Objective To search for the reports of adverse events of levofloxacin use in children using the FAERS database,and to mine and analyze the data to provide reference for safe clinical use.Methods The data reported of adverse events of levofloxacin use in children from January 1,2004 to June 30,2023 were retrieved through the OpenVigil 2.1 platform,and the relevant data were analyzed based on the reporting odds ratio(ROR)method.Results A total of 484 cases of adverse events of levofloxacin in children were retrieved,and 94 positive risk signals were found.The main systemic organs involved were various musculoskeletal and connective tissues,gastrointestinal system,systemic and administration sites,and the top five positive signals were Dimycodes infection(ROR=822.87),tendon pain(ROR=563.71),Mycobacterium ulcers infection(ROR=352.65),tendon rupture(ROR=341.91),and immune reconstitution inflammatory syndrome-related tuberculosis(ROR=310.84).The top five positive signals not mentioned in the label were Mycobacterium ulcerans infection(ROR=352.65),immune reconstitution inflammatory syndrome-associated tuberculosis(ROR=310.84),central nervous system tuberculoma(ROR=102.85),linear IgA disease(ROR=82.68),and increased intracranial pressure(ROR=32.46).Conclusion In addition to the known adverse events,levofloxacin is used in children,and the risk signal intensity of adverse reactions such as increased intracranial pressure and tuberculosis-related diseases is high,so it is recommended to carefully select and strengthen relevant safety monitoring.

The superimposition analysis of imaging data on the structure of craniomaxillofacial tissue at different time points of the same object is an important method for studying craniomaxillofacial growth and development,evaluating the efficacy of orthodontic treat-ment and orthognathic surgery.While overcoming the common shortcomings of traditional 2D imaging,3D image superimposition pro-vides more comprehensive craniomaxillofacial information and more accurate dental and bone data.Therefore,more and more scholars are validating and exploring the reliability and accuracy of 3D superimposition technology for clinical applications.This article reviews the 3D image data sources,superimposition methods,and clinical applications,to provide scientific research and clinical guidance for 3D image superimposition technology in orthodontics.

OBJECTIVES: Clinical research plays a vital role in disease research and population health. The public is the main source of clinical research volunteers. Understanding the public's cognition of clinical research plays a decisive role in the development of clinical research. This study aims to understand the Chinese public's cognition for clinical research and the influencing factors. METHODS: The questionnaire based on Chinese-translated Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment (PARTAKE) was used to investigate the public's cognition for clinical research. RESULTS: Of the 2 513 valid respondents, 91.84% had heard of "clinical research", 91.76% of the respondents believed that clinical research was beneficial to society, 65.90% were willing to participate in clinical research, 87.50% believed that confidentiality was a very important thing, 73.70% believed that their personal information had been protected when participating in clinical research, and, 46.40% did not know whether volunteers participating in clinical research could receive adequate compensation. Educational levels, employment status, and annual income impacted in public perceptions of willingness to participate in clinical research, especially in privacy protection, informed consent, whether clinical research is intended for society, compensation for clinical research, and safety of clinical research (all P<0.01). CONCLUSIONS The Chinese public's cognition level for clinical research is acceptable, but there is still a lot of room for improvement in privacy protection, informed consent, and compensation. By designing a reasonable knowledge training program for clinical research and using the multimedia, improving access to the relevant knowledge, more public will know about clinical research recruitment information, which is of great significance for the development of clinical research in China.
Humans ; China ; East Asian People ; Educational Status ; Surveys and Questionnaires ; Public Opinion ; Knowledge ; Biomedical Research

Objective:To establish the normal values of water-perfused high resolution esophageal manometry (HREM)(GAP-36A) at resting period, water swallowing, semisolid swallowing and solid swallowing in Chinese population.Methods:From September 1, 2019 to June 30, 2020, 91 healthy volunteers receiving water-perfused HREM (GAP-36A) at resting period, water swallowing, semisolid swallowing and solid swallowing were selected from 9 hospitals (Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; the First Affiliated Hospital of Dalian Medical University; the Second Hospital of Hebei Medical University; the Second Affiliated Hospital, Naval Medical University; the First Affiliated Hospital, Sun Yat-sen University; the First Affiliated Hospital, University of Science and Technology of China; Aviation General Hospital of China Medical University; the Affiliated Hospital of Medical School of Nanjing University and the First People′s Hospital of Yichang). Parameters included the position of the upper and lower edges of the upper esophageal sphincter (UES) and lower esophageal sphincter (LES), the length of the LES and UES, the position of the pressure inversion point (PIP), the resting pressure of UES and LES and swallow-related parameters such as the distal contraction integral (DCI), 4 s integrated relaxation pressure (IRP), distal latency (DL) and UES residual pressure. One-way analysis of variance, post-hoc test and sum rank test were used for statistical analysis.Results:A total of 87 healthy volunteers were enrolled, including 40 males and 47 females, aged (38.5±14.2) years old (ranged from 19 to 65 years old). The position of the upper and lower edges of the LES was (42.7±2.8) and (45.6±2.8) cm, respectively, the length of the LES was (2.9±0.4) cm, and the position of PIP was (43.3±2.8) cm. The position of the upper and lower edges of the UES was (18.1±3.0) and (22.6±2.0) cm, respectively, and the length of the UES was (4.8±1.0) cm. The resting pressure of LES and UES was (17.4±10.7) and (84.1±61.1) mmHg (1 mmHg=0.133 kPa), respectively. The DCI value at solid swallowing was higher than those at water swallowing and semisolid swallowing ((2 512.4±1 448.0) mmHg·s·cm vs. (2 183.2±1 441.2) and (2 150.8±1 244.8) mmHg·s·cm), and the differences were statistically significant ( t=-4.30 and -3.74, both P<0.001). The values of 4 s IRP at semisolid swallowing and solid swallowing were lower than that at water swallowing ((4.6±4.1) and (4.9±3.9) mmHg vs. (5.4±3.9) mmHg), and the differences were statistically significant ( t=3.38 and 2.09, P=0.001 and 0.037). The DL at water swallowing was shorter than those at semisolid swallowing and solid swallowing ((8.5±1.8) s vs. (9.8±2.2) and (10.6±2.8) s), and the DL at semisolid swallowing was shorter than that at solid swallowing, and the differences were statistically significant ( t=-10.21, -13.91 and -4.68, all P<0.001). The UES residual pressure at water swallowing was higher than those at semisolid swallowing and solid swallowing (9.5 mmHg, 6.5 to 12.3 mmHg vs. 8.0 mmHg, 4.5 to 11.7 mmHg and 5.5 mmHg, 2.0 to 9.3 mmHg), and the UES residual pressure at semisolid swallowing was higher than that at solid swallowing, and the differences were statistically significant ( t=3.48, 10.30 and 6.35, all P<0.001). Conclusions:The normal values of water-perfused HREM (GAP-36A) in Chinese population at resting period, water swallowing, semisolid swallowing and solid swallowing can provide a reference basis for clinical diagnosis and treatment for patients receiving water-perfused HREM examination.

Immune checkpoint inhibitors (ICIs) present significant efficacy in the treatment of malignant tumors, and they have been approved as the first-line of treatment for various cancers. Pembrolizumab monotherapy or combined with chemotherapy has been recommended by domestic and foreign guidelines for the first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma. Although ICIs represent a milestone in the treatment of head and neck squamous cell carcinoma, potential problems still need to be addressed, such as the selection of the efficacy predictors for ICIs, the evaluation of the tumor response to ICIs, and the treatment of immune hyperprogression and immune-related adverse events. Therefore, to form a relatively unified understanding of ICIs treatment for head and neck squamous cell carcinoma, we integrated the clinical experience of multi-disciplinary experts of head and neck cancers on the basis of current clinical hot issues and finally developed this consensus.
Humans ; Squamous Cell Carcinoma of Head and Neck/drug therapy* ; Immune Checkpoint Inhibitors ; Consensus ; Neoplasm Recurrence, Local/pathology* ; Head and Neck Neoplasms/drug therapy*

Objective:To analyze the predictive value of P504S for pathological upgrading of gastric low-grade intraepithelial neoplasia (LGIN) after endoscopic submucosal dissection (ESD).Methods:Data of 117 patients (119 lesions) who underwent ESD for LGIN at Huadong Hospital from January 2015 to March 2019 were analyzed retrospectively. Biopsy and ESD specimens were collected. According to pathology, specimens were divided into the LGIN group (postoperative pathology of non-upgrade) and the upgrade group (postoperative pathology of upgrade). The positive rates of P504S were compared between biopsy and postoperative specimens of the LGIN group, and between biopsy and postoperative specimens of the upgrade group. The consistency of the expression of P504S was examined between the biopsy specimens and the postoperative specimens in the LGIN group and the upgrade group. Receiver operator characteristic (ROC) curve of the prediction of pathological upgrading was drawn by the results of P504S in biopsy, and the cutoff value of immunohistochemical staining score was calculated.Results:The positive rate of P504S in the biopsy specimens of the LGIN group (46.8%, 36/77) was lower than that in the biopsy specimens of the upgrade group (73.2%, 30/41) with significant difference ( P=0.006). The positive rate of P504S in the postoperative specimens of the LGIN group (51.9%, 40/77) was lower than that in the postoperative specimens of the upgrade group (82.9%, 34/41) with significant difference ( P=0.001). In the LGIN group, the positive rate of P504S in biopsy specimens (46.8%, 36/77) was lower than that in postoperative specimens (51.9%, 40/77) without significant difference ( P=0.289). The expression of P504S was consistent between biopsy specimens and postoperative specimens with good consistency( K=0.793, P<0.001). In the upgrade group, the positive rate of P504S in biopsy specimens (73.2%, 30/41) was lower than that in the postoperative specimens (82.9%, 34/41) without significant difference ( P=0.219). The expression of P504S was consistent between biopsy and postoperative specimens, and the consistency was general ( K=0.579, P<0.001). ROC curve was drawn for the prediction of pathological upgrading by the results of P504S in biopsy, and the cutoff value of immunohistochemical staining score was 100. The sensitivity and specificity of pathological upgrading for positive result were 0.659 and 0.740, respectively. Conclusion:P504S staining of the postoperative specimens facilitates identification of the degree of gastric mucosal neoplasia. When the cutoff value of staining score is 100, the staining of P504S in biopsy tissue plays a role in predicting the pathological upgrading.

Objective To evaluate the value of near focus narrow-band imaging ( NF-NBI ) in differentiating hyperplastic polyp ( HP ) and sessile serrated adenomas/polyp ( SSA/P ) . Methods Data of 65 cases of pathologically confirmed HP or SSA/P with clear NF-NBI images in Huadong Hospital Affiliated to Fudan University from October 2017 to September 2018 were retrospectively analyzed. Three senior doctors observed the images of NF-NBI, including expanded crypt opening ( ECO ) and thick & branched vessel ( TBV) . The results were compared with pathological results in order to analyze differential diagnostic value of ECO and TBV for HP and SSA/P. Results Among 65 lesions, 44 were SSA/P and 21 were HP. The sensitivity, specificity, and accuracy of ECO, TBV, and ECO combined with TBV for differential diagnosis between HP and SSA/P were 80. 3％( 106/132 ) , 85. 7％( 54/63 ) and 82. 1％( 160/195 ); 38. 6％( 51/132) , 82. 5％( 52/63 ) , and 52. 8％( 103/195 ); and 84. 8％( 112/132 ) , 73. 0％( 46/63 ) , and 81. 0％(158/195), respectively. Conclusion ECO under NF-NBI has a high sensitivity for diagnosis of SSA/P . ECO combined with TBV is helpful for differential diagnosis between HP and SSA/P .

Objective: To explore the effect of the umbilical cord mesenchymal stem cells(UC-MSCs) on the pulmonary fibrosis in silicosis rats. Methods: SPF male Sprague Dawley rats were randomly divided into control group, silica model group and UC-MSCs treatment group with 12 rats each group. SiO₂ intra-tracheal injection(0.5 ml of 50 mg/ml/rat) were applied to silica model group and UC-MSCs treatment groups. After that UC-MSCs treatment group received 1 ml UC-MSCs suspension (3×10⁶ cells/ml) by tail vein injection on the 29th, 36th, 43th and 50th day after exposure to the first silica suspension. On the 60th and 75th day after exposure to silica suspension, all animals were examed for pulmonary CT. Then the rats were euthanized on 75th day after the first exposure to silica.Lung's histopathological examination of the rats from all the groups were carried out. The content of hydroxyproline in lungs, TGF-β1 and IL-6 in serum were examined. Results: The lung's histopathological examination showed no obvious inflammatory cell and no fibrosis in the lung tissue of the control group, there were a lot of inflammatory cell aggregation and collagen fiber deposition in silica model group, while in the UC-MSCs intervention group and treatment group, there were less inflammatory cells and collagen fiber. The rats from silica model groups had higher HYP, TGF-β1 and IL-6 than the rats from UC-MSCs treatment group and control group. Lung fields of rats in the control group were clear and no obvious high-density shadow. Different-sized granular high-density shadows or reticular fibrous shadows were found diffusely distributed in the lungs of the rats in silica model group. Lung field of rats in UC-MSCs intervention group and treatment group were less high density shadows, and more clear. Conclusion UC-MSCs can alleviate the pulmonary fibrosis in silica model rats through regulating the secretion of some fibrosis related cytokines.

Objective To explore the treatment methods and prognosis of early infection and delayed infection after intramedullary nail fixation.Methods Data of 22 cases of postoperative infections after intramedullary nail from January 2013 to August 2017 were retrospectively analyzed.There were 18 males and 4 females aged from 20 to 72 years old,with an average age of 46.8 years.14 cases were tibias and 8 cases were femurs.In the early infection group,6 cases showed swelling,heat and pain in the affected area with drainage and pus.In the late infection group,12 cases showed sinus formation and 4 cases showed no sinus tract.According to whether the infection occurred within six weeks,it was divided into early infection and delayed infection groups.Of 6 patients in early infection group,there was 1 case of septic shock which underwent removal of intramedullary nails,debridement and antibiotic bone cement stick implantation.5 cases were retained intramedullary nail and underwent local debridement treatment.Late infection occurred in 16 patients.One patient with tibia infection was given partial dressing to heal the fracture.Then the intramedullary nail was removed and intramedullary debridement was performed.Two patients with poor general condition,the intramedullary nails were removed and debridement was performed.Calcium sulphate cement was implanted and fixed with external fixation.The remaining 13 cases were treated with debridement and antibiotic cement stick implantation.We compared the differences between early and late infections of internal fixation,infection control,fracture healing,and secondary fracture fixation.Results Of the 6 patients with early infection,1 patient with septic shock removed intramedullary nails to control infection.After infection controlled,the fracture was treated with intramedullary nailing.Of the 5 patients with retained intramedullary nails,2 patients' infection were controlled and 3 were uncontrolled.After removal of the intramedullary nails the infection was control.The success rate of retaining intramedullary nails was 33.3％ (2/6).Late infection occurred in 16 cases and infection was all controlled.The fractures healed in 22 patients.The fracture healing time of 6 patients with early infection was 2-6 months,with an average of 3.67±2.08 months.The fracture healing time of 16 patients with late infection was 2-4 months (average 3.2±0.79) months.Conclusion Patients with early bone infections after femoral and tibial intramedullary nail surgery may attempt debridement therapy with retained intramedullary nails,but the failure rate is high.If the intramedullary nail fails to remain,follow the treatment of patients with delayed bone infection.For patients with delayed bone infection,because the fracture has not yet healed,thorough debridement is used after the removal of internal fixation,then calcium sulfate or antibiotic bone cement stick should be implanted and fixed with external fixation.For the second phase,we may choose plate,intramedullary nail or external fixation to fix the fractures according to the soft tissue condition.All of the fixation methods could provide good fracture healing.