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.Principles, technical specifications, and clinical application of lung watershed topography map 2.0: A thoracic surgery expert consensus (2024 version)
Wenzhao ZHONG ; Fan YANG ; Jian HU ; Fengwei TAN ; Xuening YANG ; Qiang PU ; Wei JIANG ; Deping ZHAO ; Hecheng LI ; Xiaolong YAN ; Lijie TAN ; Junqiang FAN ; Guibin QIAO ; Qiang NIE ; Mingqiang KANG ; Weibing WU ; Hao ZHANG ; Zhigang LI ; Zihao CHEN ; Shugeng GAO ; Yilong WU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(02):141-152
With the widespread adoption of low-dose CT screening and the extensive application of high-resolution CT, the detection rate of sub-centimeter lung nodules has significantly increased. How to scientifically manage these nodules while avoiding overtreatment and diagnostic delays has become an important clinical issue. Among them, lung nodules with a consolidation tumor ratio less than 0.25, dominated by ground-glass shadows, are particularly worthy of attention. The therapeutic challenge for this group is how to achieve precise and complete resection of nodules during surgery while maximizing the preservation of the patient's lung function. The "watershed topography map" is a new technology based on big data and artificial intelligence algorithms. This method uses Dicom data from conventional dose CT scans, combined with microscopic (22-24 levels) capillary network anatomical watershed features, to generate high-precision simulated natural segmentation planes of lung sub-segments through specific textures and forms. This technology forms fluorescent watershed boundaries on the lung surface, which highly fit the actual lung anatomical structure. By analyzing the adjacent relationship between the nodule and the watershed boundary, real-time, visually accurate positioning of the nodule can be achieved. This innovative technology provides a new solution for the intraoperative positioning and resection of lung nodules. This consensus was led by four major domestic societies, jointly with expert teams in related fields, oriented to clinical practical needs, referring to domestic and foreign guidelines and consensus, and finally formed after multiple rounds of consultation, discussion, and voting. The main content covers the theoretical basis of the "watershed topography map" technology, indications, operation procedures, surgical planning details, and postoperative evaluation standards, aiming to provide scientific guidance and exploration directions for clinical peers who are currently or plan to carry out lung nodule resection using the fluorescent microscope watershed analysis method.
3.Analysis of Major Syndromes and Their Typical Related Symptoms and Signs in 135 Patients with Metabolic Syndrome:A Clinical Study Based on Syndrome Element Differentiation and Latent Class Analysis
Tong WANG ; Mingqian JIANG ; Lifen MI ; Shanyi SHEN ; Shujie XIA ; Candong LI
Journal of Traditional Chinese Medicine 2025;66(4):376-381
ObjectiveTo explore the typical syndromes and their characteristic of symptoms and signs with high diagnostic value in patients with metabolic syndrome (MS). MethodsTraditional Chinese medicine (TCM) diagnostic information was collected from 135 MS patients. Syndrome element differentiation and latent class analysis (LCA) were applied to identify the major TCM syndromes in MS patients. Symptoms were analyzed based on the differentiated syndromes, and a binary logistic regression model was constructed to determine symptoms and signs with high diagnostic value. ResultsA total of 135 MS patients were included, involving 163 symptoms and signs with a total frequency of 1749; twenty-three syndrome elements were extracted, 367 times frequency in total, among which 8 syndrome elements occurred ≥10 times with 323 frequencies (88.01% of the total). These included location-related elements such as kidney (48 times), spleen (14 times), and stomach (14 times), and nature-related elements such as phlegm (71 times), yin deficiency (64 times), dampness (57 times), heat (42 times), and qi deficiency (13 times). Based on LCA, the 135 patients were categorized into two groups distinguished by the syndrome elements of dampness and phlegm, forming the "phlegm-dampness syndrome" as the major syndrome type. Nine high-frequency symptoms and signs associated with the phlegm-dampness syndrome were identified,i.e. obesity (39 times), greasy coating (38 times), slippery pulse (33 times), white coating (31 times), preference for fatty and heavy foods (30 times), excessive urination (30 times), fatigue and lack of strength (29 times), wiry pulse (25 times), and dark red tongue (25 times). A binary logistic regression model was constructed combining these nine symptoms and signs with the LCA classification results, ultimately identifying obesity, greasy coating, fatigue and lack of strength, and white coating as independent factors associated with the phlegm-dampness syndrome in MS patients (P<0.05). ConclusionThe major TCM syndrome in MS patients is phlegm-dampness syndrome, and obesity, greasy coating, fatigue and lack of strength, and white coating are the typical symptoms and signs for diagnosing phlegm-dampness syndrome in MS patients.
4.Construction and Verification of Prediction Model of Qi Deficiency and Blood Stasis Syndrome in Chronic Heart Failure
Tong JIANG ; Xiaodan FAN ; Shijia WANG ; Fengxia LIN ; Zhicong ZENG ; Liangzhen YOU ; Hongcai SHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):154-163
ObjectiveTo construct and validate a clinical prediction model for Qi deficiency and blood stasis syndrome in chronic heart failure (CHF),aiming to assist clinical diagnosis and provide tools and methods for individualized treatment of CHF. MethodsThe clinical data of patients with chronic heart failure treated at Dongzhimen Hospital of Beijing University of Chinese Medicine from January 2022 to January 2024 were retrospectively collected. The patients were randomly divided into a training group and a validation group with a ratio of 7∶3. First, the least absolute shrinkage and selection operator (LASSO) regression analysis was used to preliminarily screen the predictive factors affecting the diagnosis of Qi deficiency and blood stasis syndrome in CHF. Subsequently, the Logistic regression method was applied to conduct a more in-depth and detailed analysis of these factors. Variables with P<0.05 in the results of the multi-factor Logistic regression were carefully selected and included. Based on the regression coefficients obtained from this analysis, a model was constructed, and a nomogram was accurately drawn. Using R software,the receiver operating characteristic (ROC) curve,calibration curve,and decision curve analysis (DCA) were precisely drawn. These analyses were used to comprehensively evaluate the model from three crucial aspects: discrimination,calibration,and clinical applicability. Additionally, the accuracy,specificity,sensitivity,positive predictive value,and negative predictive value of the model were meticulously calculated to conduct a more all-round and comprehensive assessment. ResultsIn total, 168 cases were successfully obtained in the training group, and 71 cases were included in the validation group. After a thorough comparison, it was found that there were no statistically significant differences in the baseline data between the two groups. After being rigorously screened by the LASSO-multivariate logistic regression method, dark red tongue,smoking history,cardiac troponin I,and N-terminal pro-B-type natriuretic peptide (NT-ProBNP) were identified as the influencing factors for diagnosing patients with the Qi deficiency and blood stasis syndrome in CHF. The constructed model demonstrated an area under the curve (AUC) of 0.812 in the training group and 0.719 in the validation group. The calibration curve showed that the predicted curve of the model was close to the actual observed curve. DCA indicated that the model could provide substantial clinical benefits for patients at the decision thresholds ranging from 0.2 to 0.9. ConclusionThe clinical prediction model for Qi deficiency and blood stasis syndrome in chronic heart failure constructed in this study shows good performance. It has certain application value in clinical practice, which may contribute to the improvement of the diagnosis and treatment of CHF patients with this syndrome.
5.Surveillance for Aedes albopictus in Guangzhou City from 2021 to 2023
Jinhua ZHOU ; Shiyu HE ; Tong LIU ; Zhifei CHENG ; Xiaoning LI ; Yimin JIANG ; Xueying LIANG ; Zongqiu CHEN ; Pengzhe QIN
Chinese Journal of Schistosomiasis Control 2025;37(1):76-80
Objective To investigate the population density and seasonal fluctuations of Aedes albopictus in Guangzhou City, Guangdong Province, from 2021 to 2023, so as to provide insights into A. albopictus control and management of dengue fever. Methods The surveillance of A. albopictus density was performed in all surveillance sites assigned across all streets (townships) in Guangzhou City during the period from January to December from 2021 to 2023. The surveillance frequency was twice every half month from May to September, and once every month for the rest of a year. In each surveillance period, A. albopictus mosquito larvae were captured from indoor and outdoor small water containers in residential areas, parks, medical facilities, schools, other government sectors and social organizations, construction sites, special industries and others for mosquito species identification. Adult mosquitoes were captured using electric mosquito suction apparatus for species identification and gender classification. Adult mosquitoes and mosquito eggs were collected with mosquito and egg traps at the breeding and dwelling places of Aedes mosquitoes for identification. The mosquito oviposition index (MOI), Breteau index (BI), adult mosquito density index (ADI) and standard space index (SSI) were calculated. The A. albopictus density was classified into grades 0, 1, 2 and 3 in each surveillance site, with Grade 0 density defined eligible, and the eligible rate of A. albopictus density was calculated at all surveillance sites each year from 2021 to 2023. In addition, the changing trends in MOI, SSI, BI and ADI of A. albopictus were analyzed in Guangzhou City from 2021 to 2023. Results The eligible rates of A. albopictus density were 61.69%, 68.75% and 55.15% in surveillance sites of Guangzhou City from 2021 to 2023 (χ2 = 297.712, P < 0.001), and appeared a tendency towards a reduction followed by a rise each year, which gradually reduced since January, maintained at a low level during the period between May and October, and gradually increased from November to December. The MOI, SSI, BI and ADI of A. albopictus all appeared a tendency towards a rise followed by a reduction in Guangzhou City during the period between January and December from 2021 to 2023. The BI of A. albopictus peaked in the first half of June in 2021 (4.03), the first half of July in 2022 (3.89) and the last half of August in 2023 (5.02), and the SSI of A. albopictus peaked in the last half of June in 2021 (0.93), the last half of May in 2022 (0.59), and the last half of June (0.94) and the first half of September in 2023 (1.12). In addition, the MOI of A. albopictus peaked in the first half of May in 2021 (8.64), the first half of June in 2022 (8.96), and the last half of May (10.21) and the last half of June in 2023 (10.89), and the ADI of A. albopictus peaked in the first half of June in 2021 (3.41), the last half of June in 2022 (4.06), and the first half of July in 2023 (3.61). Conclusions The density of A. albopictus is high in Guangzhou City during the period from May to October, and the risk of local outbreak caused by imported dengue fever is high. Persistent intensified surveillance of the density and seasonal fluctuation of A. albopictus is recommended and timely mosquito prevention and control is required according to the fluctuation in the A. albopictus density.
6.Trend analysis of birth defects in Fengxian District, Shanghai, 2018‒2022
Huihui MA ; Hong CHEN ; Hong JIANG ; Guangsheng LIANG ; Qin HUANG ; Meng QIN
Shanghai Journal of Preventive Medicine 2025;37(2):174-178
ObjectiveTo retrospectively analyze the epidemiological trends of birth defects in perinatal infants in Fengxian District, Shanghai from 2018 to 2022, so as to provide a scientific evidence for the formulation of related prevention and control strategies. MethodsBased on the data from the National Birth Defects Surveillance System, statistical analysis was conducted on the perinatal birth defects from monitored hospitals within the region from 2018 to 2022. ResultsFrom 2018 to 2022, a total of 20 870 perinatal infants delivered in the monitored hospitals in Fengxian District, with 472 cases with birth defects, showing a significant increase in the prevalence of birth defects (PRR=1.49, 95%CI: 1.39‒1.59). The risk of birth defects increased with maternal age, especially for advanced maternal age (PRR=1.58, 95%CI: 1.12‒2.25). Infants born to mothers with gestational diabetes had a higher prevalence of birth defects compared to those without gestational diabetes (PRR=1.99, 95%CI: 1.46‒2.70). Infants with birth defects were more likely to be born prematurely (PRR=2.07, 95%CI:1.56‒2.76). The top three types of birth defects were congenital heart disease (CHD), other anomalies of the external ear, and polydactyly. ConclusionThe prevalence of birth defects in Fengxian District monitored hospitals showed an upward trend from 2018 to 2022. Advanced maternal age and gestational diabetes were identified as risk factors for birth defects. CHD is the leading type of birth defect in Fengxian District over the five-year period. To reduce the prevalence of birth defects, it is crucial to implement comprehensive prevention and treatment measures for CHD.
7.Characteristics of sleep quality and influencing factors in patients with burning mouth syndrome: a preliminary analysis
LU Chenghui ; YANG Chenglong ; ZHOU Xuan ; JIANG Xinxiang ; TANG Guoyao
Journal of Prevention and Treatment for Stomatological Diseases 2025;33(5):377-384
Objective:
To investigate the sleep quality in patients with burning mouth syndrome (BMS) and its influencing factors, providing a basis for developing sleep intervention measures to reduce the impact of BMS symptoms.
Methods:
This study was reviewed and approved by the Medical Ethics Committee, and informed consent was obtained from patients. A total of 150 patients with BMS and 150 healthy volunteers were enrolled as subjects in this study. The Pittsburgh sleep quality index (PSQI) was used to assess the sleep quality of patients with BMS. Visual analog scale (VAS) was used to assess the degree of oral mucosal pain, generalized anxiety disorder 7-item scale (GAD-7) was used to assess the frequency of anxiety symptoms, and the patient health questionnaire depression questionnaire (PHQ-9) was used to assess the frequency of depression symptoms. Univariate analysis was performed to identify potential influencing factors affecting sleep quality in patients with BMS, and multiple linear regression analysis was employed to determine independent risk factors.
Results:
The PSQI score for patients with BMS was 7.61 ± 4.29, which was significantly higher than that of healthy controls (P = 0.016). In the PSQI subscale analysis, patients with BMS exhibited increased sleep latency, decreased sleep duration, and lower sleep efficiency compared to healthy controls (P<0.05). Patients with BMS and comorbid sleep difficulties had significantly higher scores on GAD-7 and PHQ-9 compared to the patients with BMS without sleep difficulties (P<0.001), but there was no significant difference in pain VAS scores between the two (P = 0.068). Multiple linear regression analysis revealed that longer disease duration (>6 months), the presence of systemic concomitant symptoms (such as headache and mental stress), and higher depression scores were identified as independent risk factors affecting sleep quality in patients with BMS.
Conclusion
For patients with BMS, long course of illness, presence of headaches, high mental stress, and depressive symptoms may be independent factors affecting their sleep quality.
8.Buqi Huoxue Compounds intervene with the expression of related factors and autophagy related proteins in a rat model of cerebral ischemia/reperfusion
Yuning CHEN ; Ying JIANG ; Xiangyu LIAO ; Qiongjun CHEN ; Liang XIONG ; Yue LIU ; Tong LIU
Chinese Journal of Tissue Engineering Research 2025;29(6):1152-1158
BACKGROUND:Buqi Huoxue Compounds have significant clinical efficacy in treating ischemic stroke with Qi deficiency and phlegm stasis;however,the exact mechanism of action is not clear. OBJECTIVE:To observe the effect of Buqi Huoxue Compounds on the expression of vascular endothelial growth factor,basic fibroblast growth factor,brain-derived neurotrophic factor and autophagy related protein Beclin1 and p62 in a rat model of cerebral ischemia/reperfusion. METHODS:Forty male Sprague-Dawley rats were randomly divided into sham operation group,model group,Buqi Huoxue Compounds group and autophagy inhibitor group,with 10 rats in each group.In the latter three groups,a rat model of cerebral ischemia/reperfusion injury was established.The Buqi Huoxue Compounds group was intragastrically given Buqi Huoxue Compounds(6.49 g/kg,administered three times a day)2 hours after reperfusion;the autophagy inhibitor group was intragastrically given Buqi Huoxue Compounds(6.49 g/kg,administered three times a day)2 hours after reperfusion and intraperitoneally given 3-methyladenine 2 hours before gavage and at days 1-3 of gavage.The sham operation group and model group were given equal amounts of saline by gavage for 7 consecutive days.Neurological function,cerebral infarct volume,brain tissue morphology and expression of vascular endothelial growth factor,basic fibroblast growth factor,brain-derived neurotrophic factor and autophagy-related proteins Beclin1 and p62 in the ischemic cortical region of rats were detected at 24 hours after the final administration. RESULTS AND CONCLUSION:Zea-Longa scoring results showed that the neurological function of rats was severely damaged after modeling and neurological deficit of rats in the Buqi Huoxue Compounds group was less than that in the model group and the autophagy inhibitor group(P<0.05).TTC staining showed that cerebral infarct foci were observed in the model group,Buqi Huoxue Compounds group,and autophagy inhibitor group,and the cerebral infarct volume in the Buqi Huoxue Compounds group was lower than that in the model group and the autophagy inhibitor group(P<0.05).The results of hematoxylin-eosin staining in ischemic brain tissues showed that there were large gaps between nerve cells in the model group and cell arrangement was not neat,and cytoplasmic agglutination and pyknosis were observed.Immunohistochemical staining results showed that vascular endothelial growth factor was mostly expressed in neuronal cells,glial cells and capillary endothelium;basic fibroblast growth factor and brain-derived neurotrophic factor were mostly expressed in neuronal cells and glial cells;and there was no significant difference in the expression of vascular endothelial growth factor,basic fibroblast growth factor,and brain-derived neurotrophic factor among the four groups(P>0.05).The results of western blot assay showed that compared with the sham operation group,Beclin1 protein expression was decreased(P<0.05)and p62 protein expression was elevated(P<0.05)in the model group;compared with the model group,Beclin1 protein expression was increased(P<0.05)and p62 protein expression was reduced(P<0.05)in the Buqi Huoxue Compounds group;compared with the Buqi Huoxue Compounds group,Beclin1 protein expression was decreased(P<0.05)and p62 protein expression was elevated(P<0.05)in the autophagy inhibitor group.To conclude,Buqi Huoxue Compounds attenuate cerebral ischemia-reperfusion injury in rats by promoting autophagy.
9.Mechanism of Exogenous Melatonin in Inhibiting Early Bolting in Angelica sinensis
Jiang ZHAO ; Zhanwen TANG ; Tao YANG ; Jie SHA ; Tong PENG ; Weiwen LU ; Yinquan WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):234-240
ObjectiveThis study aims to investigate the effects of different sizes of seedlings and melatonin treatment on physiological and biochemical indicators and bolting-related gene expression in Angelica sinensis, find substances related to early bolting, and elucidate the inhibitory mechanism of melatonin on bolting. MethodsSpectrophotometry was used to detect the related enzyme activities of A. sinensis leaves. The contents of endogenous hormones and polyamines were detected using ultra-high performance liquid chromatography-tandem mass spectrometry. Real-time polymerase chain reaction (Real-time PCR) was used to detect the expression levels of bolting-related genes. Inter-group differential indicator analysis, orthogonal partial least squares discriminant analysis, and principal component analysis were comprehensively applied to identify factors related to early bolting. ResultsEndogenous jasmonic acid and melatonin were identified as the most important factors affecting early bolting. Secondly, the activity of antioxidant enzymes, abscisic acid content, gibberellin content, and the expression levels of CO3, HD3A, and FD genes had important effects on the bolting process. Compared with small seedlings, exogenous melatonin treatment mainly inhibited early bolting by increasing endogenous melatonin content, reducing gibberellin content, and decreasing the expression levels of SOC1 and FD genes. ConclusionExogenous melatonin can inhibit early bolting in A. sinensis by regulating its physiological, biochemical, and gene expression levels.
10.Mechanism of Exogenous Melatonin in Inhibiting Early Bolting in Angelica sinensis
Jiang ZHAO ; Zhanwen TANG ; Tao YANG ; Jie SHA ; Tong PENG ; Weiwen LU ; Yinquan WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):234-240
ObjectiveThis study aims to investigate the effects of different sizes of seedlings and melatonin treatment on physiological and biochemical indicators and bolting-related gene expression in Angelica sinensis, find substances related to early bolting, and elucidate the inhibitory mechanism of melatonin on bolting. MethodsSpectrophotometry was used to detect the related enzyme activities of A. sinensis leaves. The contents of endogenous hormones and polyamines were detected using ultra-high performance liquid chromatography-tandem mass spectrometry. Real-time polymerase chain reaction (Real-time PCR) was used to detect the expression levels of bolting-related genes. Inter-group differential indicator analysis, orthogonal partial least squares discriminant analysis, and principal component analysis were comprehensively applied to identify factors related to early bolting. ResultsEndogenous jasmonic acid and melatonin were identified as the most important factors affecting early bolting. Secondly, the activity of antioxidant enzymes, abscisic acid content, gibberellin content, and the expression levels of CO3, HD3A, and FD genes had important effects on the bolting process. Compared with small seedlings, exogenous melatonin treatment mainly inhibited early bolting by increasing endogenous melatonin content, reducing gibberellin content, and decreasing the expression levels of SOC1 and FD genes. ConclusionExogenous melatonin can inhibit early bolting in A. sinensis by regulating its physiological, biochemical, and gene expression levels.


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