1.Standardization Challenges in Outcome Evaluation Systems of Animal Experiments and Considerations for Core Outcome Set Construction Strategies
Qingyong ZHENG ; Yongjia ZHOU ; Tengfei LI ; Jianguo XU ; Chen TIAN ; Hui LIU ; Min TIAN ; Ziyu ZHOU ; Caihua XU ; Yating CUI ; Junfei WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2026;46(1):138-148
Animal experimentation constitutes a critical link between basic research and clinical application, making its research quality and translational efficiency paramount. Although considerable progress has been made in standardizing operational procedures and ethical guidelines, the standardization of outcome evaluation systems has significantly lagged, creating a key bottleneck that constrains the quality of biomedical research and evidence synthesis. This deficiency is manifested by pronounced heterogeneity in outcome selection across similar studies, incomplete methodological reporting, and disparate criteria for result interpretation, which severely impairs the comparability of findings and the evidence integration. To cope with this challenge, this paper systematically introduces a mature methodological tool from clinical research–the core outcome set (COS)–and explores its construction strategies and application potential in the field of animal experimentation. Given the extensive diversity of animal experiments, a pragmatic strategy of "focusing on key areas, implementing phased pilots, and promoting gradual expansion" should be adopted. This approach prioritizes the development of domain-specific COS for disease areas characterized by high research volume, urgent translational needs, and well-established animal models. A multi-source integration pathway for COS development is detailed, comprising systematic literature searches, methodological appraisals, and expert consensus, with the feasibility of leveraging artificial intelligence (AI) to enhance efficiency also being examined. The development and promotion of such COS are not intended to restrict scientific exploration; rather, they aim to establish a new, tiered evaluation paradigm consisting of "core outcomes" (mandatory), "recommended outcomes" (encouraged), and "exploratory outcomes" (optional). This framework is expected not only to enhance research quality through standardization and to adhere to the "3R" principles but also to accelerate the accumulation of high-quality evidence. This, in turn, provides a solid foundation for higher-level evidence synthesis, ultimately facilitating the effective translation of basic research findings into clinical practice and providing an essential methodological framework for scientific advancement in relevant disciplines.
2.Exploration of the role of PIVAS pharmacists in optimization of parenteral nutrition prescription systems and medication safety monitoring
Xingru DOU ; Di YU ; Ying CHEN ; Xiujuan PAN ; Yi SUN ; Jianguo ZHU
China Pharmacy 2025;36(11):1394-1398
OBJECTIVE To provide references for ensuring the safety of prescription preparation, dispensing, and use of parenteral nutrition solution, as well as for expanding the scope of pharmaceutical services provided by pharmacists in the Pharmacy Intravenous Admixture Services (PIVAS). METHODS Under the guidance of PIVAS pharmacists, the rules for reviewing medical orders of parenteral nutrition in the PIVAS system and the information displayed on the infusion labels of finished parenteral nutrition solutions were refined. The process management of dispensing parenteral nutrition solution was strengthened, and detailed quality control and inspection rules were formulated. Additionally, Clinical Safety Monitoring Form for Finished Parenteral Nutrition Infusions was designed to conduct clinical monitoring and inspections for abnormalities in the finished infusions, infusion operations, and complications that may arise during the use of finished parenteral nutrition infusions. The implementation effects of the aforementioned optimization/inspection measures were evaluated by comparing data on the efficiency of medical order review for parenteral nutrition, the rate of irrational medical orders, the compliance rate of vascular access selection and infusion rate standardization, the rate of dispensing error, as well as the abnormalities occurring during clinical use, before and after the optimization/inspection initiatives were put into place. RESULTS The optimized prescription review system achieved automatic review of medical orders for parenteral nutrition, enhancing the efficiency of order review. The average time taken to review one parenteral nutrition medical order was reduced from approximately 1 minute to 10 seconds. The irrational rate of parenteral nutrition orders decreased by 31.87%. The dispensing error rate of parenteral nutrition decreased by 56.55%. The standard rate of vascular access selection and standard rate of infusion speed were increased by 13.29% and 3.54%, respectively. The PIVAS pharmacists identified and intervened in 5 abnormal cases out of 298 cases examined for use of parenteral nutrition solutions. CONCLUSIONS By optimizing the prescription review system, improving labeling information, and strengthening quality control inspections during both preparation and administration processes, PIVAS pharmacists have enhanced the safety of compounded parenteral nutrition solutions. This initiative has expanded the scope and depth of pharmaceutical care provided by dispensing pharmacists.
3.Hepatitis B virus serological marker and liver function index among patients with primary liver cancer
PENG Lijun ; GONG Li ; JI Shenjie ; XUE Xuefeng ; CHEN Jianguo
Journal of Preventive Medicine 2025;37(10):1024-1028
Objective:
To analyze the hepatitis B virus serological markers (HBVM) and abnormal rates of liver function indexes among primary liver cancer (PLC) patients with different HBVM profiles, so as to provide a reference for risk stratification and optimization of diagnosis and treatment strategies for PLC patients.
Methods:
Patients diagnosed with PLC at Qidong People's Hospital between January 2017 and June 2024 were selected for this study. Basic information such as gender and age was collected through the hospital information management system. Venous blood samples were drawn to test for HBsAg, anti-HBs, HBeAg, anti-HBe, and anti-HBc, as well as ten liver function indexes such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), cholinesterase (CHE), and adenosine deaminase (ADA). Compare the abnormal rates of liver function indexes among the six HBVM profiles: "big three yang" (HBsAg+, HBeAg+, anti-HBc+), "small three yang" (HBsAg+, anti-HBe+, anti-HBc+), triple antibody positive (anti-HBs+, anti-HBe+, anti-HBc+), s/c antibody positive (anti-HBs+, anti-HBc+), e/c antibody positive (anti-HBe+, anti-HBc+), and all negative.
Results:
A total of 1 434 patients with PLC were enrolled in this study. Among them, 1 043 (72.73%) were males and 391 (27.27%) were females. The median age was 64.00 (interquartile range, 16.00) years. The positive rates for HBsAg, anti-HBs, HBeAg, anti-HBe, and anti-HBc were 51.95%, 29.43%, 10.81%, 60.32%, and 88.42%, respectively. The "big three yang", "small three yang", triple-antibody positive, s/c antibody positive, e/c antibody positive, and all-negative profiles accounted for 85 (5.93%), 491 (34.24%), 170 (11.85%), 148 (10.32%), 100 (6.97%), and 121 (8.44%) cases, respectively. The abnormal rates of ALT among PLC patients with six HBVM profiles were 26.19%, 28.33%, 13.94%, 22.60%, 20.41%, and 14.91%, respectively. The abnormal rates of AST were 33.33%, 36.17%, 23.03%, 24.66%, 22.45%, and 18.42%, respectively. The abnormal rates of LDH were 62.16%, 68.22%, 53.73%, 61.19%, 60.00%, and 68.42%, respectively. The abnormal rates of CHE were 0%, 1.81%, 0%, 2.11%, 2.22%, and 3.88%, respectively. The abnormal rates of ADA were 59.09%, 57.27%, 24.27%, 33.33%, 45.00%, and 37.04%, respectively. These differences were statistically significant (all P<0.05).
Conclusions
In this study, the HBVM profiles were mainly characterized by "small triple positive" among PLC patients. The significant differences in liver function indexes abnormal rates among PLC patients with six HBVM profiles could reflect the liver injury status.
4.Study on nonlinear spatiotemporal response characteristics of acupoint electrical signals to multi-mode acupuncture and moxibustion stimulation based on array multichannel data.
Shiyi QI ; Jinwen LIN ; Shihao WANG ; Jianguo CHEN ; Lili LIN ; Youcong NI ; Xin DU ; Dong LIN
Chinese Acupuncture & Moxibustion 2025;45(9):1209-1217
OBJECTIVE:
To elucidate the rules of temporal and spatial variations in distal skin potential at Hegu (LI4) under different stimulation modes by extracting nonlinear characteristic parameters from array multichannel data and adopting multivariate statistical analysis.
METHODS:
Seven healthy subjects were selected and the surface potential at the left Quchi (LI11) was collected using 14×9 array multichannel electrodes. Using Hegu (LI4) on the left as the stimulation point, four stimulation modes were applied, i.e. being quiescent, point pressing, moxibustion, and manual needling manipulation. Electrical signals were collected for 30 s in each mode, with a 5-min interval between operations, and a sampling frequency of 16 384 Hz. The data was denoised using ensemble empirical mode decomposition (EEMD), and sample entropy (SaEn) features were extracted. Statistical analysis was conducted on these data using factor analysis and multivariate analysis of variance.
RESULTS:
The SaEn values of most electrode channels were higher under point pressing, moxibustion and manual needling manipulation compared with those under quiescent condition. Under manual needling manipulation, the SaEn value of the electrode channel reached the peak in the first time interval (1-5 s) and it was declining thereafter. Factor analysis showed that the specificity of activation channels was concentrated at the left Quchi (LI11) (loading capacity ≥0.90). Analysis of variance indicated that the significant differences were presented in average sample entropy (SaEn()) values of activation channels among different stimulation modes at Hegu (LI4) (P<0.001), but there was no statistically significant interaction effect between groups and time intervals (P>0.05).
CONCLUSION
Through nonlinear characteristic parameter extraction and multivariate statistical analysis, we have uncovered the complex temporal and spatial dynamical rules of distal skin potential at Hegu (LI4) under various stimulation modes and successfully identified the specific activation characteristics at Quchi (LI11).
Humans
;
Moxibustion
;
Acupuncture Points
;
Male
;
Adult
;
Female
;
Young Adult
;
Acupuncture Therapy/instrumentation*
5.Study on distribution characteristics of pressure-sensitive points on body surface around acupoints in patients with chronic non-specific low back pain based on Euclidean distance.
Dong LIN ; Shiyi QI ; Youcong NI ; Xin DU ; Zijuan HUANG ; Xiang ZHAO ; Jianguo CHEN ; Lili LIN
Chinese Acupuncture & Moxibustion 2025;45(12):1743-1750
OBJECTIVE:
To explore the pain-location interaction between pressure-sensitive points on the body surface and traditional acupoints in patients with chronic non-specific low back pain (CNLBP) under different disease courses, using Euclidean distance and multivariate statistical analysis.
METHODS:
A pressure-sensitive point detection was performed on 30 CNLBP patients with varying disease courses. A constant pressure was applied using an FDK20 algometer within a designated lumbar area, a total of 50 points were tested, and the tested points were numbered; the visual analogue scale (VAS) pain score was recorded simultaneously. MatlabR2022a9.12. software was used to extract the positions of pressure-sensitive points, and preprocessing and normalization of point location and VAS scores data were conducted. Under constraint conditions (VAS≥8.0 ∩ Euclidean distance to acupoint≤0.5), the proportion of pressure-sensitive points within the Euclidean distance threshold to each acupoint (PVDacupoint) was calculated, followed by multivariate statistical analysis.
RESULTS:
①Constrained analysis of PVDacupoint showed that PVDQihaishu (BL24) and PVDDachangshu (BL25) were positively correlated with disease course (r=0.55, P<0.01). ②Factor analysis and silhouette analysis revealed that PVDShenshu (BL23) and PVDDachangshu (BL25) exhibited trends consistent with disease course progression (P>0.05), with different degree (P<0.01).
CONCLUSION
The PVDacupoint value based on Euclidean distance can characterize the pressure sensitivity features of traditional acupoints associated with disease. Multivariate statistical analysis of PVDacupoint confirms that selecting the acupoint combination of Shenshu (BL23) and Dachangshu (BL25) for CNLBP is associated with the distribution of surrounding pressure-sensitive points and the pathological characteristics of the condition.
Humans
;
Acupuncture Points
;
Low Back Pain/physiopathology*
;
Male
;
Female
;
Middle Aged
;
Adult
;
Aged
;
Acupuncture Therapy
;
Young Adult
;
Pressure
7.Diagnosis and treatment of colorectal liver metastases: Chinese expert consensus-based multidisciplinary team (2024 edition).
Wen ZHANG ; Xinyu BI ; Yongkun SUN ; Yuan TANG ; Haizhen LU ; Jun JIANG ; Haitao ZHOU ; Yue HAN ; Min YANG ; Xiao CHEN ; Zhen HUANG ; Weihua LI ; Zhiyu LI ; Yufei LU ; Kun WANG ; Xiaobo YANG ; Jianguo ZHOU ; Wenyu ZHANG ; Muxing LI ; Yefan ZHANG ; Jianjun ZHAO ; Aiping ZHOU ; Jianqiang CAI
Chinese Medical Journal 2025;138(15):1765-1768
8.Research progress on estimating internal radiation dose of radiopharmaceuticals for targeted α radionuclide therapy in preclinical evaluation
Xufu CHEN ; Jie GAO ; Zhaolong WANG ; Haili LU ; Shu ZHANG ; Zongtai HAN ; Jianguo LI
Chinese Journal of Nuclear Medicine and Molecular Imaging 2025;45(1):57-60
Due to the specificity of radiopharmaceuticals for targeted α radionuclide therapy, such as radioactivity and radiation damage risk, it is necessary to estimate the internal radiation dose in preclinical evaluation to correctly evaluate the efficacy and safety of the drug, as well as in subsequent clinical studies. This review illustrates current research status of estimating internal radiation dose of targeted α radionuclide therapeutic radiopharmaceuticals based on preclinical studies, in order to add insights for understanding estimation of radiopharmaceuticals internal radiation dose and provide reference for the preclinical evaluation of radiopharmaceuticals.
9.Synthesis and preliminary biological evaluation of estrogen receptor α-targeted PET imaging probe
Ying PENG ; Panpan CHEN ; Ling QIU ; Jianguo LIN
Chinese Journal of Nuclear Medicine and Molecular Imaging 2025;45(8):452-457
Objective:To synthesize 18F labeled PET imaging probe based on giredestrant (GDC-9545), an estrogen receptor α (ERα) degrader and antagonist, and evaluate its ERα-targeting properties. Methods:The precursor-GDC (PGDC), GDC and 18F-GDC were synthesized. The radiochemical yields, radiochemical purity, specific activity, lipid water partition coefficient log P, and stability of 18F-GDC were determined. Cellular uptake and blocking assays of 18F-GDC were performed using ERα high-expressing MCF-7 cells and ERα low-expressing MDA-MB-231 cells. MCF-7 and MDA-MB-231 tumor-bearing mice were constructed and microPET imaging was performed. The biodistribution of 18F-GDC in MCF-7 tumor-bearing mice was studied. Data were analyzed by using two-way repeated measures analysis of variance and Bonferroni correction method. Results:PGDC and GDC were successfully prepared with the purity more than 95%. 18F-GDC was successfully synthesized with the labeling yield of (11.25±3.18)%, radiochemical purity more than 98%, specific activity of (140.66±17.20)GBq/μmol and lipid water partition coefficient log P of 2.12±0.13. 18F-GDC was stable in PBS or mouse serum, with the radiochemical purity still more than 98% after 2 h of incubation. After incubation for 60 and 120min, the uptakes of 18F-GDC in MCF-7 cells were significantly higher than those in MDA-MB-231 cells ( F values: 113.78, 369.70, P values: 0.002, 0.001 (Bonferroni correction method)), and could be blocked by GDC. 18F-GDC had a high uptake in MCF-7 tumors and could be blocked by GDC. Tumor uptake at 60 min post-injection was (7.23±0.74) percentage activity of injection dose per gram of tissue (%ID/g) and the tumor/muscle uptake ratio was 2.83±0.29 in MCF-7 tumors, while 18F-GDC had a lower uptake in MDA-MB-231 tumors, with (2.01±0.46)%ID/g at 60min post-injection, and a tumor/muscle uptake ratio of 0.96±0.22 ( F values: 77.28, 55.44, P values: 0.002, 0.006 (Bonferroni correction method)). 18F-GDC was mainly distributed in MCF-7 tumors and organs including heart, liver, spleen, kidney, stomach and intestines. Conclusions:18F-GDC is successfully synthesized, with high radiochemical purity and stability, and can concentrate in the ERα-overexpressing cancer cells and lesion area of xenograft tumor mouse. It presents good image contrast in PET imaging, indicating excellent diagnostic performance.
10.GPSM2 is highly expressed in gastric cancer to affect patient prognosis by promoting tumor cell proliferation.
Xue SONG ; Yue CHEN ; Min ZHANG ; Nuo ZHANG ; Lugen ZUO ; Jing LI ; Zhijun GENG ; Xiaofeng ZHANG ; Yueyue WANG ; Lian WANG ; Jianguo HU
Journal of Southern Medical University 2025;45(2):229-238
OBJECTIVES:
To explore the association between GPSM2 expression level and gastric cancer progression and analyze the functional pathways and action mechanism of GPSM2.
METHODS:
We analyzed GPSM2 expression levels in gastric cancer tumors based on data from the GEPIA database and the clinical data of 109 patients. Public databases enrichment analysis were used to assess the impact of GPSM2 expression level on survival outcomes and the functional pathways and action mechanism of GPSM2. We further observed the effects of GPSM2 knockdown and overexpression on proliferation, migration and apoptosis of MGC803 cells using CCK-8 assay, colony formation assay, flow cytometry and immunoblotting and on the growth of MGC803 cell xenografts in nude mice.
RESULTS:
Bioinformatic analysis and immunohistochemical staining of the clinical specimens both revealed high GPSM2 expressions in gastric cancer (P<0.01). A high GPSM2 expression was significantly correlated with T3-4 stages, N2-3 stages, a carcinoembryonic antigen (CEA) level ≥5 μg/L, and a carbohydrate antigen (CA) 19-9 level ≥37 kU/L (P<0.05). Cox regression analysis identified high GPSM2 expression as an independent risk factor affecting 5-year survival of the patients (P<0.05). Gene ontology (GO) analysis suggested that GPSM2 was involved in cell cycle regulation. In MGC803 cells, GPSM2 overexpression significantly promoted cell proliferation and G1/S transition and xenograft growth in nude mice. KEGG pathway enrichment analysis indicated that GPSM2 executed its biological functions by regulating the p53 signaling pathway, which was confirmed by the results of immunoblotting experiments showing suppression of p53 signaling pathway activity in GPSM2-over expressing MGC803 cells.
CONCLUSIONS
GPSM2 is highly expressed in gastric cancer to affect patient prognosis by promoting tumor cell proliferation and G1/S transition possibly via inhibiting the p53 pathway.
Stomach Neoplasms/metabolism*
;
Humans
;
Cell Proliferation
;
Prognosis
;
Animals
;
Mice, Nude
;
Cell Line, Tumor
;
Mice
;
Apoptosis
;
Tumor Suppressor Protein p53/metabolism*
;
Cell Movement


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