OBJECTIVE: To accurately measure human energy metabolism with high temporal resolution, a respiratory gas analysis system was designed using a breath-by-breath approach. METHODS: Firstly, indirect calorimetry was employed in respiratory gas analysis to measure the respiratory flow and concentration signals in real-time. Secondly, oxygen consumption QO2 and carbon dioxide production QCO2 were calculated through respiratory characteristic alignment and respiratory signal segmentation. Finally, metabolic indexes were calculated according to the Weir formula. Furthermore, a controlled trial was formulated for validation comparisons with the MGC ULTIMA SYSTEM PFX CARDIO2. RESULTS: The results indicate that the data points of metabolic indexes measured by this system all fall within the confidence interval when compared with those of the MGC. CONCLUSION The system has high consistency with the MGC measurement results. Thus, the system can accurately measure metabolism in real-time and provide data support for clinical nutrition assessment and therapy.
Humans ; Energy Metabolism ; Breath Tests/instrumentation* ; Calorimetry, Indirect/instrumentation* ; Equipment Design

Objective:To design an inspection system for quality of metabolism tester based on alcohol combustion mode for human body,so as to realize assessment for accuracy degree of human metabolism tester.Methods:According to the specific indicators that were measured by the metabolism tester for human body,a simulation of bidirectional controllable flow and a simulation of component concentration of exhaled breath were designed and realized.Then,the ratio of alcohol consumption to oxygen consumption and carbon dioxide production were calculated by the formula of alcohol combustion.Finally,the metabolic indexes(volume of gas flow,oxygen consumption,dioxide carbon production,rate of energy metabolism,respiratory quotient)that were outputted by the inspection system for quality were calculated according to Weir formula.Furthermore,the verification for precision of simulation modules of exhale and inhalation,and weighing device module was carried out,and an application test of inspection system for quality was also carried out.Results:The errors of the volume of gas flow and alcohol consumption that were outputted by simulation modules of exhale and inhalation,and weighing device module were all within±1%,and the errors between the reference value of the metabolic index of the inspection system for quality and the actually measured value of the metabolic index of the hood calorimeter were all within 10%.Conclusion:There was higher consistency between inspection system for quality of metabolism tester for human body and the actual measurement data of calorimeter,which can better simulate the process of respiratory metabolism of human body,and provide standardized testing means for the performance verification of metabolic tester.

Objective:To explore the construction requirements and solutions for a digital full-process management platform for Investigator-Initiated Trials (IIT) in pediatrics in China.Methods:By reviewing literature, the current status and highlights of pediatric IIT digital management systems in Europe and the United States were analyzed. The challenges faced in building a digital full-process management platform for pediatric IIT in China were summarized. The exploration and implementation achievements of our hospital in platform construction were introduced, and future construction priorities were proposed based on practical considerations.Results:The construction and application of digital full-process management platforms for pediatric IIT in Europe and the United States were relatively mature, providing comprehensive digital support for pediatric IIT research, ranging from project management to research design implementation, multi-center data interoperability, and personnel training. In China, the pediatric IIT digital management platform was still under construction, with main challenges including the formulation of construction plans based on hospital-specific conditions, data standardization, and remote recruitment and follow-up platforms.Conclusions:Considering the current status of pediatric IIT digital full-process management systems both domestically and internationally, efforts should be made to further strengthen data standardization, remote subject management, and digital pediatric IIT training from both policy and technical perspectives. This will provide one-stop services and management for projects and researchers, promoting the development of pediatric medical research.

Objective:To investigate the expressions of serum cytokines in patients with autoimmune retinopathy (AIR), and their association with disease diagnosis as well as clinical features.Methods:A prospective case-control study was conducted.A total of 90 eyes of 45 AIR patients were consecutively collected in Beijing Tongren Hospital from September 2018 to December 2023.Additionally, age-matched 43 controls (86 eyes) were enrolled, consisting of 21 patients (42 eyes) with retinitis pigmentosa as a disease control group and 22 healthy subjects (44 eyes) as a normal control group.The main clinical outcome measures included best-corrected visual acuity (BCVA), mean deviation (MD) of visual field, central retinal thickness and the maximal response amplitude and implicit time of full-field electroretinography (ff-ERG). A total of 21 serum cytokines were detected by Luminex multiple cytokines assay or ELISA.Differences in serum cytokine concentrations of among groups, the correlation between cytokine levels and clinical outcomes, and the contribution of cytokines to the diagnosis of AIR were analyzed.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Beijing Tongren Hospital (No.TRECKY2018-048). Written informed consent was obtained from each subject.Results:In AIR patients, the expression levels of Th1-type cytokines or receptors (including interferon-γ[IFN-γ], interleukin [IL]-8, C-X-C motif chemokine ligand [CXCL]9, and CXCL10) and Th17-type cytokines (including IL-17 and IL-6) were elevated.There were statistically significant overall differences in pro-inflammatory cytokines/chemokines (IL-6, IL-8, CXCL10, IL-10, IFN-γ, IL-17, C-X3-C motif chemokine ligand 1 [CX3CL]1, CXCL9) among the three groups ( H=10.823, 10.816, 9.633, 10.103, 23.670, 16.493, 9.050, 9.253; all P<0.05). Compared with the disease control group and the healthy control group, the IFN-γ level was significantly increased in the AIR group (both P=0.001). Compared with the healthy control group, the serum levels of IL-6, IL-8, CXCL10, IL-10, IL-17, and CXCL9 in the AIR group were significantly elevated (all P<0.05). The serum level of CX3CL1 was significantly higher in the AIR group than in the disease control group ( P=0.039). The serum level of IFN-γ was significantly higher in the AIR group than in the healthy control and disease control groups, but no association with AIR diagnosis was found ( OR=1.402, 95% CI: 0.710-2.870, P=0.245). Multilevel mixed-effects regression modeling analysis showed that the serum levels of IL-8 and CXCL9 in AIR patients were positively correlated with LogMAR BCVA ( β=0.028, P=0.033; β=0.023, P=0.003). The C-C motif chemokine ligand 11 level was positively correlated with implicit time of ERG a-wave ( β=13.950, P<0.001). The tumor necrosis factor-α level was positively correlated with MD value of visual field ( β=6.310, P=0.002). Granulocyte-macrophage colony-stimulating factor was negatively correlated with the amplitude of ERG a-wave and granulocyte colony-stimulating factor was negatively correlated with ERG b-wave amplitude ( β=-152.700, P<0.001; β=-14.790, P=0.003). Conclusions:Serum Th1 and Th17-type cytokines/chemokines may be involved in the pathogenesis of AIR and are related to disease severity.

As the most distal branches of the meridian system,tertiary collaterals(sunluo)are morphologically similar to microvessels in western medicine,while Henoch-Sch?nlein purpura(HSP)is a manifestation of systemic vascular inflammation.The discussion in Huang Di Nei Jing(The Yellow Emperor's Inner Classic)regarding tertiary collaterals"draining pathogenic factors and regulating ying-wei"provides valuable theoretical guidance for the traditional Chinese medicine(TCM)treatment of HSP.This article thoroughly analyzes the physiological functions of tertiary collaterals and proposes that the formation of HSP is due to the invasion of pathogenic factors into the tertiary collaterals,leading to the imbalance of ying-wei,heat stasis obstructing the vessels,and blood extravasation,resulting in symptoms such as skin purpura,gastrointestinal bleeding,and joint pain.These symptoms further interfere with the convergence and biochemical processes of ying-wei,causing an imbalance of body fluids and blood.The overflow of body fluids from the tertiary collaterals,unable to return,leads to fluid stagnation.The accumulation of blood stasis and dampness in the kidney collaterals may cause kidney damage,manifesting as hematuria and proteinuria.The pathogenesis at different stages of the disease can be summarized as follows:in the early stage,pathogenic factors invade the tertiary collaterals,causing wei stagnation and ying obstruction;in the middle stage,fire toxin scorches the tertiary collaterals,affecting ying-wei,damaging yang and yin;or damp pathogens invade the lower regions through the tertiary collaterals,affecting the yin organs;in the late stage,deficiency of vital qi and collateral stasis lead to kidney dysfunction.Based on these pathological mechanisms,the treatment principle should focus on"harmonizing pathogenic wind and blood circulation,and unblocking the tertiary collaterals,"aiming to alleviate purpura symptoms,shorten the disease course,promote recovery,and achieve comprehensive prevention and treatment effects.

Objective:To investigate the expressions of serum cytokines in patients with autoimmune retinopathy (AIR), and their association with disease diagnosis as well as clinical features.Methods:A prospective case-control study was conducted.A total of 90 eyes of 45 AIR patients were consecutively collected in Beijing Tongren Hospital from September 2018 to December 2023.Additionally, age-matched 43 controls (86 eyes) were enrolled, consisting of 21 patients (42 eyes) with retinitis pigmentosa as a disease control group and 22 healthy subjects (44 eyes) as a normal control group.The main clinical outcome measures included best-corrected visual acuity (BCVA), mean deviation (MD) of visual field, central retinal thickness and the maximal response amplitude and implicit time of full-field electroretinography (ff-ERG). A total of 21 serum cytokines were detected by Luminex multiple cytokines assay or ELISA.Differences in serum cytokine concentrations of among groups, the correlation between cytokine levels and clinical outcomes, and the contribution of cytokines to the diagnosis of AIR were analyzed.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Beijing Tongren Hospital (No.TRECKY2018-048). Written informed consent was obtained from each subject.Results:In AIR patients, the expression levels of Th1-type cytokines or receptors (including interferon-γ[IFN-γ], interleukin [IL]-8, C-X-C motif chemokine ligand [CXCL]9, and CXCL10) and Th17-type cytokines (including IL-17 and IL-6) were elevated.There were statistically significant overall differences in pro-inflammatory cytokines/chemokines (IL-6, IL-8, CXCL10, IL-10, IFN-γ, IL-17, C-X3-C motif chemokine ligand 1 [CX3CL]1, CXCL9) among the three groups ( H=10.823, 10.816, 9.633, 10.103, 23.670, 16.493, 9.050, 9.253; all P<0.05). Compared with the disease control group and the healthy control group, the IFN-γ level was significantly increased in the AIR group (both P=0.001). Compared with the healthy control group, the serum levels of IL-6, IL-8, CXCL10, IL-10, IL-17, and CXCL9 in the AIR group were significantly elevated (all P<0.05). The serum level of CX3CL1 was significantly higher in the AIR group than in the disease control group ( P=0.039). The serum level of IFN-γ was significantly higher in the AIR group than in the healthy control and disease control groups, but no association with AIR diagnosis was found ( OR=1.402, 95% CI: 0.710-2.870, P=0.245). Multilevel mixed-effects regression modeling analysis showed that the serum levels of IL-8 and CXCL9 in AIR patients were positively correlated with LogMAR BCVA ( β=0.028, P=0.033; β=0.023, P=0.003). The C-C motif chemokine ligand 11 level was positively correlated with implicit time of ERG a-wave ( β=13.950, P<0.001). The tumor necrosis factor-α level was positively correlated with MD value of visual field ( β=6.310, P=0.002). Granulocyte-macrophage colony-stimulating factor was negatively correlated with the amplitude of ERG a-wave and granulocyte colony-stimulating factor was negatively correlated with ERG b-wave amplitude ( β=-152.700, P<0.001; β=-14.790, P=0.003). Conclusions:Serum Th1 and Th17-type cytokines/chemokines may be involved in the pathogenesis of AIR and are related to disease severity.

Objective:To design an inspection system for quality of metabolism tester based on alcohol combustion mode for human body,so as to realize assessment for accuracy degree of human metabolism tester.Methods:According to the specific indicators that were measured by the metabolism tester for human body,a simulation of bidirectional controllable flow and a simulation of component concentration of exhaled breath were designed and realized.Then,the ratio of alcohol consumption to oxygen consumption and carbon dioxide production were calculated by the formula of alcohol combustion.Finally,the metabolic indexes(volume of gas flow,oxygen consumption,dioxide carbon production,rate of energy metabolism,respiratory quotient)that were outputted by the inspection system for quality were calculated according to Weir formula.Furthermore,the verification for precision of simulation modules of exhale and inhalation,and weighing device module was carried out,and an application test of inspection system for quality was also carried out.Results:The errors of the volume of gas flow and alcohol consumption that were outputted by simulation modules of exhale and inhalation,and weighing device module were all within±1%,and the errors between the reference value of the metabolic index of the inspection system for quality and the actually measured value of the metabolic index of the hood calorimeter were all within 10%.Conclusion:There was higher consistency between inspection system for quality of metabolism tester for human body and the actual measurement data of calorimeter,which can better simulate the process of respiratory metabolism of human body,and provide standardized testing means for the performance verification of metabolic tester.

Objective:To explore the construction requirements and solutions for a digital full-process management platform for Investigator-Initiated Trials (IIT) in pediatrics in China.Methods:By reviewing literature, the current status and highlights of pediatric IIT digital management systems in Europe and the United States were analyzed. The challenges faced in building a digital full-process management platform for pediatric IIT in China were summarized. The exploration and implementation achievements of our hospital in platform construction were introduced, and future construction priorities were proposed based on practical considerations.Results:The construction and application of digital full-process management platforms for pediatric IIT in Europe and the United States were relatively mature, providing comprehensive digital support for pediatric IIT research, ranging from project management to research design implementation, multi-center data interoperability, and personnel training. In China, the pediatric IIT digital management platform was still under construction, with main challenges including the formulation of construction plans based on hospital-specific conditions, data standardization, and remote recruitment and follow-up platforms.Conclusions:Considering the current status of pediatric IIT digital full-process management systems both domestically and internationally, efforts should be made to further strengthen data standardization, remote subject management, and digital pediatric IIT training from both policy and technical perspectives. This will provide one-stop services and management for projects and researchers, promoting the development of pediatric medical research.

Objective:To standardize the management of pediatric Investigator-Initiated Trails (IIT) and improve the execution quality, this study takes a tertiary hospital for children in Shanghai as an example to analyze and summarize the main quality problems in the implementation of pediatric IIT projects and provide appropriate suggestions.Methods:From 2020 to 2022, based on the quality indicators of the IIT project of Shanghai Jiao Tong University School of Medicine, and combined with the characteristics of pediatrics, a centralized monitoring method was used to conduct spot checks and evaluations on the IIT project of a tertiary hospital for children in Shanghai.Results:From 2020 to 2022, a total of 77 IIT projects were inspected, including 27 in the initiation stage, 36 in the execution stage, and 14 in the conclusion stage. In terms of ethical compliance, there are issues with researchers′ weak ethical awareness and non-standard signing of informed consent in the pediatric IIT project. The main problems in terms of execution quality and science include non-standard CRF table design, insufficient awareness of safety management, lack of emphasis on research registration and specialized data management, randomization and blind methods. There are issues with low enrollment rate and low funding execution rate in terms of execution progress.Conclusions:There are certain quality problems during the execution of pediatric IIT projects. Strengthen the establishment of an effective process management and supervision system to improve the quality management of pediatric IIT research processes is needed.

Objective An X-shaped cushioning insole with variable stiffness was designed to explore its effects on plantar pressure and internal stress of diabetic patients with toe amputation. Methods Based on CT images, the feet-calf finite element model of diabetic patients with toe amputation was established, and the insole was divided into different areas according to distribution characteristics of the planter pressure. The three-dimensional (3D) printed cushioning insole with an X-shaped sandwich structure was designed. The modulus of the sandwichstructure was changed by changing thickness of the sandwich structure panel. For simulation analysis, the divided area was filled with the X-shaped sandwich structure with different modulus. Results The peak plantar pressure of diabetic patients with toe amputation was in calcaneal region, and the combined insoles with 1. 2 mpanel thickness in toe area, 1. 4 mm panel thickness in metatarsal area, 2. 0 mm panel thickness in middle area and 1. 6 mm panel thickness in heel area had the best decompression effect. Compared with bare feet, the peak pressure in heel area of the insole, the peak pressure in phalangeal head area and the stress in plantar softissues were reduced by 40. 18% , 31. 7% , and 50. 44% , respectively. Conclusions The 3D printed insoles with variable stiffness can effectively reduce surface pressure and internal stress of the sole and reduce probability of the 2nd toe amputation