoying significant differences with clinical indexes and imaging scores between NPSLE group and non-NPSLE group. Efficacy of imaging indexes in brain regions enjoying significant difference in differentiating NPSLE from non-NPSLE was analyzed by receiver operating characteristic (ROC) curve.Results:(1) Covariance analysis among the 3 groups showed that the gray matter volume in the left inferior frontal gyrus of orbit, left superior frontal gyrus, right rectus gyrus, right transverse temporal gyrus, and right superior frontal gyrus was significantly different among the 3 groups ( P<0.001, FDR corrected); compared with the healthy control group, the NPSLE group had significantly reduced gray matter volume in the left inferior frontal gyrus of orbit, left superior frontal gyrus of orbit, right rectus gyrus, right transverse temporal gyrus, and right superior frontal gyrus ( P<0.001, FDR corrected); compared with the non-NPSLE group, the NPSLE group had significantly decreased gray matter volume in the left inferior frontal gyrus of orbit, right rectus gyrus, and right transverse temporal gyrus ( P<0.001, FDR corrected). (2) Whole brain FC analysis with brain regions enjoying significant differences as seed points showed that Fisher z-transformed FC (zFC) in the right transverse temporal gyrus and bilateral postcentral gyrus of the NPSLE group were significantly decreased ( P<0.001, FDR corrected). (3) Partial correlation analysis showed that, in the NPSLE group, zFC from the right transverse temporal gyrus to left posterior central gyrus was negatively correlated with disease course ( r=-0.390, P=0.027); gray matter volume in the right orbital superior frontal gyrus was negatively correlated with FSMC-cognitive ( r=-0.401, P=0.023); the gray matter volume in the right orbital superior frontal gyrus was negatively correlated with FSMC-motor ( r=-0.374, P=0.035). (4) ROC curve found that gray matter volume in the right rectus gyrus and zFC from the right transverse temporal gyrus to the right posterior central gyrus had relatively high efficacy in differentiating NPSLE from non-NPSLE, with AUC of 0.771 (95% CI: 0.658-0.885, P<0.001) and 0.794 (95% CI: 0.685-0.904, P<0.001), respectively. Conclusion:NPSLE patients have reduced gray matter volume in multiple brain regions (concentrating in the prefrontal limbic system); and reduced FC with some brain regions is noted; multiple indexes are correlated with clinical indexes.

Human still has limited understanding of respiratory infectious diseases, especially emerging acute respiratory infectious diseases. Once the pandemic of this kind of infectious disease occur, it would be a serious challenge to health, political security, the economic development, and social stability. People hope to detect the changes in infectious diseases in early phase through surveillance and give early warning in time. In the field of public health, more attention has been paid to syndrome surveillance as an effective supplement to traditional surveillance. This paper summarizes the current surveillance system of infectious diseases abroad, introduces the syndrome surveillance system of acute respiratory infectious disease and its application in China, and discusses the development of syndrome surveillance and early warning technology for acute respiratory infectious diseases in the future.

Intelligent syndromic surveillance is an important part of multi-point triggering and multi-channel surveillance system of intelligent early warning of infectious diseases in China, and an inevitable development process of traditional syndromic surveillance as the constant emergence of new technologies. Intelligent syndromic surveillance collects not only the medical data of patients seeking medical care in hospitals but also massive non-medical information. However, along with its rapid development, challenges in intelligent syndromic surveillance have emerged, such as information explosion, cost-effective balance, information sharing, data security and privacy. This paper summarizes the concept and development of intelligent syndromic surveillance to provide references for the method and technique development of intelligent early warning of infectious diseases and new thought for the prevention and control of infectious diseases in China and in the world.