ObjectiveTo elucidate the critical role of rehabilitation medical records (including electronic records) in rehabilitation medicine's clinical practice and management, comprehensively analyzed the structure, core content and data standards of rehabilitation medical records, to develop a standardized medical record data architecture and core dataset suitable for rehabilitation medicine and to explore the application of rehabilitation data in performance evaluation and payment. MethodsBased on the regulatory documents Basic Specifications for Medical Record Writing and Basic Specifications for Electronic Medical Records (Trial) issued by National Health Commission of China, and referencing the World Health Organization (WHO) Family of International Classifications (WHO-FICs) classifications, International Classification of Diseases (ICD-10/ICD-11), International Classification of Functioning, Disability and Health (ICF), and International Classification of Health Interventions (ICHI Beta-3), this study constructed the data architecture, core content and data standards for rehabilitation medical records. Furthermore, it explored the application of rehabilitation record summary sheets (home page) data in rehabilitation medical statistics and payment methods, including Diagnosis-related Groups (DRG), Diagnosis-Intervention Packet (DIP) and Case Mix Index. ResultsThis study proposed a systematic standard framework for rehabilitation medical records, covering key components such as patient demographics, rehabilitation diagnosis, functional assessment, rehabilitation treatment prescriptions, progress evaluations and discharge summaries. The research analyzed the systematic application methods and data standards of ICD-10/ICD-11, ICF and ICHI Beta-3 in the fields of medical record terminology, coding and assessment. Constructing a standardized data structure and data standards for rehabilitation medical records can significantly improve the quality of data reporting based on the medical record summary sheet, thereby enhancing the quality control of rehabilitation services, effectively supporting the optimization of rehabilitation medical insurance payment mechanisms, and contributing to the establishment of rehabilitation medical performance evaluation and payment based on DRG and DIP. ConclusionStructured rehabilitation records and data standardization are crucial tools for quality control in rehabilitation. Systematically applying the three reference classifications of the WHO-FICs, and aligning with national medical record and electronic health record specifications, facilitate the development of a standardized rehabilitation record architecture and core dataset. Standardizing rehabilitation care pathways based on the ICF methodology, and developing ICF- and ICD-11-based rehabilitation assessment tools, auxiliary diagnostic and therapeutic systems, and supporting terminology and coding systems, can effectively enhance the quality of rehabilitation records and enable interoperability and sharing of rehabilitation data with other medical data, ultimately improving the quality and safety of rehabilitation services.

Objective:To establish graded forecast models of pollen concentration in spring and summer-autumn in northern China, based on long-term data of pollen and allergic rhinitis (AR) medical visits in 8 cities of northern China.Methods:Pollen concentration and the characteristics of AR patients from 8 cities of northern China, including Beijing, Baotou, Hohhot, Xi′an, Xining, Cangzhou, Liaocheng and Zibo, were analyzed. Spearman′s correlation was used to examine the relationship between pollen concentration and daily AR patient visits. A pollen concentration grading was establish, and a pollen forecast model was created using the eXtreme gradient boosting (XGBoost) algorithm. The model incorporated meteorological factors and the 3-day moving average of pollen concentrations.Results:The spring pollen period started early and lasted long in Beijing and Xi ′an, while the summer-autumn pollen period started earlier and persisted longer in Xining, Baotou and Hohhot. During summer-autumn pollen period, and the spring period in most cities (except Baotou and Cangzhou), average daily patient visits were significantly higher than those in non-pollen periods. A strong correlation was observed between daily AR patient visits and the 3-day moving average of pollen concentrations in both the spring and summer-autumn periods across all cities. Based on the correlation, a pollen concentration grading standard of northern China was established. The accuracy evaluation of pollen concentration prediction model showed that the percentage of forecasts with either completely accurate or within one level difference exceeded 91% in spring and 95% in summer-autumn. The most important predictive variable in the model was the pollen level from previous day, followed by the temperature and humidity.Conclusion:The grading prediction model for pollen concentration provides guidance for AR patients in term of travel, early defense and treatment, as well as the determining medication schedules for clinical drug research and specific immunotherapy.

Objective To explore the efficacy of two lipopolysaccharide(LPS)two-hit methods in establishing an acute lung injury(ALI)mouse model and analyze the characteristics of this model within the context of both Western and traditional Chinese medicine(TCM).Methods Healthy male C57BL/6 mice were randomly divided into six groups:PBS instillation control group,PBS nebulization control group,instillation two-hit group,nebulization two-hit group I,nebulization two-hit group Ⅱ,and nebulization two-hit group Ⅲ.Using LPS as a stimulant,a"two-hit"approach was employed to establish an ALI mouse model.Body temperature,weight,pulse oximetric oxygen saturation(SpO2),lung tissue wet-to-dry weight ratio(W/D),levels of tumor necrosis factor(TNF-α),interleukin-1β(IL-1β),and myeloperoxidase(MPO)activity in lung tissue,as well as total protein concentration and white blood cell count in bronchoalveolar lavage fluid were measured.Through evaluating the consistency between TCM and Western medical syndromes,the classification,characteristics,modeling methods,advantages,and disadvantages of the two-hit ALI animal model were summarized and analyzed based on the clinical diagnostic criteria and syndrome characteristics of ALI in both TCM and Western medicine.Results Compared with the control group,the body temperature,weight,and SpO2 of model group decreased,W/D increased,levels of TNF-α,IL-1β,and MPO activity in lung tissue increased.The alveolar walls thickened with a large exudate of red blood cells.The total protein concentration and white blood cell count in bronchoalveolar lavage fluid significantly increased.The existing two-hit ALI animal model showed a high degree of consistency with Western medical diagnostic main symptoms.Conclusion Both methods of two-hit can prepare mouse ALI models,among which the nebulization two-hit Group Ⅲ showed more pronounced effects in simulating the pathological changes and clinical symptoms of ALI.

OBJECTIVE To investigate the vasodilatory effect of dimethyl sulfoxide(DMSO)on isolated aortic arteries and intrarenal arteries of rats and the mechanisms.METHODS ① Rat aortas and intrarenal arteries were pre-contracted with KCl 60 mmol·L-1,U46619 0.3 μmol·L-1 or PE 3 μmol·L-1.Following equilibration,dimethyl sulfoxide(DMSO)was cumulatively administered at concentrations of 0.1%,0.3%,1.0%,3.0%and 10.0%.Changes in the vascular tension of aortic and intrarenal arterial rings were recorded using an isolated vessel tension measurement system.Rat intrarenal arteries were pre-contracted with KCl 60 mmol·L-1,U46619 0.3 μmol·L-1 or PE 3 μmol·L-1.Cumulative additions of DMSO(3.0%and 10.0%)were administered as the control group.Following pre-contraction with each of the three stimulants,the voltage-gated potassium channel(Kv)inhibitor 4-AP(0.5 mmol·L-1)was incubated for 15 min.Cumulative additions of DMSO(3.0%and 10.0%)were then administered,and the vascular relaxation percentages induced by DMSO before and after treatment were calculated.Whole-cell patch-clamp recordings were performed on acutely isolated intrarenal arterial smooth muscle cells of rat to assess Kv currents during cumulative DMSO applications(0.1%,0.3%,1.0%and 3.0%).② Rat aortic smooth muscle cells(A7r5)were exposed to DMSO concentration of 0.0%(control),0.1%,0.3%,1.0%and 3.0%for 24 h.Intracellular reactive oxygen species(ROS)levels were detected using the DCFH-DA fluorescent probe.Malondialdehyde(MDA)content,catalase(CAT)activity,and superoxide dismutase(SOD)activity in A7r5 cells were measured by chemical colorimetry.Mitochondrial membrane potential was evaluated using the JC-1 fluorescent probe.RESULTS ① DMSO(0.1%-10.0%)dose-dependently relaxed rats aortic and intrarenal arteries pre-contracted with either KCl 60 mmol·L-1,U46619 0.3 μmol·L-1 or PE 3 μmol·L-1.The values of maximum relaxation were(42.3±9.7)%,(73.2±8.4)%,(99.2±4.7)%and(84.0±1.9)%,(80.5±6.1)%and(81.2±4.4)%,respectively.Compared with the control group,vasorelaxation of DMSO on IRAs precontracted with U46619 was significantly attenuated by Kv inhibitor 4-AP.② Low concentrations(0.1%and 0.3%)of DMSO significantly increased Kv currents,while high concentrations(1.0%and 3.0%)of DMSO significantly decreased Kv currents.High concentrations(1.0%and 3.0%)of DMSO remarkablely increased ROS and MDA levels,but significantly decreased CAT activity,SOD activity and mitochondrial membrane potential in A7r5 cells.CONCLUSION DMSO(0.1%-10.0%)can relax rats aortal and intrarenal arteries in a concentra-tion-dependent manner,and the mechanism may be related to Kv,oxidative stress and mitochondrial damage.

Objective To explore the efficacy of two lipopolysaccharide(LPS)two-hit methods in establishing an acute lung injury(ALI)mouse model and analyze the characteristics of this model within the context of both Western and traditional Chinese medicine(TCM).Methods Healthy male C57BL/6 mice were randomly divided into six groups:PBS instillation control group,PBS nebulization control group,instillation two-hit group,nebulization two-hit group I,nebulization two-hit group Ⅱ,and nebulization two-hit group Ⅲ.Using LPS as a stimulant,a"two-hit"approach was employed to establish an ALI mouse model.Body temperature,weight,pulse oximetric oxygen saturation(SpO2),lung tissue wet-to-dry weight ratio(W/D),levels of tumor necrosis factor(TNF-α),interleukin-1β(IL-1β),and myeloperoxidase(MPO)activity in lung tissue,as well as total protein concentration and white blood cell count in bronchoalveolar lavage fluid were measured.Through evaluating the consistency between TCM and Western medical syndromes,the classification,characteristics,modeling methods,advantages,and disadvantages of the two-hit ALI animal model were summarized and analyzed based on the clinical diagnostic criteria and syndrome characteristics of ALI in both TCM and Western medicine.Results Compared with the control group,the body temperature,weight,and SpO2 of model group decreased,W/D increased,levels of TNF-α,IL-1β,and MPO activity in lung tissue increased.The alveolar walls thickened with a large exudate of red blood cells.The total protein concentration and white blood cell count in bronchoalveolar lavage fluid significantly increased.The existing two-hit ALI animal model showed a high degree of consistency with Western medical diagnostic main symptoms.Conclusion Both methods of two-hit can prepare mouse ALI models,among which the nebulization two-hit Group Ⅲ showed more pronounced effects in simulating the pathological changes and clinical symptoms of ALI.

OBJECTIVE To investigate the vasodilatory effect of dimethyl sulfoxide(DMSO)on isolated aortic arteries and intrarenal arteries of rats and the mechanisms.METHODS ① Rat aortas and intrarenal arteries were pre-contracted with KCl 60 mmol·L-1,U46619 0.3 μmol·L-1 or PE 3 μmol·L-1.Following equilibration,dimethyl sulfoxide(DMSO)was cumulatively administered at concentrations of 0.1%,0.3%,1.0%,3.0%and 10.0%.Changes in the vascular tension of aortic and intrarenal arterial rings were recorded using an isolated vessel tension measurement system.Rat intrarenal arteries were pre-contracted with KCl 60 mmol·L-1,U46619 0.3 μmol·L-1 or PE 3 μmol·L-1.Cumulative additions of DMSO(3.0%and 10.0%)were administered as the control group.Following pre-contraction with each of the three stimulants,the voltage-gated potassium channel(Kv)inhibitor 4-AP(0.5 mmol·L-1)was incubated for 15 min.Cumulative additions of DMSO(3.0%and 10.0%)were then administered,and the vascular relaxation percentages induced by DMSO before and after treatment were calculated.Whole-cell patch-clamp recordings were performed on acutely isolated intrarenal arterial smooth muscle cells of rat to assess Kv currents during cumulative DMSO applications(0.1%,0.3%,1.0%and 3.0%).② Rat aortic smooth muscle cells(A7r5)were exposed to DMSO concentration of 0.0%(control),0.1%,0.3%,1.0%and 3.0%for 24 h.Intracellular reactive oxygen species(ROS)levels were detected using the DCFH-DA fluorescent probe.Malondialdehyde(MDA)content,catalase(CAT)activity,and superoxide dismutase(SOD)activity in A7r5 cells were measured by chemical colorimetry.Mitochondrial membrane potential was evaluated using the JC-1 fluorescent probe.RESULTS ① DMSO(0.1%-10.0%)dose-dependently relaxed rats aortic and intrarenal arteries pre-contracted with either KCl 60 mmol·L-1,U46619 0.3 μmol·L-1 or PE 3 μmol·L-1.The values of maximum relaxation were(42.3±9.7)%,(73.2±8.4)%,(99.2±4.7)%and(84.0±1.9)%,(80.5±6.1)%and(81.2±4.4)%,respectively.Compared with the control group,vasorelaxation of DMSO on IRAs precontracted with U46619 was significantly attenuated by Kv inhibitor 4-AP.② Low concentrations(0.1%and 0.3%)of DMSO significantly increased Kv currents,while high concentrations(1.0%and 3.0%)of DMSO significantly decreased Kv currents.High concentrations(1.0%and 3.0%)of DMSO remarkablely increased ROS and MDA levels,but significantly decreased CAT activity,SOD activity and mitochondrial membrane potential in A7r5 cells.CONCLUSION DMSO(0.1%-10.0%)can relax rats aortal and intrarenal arteries in a concentra-tion-dependent manner,and the mechanism may be related to Kv,oxidative stress and mitochondrial damage.

Objective:To establish graded forecast models of pollen concentration in spring and summer-autumn in northern China, based on long-term data of pollen and allergic rhinitis (AR) medical visits in 8 cities of northern China.Methods:Pollen concentration and the characteristics of AR patients from 8 cities of northern China, including Beijing, Baotou, Hohhot, Xi′an, Xining, Cangzhou, Liaocheng and Zibo, were analyzed. Spearman′s correlation was used to examine the relationship between pollen concentration and daily AR patient visits. A pollen concentration grading was establish, and a pollen forecast model was created using the eXtreme gradient boosting (XGBoost) algorithm. The model incorporated meteorological factors and the 3-day moving average of pollen concentrations.Results:The spring pollen period started early and lasted long in Beijing and Xi ′an, while the summer-autumn pollen period started earlier and persisted longer in Xining, Baotou and Hohhot. During summer-autumn pollen period, and the spring period in most cities (except Baotou and Cangzhou), average daily patient visits were significantly higher than those in non-pollen periods. A strong correlation was observed between daily AR patient visits and the 3-day moving average of pollen concentrations in both the spring and summer-autumn periods across all cities. Based on the correlation, a pollen concentration grading standard of northern China was established. The accuracy evaluation of pollen concentration prediction model showed that the percentage of forecasts with either completely accurate or within one level difference exceeded 91% in spring and 95% in summer-autumn. The most important predictive variable in the model was the pollen level from previous day, followed by the temperature and humidity.Conclusion:The grading prediction model for pollen concentration provides guidance for AR patients in term of travel, early defense and treatment, as well as the determining medication schedules for clinical drug research and specific immunotherapy.

Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.

Human epidermal growth factor receptor 2 （HER2）-positive breast cancer is aggressive and prone to metastasis，and the applications of HER2 agents have improved the prognosis of patients with HER2-positive breast cancer. Among the marketed HER2 agents，macromolecular monoclonal antibodies that target the extracellular domain Ⅳ of HER2 were the cornerstone drugs of HER2-positive breast cancer，including trastuzumab，inetetamab，and margetuximab. Trastuzumab is available for the full-line treatment of breast cancer with sufficient proof of evidence-based medicine，sufficient practical experience and controllable safety. Inetetamab and trastuzumab have similar efficacy and controllable safety in HER2-positive metastatic breast cancer and neoadjuvant/ adjuvant therapy. Margetuximab focuses on patients carrying the CD16A-158F allele，and is an option of posterior line treatment for advanced breast cancer. It is necessary to select the most suitable drugs clinically according to the specific condition of the patient.

Objective To investigate the immediate brain effect of acupuncture at Fengchi using amplitude of low-frequency fluctuation(ALFF)and functional connectivity by the resting-state functional magnetic resonance imaging(rs-fMRI)in patients with posterior circulation ischemia vertigo(PCIV).Methods Twenty patients with PCIV were enrolled.The dizziness handicap inventory(DHI)was used to evaluate the severity of vertigo.The patients were randomly divided into acupuncture group and sham acupoint acupuncture group.Rs-fMRI scan was performed before and after acupuncture.MATLAB-based DPABI 6.1 software was used to analyze rs-fMRI data.Correlation analysis was used between the altered ALFF values and DHI scores.The regions of altered ALFF were taken as seeds to analyze functional connectivity.Results Compared with the sham acupoint acupuncture group,the increased ALFF values were mainly located on the left precuneus,left superior frontal gyrus and left caudate nucleus after acupuncture in the acupuncture group;the decreased ALFF values were mainly located on the left cerebellum and right inferior occipital gyrus.The ALFF value of the left superior frontal gyrus was negatively correlated with the DHI score(P=0.04).The increased functional connectivity was mainly found between left precuneus and the right middle frontal gyrus,the right superior frontal gyrus,the decreased functional connectivity was mainly found between left precuneus and the bilateral paracentral lobule and right cerebellum.Conclusion The ALFF value and functional connectivity are different before and after acupuncture,indicating that the vestibular network,visual and motor brain regions functional activities are changed after needling at Fengchi,which may be the brain functional basis of Fengchi for vertigo in PCIV.