1.Long-term survival outcomes and prognostic factors following radical resection of pancreatic body and tail cancer:a retrospective analysis of 992 patients
Dong XU ; Yang WU ; Kai ZHANG ; Nan LYU ; Qianqian WANG ; Pengfei WU ; Jie YIN ; Baobao CAI ; Guodong SHI ; Jianzhen LIN ; Yazhou WANG ; Lingdi YIN ; Zipeng LU ; Min TU ; Jianmin CHEN ; Feng GUO ; Jishu WEI ; Junli WU ; Wentao GAO ; Cuncai DAI ; Yi MIAO ; Kuirong JIANG
Chinese Journal of Surgery 2026;64(1):46-54
Objective:To investigate the survival outcomes and prognostic factors in patients undergoing radical resection for pancreatic body and tail cancer.Methods:A retrospective case series study was conducted on 992 patients who underwent radical resection for pancreatic body and tail cancer at the Pancreatic Center of the First Affiliated Hospital of Nanjing Medical University from January 2016 to June 2024. In this study, 577 (58.2%) were male and 415 (41.8%) were female,with an age of (65±9) years (range: 26 to 86 years). Follow-up continued until June 2024. Survival rates were estimated using the Kaplan-Meier method,and prognostic factors were identified using univariate and multivariate Cox proportional hazards models.Results:Among 992 patients,open surgery was the predominant approach (89.1%, 884/992), and radical antegrade modular pancreatosplenectomy (RAMPS) was performed in 317 patients (32.0%). Combined organ resection,venous resection,and arterial resection were performed in 23.5%, 9.3%,and 11.2% of patients,respectively. The rates of R0, R1-1 mm, and R1-direct resections were 49.8% (494/992),41.5% (412/992), and 8.7% (86/992),respectively. Stage ⅡB was the most common TNM stage (32.2%,319/992). A total of 801 patients (80.8%) received adjuvant chemotherapy. The median follow-up period was 32.0(8.8) months(range:3.2 to 105.3 months),during which 508 patients (51.2%) died. The overall median survival (OS) was 26.4 months,with 1-,3-, and 5-year survival rates of 79.0%,40.0%, and 29.0%, respectively. In the recent five years (from 2020 to 2024), the median OS improved significantly to 34.1 months compared to 20.0 months from 2016 to 2019 ( P<0.01). Histological subtype analysis showed that the median OS time was 26.7 months for pancreatic ductal adenocarcinoma (PDAC, n=855),58.9 months for invasive intraductal papillary mucinous carcinoma (IPMC, n=32),and 15.7 months for adenosquamous carcinoma of pancreas (ASCP, n=73) ( P=0.001). Among PDAC patients, adjuvant chemotherapy significantly improved survival (29.1 months vs. 14.4 months, P<0.01);in IPMC patients, adjuvant chemotherapy also extended survival (65.7 months vs. 58.9 months, P=0.047). Although ASCP patients receiving chemotherapy had a longer median OS time than those without (18.8 months vs. 8.9 months),the difference was not statistically significant ( P=0.151). Multivariate Cox regression analysis in PDAC patients indicated that adjuvant chemotherapy, R0 resection, T stage,N stage,and tumor differentiation were independent prognostic factors ( P<0.01). The median OS time by TNM stage was:not reached for stage ⅠA, 51.6 months for ⅠB, 25.5 months for ⅡA, 23.7 months for ⅡB, 23.0 months for Ⅲ, and 14.4 months for Ⅳ. The median OS time for R0,R1-1 mm,and R1-direct resections was 34.1,24.7,and 15.7 months,respectively ( P<0.01). Conclusion:Adjuvant chemotherapy,R0 resection,tumor stage,and differentiation are independent prognostic factors for pancreatic body and tail cancer.
2.Long-term survival outcomes and prognostic factors following radical resection of pancreatic body and tail cancer:a retrospective analysis of 992 patients
Dong XU ; Yang WU ; Kai ZHANG ; Nan LYU ; Qianqian WANG ; Pengfei WU ; Jie YIN ; Baobao CAI ; Guodong SHI ; Jianzhen LIN ; Yazhou WANG ; Lingdi YIN ; Zipeng LU ; Min TU ; Jianmin CHEN ; Feng GUO ; Jishu WEI ; Junli WU ; Wentao GAO ; Cuncai DAI ; Yi MIAO ; Kuirong JIANG
Chinese Journal of Surgery 2026;64(1):46-54
Objective:To investigate the survival outcomes and prognostic factors in patients undergoing radical resection for pancreatic body and tail cancer.Methods:A retrospective case series study was conducted on 992 patients who underwent radical resection for pancreatic body and tail cancer at the Pancreatic Center of the First Affiliated Hospital of Nanjing Medical University from January 2016 to June 2024. In this study, 577 (58.2%) were male and 415 (41.8%) were female,with an age of (65±9) years (range: 26 to 86 years). Follow-up continued until June 2024. Survival rates were estimated using the Kaplan-Meier method,and prognostic factors were identified using univariate and multivariate Cox proportional hazards models.Results:Among 992 patients,open surgery was the predominant approach (89.1%, 884/992), and radical antegrade modular pancreatosplenectomy (RAMPS) was performed in 317 patients (32.0%). Combined organ resection,venous resection,and arterial resection were performed in 23.5%, 9.3%,and 11.2% of patients,respectively. The rates of R0, R1-1 mm, and R1-direct resections were 49.8% (494/992),41.5% (412/992), and 8.7% (86/992),respectively. Stage ⅡB was the most common TNM stage (32.2%,319/992). A total of 801 patients (80.8%) received adjuvant chemotherapy. The median follow-up period was 32.0(8.8) months(range:3.2 to 105.3 months),during which 508 patients (51.2%) died. The overall median survival (OS) was 26.4 months,with 1-,3-, and 5-year survival rates of 79.0%,40.0%, and 29.0%, respectively. In the recent five years (from 2020 to 2024), the median OS improved significantly to 34.1 months compared to 20.0 months from 2016 to 2019 ( P<0.01). Histological subtype analysis showed that the median OS time was 26.7 months for pancreatic ductal adenocarcinoma (PDAC, n=855),58.9 months for invasive intraductal papillary mucinous carcinoma (IPMC, n=32),and 15.7 months for adenosquamous carcinoma of pancreas (ASCP, n=73) ( P=0.001). Among PDAC patients, adjuvant chemotherapy significantly improved survival (29.1 months vs. 14.4 months, P<0.01);in IPMC patients, adjuvant chemotherapy also extended survival (65.7 months vs. 58.9 months, P=0.047). Although ASCP patients receiving chemotherapy had a longer median OS time than those without (18.8 months vs. 8.9 months),the difference was not statistically significant ( P=0.151). Multivariate Cox regression analysis in PDAC patients indicated that adjuvant chemotherapy, R0 resection, T stage,N stage,and tumor differentiation were independent prognostic factors ( P<0.01). The median OS time by TNM stage was:not reached for stage ⅠA, 51.6 months for ⅠB, 25.5 months for ⅡA, 23.7 months for ⅡB, 23.0 months for Ⅲ, and 14.4 months for Ⅳ. The median OS time for R0,R1-1 mm,and R1-direct resections was 34.1,24.7,and 15.7 months,respectively ( P<0.01). Conclusion:Adjuvant chemotherapy,R0 resection,tumor stage,and differentiation are independent prognostic factors for pancreatic body and tail cancer.
3.Role of prohibitin 2 in mitophagy pathway against atherosclerosis in rats undergoing endurance training
Mingxiao SONG ; Junshunzi CHEN ; Ningwei WANG ; Huan CAI ; Hong FENG
Chinese Journal of Tissue Engineering Research 2025;29(11):2294-2300
BACKGROUND:Exercises can reduce blood lipids and slow down the development of atherosclerosis.Atherosclerosis begins with mitochondrial dysfunction,and prohibitin 2 is involved in mitophagy by endurance training. OBJECTIVE:To explore the role of endurance training in the intervention of prohibitin 2 protein in the mitophagy autophagy pathway in atherosclerosis. METHODS:A total of 40 Wistar rats were randomly divided into control group,exercise group,atherosclerosis group and atherosclerosis combined with exercise group,with 10 rats in each group.A rat model of atherosclerosis was constructed by combining a high-fat diet(9 weeks)with vitamin D injections(weeks 1,3,and 6)in the latter two groups,while the two exercise groups were subjected to progressing intensity endurance training for 9 weeks.After the intervention,lipid and pathological detections were conducted to observe the modeling and interventional effects.Mitochondrial membrane potential and mitophagy proteins were detected by microplate reader and western blot.Immunofluorescence staining was used to observe the co-localization of mitophagy proteins in aortic tissue. RESULTS AND CONCLUSION:Lipid and pathological sections showed that compared with the atherosclerosis group,the serum low-density lipoprotein cholesterol and total cholesterol levels and aortic lipid deposition area were significantly reduced in the atherosclerosis combined with exercise group(P<0.001).The results of mitochondrial membrane potential showed that the significant decrease in mitochondrial membrane potential of the aorta in the atherosclerosis combined with exercise group was reversed(P<0.01).The results of western blot assay showed that compared with the control group,the mitochondrial protein expression of prohibitin 2,LC3Ⅱ/Ⅰ,PINK1 and Parkin was significantly increased(P<0.05),and the protein expression of PARL and PGAM5 decreased(P<0.05).Compared with the atherosclerosis group,the protein expression of PINK1 and Parkin in the mitchondria of rats in the atherosclerosis combined with exercise group was significantly decreased(P<0.05),and the protein expressions of prohibitin 2,LC3Ⅱ/Ⅰ,PARL and PGAM5 were significantly increased(P<0.05).Immunofluorescence results showed that compared with the control group,the co-localization of LC3 and PINK1 with TOMM20 was significantly increased in the atherosclerosis group(P<0.05),while compared with the atherosclerosis group,the co-localization of LC3 and PINK1 with TOMM20 was significantly increased in the atherosclerosis combined with exercise group(P<0.05).Co-localization of LC3 and PARL with prohibitin 2 was significantly increased in the atherosclerosis group compared with the control group(P<0.01),co-localization of LC3 with prohibitin 2 was significantly increased in the atherosclerosis combined with exercise group compared with the atherosclerosis group(P<0.01),and co-localization of PARL protein with prohibitin 2 was significantly decreased in the atherosclerosis combined with exercise group compared with the atherosclerosis group(P<0.01).To conclude,endurance training can induce the expression of prohibitin 2 in the inner mitochondrial membrane and promote the binding of prohibitin 2 to the mitophagy junction protein to complete mitophagy,restore mitochondrial function,and slow down the occurrence of atherosclerosis.
4.Analysis on epidemiological characteristics of population receiving assisted reproductive technology therapy and their offspring in Shanghai, 2011-2020
Huiting YU ; Xin CUI ; Naisi QIAN ; Shan JIN ; Lei CHEN ; Feng ZHOU ; Qi LI ; Renzhi CAI ; Chunfang WANG
Chinese Journal of Epidemiology 2025;46(3):484-491
Objective:To analyze the epidemiological characteristics of the population receiving assisted reproductive technology (ART) therapy and the health status of their offspring in Shanghai from 2011 to 2020.Methods:Based on the birth cohort of the entire population in Shanghai, the proportion and trend changes of ART offspring in the birth cohort were analyzed. The characteristics of ART and naturally conceived populations, including household registration, education level, maternal age, and reproductive history, were examined. Additionally, the health status between ART offspring and naturally conceived offspring were compared.Results:From 2011 to 2020, a total of 70 729 ART offspring were born in Shanghai, accounting for 3.69% of the total births. In 2020, this proportion reached 7.79%. The ART conception rate for primiparous women was higher than that for multiparous women, with both showing upward trends and reaching 9.87% and 2.36%, respectively, in 2020. The ART conception rate was higher in women with higher education levels and local household registration than in those with lower education levels and non-local household registration. The incidence rates of preterm birth and low birth weight in ART singleton offspring were 7.76% and 4.82%, respectively, higher than the 4.69% and 2.87% in naturally conceived offspring, but no increasing trend was observed in naturally conceived offspring. Among twin and multiple newborns, the incidence rates of preterm birth and low birth weight were 56.98% and 46.82% for ART, lower than the 58.51% and 51.32% for natural conception.Conclusions:The difference in social and demographic characteristics was obvious in population receiving ART, suggesting that the differed demand of some people for ART therapy, and it is necessary to strengthen the construction of public health services and further expand the coverage and accessibility of ART services. With technological advancements, the rates of preterm birth and low birth weight remain relatively stable, and even decrease in twin and multiple newborns.
5.Health Economic Analysis of Central Line-associated Bloodstream Infections in Critically Ill Patients in Intensive Care Unit
Li CAI ; Xiaomin FENG ; Jing HUANG ; Huichao CHEN ; Jian LI ; Honglian OUYANG
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(2):301-310
[Objective]To explore the incremental cost of central line-associated bloodstream infections(CLABSI)after central venous catheterization(CVC)in critically ill patients in the intensive care unit(ICU),as well as the main cost of nosocomial infection prevention and control.By comparing these two costs,the medical personnel to pay more attention should CLABSI prevention and control from the perspectives of medical quality and economic benefits,and promote the implementation of prevention and control measures.[Methods]Cluster sampling was used to select 126 critically ill patients who underwent CVC in the ICU of a tertiary traditional Chinese medicine hospital from January 2021 to December 2023,including 65 cases in the CLABSI group and 61 in the non-CLABSI group.Patients'data were retrospectively collected from the hospital medical records,including the disease type,gender,age,length of hospital stay,outcome,and hospitalization expenses.The costs of different hand hygiene methods and differing approaches to environmental cleaning and disinfection were analyzed and compared.[Results]There were significant differences in the length of hospital stay(Z=-5.35,P<0.05)and total hospitalization expenses(Z=-6.79,P<0.05)between the CLABSI and non-CLABSI group.Total hospitalization expenses showed significant differences among patients with different lengths of hospital stay(H=43.01,P<0.05),with much higher median one in those with 60 or more days of hospital stay than other patients.Greater differences of median total hospitalization expenses were found in males than in females(Z=-3.98,P<0.05),as well as in patients aged 60-80 years than in patients of other ages(Z=-5.79,P<0.05).[Conclusions]The occurrence of CLABSI significantly increases the ICU patients'length of hospital stay and hospitalization expenses.There are differences in the costs of different hand hygiene methods and differing approaches to environmental cleaning and disinfection,but these costs are acceptable compared to the incremental costs directly attributable to CLABSI.Therefore,medical institutions should attach importance to the investment in prevention and control of nosocomial infections such as hand hygiene and environmental cleaning and disinfection,formulate practical,reasonable and feasible plans,and ensure their implementation,in order to avoid nosocomial infections,improve the medical quality,effectively control patients'length of hospital stay and hospitalization costs,and strive to maintain patient safety.
6.Clinical laboratory testing and molecular epidemiological characterization of influenza A virus in a hospital in Henan Province from 2016-2024
Haixia WANG ; Yue WU ; Jingjing CAI ; Yingying ZHAO ; Yangfan FENG ; Qing CHEN ; Kai DU ; Shulin ZHANG ; Xuedong ZHANG
Chinese Journal of Laboratory Medicine 2025;48(9):1185-1193
Objective:To investigate the methodological differences in the detection, the inflammatory markers and the pathogenic epidemiological characteristics of influenza A virus in clinical laboratories, in order to provide more diagnostic and epidemiological data for diagnosis and prevention for children with influenza A.Methods:A retrospective cross-sectional study was conducted to collect 96 731 patients with suspected influenza A from January 2016 to October 2024 in Nanyang City Center Hospital from the Clinical Laboratory Testing Information System, including 5 731 patients with confirmed influenza A, aged 5.2 (2.8, 43.7) years old. We analyzed the distribution of influenza A patients from age and mixed infections, the relationship between patient age and positive detection rate by restricted cubic spline (RCS), analyzed differences in testing methods used Kappa consistency testing and receiver operating characteristic (ROC) curves, established a model of inflammatory markers by logistic regression, as well as developed a prediction model and also the mutation of the hemagglutinin (HA) sequence of the influenza A subtype H3N2 virus using evolutionary tree analysis.Results:RCS analysis showed an inverted 'S' shaped non-linear relationship between the positive detection rate of influenza A and the age groups of the patients. Among the mixed infections, 1.43%(1 352/94 867) of the cases were combined with Mycoplasma pneumoniae infection. The Kappa values of reverse transcription PCR (RT-PCR) and serological indirect immunofluorescence assay (IFA) for detecting influenza A in nasopharyngeal swabs and alveolar lavage fluid in clinical laboratories were 0.632 and 0.809, respectively, and those of magnetic particle chemiluminescence assay were 0.614 and 0.668, respectively, and the area under curves in ROC curve of IFA and RT-PCR were 0.869 and 0.792, respectively. The inflammatory indexes were usually elevated in severe children compared with mild children. By binary logistic regression model analysis, neutrophil-to-lymphocyte ratio, D-dimer/fibrinogen and prognosis nutrition index were the risk factors and serum amyloid A/C reactive protein ratio was the protective factor for severe children with influenza A, and the OR values of the above factors were 1.760, 7.076, 1.045, and 0.719, respectively, and P<0.01. By the Bayesian Interdiction Criterion, the optimal seasonal autoregressive moving average mixed model for influenza A epidemics was ARIMA (1, 1, 1) (2, 1, 2) 12 with the highest prediction accuracy of 98.63%. The seven strains of H3N2 all belonged to the same isoforms, with nucleotide similarity of the HA gene ranging from 99.5% to 99.9%, and the glycosylation site, receptor-binding site, and the conserved amino acid residue Glycosylation sites, receptor binding sites and conserved amino acid residues remained unchanged. HA sequence analysis showed that the prevalent strains in Nanyang had undergone mutation to different degree compared with the vaccine strains. Conclusion:Scientific and rational testing and characteristic inflammatory markers in the clinical laboratory are of great clinical value in the diagnosis of children with severe influenza A. At the same time, the epidemiological monitoring of influenza A variants should be strengthened.
7.Mechanism of di-(2-ethylhexyl)phthalate promoting the development of polycystic ovary syndrome
Liang CAI ; An-Ni FENG ; Yu-Hua CHEN ; Yu-Bo XIAO ; Zhong-Cheng MO ; Yuan-Jie XIE
Acta Anatomica Sinica 2025;56(5):625-633
Di-(2-ethylhexyl)phthalate(DEHP)is an environmental pollutant commonly found in plastic products and has toxic effects on female reproductive system.DEHP can interfere with the synthesis of progesterone,testosterone and estradiol through female hypothalamic-pituitary-ovarian axis,aggravate insulin resistance and obesity by affecting glucose and lipid metabolism,and cause ovarian damage through inducing oxidative stress,excessive autophagy and pyroptosis of oocyte or granulosa cells.It can also alter epigenetic genes relating to follicular development and prevent follicles from mature.These factors are closely contribute to the pathogenesis of polycystic ovary syndrome.We systematically summarizes the mechanism of DEHP interfering with ovarian function and inducing polycystic ovary syndrome,in order to provide help for the prevention and treatment of female reproductive injury from environmental pollutant.
8.Mechanism of Colquhounia Root Tablets against diabetic kidney disease via RAGE-ROS-PI3K-AKT-NF-κB-NLRP3 signaling axis.
Ming-Zhu XU ; Zhao-Chen MA ; Zi-Qing XIAO ; Shuang-Rong GAO ; Yi-Xin YANG ; Jia-Yun SHEN ; Chu ZHANG ; Feng HUANG ; Jiang-Rui WANG ; Bei-Lei CAI ; Na LIN ; Yan-Qiong ZHANG
China Journal of Chinese Materia Medica 2025;50(7):1830-1840
This study aimed to explore the therapeutic mechanisms of Colquhounia Root Tablets(CRT) in treating diabetic kidney disease(DKD) by integrating biomolecular network mining with animal model verification. By analyzing clinical transcriptomics data, an interaction network was constructed between candidate targets of CRT and DKD-related genes. Based on the topological eigenvalues of network nodes, 101 core network targets of CRT against DKD were identified. These targets were found to be closely related to multiple pathways associated with type 2 diabetes, immune response, and metabolic reprogramming. Given that immune-inflammatory imbalance driven by metabolic reprogramming is one of the key pathogenic mechanisms of DKD, and that many core network targets of CRT are involved in this pathological process, receptor for advanced glycation end products(RAGE)-reactive oxygen species(ROS)-phosphatidylinositol 3-kinase(PI3K)-protein kinase B(AKT)-nuclear factor-κB(NF-κB)-NOD-like receptor family pyrin domain containing 3(NLRP3) signaling axis was selected as a candidate target for in-depth research. Further, a rat model of DKD induced by a high-sugar, high-fat diet and streptozotocin was established to evaluate the pharmacological effects of CRT and verify the expression of related targets. The experimental results showed that CRT could effectively correct metabolic disturbances in DKD, restore immune-inflammatory balance, and improve renal function and its pathological changes by inhibiting the activation of the RAGE-ROS-PI3K-AKT-NF-κB-NLRP3 signaling axis. In conclusion, this study reveals that CRT alleviates the progression of DKD through dual regulation of metabolic reprogramming and immune-inflammatory responses, providing strong experimental evidence for its clinical application in DKD.
Animals
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Diabetic Nephropathies/metabolism*
;
Receptor for Advanced Glycation End Products/genetics*
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NF-kappa B/genetics*
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Signal Transduction/drug effects*
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Rats
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NLR Family, Pyrin Domain-Containing 3 Protein/genetics*
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Proto-Oncogene Proteins c-akt/genetics*
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Drugs, Chinese Herbal/administration & dosage*
;
Male
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Phosphatidylinositol 3-Kinases/genetics*
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Reactive Oxygen Species/metabolism*
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Humans
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Plant Roots/chemistry*
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Rats, Sprague-Dawley
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Tablets/administration & dosage*
9.Multifaceted mechanisms of Danggui Shaoyao San in ameliorating Alzheimer's disease based on transcriptomics and metabolomics.
Min-Hao YAN ; Han CAI ; Hai-Xia DING ; Shi-Jie SU ; Xu-Nuo LI ; Zi-Qiao XU ; Wei-Cheng FENG ; Qi-Qing WU ; Jia-Xin CHEN ; Hong WANG ; Qi WANG
China Journal of Chinese Materia Medica 2025;50(8):2229-2236
This study explored the potential therapeutic targets and mechanisms of Danggui Shaoyao San(DSS) in the prevention and treatment of Alzheimer's disease(AD) through transcriptomics and metabolomics, combined with animal experiments. Fifty male C57BL/6J mice, aged seven weeks, were randomly divided into the following five groups: control, model, positive drug, low-dose DSS, and high-dose DSS groups. After the intervention, the Morris water maze was used to assess learning and memory abilities of mice, and Nissl staining and hematoxylin-eosin(HE) staining were performed to observe pathological changes in the hippocampal tissue. Transcriptomics and metabolomics were employed to sequence brain tissue and identify differential metabolites, analyzing key genes and metabolites related to disease progression. Reverse transcription-quantitative polymerase chain reaction(RT-qPCR) was employed to validate the expression of key genes. The Morris water maze results indicated that DSS significantly improved learning and cognitive function in scopolamine(SCOP)-induced model mice, with the high-dose DSS group showing the best results. Pathological staining showed that DSS effectively reduced hippocampal neuronal damage, increased Nissl body numbers, and reduced nuclear pyknosis and neuronal loss. Transcriptomics identified seven key genes, including neurexin 1(Nrxn1) and sodium voltage-gated channel α subunit 1(Scn1a), and metabolomics revealed 113 differential metabolites, all of which were closely associated with synaptic function, oxidative stress, and metabolic regulation. RT-qPCR experiments confirmed that the expression of these seven key genes was consistent with the transcriptomics results. This study suggests that DSS significantly improves learning and memory in SCOP model mice and alleviates hippocampal neuronal pathological damage. The mechanisms likely involve the modulation of synaptic function, reduction of oxidative stress, and metabolic balance, with these seven key genes serving as important targets for DSS in the treatment of AD.
Animals
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Alzheimer Disease/genetics*
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Male
;
Drugs, Chinese Herbal/administration & dosage*
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Mice
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Mice, Inbred C57BL
;
Metabolomics
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Transcriptome/drug effects*
;
Maze Learning/drug effects*
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Hippocampus/metabolism*
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Humans
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Disease Models, Animal
;
Memory/drug effects*
10.Construction of core outcome set for clinical research on traditional Chinese medicine treatment of simple obesity.
Tong-Tong WU ; Yan YU ; Qian HUANG ; Xue-Yin CHEN ; Fu-Ming-Xiang LIU ; Li-Hong YANG ; Chang-Cai XIE ; Shao-Nan LIU ; Yu CHEN ; Xin-Feng GUO
China Journal of Chinese Materia Medica 2025;50(12):3423-3430
Following the core outcome set standards for development(COS-STAD), this study aims to construct core outcome set(COS) for clinical research on traditional Chinese medicine(TCM) treatment of simple obesity. Firstly, a comprehensive review was conducted on the randomized controlled trial(RCT) and systematic review(SR) about TCM treatment of simple obesity that were published in Chinese and English databases to collect reported outcomes. Additional outcomes were obtained through semi-structured interviews with patients and open-ended questionnaire surveys for clinicians. All the collected outcomes were then merged and organized as an initial outcome pool, and then a preliminary list of outcomes was formed after discussion by the working group. Subsequently, two rounds of Delphi surveys were conducted with clinicians, methodology experts, and patients to score the importance of outcomes in the list. Finally, a consensus meeting was held to establish the COS for clinical research on TCM treatment of simple obesity. A total of 221 RCTs and 12 SRs were included, and after integration of supplementary outcomes, an initial outcome pool of 141 outcomes were formed. Following discussions in the steering advisory group meeting, a preliminary list of 33 outcomes was finalized, encompassing 9 domains. Through two rounds of Delphi surveys and a consensus meeting, the final COS for clinical research on TCM treatment of simple obesity was determined to include 8 outcomes: TCM symptom scores, body mass index(BMI), waist-hip ratio, waist circumference, visceral fat index, body fat rate, quality of life, and safety, which were classified into 4 domains: TCM-related outcomes, anthropometric measurements, quality of life, and safety. This study has preliminarily established a COS for clinical research on TCM treatment of simple obesity. It helps reduce the heterogeneity in the selection and reporting of outcomes in similar clinical studies, thereby improving the comparability of research results and the feasibility of meta-analysis and providing higher-level evidence support for clinical practice.
Humans
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Obesity/therapy*
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Medicine, Chinese Traditional
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Randomized Controlled Trials as Topic
;
Treatment Outcome
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Drugs, Chinese Herbal/therapeutic use*

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