1.Structure, content and data standardization of rehabilitation medical records
Yaru YANG ; Zhuoying QIU ; Di CHEN ; Zhongyan WANG ; Meng ZHANG ; Shiyong WU ; Yaoguang ZHANG ; Xiaoxie LIU ; Yanyan YANG ; Bin ZENG ; Mouwang ZHOU ; Yuxiao XIE ; Guangxu XU ; Jiejiao ZHENG ; Mingsheng ZHANG ; Xiangming YE ; Jian YANG ; Na AN ; Yuanjun DONG ; Xiaojia XIN ; Xiangxia REN ; Ye LIU ; Yifan TIAN
Chinese Journal of Rehabilitation Theory and Practice 2025;31(1):21-32
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.
2.Analysis on prevalence of chronic kidney disease in adults in Qingdao, 2019-2020
Longfei QIU ; Yuanyuan ZHAO ; Hua ZHANG ; Xiaojia XUE ; Yang ZHAO ; Yaoyao XU ; Haiping DUAN
Chinese Journal of Epidemiology 2024;45(5):694-699
Objective:To understand the prevalence of chronic kidney disease (CKD) in adults in Qingdao.Methods:A multi-stage stratified random sampling method was used to select 6 240 local residents aged ≥18 years in Qingdao as study subjects from May 2019 to September 2020, the demographic data of the study subjects were collected by face-to-face survey method. The prevalence of CKD in adults in Qingdao were analyzed using software SPSS 25.0.Results:A total of 5 996 adults in Qingdao were included in this study. The overall prevalence rate of CKD in the adults was 8.22%. The prevalence rates of CKD in men and women were 7.70% and 8.74%, respectively. The prevalence rate of CKD was 10.28% in urban residents and 7.25% in rural residents, the differences in the prevalence of CKD among different age, educational level and marital status groups were significant ( P<0.001). The prevalence of CKD tended to increase with age and decrease with the increase of education level. Conclusions:The prevalence of CKD in adults of Qingdao was relatively high. It is necessary to actively carry out the early prevention and treatment of CKD and strengthen the screening and prevention of CKD to reduce the incidence and slow development of CKD.
3.Efficacy,metabolic characteristics,safety and immunogenicity of AK-HER2 compared with reference trastuzumab in patients with metastatic HER2-positive breast cancer:a multicenter,randomized,double-blind phase Ⅲ equivalence trial
Yang LUO ; Tao SUN ; Zhimin SHAO ; Jiuwei CUI ; Yueyin PAN ; Qingyuan ZHANG ; Ying CHENG ; Huiping LI ; Yan YANG ; Changsheng YE ; Guohua YU ; Jingfen WANG ; Yunjiang LIU ; Xinlan LIU ; Yuhong ZHOU ; Yuju BAI ; Yuanting GU ; Xiaojia WANG ; Binghe XU ; Lihua SONG
China Oncology 2024;34(2):161-175
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.
4.Clinical application and progression of monoclonal antibodies targeting HER2 extracellular domain Ⅳ in breast cancer
Jiaojiao XU ; Jiani TAO ; Xiaojia WANG ; Zhanhong CHEN
China Pharmacy 2024;35(5):635-640
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.
5.The immediate brain effect of acupuncture at Fengchi in patients with posterior circulation ischemia vertigo:a resting-state functional MRI study
Xiaojia YUAN ; Yu XU ; Weitao WANG ; Liqun ZHONG ; Xiaozhen LI ; Dan XU ; Wenlong SHE ; Zhengguang CHEN
Journal of Practical Radiology 2024;40(2):186-189
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.
6.Analysis of pollen sensitization characteristics of artemisia allergic rhinitis in three urban and rural areas of Inner Mongolia
Chunying LI ; Xiaojia LIU ; Haixia XU ; Qiang FU ; Dongyue XU ; Xiaobo CUI ; Ji LIU ; Bolong SONG ; Ming ZHENG ; Yuhui OUYANG ; Xiangdong WANG ; Xiaoling LIU
Chinese Journal of Preventive Medicine 2024;58(6):806-814
Objective:To investigate the distribution rules of artemisia pollen and the clinical sensitization characteristics of allergic rhinitis (AR) induced by artemisia pollen in three urban and rural areas of Inner Mongolia.Methods:From March to October 2019, in 3 central cities (Chifeng, Hohhot, Ordos) and rural areas of Inner Mongolia, an epidemiological investigation method combining multi-stage stratified random sampling and face-to-face questionnaire survey was adopted to screen suspected AR patients, and skin prick test (SPT) was applied for diagnosis. At the same time, pollen monitoring was carried out in 3 areas to analyze the distribution and clinical sensitization characteristics of artemisia pollen.SPSS26.0 statistical software was used to process all the data. Chi-square test was used to compare rates among different age, sex, region and nationality, Spearman test was used to describe correlation analysis, and pairwise comparison of positive rates among multiple samples was used Bonferroni method.Results:Among the 6 393 subjects, 1 093 cases were diagnosed with AR, and the prevalence of AR was 17.10% (1 093/6 393). Among them, pollen-induced allergic rhinitis, the prevalence of PiAR was 10.97% (701/6 393), accounting for 64.14%(701/1 093).The highest incidence was in the youth group (20-39 years old), accounting for 46.94% (329/701).The diagnosed prevalence was higher in females than in males (11.35% vs. 10.64%, χ2 value 12.304, P<0.001).The prevalence rate of ethnic minority was higher than that of Han nationality (13.01% vs. 10.65%, χ2 value 6.296, P=0.008).The prevalence in urban areas was also significantly higher than that in rural areas (18.40% vs. 5.50%, χ2 value 10.497, P<0.001).There was significant difference in prevalence rate among the three regions in Inner Mongolia (6.06% in Chifeng, 13.46% in Hohhot, 16.39% in Ordos, χ2 value 70.054, P<0.001).The main clinical symptoms of artemisia PiAR were sneezing (95.58%), nasal congestion (91.73%) and nasal itching (89.30%).Allergic conjunctivitis accounted for 79.60% (558/701), chronic sinusitis for 55.63% (390/701), asthma for 23.25% (163/701).The pattern of artemisia pollen sensitization was mainly multiple sensitization, and the frequency of clinical symptoms and clinical diseases induced by hypersensitization with other allergens accounted for more than that caused by single artemisia pollen. The spread period of Artemisia pollen in the three regions was from June to October, and the peak state was in August in summer. The peak time of clinical symptoms in artemisia PiAR patients was about 2 weeks earlier than the peak time of pollen concentration, and the two were significantly positively correlated ( R=0.7671, P<0.001). Conclusion:Artemisia pollens are the dominant pollens in late summer and early autumn in Inner Mongolia, and the prevalence of artemisia PiAR is high. Controlling the spread of Artemisia pollens is of great significance for the prevention and treatment of AR.
7.Risk factors for permanent nerve damage after aortic arch surgery in patients with acute type A aortic dissection
Jiangli WU ; Xiaojia XU ; Xuan XIE ; Liping MA ; Shuxian MA ; Xiaoxian FENG ; Jianjun REN
Chinese Journal of Anesthesiology 2024;44(11):1311-1316
Objective:To determine the risk factors for permanent nerve damage (PND) after aortic arch surgery in patients with acute type A aortic dissection (AAAD).Methods:This was a retrospective case-control study. The medical records from patients of both sexes with AAAD, aged > 18 yr, of American Society of Anesthesiologists Physical Status classification IV, who underwent aortic arch surgery in the Second Hospital of Hebei Medical University from December 2018 to December 2023, were collected. The patients were divided into non-PND group and PND group according to whether PND occurred after operation. The preoperative data of patients were collected, including age, gender, body mass index; comorbidities (hypertension, coronary heart disease, diabetes mellitus), history of smoking, history of stroke, and history of cardiovascular surgeries; syncope at onset, preoperative low SpO 2, preoperative low systolic blood pressure, and preoperative low diastolic blood pressure. The intraoperative data included surgical procedure (total aortic arch replacement or half aortic arch replacement), selective antegrade cerebral perfusion during operation, cardiopulmonary bypass (CPB) time, aortic cross-clamp time, post-parallel time, moderate hypothermia circulatory arrest time, nasopharyngeal temperature and rectal temperature during circulatory arrest, and BIS value during circulatory arrest; blood pressure during cardiopulmonary bypass and after restoration of heart beat; the incidence of dysfunction after recovery of heart beat and difficulty in hemostasis after termination of CPB. The aforementioned indicators were analyzed for difference, and the indicators with P<0.05 were included in the multivariate logistic regression analysis. Results:A total of 292 patients were ultimately included, among which 73 developed postoperative PND, resulting in an incidence of 25.0%. The results of multivariate logistic regression analysis showed that age ≥62 yr ( OR=3.783, 95% confidence interval [ CI] 1.513-10.346, P=0.006), preoperative hypertension ( OR=2.230, 95% CI 1.118-4.715, P=0.028), syncope at onset ( OR=3.001, 95% CI 1.343-6.710, P=0.007), BIS value > 14 during circulatory arrest ( OR=2.439, 95% CI 1.249-4.755, P=0.009) and difficult hemostasis after termination of CPB ( OR=3.465, 95% CI 1.758-6.882, P<0.001) were risk factors for PND after surgery. Conclusions:Age ≥ 62 yr, history of hypertension, syncope at onset, BIS value greater than 14 during circulatory arrest and difficulty in hemostasis after termination of CPB are risk factors for PND after aortic arch surgery in patients with AAAD.
8.Analysis of pollen sensitization characteristics of artemisia allergic rhinitis in three urban and rural areas of Inner Mongolia
Chunying LI ; Xiaojia LIU ; Haixia XU ; Qiang FU ; Dongyue XU ; Xiaobo CUI ; Ji LIU ; Bolong SONG ; Ming ZHENG ; Yuhui OUYANG ; Xiangdong WANG ; Xiaoling LIU
Chinese Journal of Preventive Medicine 2024;58(6):806-814
Objective:To investigate the distribution rules of artemisia pollen and the clinical sensitization characteristics of allergic rhinitis (AR) induced by artemisia pollen in three urban and rural areas of Inner Mongolia.Methods:From March to October 2019, in 3 central cities (Chifeng, Hohhot, Ordos) and rural areas of Inner Mongolia, an epidemiological investigation method combining multi-stage stratified random sampling and face-to-face questionnaire survey was adopted to screen suspected AR patients, and skin prick test (SPT) was applied for diagnosis. At the same time, pollen monitoring was carried out in 3 areas to analyze the distribution and clinical sensitization characteristics of artemisia pollen.SPSS26.0 statistical software was used to process all the data. Chi-square test was used to compare rates among different age, sex, region and nationality, Spearman test was used to describe correlation analysis, and pairwise comparison of positive rates among multiple samples was used Bonferroni method.Results:Among the 6 393 subjects, 1 093 cases were diagnosed with AR, and the prevalence of AR was 17.10% (1 093/6 393). Among them, pollen-induced allergic rhinitis, the prevalence of PiAR was 10.97% (701/6 393), accounting for 64.14%(701/1 093).The highest incidence was in the youth group (20-39 years old), accounting for 46.94% (329/701).The diagnosed prevalence was higher in females than in males (11.35% vs. 10.64%, χ2 value 12.304, P<0.001).The prevalence rate of ethnic minority was higher than that of Han nationality (13.01% vs. 10.65%, χ2 value 6.296, P=0.008).The prevalence in urban areas was also significantly higher than that in rural areas (18.40% vs. 5.50%, χ2 value 10.497, P<0.001).There was significant difference in prevalence rate among the three regions in Inner Mongolia (6.06% in Chifeng, 13.46% in Hohhot, 16.39% in Ordos, χ2 value 70.054, P<0.001).The main clinical symptoms of artemisia PiAR were sneezing (95.58%), nasal congestion (91.73%) and nasal itching (89.30%).Allergic conjunctivitis accounted for 79.60% (558/701), chronic sinusitis for 55.63% (390/701), asthma for 23.25% (163/701).The pattern of artemisia pollen sensitization was mainly multiple sensitization, and the frequency of clinical symptoms and clinical diseases induced by hypersensitization with other allergens accounted for more than that caused by single artemisia pollen. The spread period of Artemisia pollen in the three regions was from June to October, and the peak state was in August in summer. The peak time of clinical symptoms in artemisia PiAR patients was about 2 weeks earlier than the peak time of pollen concentration, and the two were significantly positively correlated ( R=0.7671, P<0.001). Conclusion:Artemisia pollens are the dominant pollens in late summer and early autumn in Inner Mongolia, and the prevalence of artemisia PiAR is high. Controlling the spread of Artemisia pollens is of great significance for the prevention and treatment of AR.
9.Efficacy of MCA blood flow velocity-rScO 2 monitoring in guiding anterograde cerebral perfusion in patients undergoing TAR
Chinese Journal of Anesthesiology 2023;43(12):1482-1485
Objective:To evaluate the efficacy of middle cerebral artery (MCA) blood flow velocity combined with regional saturation of cerebral oxygen (rScO 2) monitoring in guiding anterograde cerebral perfusion in the patients undergoing total arch replacement (TAR). Methods:Ninety-eight patients of either sex, aged 18-72 yr, with body mass index of 24-30 kg/m 2, of American Society of Anesthesiologists Physical Status classification Ⅳ, undergoing elective TAR, were selected. The patients whose anterograde cerebral perfusion mode was determined by the surgeon were enrolled in control group (group C), and the patients who selected the anterograde perfusion mode according to the guiding criteria were included in guidance group (group G), with 49 cases in each group. Cerebral anterograde perfusion mode, postoperative retention time of tracheal intubation, duration of stay in intensive care unit, total hospital stay, tracheotomy, recovery and discharge, postoperative stroke and death of patients were recorded in two groups. Results:Compared with group C, the ratios of bilateral cerebral perfusion and postoperative tracheotomy, incidence of stroke and postoperative mortality were significantly decreased, the ratio of good perfusion and rate of recovery and discharge were increased ( P<0.05), and no significant change was found in the retention time of endotracheal intubation, duration of stay in intensive care unit, and length of hospital stay in group G ( P>0.05). Conclusions:MCA blood flow velocity-rScO monitoring provides a good efficacy in guiding anterograde cerebral perfusion during TAR.
10.Liensinine promotes apoptosis of bladder cancer 5637 cells and enhances Caspase-7 expression and activation
Bin XU ; Tianyu ZHANG ; Ning TAN ; Qi YAN ; Lingli XU ; Xiaojia LIU ; Li GAO
Tianjin Medical Journal 2015;(7):724-727
Objective To study the effects of Liensinine on apoptosis of 5637 cells, and its mechanism thereof. Meth?ods CCK-8 method and the colony formation test were used to detect cell viabilities, and then inhibition rates were calcu?lated. Flow cytometry was used to detect the effects of Liensinine on apoptosis of 5637 cells. Western blot assay was used to detect Caspase-7 protein expression. Results CCK-8 assay and colony formation test indicated that Liensinine inhibited the cell proliferation significantly. Results of flow cytometry indicated that Liensinine induced early apoptosis of 5637 cells. Western blot assay showed that Liensinine improved the expression of Caspase-7 and enhanced the activation of Caspase-7 in 5637 cells. Conclusion Liensinine could inhibit the proliferation of 5637 cells, induce early apoptosis, which may be re?lated with the enhanced expression of Caspase-7 and its activation.

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