1.Guidelines of ethics review for clinical application of medical technology
Jiyin ZHOU ; Mingjie ZI ; Qi LU ; Hui JIANG
Chinese Medical Ethics 2025;38(1):15-22
Access to the clinical application of medical technology is one of the core institutional contents of medical quality management, involving medical quality assurance, the achievement of patient safety goals, and medical service satisfaction. Medical technology is only permitted for clinical use after its safety and effectiveness have been verified through clinical research, as well as evaluated and reviewed by the medical technology clinical application management committee and ethics committee of this medical and health institution. Based on the relevant laws, regulations, and ethical principles, combined with the experience of ethical review in the clinical application of medical technology from some medical and health institutions, a thematic discussion was held to formulate ethical review guidelines for the clinical application of medical technology for references. These guidelines elaborated on the management system for access to the clinical application of medical technology in medical and health institutions, the system of ethics committees and the requirements of review norms, technical plans and their review points, key points for the implementation of informed consent, technical teams and conditions, and other aspects.
2.Exploration on the relation between tumors and anaphylactic reaction from the perspective of traditional Chinese medicine constitution
Yuhan ZONG ; Huaiyu WANG ; Mengru ZHOU ; Haoyue JIANG ; Luyao JIN ; Xihuan ZHU ; Ji WANG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(2):240-245
The etiology of tumors is complex and influenced by multiple factors, including the host and environmental conditions. Allergy is primarily driven by the immune response of helper T cell 2 (Th2). Research has shown that the Th2 immune response is closely related to tumors, which is specifically manifested through Th2 antibodies, allergy-related effector cells and mediators within the tumors, as well as tumor immune-related functions. This internal interaction mechanism will increase the complexity and challenges associated with the clinical diagnosis and treatment of tumors and allergy. The formation of allergic constitution is shaped by both congenital and acquired factors, and its physical state is closely linked to the occurrence and progression of allergic diseases. Therefore, this paper aims to explore the relationship between tumors and allergic reactions from the perspective of traditional Chinese medicine (TCM) constitution theory. Based on the four basic principles of the TCM constitution, including endowment inheritance theory, environment constraint theory, body-spirit composition theory, and life process theory, this exploration will focus on four aspects: genetic factors and internal disease causes, inflammatory environments and functional regulation, psychological disorders and emotional pathogenesis, as well as age structure and disease risk. Furthermore, from the perspective of constitution-disease relation of chronic disease prevention, this paper will discuss the significant importance of adjusting allergic constitution to improve both subjective symptoms and objective indicators of allergic reactions in tumor patients.
3.Three-dimensional videonystagmography characteristics in patients with benign paroxysmal positional vertigo
Yujin ZHENG ; Keguang CHEN ; Kanglun JIANG ; Feng XU ; Ying QI ; Xinsheng HUANG ; Huaili JIANG
Chinese Journal of Clinical Medicine 2025;32(2):177-182
Objective To analyze the characteristics of nystagmus during the Dix-Hallpike and Roll tests in patients with benign paroxysmal positional vertigo (BPPV) using three-dimensional videonystagmography (3D-VNG), in order to to optimize diagnostic and therapeutic strategies of BPPV. Methods A retrospective analysis was conducted on 68 patients with posterior semicircular canal (PSC)-BPPV and 26 patients with horizontal semicircular canal (HSC)-BPPV. Nystagmus data obtained from 3D-VNG were reviewed for all patients, with a focus on the eye movement components during the Dix-Hallpike test in PSC-BPPV patients and the Roll test in HSC-BPPV patients. The direction and reversal rates of the vertical, horizontal, and torsional components were recorded and analyzed. Results All PSC-BPPV patients exhibited highly consistent three-dimensional nystagmus characteristics during the Dix-Hallpike test: vertical nystagmus was uniformly upward, torsional nystagmus was predominantly clockwise in left-side BPPV patients (17/23) and counterclockwise in right-side BPPV patients (44/45), while the horizontal component was mostly directed contralaterally (50/68); upon transitioning from the head-hanging to the sit-up position, vertical nystagmus components in all patients reversed, and torsional and horizontal nystagmus components reversed in approximately 50.0% or more patients. Among HSC-BPPV patients, right-side BPPV patients all showed right-beating (geotropic) horizontal nystagmus with predominantly upward vertical component (16/19), while most left-side BPPV patients showed left-beating horizontal nystagmus (6/7) with predominantly downward vertical component (6/7). During head rotation toward the healthy side, most (25/26) HSC-BPPV patients exhibited a reversal in the horizontal nystagmus direction, reduced intensity compared to the affected side, with a reversal in vertical components in 3 patients, and atypical torsional components. Conclusions 3D-VNG could precisely quantitative analyze three-dimensional features of nystagmus in BPPV patients, improve diagnostic accuracy in canal and side localization, particularly in PSC-BPPV patients.
4.Influence evaluation of pharmaceutical quality control on medication therapy management services by the ECHO model
Kun LIU ; Huanhuan JIANG ; Yushuang LI ; Yan HUANG ; Qianying ZHANG ; Dong CHEN ; Xiulin GU ; Jinhui FENG ; Zijian WANG ; Yunfei CHEN ; Yajuan QI ; Yanlei GE ; Aishuang FU
China Pharmacy 2025;36(9):1123-1128
OBJECTIVE To evaluate the influence of pharmaceutical quality control on the efficiency and outcomes of standardized medication therapy management (MTM) services for patients with coronary heart disease by using Economic, Clinical and Humanistic Outcomes (ECHO) model. METHODS This study collected case data of coronary heart disease patients who received MTM services during January-March 2023 (pre-quality control implementation group, n=96) and June-August 2023 (post-quality control implementation group, n=164). Using propensity score matching analysis, 80 patients were selected from each group. The study subsequently compared the economic, clinical, and humanistic outcome indicators of pharmaceutical services between the two matched groups. RESULTS There were no statistically significant differences in baseline data between the two groups after matching (P>0.05). Compared with pre-quality control implementation group, the daily treatment cost (16.26 yuan vs. 24.40 yuan, P<0.001), cost-effectiveness ratio [23.12 yuan/quality-adjusted life year (QALY) vs. 32.32 yuan/QALY, P<0.001], and the incidence of general adverse drug reactions (2.50% vs. 10.00%, P=0.049) of post-quality control implementation group were decreased significantly; the utility value of the EuroQol Five-Dimensional Questionnaire (0.74± 0.06 vs. 0.71±0.07, P=0.003), the reduction in the number of medication related problems (1.0 vs. 0.5, P<0.001), the medication adherence score ([ 6.32±0.48) points vs. (6.10±0.37) points, P=0.001], and the satisfaction score ([ 92.56±1.52) points vs. (91.95±1.56) points, P=0.013] all showed significant improvements. Neither group experienced serious adverse drug reactions. There was no statistically significant difference in the incidence of new adverse reactions between the two groups (1.25% vs. 3.75%, P=0.310). CONCLUSIONS Pharmaceutical quality control can improve the quality of pharmaceutical care, and the ECHO model can quantitatively evaluate the effect of MTM services, making pharmaceutical care better priced and more adaptable to social needs, thus being worthy of promotion.
5.Shaoyaotang Regulates Glucose Metabolism Reprogramming to Inhibit Macrophage Polarization Toward M1 Phenotype
Shaijin JIANG ; Hui CAO ; Dongsheng WU ; Bo ZOU ; Yiwen WANG ; Yiling XIA ; Erle LIU ; Qi CHENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):86-93
ObjectiveTo explore the regulation of Shaoyaotang on glucose metabolism reprogramming of macrophages and the mechanism of this decoction in inhibiting macrophage polarization toward the M1 phenotype. MethodsHuman monocytic leukemia-1 (THP-1) cells were treated with 100 ng·L-1 phorbol myristate acetate for induction of macrophages as the normal control group. The cells treated with 100 ng·L-1 lipopolysaccharide combined with 20 ng·L-1 interferon (IFN)-γ for induction of M1-type macrophages were taken as the M1 model group. M1-type macrophages were treated with the blank serum, Shaoyaotang-containing serum, 0.5 mol·L-1 2-deoxy-D-glucose (2-DG), and Shaoyaotang-containing serum + 2-DG, respectively. After intervention, the expression of CD86 and CD206 was examined by flow cytometry. The levels of interleukin (IL)-6, tumor necrosis factor (TNF)-α, IL-10, and transforming growth factor (TGF)-β were assessed by ELISA. Real-time PCR and Western blot were employed to determine the mRNA and protein levels, respectively, of hypoxia-inducible factor-1 alpha (HIF-1α), glucose transporter 1 (GLUT1), hexokinase 2 (HK2), glyceraldehyde-3-phosphate dehydrogenase (GAPDH), and 6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 3 (PFKFB3). ResultsCompared with that in the normal control group, the expression of CD86, the marker of M1-type macrophages, increased in the M1 model group and blank serum group (P<0.01), which indicated that the M1 inflammatory model was established successfully. In addition, the M1 model group was observed with up-regulated mRNA and protein levels of proinflammatory cytokines IL-6 and TNF-α and glycolysis-related factors HIF-1α, GLUT1, HK2, GAPDH, and PFKFB3 (P<0.01). Compared with the M1 model group, the Shaoyaotang-containing serum, 2-DG, and combined intervention groups showed decreased expression of CD86 (P<0.01), down-regulated mRNA and protein levels of proinflammatory factors IL-6 and TNF-α and glycolysis-related factors HIF-1α, GLUT1, HK2, GAPDH, and PFKFB3 produced by M1-type macrophages (P<0.01), increased expression of CD206 (marker of M2-type macrophages) (P<0.01), and elevated levels of IL-10 and TGF-β produced by M2-type macrophages (P<0.01). ConclusionShaoyaotang inhibits macrophage differentiation toward pro-inflammatory M1-type macrophages and promotes the differentiation toward anti-inflammatory M2-type macrophages by regulating glucose metabolism reprogramming. The evidence gives insights into new molecular mechanisms and targets for the treatment of ulcerative colitis with Shaoyaotang.
6.Shaoyaotang Regulates Glucose Metabolism Reprogramming to Inhibit Macrophage Polarization Toward M1 Phenotype
Shaijin JIANG ; Hui CAO ; Dongsheng WU ; Bo ZOU ; Yiwen WANG ; Yiling XIA ; Erle LIU ; Qi CHENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):86-93
ObjectiveTo explore the regulation of Shaoyaotang on glucose metabolism reprogramming of macrophages and the mechanism of this decoction in inhibiting macrophage polarization toward the M1 phenotype. MethodsHuman monocytic leukemia-1 (THP-1) cells were treated with 100 ng·L-1 phorbol myristate acetate for induction of macrophages as the normal control group. The cells treated with 100 ng·L-1 lipopolysaccharide combined with 20 ng·L-1 interferon (IFN)-γ for induction of M1-type macrophages were taken as the M1 model group. M1-type macrophages were treated with the blank serum, Shaoyaotang-containing serum, 0.5 mol·L-1 2-deoxy-D-glucose (2-DG), and Shaoyaotang-containing serum + 2-DG, respectively. After intervention, the expression of CD86 and CD206 was examined by flow cytometry. The levels of interleukin (IL)-6, tumor necrosis factor (TNF)-α, IL-10, and transforming growth factor (TGF)-β were assessed by ELISA. Real-time PCR and Western blot were employed to determine the mRNA and protein levels, respectively, of hypoxia-inducible factor-1 alpha (HIF-1α), glucose transporter 1 (GLUT1), hexokinase 2 (HK2), glyceraldehyde-3-phosphate dehydrogenase (GAPDH), and 6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 3 (PFKFB3). ResultsCompared with that in the normal control group, the expression of CD86, the marker of M1-type macrophages, increased in the M1 model group and blank serum group (P<0.01), which indicated that the M1 inflammatory model was established successfully. In addition, the M1 model group was observed with up-regulated mRNA and protein levels of proinflammatory cytokines IL-6 and TNF-α and glycolysis-related factors HIF-1α, GLUT1, HK2, GAPDH, and PFKFB3 (P<0.01). Compared with the M1 model group, the Shaoyaotang-containing serum, 2-DG, and combined intervention groups showed decreased expression of CD86 (P<0.01), down-regulated mRNA and protein levels of proinflammatory factors IL-6 and TNF-α and glycolysis-related factors HIF-1α, GLUT1, HK2, GAPDH, and PFKFB3 produced by M1-type macrophages (P<0.01), increased expression of CD206 (marker of M2-type macrophages) (P<0.01), and elevated levels of IL-10 and TGF-β produced by M2-type macrophages (P<0.01). ConclusionShaoyaotang inhibits macrophage differentiation toward pro-inflammatory M1-type macrophages and promotes the differentiation toward anti-inflammatory M2-type macrophages by regulating glucose metabolism reprogramming. The evidence gives insights into new molecular mechanisms and targets for the treatment of ulcerative colitis with Shaoyaotang.
7.Preliminary development of Health Literacy Evaluation Scale for Chinese High School Students
GUO Shihao, ZHU Fan, ZHU Guiyin, QI Tiantian, YANG Shuang, HU Bin, WU Huiyun, JIANG He, MA Yinghua
Chinese Journal of School Health 2025;46(5):676-680
Objective:
To develop a health literacy evaluation scale for Chinese high school students, providing a tool for dynamic monitoring of health literacy among high school students and evaluating the effectiveness of health school construction.
Methods:
Through theoretical research, an evaluation index system for health literacy of Chinese high school students was constructed. Two rounds of Delphi expert consultations were conducted to quantitatively screen the items, and the item pool was revised based on expert opinions to compile the health literacy evaluation scale for Chinese students. Two focus group interviews were held to collect suggestions from health educators, high school teachers, and high school students regarding optimized scale length, question types, difficulty and wording of the scale. The scale was revised accordingly. A pilot survey was conducted in Beijing and Tianjin in November 2024, and the reliability and validity of the scale were evaluated based on the pilot survey data.
Results:
The response rate in both rounds of Delphi expert consultations was over 80%, and the expert authority coefficient was over 0.70. The expert opinions were highly concentrated, and the dispersion was small. The revised item pool based on expert opinions contained 39 items. The revised scale based on the suggestions and opinions collected from the focus group interviews had a moderate number of questions and difficulty level. The pilot survey obtained 800 valid responses, with the response rate of 89.39%. The Cronbach α coefficient of the scale was 0.911, χ 2/df =3.321, the root mean square error of approximation was 0.054, the adjusted goodness-of-fit index was 0.991 , and the factor loadings of some items were less than 0.40.
Conclusion
The health literacy evaluation scale for Chinese high school students demonstrates scientific rigor and practical applicability, with good internal consistency and structural validity.
8.Preliminary development with reliability and validity testing of health literacy assessment scale for junior high school students
QI Tiantian, ZHU Fan, ZHU Guiyin, GUO Shihao, YANG Shuang, WU Huiyun, HU Bin, JIANG He, MA Yinghua
Chinese Journal of School Health 2025;46(6):816-820
Objective:
To develop and validate a health literacy assessment scale for junior high school students, providing an effective tool for evaluating and monitoring health literacy among Chinese adolescents.
Methods:
Based on school health education policy documents, a health literacy assessment framework was constructed, comprising five horizontal and four vertical dimensions. From May to June and August to September in 2024, the framework was refined through Delphi expert consultations and focus group discussions, leading to the development of the Health Literacy Assessment Scale for Junior High School Students. In September 2024, a convenience sample of 625 students from three junior high schools in Beijing and Tianjin completed the questionnaire. Item analysis, reliability, and validity tests were conducted to evaluate the scale.
Results:
The recovery rate for two rounds of expert consultation questionnaires was 100%. The expert authority coefficients ( Cr ) were 0.86 and 0.87 respectively (both >0.70), with Kendall W values of 0.34 and 0.27 ( P <0.05). The focus group discussions followed a rigorous structure, and after multiple rounds of item screening and revision, the version 3.0 of the junior high school students health literacy assessment scale was developed, comprising 57 items. Three items that failed to meet the comprehensive screening criteria were preliminarily removed, and the final scale contained 54 items. The scale demonstrated excellent reliability, with an overall Cronbach s α coefficient of 0.92 and split half reliability of 0.93. Confirmatory factor analysis [ χ 2/df =2.094, root mean square error of approximation ( RMSEA )=0.042, comparative fit index ( CFI )=0.911, Tucker Lewis index ( TLI )=0.907] indicated good model fit indices.
Conclusions
The preliminary development of the health literacy assessment scale for junior high school students follows a rigorous item screening process with well designed dimensions, demonstrating good reliability and validity, thus serving as an appropriate evaluation tool for adolescent health literacy.
9.Association of diabetes and risk of tuberculosis in community population in Shanghai
Jin LI ; Qi ZHAO ; Jinyan ZOU ; Yong LI ; Genming ZHAO ; Yonggen JIANG ; Liping LU
Journal of Public Health and Preventive Medicine 2025;36(4):42-46
Objective To explore the association of diabetes status with the development of tuberculosis (TB) among the community population in Shanghai, and to provide evidence for the formulation of tuberculosis prevention and control strategies. Methods This population-based cohort study was based on Shanghai Suburban Adult Cohort and Biobank (SSACB) in China. The baseline data were acquired by questionnaires, physical examinations and blood biochemistry tests. TB incidence was obtained by matching with TB management information system data. A Cox proportional risk model was established to assess the risk of tuberculosis. Results A total of 36 014 research subjects were included, with an average age of 56.3±11.3 years, of which 14 587 (40.5%) were male. Over 6 years of follow-up, 47 individuals progressed to tuberculosis (incidence rate: 19.8 per 100 000 person-year, 95% CI: 14.6 -26.4). An increased risk of TB was observed in participants with newly diagnosed diabetes compared with those without diabetes (adjusted hazard ratio [aHR], 2.73; 95% CI, 1.19 - 6.28). Conclusion The risk of tuberculosis in newly diagnosed diabetic patients is significantly increased, and strengthening tuberculosis screening for this population should be considered in practical work.
10.Houshihei San Repairs Skeletal Muscle Injury After Ischaemic Stroke by Regulating Ferroptosis Pathway
Hu QI ; Dan TIAN ; Xiongwei ZHANG ; Zeyang ZHANG ; Yuanlin GAO ; Yanning JIANG ; Xinran MIN ; Jiamin ZOU ; Jiuseng ZENG ; Nan ZENG ; Ruocong YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):1-11
ObjectiveTo investigate the pharmacodynamic effects of Houshihei San (HSHS) recorded with the effects of treating wind and limb heaviness on muscle tissue injury after middle cerebral artery occlusion (MCAO) in rats through the ferroptosis pathway. MethodsThirty SD male rats were selected and randomly grouped as follows: sham, MCAO, deferoxamine mesylate, high-dose HSHS (HSHS-H, 0.54 g·kg-1), and low-dose HSHS (HSHS-L, 0.27 g·kg-1), with 6 rats in each group. A laser scattering system was used to evaluate the stability of the MCAO model, and rats were administrated with corresponding agents by gavage for 7 days. During the administration period, behavioral, imaging and other methods were used to systematically evaluate the skeletal muscle tissue injury after MCAO and the therapeutic effect in each administration group. Hematoxylin-eosin staining was employed to evaluate the cross-section of muscle cells. Subsequently, immunohistochemistry was used to detect tumor suppressor p53 and glutathione peroxidase 4 (GPX4) in the soleus tissue. Western blot was employed to determine the protein levels of p53, GPX4, myogenic differentiation 1 (MyoD1), nuclear factor E2-related factor 2 (Nrf2), Myostatin, solute carrier family 7 member 11 (SLC7A11), muscle ring-finger protein-1 (MuRF1), and muscle atrophy F-box protein (MAFbx) to verify the therapeutic effect in each group. ResultsCompared with the MCAO group, HSHS enhanced the locomotor ability and promoted muscle regeneration, which suggested that the pharmacological effects of HSHS were related to the inhibition of muscle tissue ferroptosis to reduce the expression of muscle atrophy factors. Behavioral and imaging results suggested that compared with the MCAO group, HSHS ameliorated neurological impairments in rats on day 7 (P<0.01), enhanced 5-min locomotor distance and postural control (P<0.01), strengthened grasping power and promoted muscle growth (P<0.01), stabilized skeletal muscle length and weight (P<0.01), and increased the cross-section of muscle cells (P<0.01). Compared with the MCAO group, HSHS promoted the increases in glutathione and superoxide dismutase content and inhibited the increase in malondialdehyde content (P<0.05,P<0.01). Ferroptosis pathway-related assays suggested that HSHS reduced the p53-positive cells and increased the GPX4-positive cells (P<0.01). HSHS ameliorated muscle function decline after stroke by promoting the expression of GPX4, Nrf2, SLC7A11, and MyoD1 and inhibiting the expression of p53, Myostatin, MurRF1, and MAFbx to reduce ferroptosis in the muscle (P<0.01). ConclusionHSHS, prepared with reference to the method in the Synopsis of Golden Chamber, can simultaneously reduce the myolysis and increase the protein synthesis in the skeletal muscle tissue after ischemic stroke by regulating the ferroptosis pathway.


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