1.Issues and recommendations in the implementation of mutual recognition for ethical review outcomes in multicenter clinical research: a case study of 10 contracting institutions in Guangdong province
Xu LU ; Feng CAO ; Xuan DUAN ; Junrong LIU
Chinese Medical Ethics 2026;39(1):64-70
ObjectiveTo investigate the current situation of mutual recognition for ethical review outcomes in multicenter clinical research across 10 contracting medical institutions in Guangdong Province, analyze existing issues and propose improvement recommendations, thereby promoting the standardized management of mutual recognition for ethical review outcomes in medical institutions. MethodsData from 381 multicenter clinical studies conducted in these 10 medical institutions from January 24 to October 31, 2024, were collected. Text visualization was performed using Python and the WordCloud library, and statistical analyses were conducted with SPSS 25.0. ResultsOf the 381 studies investigated, industry-sponsored clinical trials (ISTs) accounted for 51.71%, while investigator-initiated clinical trials (IITs) constituted 48.29%. The proportions of ethical committees serving as primary reviewers and collaborative reviewers were 33.33% and 66.67%, respectively. The confirmation methods of mutual recognition outcomes were primarily expedited reviews (50.66%) and meeting reviews (49.34%), and no cases of “direct confirmation” were found. The Chi-square test revealed statistically significant differences in review confirmation methods based on project type (χ²=14.851, P<0.001) and ethics committee role (χ²= 69.435, P<0.001). The frequency distribution trend of the contingency table showed that IST projects and primary ethics committees preferred to employ meeting review (58.88% and 79.53% respectively, both higher than the average level of 49.34%), while IIT projects and the collaborative ethics committees more frequently utilized expedited review (60.87% and 65.75% respectively, both higher than the average level of 50.66%). ConclusionThe confirmation methods of mutual recognition for ethical review outcomes in multicenter clinical research are significantly associated with the role of the ethics committee and the type of project. It is recommended to improve management systems, enhance information construction and personnel training, as well as clarify mutual recognition responsibilities and strengthen supervision. This aims to ensure review quality while improving mutual recognition efficiency, thereby safeguarding the rights and interests of research participants.
2.Relationship of non-suicidal self-injury behavior with serum lipid levels and thyroid function among college students with depression
CHEN Lu, YANG Zhiqiang, CAO Xiaoping, ZHAO Yanxia, LIANG Shaoying, LUO Yi, LI Hongyu
Chinese Journal of School Health 2026;47(3):394-397
Objective:
To explore the relationship between non suicidal self injury (NSSI) behavior and serum lipid levels as well as thyroid function among college students with depression.
Methods:
A total of 169 college students with depression in the psychiatry departments of tertiary hospitals (grade 3A and 3B) in Ningbo from December 2023 to April 2025 were selected. The Adolescent Self injury Scale (ASIS) was used to assess the presence of NSSI, and participants were accordingly divided into a NSSI group ( n =51) and a non NSSI group ( n =118). General demographic data (including gender, age, and family situation) were collected from both groups. Blood tests were performed to measure lipid profiles [triglyceride (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C)] and thyroid hormones [triiodothyronine (T3), thyroxine (T4), free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH)]. Multivariate Logistic regression was employed to analyze risk factors for NSSI, and receiver operating characteristic (ROC) curve analysis was used to evaluate the predictive value of serum lipid and thyroid hormone levels for NSSI occurrence in college students with depression.
Results:
The levels of TC, LDL-C, and TSH in the NSSI group were (4.02±0.73) mmol/L, (2.32±0.36) mmol/L, and (6.57±1.95) mU/L , which were significantly higher than those in the non NSSI group [(3.41±0.56) mmol/L, (2.00±0.27) mmol/L, and ( 4.48± 1.09) mU/L, respectively] ( t =5.32, 5.60, 7.20, all P <0.05). Logistic regression analysis revealed that college students from single parent/reconstituted families, those who had experienced school bullying, and those with higher levels of TC, LDL-C, and TSH had a significantly increased risk of engaging in NSSI ( OR =5.22, 6.12, 5.90, 83.64, 3.64, all P <0.05). ROC curve analysis demonstrated that the combined detection of TC, LDL-C, and TSH had high diagnostic efficacy for predicting NSSI in college students with depression, with a sensitivity of 86.3% and a specificity of 94.9%.
Conclusions
NSSI behavior in college students with depression is associated with serum lipid levels and thyroid function. These biomarkers may serve as useful reference indicators for assessing the conditions of these patients.
3.The Mechanisms of Neurotransmitters and Their Receptors in Exercise Central Fatigue
Lu-Lu GUAN ; Bo-Te QI ; Du-Shuo FENG ; Jing-Wang TAN ; Meng CAO ; Yu ZOU
Progress in Biochemistry and Biophysics 2025;52(6):1321-1336
Exercise fatigue is a complex physiological and psychological phenomenon that includes peripheral fatigue in the muscles and central fatigue in the brain. Peripheral fatigue refers to the loss of force caused at the distal end of the neuromuscular junction, whereas central fatigue involves decreased motor output from the primary motor cortex, which is associated with modulations at anatomical sites proximal to nerves that innervate skeletal muscle. The central regulatory failure reflects a progressive decline in the central nervous system’s capacity to recruit motor units during sustained physical activity. Emerging evidence highlights the critical involvement of central neurochemical regulation in fatigue development, particularly through neurotransmitter-mediated modulation. Alterations in neurotransmitter release and receptor activity could influence excitatory and inhibitory signal pathways, thus modulating the perception of fatigue and exercise performance. Increased serotonin (5-HT) could increase perception of effort and lethargy, reduce motor drive to continue exercising, and contribute to exercise fatigue. Decreased dopamine (DA) and noradrenaline (NE) neurotransmission can negatively impact arousal, mood, motivation, and reward mechanisms and impair exercise performance. Furthermore, the serotonergic and dopaminergic systems interact with each other; a low 5-HT/DA ratio enhances motor motivation and improves performance, and a high 5-HT/DA ratio heightens fatigue perception and leads to decreased performance. The expression and activity of neurotransmitter receptors would be changed during prolonged exercise to fatigue, affecting the transmission of nerve signals. Prolonged high-intensity exercise causes excess 5-HT to overflow from the synaptic cleft to the axonal initial segment and activates the 5-HT1A receptor, thereby inhibiting the action potential of motor neurons and affecting the recruitment of motor units. During exercise to fatigue, the DA secretion is decreased, which blocks the binding of DA to D1 receptor in the caudate putamen and inhibits the activation of the direct pathway of the basal ganglia to suppress movement, meanwhile the binding of DA to D2 receptor is restrained in the caudate putamen, which activates the indirect pathway of the basal ganglia to influence motivation. Furthermore, other neurotransmitters and their receptors, such as adenosine (ADO), glutamic acid (Glu), and γ‑aminobutyric acid (GABA) also play important roles in regulating neurotransmitter balance and fatigue. The occurrence of central fatigue is not the result of the action of a single neurotransmitter system, but a comprehensive manifestation of the interaction between multiple neurotransmitters. This review explores the important role of neurotransmitters and their receptors in central motor fatigue, reveals the dynamic changes of different neurotransmitters such as 5-HT, DA, NE, and ADO during exercise, and summarizes the mechanisms by which these neurotransmitters and their receptors regulate fatigue perception and exercise performance through complex interactions. Besides, this study presents pharmacological evidence that drugs such as agonists, antagonists, and reuptake inhibitors could affect exercise performance by regulating the metabolic changes of neurotransmitters. Recently, emerging interventions such as dietary bioactive components intake and transcranial electrical stimulation may provide new ideas and strategies for the prevention and alleviation of exercise fatigue by regulating neurotransmitter levels and receptor activity. Overall, this work offers new theoretical insights into the understanding of exercise central fatigue, and future research should further investigate the relationship between neurotransmitters and their receptors and exercise fatigue.
4.Association between non-alcoholic fatty liver disease and depression: A systematic review and Meta-analysis
Shudi LI ; Shuaibing CAO ; Mingyu BA ; Suling LI ; Fei DUAN ; Baoping LU
Journal of Clinical Hepatology 2025;41(9):1795-1801
ObjectiveTo systematically review the association between non-alcoholic fatty liver disease (NAFLD) and depression, and to provide a basis for synergistic management in clinical practice. MethodsThis study was conducted according to the PRISMA guidelines, with the PROSPERO registration number of CRD42023482013. PubMed, Embase, the Cochrane Library, Web of Science, CNKI, Wanfang Data, VIP, and CBM were searched for articles on the association between NAFLD and depression published up to November 1, 2024. The articles were screened according to the inclusion and exclusion criteria, and related data were extracted. RevMan 5.3 was used to perform the Meta-analysis. ResultsA total of 18 studies were included, involving 396 793 participants. Among these studies, 12 discussed the influence of NAFLD on depression, involving 224 269 participants, among whom there were 75 574 patients with NAFLD. The Meta-analysis showed that NAFLD was significantly associated with the risk of depression (odds ratio [OR]=1.21, 95% confidence interval [CI]: 1.12 — 1.30, P0.001). Six studies examined the influence of depression on NAFLD, involving 172 524 participants, among whom there were 29 368 patients with depression. The meta-analysis showed that depression caused a significant increase in the risk of NAFLD (OR=1.13, 95%CI: 1.05 — 1.22, P=0.001). ConclusionThere is a significant bidirectional association between NAFLD and depression. It is recommended to perform the screening for depression and enhance mental health monitoring in patients with NAFLD, and metabolic function assessment and exercise intervention should be performed for patients with depression.
5.Comparison of predictive accuracy and clinical applicability among four vancomycin individualized dosing tools
Shu CHEN ; Yanqin LU ; Yun SHEN ; Chang CAO ; Kunming PAN ; Xiaoyu LI ; Qianzhou LYU
China Pharmacy 2025;36(22):2822-2827
OBJECTIVE To compare the predictive accuracy and clinical applicability of four vancomycin individualized dosing tools (SmartDose, ClinCalc, Gulou, Pharmado) and provide a basis for rational clinical medication use. METHODS A retrospective cohort study was conducted, enrolling 479 adult patients who received vancomycin therapy and underwent steady-state trough concentration monitoring in Zhongshan Hospital, Fudan University (Xiamen Branch) from January 1, 2022, to June 30, 2024. The predictive accuracy of each tool was evaluated using indicators, such as mean error (ME), mean absolute error (MAE), mean percentage error (MPE), mean absolute percentage error (MAPE), the proportion of patients with an absolute percentage error (APE) of less than 30%, the 95% limits of agreement, and the overall relative percentage difference between predicted and measured values. Using indicators such as accessibility, patient management, and recommendation of multiple treatment options, the clinical panxso@163.com applicability of the tools for all patients was evaluated; using the discrepancy in accuracy between the predicted and actual measured blood drug concentrations as an indicator, the clinical applicability was assessed for patients in different renal function subgroups (hyperfunction, normal, mild impairment, moderate impairment, and severe impairment). RESULTS In terms of accuracy, SmartDose demonstrated the best overall performance with an MAPE of 46.40% and a proportion of APE <30% (46.56%). Bland-Altman analysis indicated that SmartDose had the smallest overall relative percentage difference (-7.25%), although the 95% limits of agreement were broad for all tools, with differences between the upper and lower limits exceeding 200%. In terms of applicability, all four dosing tools were freely accessible and demonstrated good availability; SmartDose and Pharmado provided the most comprehensive solutions, offering features such as patient management, multiple regimen recommendations, and drug concentration-time curve plotting. Stratified analysis based on renal function revealed that Pharmado showed optimal prediction for hyperfiltration patients (mean difference: 0.11 mg/L). SmartDose and ClinCalc showed relatively better performance in normal and mild renal impaiment (mean difference: 0.37, 0.51 mg/L and -1.13, -1.33 mg/L,respectively). SmartDose performed best in moderate renal impairment (mean difference: -2.60 mg/L). Pharmado and Gulou had smaller prediction biases in severe renal impairment (mean differences: 1.52 mg/L and -0.23 mg/L, respectively). CONCLUSIONS The four individualized dosing tools demonstrated limited accuracy in the initial prediction of vancomycin concentrations. Among them, SmartDose demonstrates the highest overall prediction accuracy and possesses comprehensive clinical management features. It is recommended that Pharmado be preferred for patients with renal hyperfiltration; SmartDose or ClinCalc can be used for patients with normal or mildly impaired renal function; SmartDose is recommended for patients with moderately impaired renal function; Pharmado or Gulou may be considered for patients with severely impaired renal function.
7.Granulocyte colony-stimulating factor in neutropenia management after CAR-T cell therapy: A safety and efficacy evaluation in refractory/relapsed B-cell acute lymphoblastic leukemia.
Xinping CAO ; Meng ZHANG ; Ruiting GUO ; Xiaomei ZHANG ; Rui SUN ; Xia XIAO ; Xue BAI ; Cuicui LYU ; Yedi PU ; Juanxia MENG ; Huan ZHANG ; Haibo ZHU ; Pengjiang LIU ; Zhao WANG ; Yu ZHANG ; Wenyi LU ; Hairong LYU ; Mingfeng ZHAO
Chinese Medical Journal 2025;138(1):111-113
8.Mineralogical studies on iron-containing mineral medicines, Haematitum and Limonitum.
Min LU ; Xiao-Fei WANG ; Cheng-Cheng WANG ; Jing-Xu CHEN ; Hang-Jie ZHU ; Juan LI ; Yan CAO
China Journal of Chinese Materia Medica 2025;50(5):1179-1186
Haematitum and Limonitum are two iron-containing mineral medicines included in the 2020 edition of the Chinese Pharmacopoeia. They have similar main components and major differences in their property, flavor, channel tropism, and clinical uses. In this study, we investigated the surface properties, mineral composition, mineral dissociation, elemental composition, and iron state of Haematitum and Limonitum to explore their mineralogical differences. Scanning electron microscopy(SEM), specific surface and porosity analyzer, X-ray diffractometer(XRD), X-ray photoelectron spectrometer(XPS), and advanced mineral identification and characterization system(AMICS) were used to analyze the mineralogy of Haematitum and Limonitum. The results showed that Haematitum had an angular surface with granular attachments and a specific surface area of 17.04 m~2·g~(-1). In comparison, Limonitum had a smooth and flat surface with a bundled acicular crystal structure and a specific surface area of 46.29 m~2·g~(-1). Haematitum consists of 31 detectable minerals containing 18 elements, with the major element, iron(44.5% Fe~(2+) and 55.5% Fe~(3+)) distributed in 17 minerals, including hematite, iron oxide, knebelite, siderite, and magnesioferrite. Limonitum consists of 32 detectable minerals containing 17 elements, with the major element, iron(14.5% Fe~(2+) and 85.5% Fe~(3+)) distributed in 19 minerals, including limonite, iron oxide, chlorite, and knebelite. In summary, the elemental composition of Haematitum and Limonitum does not differ greatly, but there are large differences in the mineral composition and iron state. The large specific surface area and strong adsorption capacity of Limonitum may be one of the mechanisms of its anti-diarrheal action. The Fe_2O_3 and illite contained in Haematitum and Limonitum may be the key substances for their hemostasis effects. The mineralogical differences are expected to provide a reference for explaining the scientific connotation of mineral medicine and laying a material foundation for studying its mechanism of action.
Iron/analysis*
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Minerals/chemistry*
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Drugs, Chinese Herbal/chemistry*
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X-Ray Diffraction
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Microscopy, Electron, Scanning
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Photoelectron Spectroscopy
9.Research progress in effect of traditional Chinese medicine on aerobic glycolysis in colorectal cancer.
Xu MA ; Sheng-Long LI ; Guang-Rong ZHENG ; Da-Cheng TIAN ; Gang-Gang LU ; Jie GAO ; Yu-Qi AN ; Li-Yuan CAO ; Liang LI ; Xiao-Yong TANG
China Journal of Chinese Materia Medica 2025;50(6):1496-1506
Colorectal cancer(CRC) is a common malignant tumor worldwide. Due to the treatment intolerance and side effects, CRC rank the top among various cancers regarding the incidence and mortality rates. Therefore, exploring new therapies is of great significance for the treatment of CRC. Aerobic glycolysis(AEG) plays an important role in the microenvironment formation, proliferation, metastasis, and recurrence of CRC and other tumor cells. It has been confirmed that intervening in the AEG pathway can effectively curb CRC. The active ingredients and compound prescriptions of traditional Chinese medicine(TCM) can effectively inhibit the proliferation, metastasis, and drug resistance and regulate the apoptosis of tumor cells by modulating AEG-associated transport proteins [eg, glucose transporters(GLUT)], key enzymes [hexokinase(HK) and phosphofructokinase(PFK)], key genes [hypoxia-inducible factor 1(HIF-1) and oncogene(c-Myc)], and signaling pathways(MET/PI3K/Akt/mTOR). Accordingly, they can treat CRC, reduce the recurrence, and improve the prognosis of CRC. Although AEG plays a key role in the development and progression of CRC, the specific mechanisms are not yet fully understood. Therefore, this article delves into the intrinsic connection of the targets and mechanisms of the AEG pathway with CRC from the perspective of tumor cell glycolysis and explores how active ingredients(oxymatrine, kaempferol, and dioscin) and compound prescriptions(Quxie Capsules, Jiedu Sangen Decoction, and Xianlian Jiedu Prescription) of TCM treat CRC by intervening in the AEG pathway. Additionally, this article explores the shortcomings in the current research, aiming to provide reliable targets and a theoretical basis for treating CRC with TCM.
Humans
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Colorectal Neoplasms/genetics*
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Drugs, Chinese Herbal/therapeutic use*
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Glycolysis/drug effects*
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Animals
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Medicine, Chinese Traditional
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Signal Transduction/drug effects*
10.Effects of Sishen Pills and its separated prescriptions on human intestinal flora based on in vitro fermentation model.
Jia-Yang XI ; Qi-Qi WANG ; Xue CHENG ; Hui XIA ; Lu CAO ; Yue-Hao XIE ; Tian-Xiang ZHU ; Ming-Zhu YIN
China Journal of Chinese Materia Medica 2025;50(11):3137-3146
Sishen Pills and its separated prescriptions are classic prescriptions of traditional Chinese medicine to treat intestinal diseases. In this study, a high-performance liquid chromatography-electrospray ionization tandem mass spectrometry(HPLC-ESI-MS/MS) technology was used to identify the components of Sishen Pills, Ershen Pills, and Wuweizi Powder. The positive and negative ion sources of electrospray ionization were simultaneously collected by mass spectrometry. A total of 11 effective components were detected in Sishen Pills, with four effective components detected in Ershen Pills and eight effective components detected in Wuweizi Powder, respectively. To explore the effects of Sishen Pills and its separated prescriptions on the human intestinal flora, an in vitro anaerobic fermentation model was established, and the human intestinal flora was incubated with Sishen Pills, Ershen Pills, and Wuweizi Powder in vitro. The 16S rDNA sequencing technology was used to analyze the changes in the intestinal flora. The results showed that compared with the control group, Sishen Pills, and its separated prescriptions could decrease the intestinal flora abundance and increase the Shannon index after fermentation. The abundance of Bifidobacterium was significantly increased in the Sishen Pills and Ershen Pills groups. However, the abundance of Lactobacillus, Weissella, and Pediococcus was significantly increased in the Wuweizi Powder group. After fermentation for 12 h, the pH of the fermentation solution of three kinds of liquids with feces gradually decreased and was lower than that of the control group. The decreasing amplitude in the Wuweizi Powder group was the most obvious. The single-bacteria fermentation experiments further confirmed that Sishen Pills and Wuweizi Powder had inhibitory effects on Escherichia coli, Staphylococcus aureus, and Enterococcus faecalis, and the antibacterial activity of Wuweizi Powder was stronger than that of Sishen Pills. Both Sishen Pills and Ershen Pills could promote the growth of Lactobacillus brevis, and Ershen Pills could promote the growth of Bifidobacterium adolescentis. This study provided a more sufficient theoretical basis for the clinical application of Sishen Pills and its separated prescriptions.
Humans
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Gastrointestinal Microbiome/drug effects*
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Drugs, Chinese Herbal/chemistry*
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Fermentation/drug effects*
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Bacteria/drug effects*
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Chromatography, High Pressure Liquid
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Tandem Mass Spectrometry
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Intestines/microbiology*


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