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.

ObjectiveTo investigate the effects of Jianpi Qinghua granules on blood glucose fluctuations in patients with newly diagnosed overweight/obese type 2 diabetes mellitus （T2DM） and Qi-Yin deficiency syndrome from the perspective of skeletal muscle mass and function， while providing new insights for the treatment of diabetes. MethodsThis study employed a randomized， double-blind， placebo-controlled design. A total of 110 newly diagnosed overweight/obese T2DM patients meeting the inclusion criteria were randomly assigned to either the traditional Chinese medicine （TCM） group （54 cases） or the control group （56 cases）. Patients in the TCM group received Jianpi Qinghua Granules， while those in the control group received a placebo. Both groups underwent dietary and exercise guidance. After 12 weeks of intervention， blood glucose fluctuations were assessed using the following parameters： time in the target blood glucose range （TIR）， mean daily blood glucose （MBG）， standard deviation of mean daily blood glucose （SDBG）， mean amplitude of glycemic excursions （MAGE）， coefficient of variation of blood glucose （CV）， glycated hemoglobin （HbA1c） achievement rate， fasting plasma glucose （FPG）， and 2 hour postprandial glucose （2 hPG）. Skeletal muscle mass was measured by dual-energy X-ray absorptiometry （DXA）， while skeletal muscle function was evaluated using a handheld dynamometer for distal muscle strength and a 5-time sit-to-stand test for lower limb function. Additionally， pancreatic islet function and TCM syndrome scores were analyzed. ResultsNo significant differences were observed in baseline data between the two groups before intervention， ensuring comparability. After treatment， compared to the control group， the TCM group showed a significant increase in TIR （P<0.01）. While the SDBG and CV decreased， and MBG and MAGE increased in the TCM group， these differences were not statistically significant. Notably， the TCM group exhibited significant reductions in 2 hPG （P<0.01） and HbA1c （P<0.05）， though the decrease in FPG was not statistically significant. The HbA1c achievement rate in the TCM group was significantly higher than that in the control group （χ²=45.498， P<0.01）. In terms of skeletal muscle mass and function， the TCM group demonstrated a significant increase in handgrip strength （P<0.01） and a significant reduction in the 5-time sit-to-stand duration （P<0.05）. However， although body fat percentage increased， leading to a decrease in skeletal muscle mass and the ratio of skeletal muscle to fat， these changes were not statistically significant. For pancreatic islet function， the TCM group showed significant reductions in fasting insulin （FINS） and homeostasis model assessment of insulin resistance （HOMA-IR） （P<0.01）. Additionally， the TCM syndrome score in the TCM group was significantly reduced （P<0.01）. ConclusionJianpi Qinghua granules may reduce blood glucose fluctuations in newly diagnosed overweight/obese T2DM patients with Qi-Yin deficiency syndrome by enhancing skeletal muscle function， improving pancreatic islet function， and ameliorating related TCM syndromes.

Breast cancer is one of the most common cancers in the world， and its incidence rate is also rising in China and tends to happen in younger age groups. The classical Wnt/β-catenin signaling pathway is an important target in the treatment of breast cancer， playing a key role in the whole process of breast cancer development by regulating the expression of related signal proteins and genes. Traditional Chinese medicine has a profound history and practical experience in the treatment of malignant tumors， and the development of modern technology further highlights the therapeutic advantages of traditional Chinese medicine， which has multiple targets and components. Research shows that Chinese medicine can effectively slow down the proliferation of breast cancer cells by regulating the Wnt/β-catenin signaling pathway， and has a significant inhibitory effect on the development of breast cancer. Based on this， this paper summarized domestic and foreign relevant studies on the regulation of the Wnt/β-catenin signaling pathway with traditional Chinese medicine in the treatment of breast cancer， analyzed the mechanism of traditional Chinese medicine treating breast cancer by intervening in this signaling pathway， and summarized 44 different types of traditional Chinese medicine monomers， including terpenes （triptolide， andrographolide， etc.）， flavonoids （scutellarin， sinensetin， etc.）， polysaccharides （Angelica sinensis polysaccharides， etc.）， phenols （curcumin， polydatin， etc.）， and alkaloids （lycorine， etc.）. In addition， there are 3 traditional Chinese medicines （Ganoderma lucidum， Radix actinidia chinensis， and Antrodia camphorata）， 1 group of medicine pairs （Trionycis Carapax-Zedoary Turmeric）， and 8 traditional Chinese medicine formulas （Compound Tubeimu， Huangqi Jiedu Tang， Xihuang Wan， Liuwei Dihuang Wan， Jiazhu Tang， Aiduqing Fang， Sini San， and compound Kushen injection）. By regulating the Wnt/β-catenin signaling pathway and its key molecules， these single herbs， monomers， and compound herbs can reverse the epithelial mesenchymal transformation process， reduce the activity of stem cells， and inhibit the growth and metastasis of cancer cells. Besides， it can also enhance the sensitivity of drugs and radiotherapy and combat breast cancer， providing a new perspective for drug development and treatment strategies for breast cancer.

Prostate cancer is a malignant tumor that primarily arises from the epithelial tissue of the prostate in men. With the aggravation of population aging in China， the incidence rate of this disease has been continuously rising. Although the exact cause of prostate cancer remains unclear， it has been proven to be closely related to various factors， including individual genetic susceptibility， genetic mutations， dietary habits， and lifestyle. Research has shown that abnormal activation of the Wnt/β-catenin signaling pathway also plays an important role in the occurrence and development of prostate cancer. Multiple experimental results have revealed that traditional Chinese medicine （TCM）， with its multi-target and multi-stage mechanisms of action， exerts significant regulatory effects on key biological processes such as proliferation， migration， invasion， angiogenesis， and epithelial-mesenchymal transition （EMT） of prostate cancer cells. TCM has shown excellent potential in preventing prostate cancer progression and improving patient prognosis and has become a research focus in prostate cancer treatment in recent years. Based on this， this study reviewed the research on the regulation of the Wnt/β-catenin signaling pathway by TCM in the treatment of prostate cancer at home and abroad. It analyzed the mechanisms by which TCM intervention exerts anti-prostate cancer effects via this signaling pathway， identifying 29 different types of active ingredients in TCM， including alkaloids （e.g.， capsaicin， berberine）， flavonoids （e.g.， icariin and hyperoside）， polyphenols （e.g.， gastrodin and honokiol）， terpenes （e.g.， oridonin）， quinones （e.g.， aloe-emodin）， coumarins （e.g.， agrimonolide）， and saponins （e.g.， saikosaponin-d）. Additionally， one TCM medicinal substance （arsenic）， one drug pair （Danggui - Qieyi combination）， and two TCM formulae （Yishen Tonglong Tang and Guben Qingyuan Formula） were included. The study aims to deepen the understanding of the pathological mechanism of prostate cancer and to explore possible therapeutic targets， thereby providing new perspectives and approaches for clinical research and new drug development， and ultimately promoting the advancement and innovation of prostate cancer treatment strategies.

Prostate cancer is a malignant tumor that primarily arises from the epithelial tissue of the prostate in men. With the aggravation of population aging in China， the incidence rate of this disease has been continuously rising. Although the exact cause of prostate cancer remains unclear， it has been proven to be closely related to various factors， including individual genetic susceptibility， genetic mutations， dietary habits， and lifestyle. Research has shown that abnormal activation of the Wnt/β-catenin signaling pathway also plays an important role in the occurrence and development of prostate cancer. Multiple experimental results have revealed that traditional Chinese medicine （TCM）， with its multi-target and multi-stage mechanisms of action， exerts significant regulatory effects on key biological processes such as proliferation， migration， invasion， angiogenesis， and epithelial-mesenchymal transition （EMT） of prostate cancer cells. TCM has shown excellent potential in preventing prostate cancer progression and improving patient prognosis and has become a research focus in prostate cancer treatment in recent years. Based on this， this study reviewed the research on the regulation of the Wnt/β-catenin signaling pathway by TCM in the treatment of prostate cancer at home and abroad. It analyzed the mechanisms by which TCM intervention exerts anti-prostate cancer effects via this signaling pathway， identifying 29 different types of active ingredients in TCM， including alkaloids （e.g.， capsaicin， berberine）， flavonoids （e.g.， icariin and hyperoside）， polyphenols （e.g.， gastrodin and honokiol）， terpenes （e.g.， oridonin）， quinones （e.g.， aloe-emodin）， coumarins （e.g.， agrimonolide）， and saponins （e.g.， saikosaponin-d）. Additionally， one TCM medicinal substance （arsenic）， one drug pair （Danggui - Qieyi combination）， and two TCM formulae （Yishen Tonglong Tang and Guben Qingyuan Formula） were included. The study aims to deepen the understanding of the pathological mechanism of prostate cancer and to explore possible therapeutic targets， thereby providing new perspectives and approaches for clinical research and new drug development， and ultimately promoting the advancement and innovation of prostate cancer treatment strategies.

Objective To explore a standardized approach for indicating dosages in Chinese patent medicines(CPM)instructions.Methods A review of 1 378 classic formulas of traditional Chinese medicine in the 2020 edition of the Pharmaco-poeia of the People's Republic of China(Chinese Pharmacopoeia)was conducted,focusing on three aspects:overdose,different dosage forms,and inclusion of toxic herbs.Approximately 50 representative formulas were selected,and their daily dosage of herbal pieces and the corresponding dosage of individual herbs were calculated.These results were then compared and analyzed against the dosages stipulated in the Chinese Pharmacopoeia.Results ①Overdose:Among the 1 378 reviewed formulas,146(10.60％)were found to involve overdose.Specifically,eight formulas were identified as having an overdose of approximately 3 to 5 times the recommended dose,including Duanxueliu tablets and Zhixue Fumai mixture.②Dosage variations across dosage forms:Based on the conversion of the Ming-Qing dynasty dosage of one liang(Chinese traditional weight unit)to 36 g,the estimated dai-ly dose per component of crude herbs in Yinqiao powder was close to the upper limit specified in the Chinese Pharmacopoeia.The total daily dose of crude herbs(75.60 g)was approximately five times that of the Yinqiao powder(15 g)listed in the Chinese Pharmacopoeia and three times that of the Japanese Kampo Yinqiao powder(23.868 g).Significant differences in dosage were ob-served among Yinqiao Jiedu preparations of different dosage forms.In terms of total daily dose of crude herbs,granules(52.50 g)had the highest dose,approximately 3-5 times that of tablets/capsules(11.20 g),soft capsules(13.44 g),and powders(15.00 g),but still 30％ lower than the original prescription from ancient texts(75.6 g).Comparing the daily dose per compo-nent,granules fell within the Chinese Pharmacopoeia dose range,while tablets,capsules,soft capsules,and powders were all below the Chinese Pharmacopoeia dose.③Inclusion of toxic herbs:Among the 20 oral formulations containing Strychnos nux-vomica(Maqianzi)listed in the Chinese Pharmacopoeia,seven species exceeded the pharmacopoeial dose of 0.3-0.6 g per day.Notably,Shenjin Huoluo pill and Shufeng Dingtong pill exceeded the Chinese Pharmacopoeia dose by 1.5-2 times.The daily dose of strych-nosine in Shenjin Huoluo pill was 21.3 mg,exceeding the toxic dose range of 5-10 mg.Conclusions The dosage indications in CPM instructions must adhere to a unified format,clearly stating the daily dose per component of crude herbs,the total daily dose of crude herbs,and the total number of administrations under the"Dosage and Administration"section.For instance,"Yinqiao Jiedu granules,with a total daily dose equivalent to 60 g of crude herbs taken in four doses(including:Flos Lonicerae 10.71 g,Fructus Forsythiae 10.71 g,Radix Platycodi 6.43 g,Herba Menthae Haplocalycis 6.43 g,Fructus Arctii 6.43 g,Semen Sojae Preparatum 5.36 g,Radix Glycyrrhizae 5.36 g,Herba Lophatheri 4.29 g,Herba Schizonepetae 4.29 g)."For CPM containing tox-ic herbs,dosage indications are even more crucial,such as specifying the daily dose of Maqianzi powder/processed Maqianzi and strychnosine in formulations containing this herb.

Objective To explore the risk factors for healthcare-associated infection(HAI)in lung transplant re-cipients(LTRs),and construct a predictive nomogram model.Methods Clinical data of patients who underwent lung transplant in Wuxi People's Hospital from January 2019 to December 2023 were analyzed retrospectively.The patients were divided into a training set(n=506)and a validation set(n=218).Independent risk factors were screened through LASSO regression,and multivariate logistic regression was included to construct a nomogram pre-diction model.The discrimination,calibration,and clinical applicability of the model were evaluated using receiver operating characteristic(ROC)curves,Hosmer-Lemeshow goodness-of-fit,and decision curves.Results Among the 506 LTRs,201 developed HAIs,with an incidence of 39.72％.The major infection site was lower respiratory tract,and the major pathogen were Gram-negative bacilli(Acinetobacter baumannii).Older age,use of extracorpo-real membrane oxygenation(ECMO),double-lung transplant,surgery duration＞3 hours,long duration of contin-uous fever,frequent abnormal blood routine examination,and long duration of combined use of antimicrobial agents were identified as independent risk factors for HAI after lung transplant.The ROC curve analysis results showed that the areas under the curve(AUCs)of the training set and the validation set were 0.74(95％CI:0.70-0.78)and 0.71(95％CI:0.64-0.78),respectively.The Hosmer-Lemeshow test results showed that there was no sta-tistically significant difference between the predictive and actual probability of HAI(P＞0.05).The clinical decision curve results indicated that the model had clinical benefits at a threshold probability value of 7％-71％.Conclusion The nomogram prediction model constructed in this study can effectively evaluate the risk of postoperative infection in LTRs.The model is stable and has high clinical application value,providing scientific reference for postoperative infection prevention and control.

Objective:To analyze the clinical characteristics of immune checkpoint inhibitor (ICI)-induced type 1 diabetes (T1D).Methods:This was a retrospective case series study of clinical data from 24 patients with ICI-T1D admitted to People′s Hospital of Henan Provincial between January 2018 and December 2024. The data collected included demographic characteristics, ICI usage, clinical manifestations, laboratory test results, and clinical outcome. Patients were categorized into mild and severe groups based on disease severity. Clinical characteristics between the two groups were compared using the Mann-Whitney U test. Results:Of the 24 patients, 21 (87.5%) were male and 3 (12.5%) were female, with an average age of (62.0±10.6) years. Patients in the severe disease group were significantly older than those in the mild disease group [(68.0±9.5) years vs. (58.4±9.8) years, P<0.05]. Compared to patients with mild disease, those with severe disease had significantly higher rates of impaired consciousness (9/9 vs.2/15), shorter ICI treatment cycles [3 (2, 6) vs. 6 (5, 8)], shorter time from ICI initiation to diabetes diagnosis [68 (31, 168) d vs. 162 (135, 235) d], and shorter time from the onset of diabetes symptoms to medical consultation [4 (2, 5) d vs. 8 (4, 26) d] (all P<0.05). The severe disease group also showed significantly higher blood glucose levels [43.0 (39.1, 57.3) mmol/L vs. 24.6 (19.6, 29.6) mmol/L] and a lower glycated hemoglobin level [6.8% (6.3%, 7.6%) vs. 7.9% (7.6%, 8.6%)], along with a higher incidence of fulminant T1D (8/9 vs. 2/15, all P<0.05). All patients received insulin injection therapy. After discharge, fasting C-peptide levels in 3 patients with mild disease showed a transient increase to 0.26, 0.43, 0.49 nmol/L but declined again after six months. Conclusions:ICI-T1D is characterized by acute onset and rapid progression. Older patients are more likely to develop severe disease. All patients require insulin therapy.

Objective:To investigate the effect and mechanism of Jianpi Qinghua granule in improving skeletal muscle insulin resistance induced by long-term low-dose cadmium exposure in rats.Methods:A total of 24 SPF-grade healthy 2-month-old Sprague-Dawley rats were assigned to normal control(NC) group, cadmium exposure(Cd) group, and Jianpi Qinghua granule protection(Cd+ JPQHG) group. After 24 weeks, fasting blood glucose and insulin levels were measured, and HOMA-IR was calculated. The intraperitoneal glucose tolerance test and insulin tolerance test were conducted to assess insulin sensitivity. Skeletal muscle tissues were extracted for Western blot analysis to detect levels of insulin signaling pathway-related proteins. Immunofluorescence was used to assess the translocation of glucose transporter 4(GLUT4), and oxidative stress markers were measured.Results:Compared to the NC group, the Cd group showed significant increases in fasting plasma glucose, fasting insulin levels, and HOMA-IR after 24-week exposure. Abnormal glucose and insulin tolerance were also observed in the Cd group. The 12-week intervention with Jianpi Qinghua granule significantly improved glucose metabolism and alleviated the abnormalities in glucose and insulin tolerance. Western blot results indicated that the phosphorylation levels of PI3K and Akt in the skeletal muscle of the Cd group were significantly reduced compared to the NC group, while these levels were significantly elevated in the Cd+ JPQHG group, along with increased translocation of GLUT4 to the cell membrane. Additionally, cadmium exposure significantly increased H 2O 2 and malondialdehyde levels while decreased antioxidant enzyme activity. These oxidative stress indicators improved significantly after Jianpi Qinghua granule intervention( P<0.05). Conclusion:Jianpi Qinghua granule may improve skeletal muscle insulin resistance and glucose metabolism disorders due to long-term low-dose cadmium exposure by reducing oxidative stress, regulating the phosphorylation levels of key proteins in the insulin signaling pathway, and promoting GLUT4 translocation to the cell membrane.

Objective:To analyze the clinical characteristics of immune checkpoint inhibitor (ICI)-induced type 1 diabetes (T1D).Methods:This was a retrospective case series study of clinical data from 24 patients with ICI-T1D admitted to People′s Hospital of Henan Provincial between January 2018 and December 2024. The data collected included demographic characteristics, ICI usage, clinical manifestations, laboratory test results, and clinical outcome. Patients were categorized into mild and severe groups based on disease severity. Clinical characteristics between the two groups were compared using the Mann-Whitney U test. Results:Of the 24 patients, 21 (87.5%) were male and 3 (12.5%) were female, with an average age of (62.0±10.6) years. Patients in the severe disease group were significantly older than those in the mild disease group [(68.0±9.5) years vs. (58.4±9.8) years, P<0.05]. Compared to patients with mild disease, those with severe disease had significantly higher rates of impaired consciousness (9/9 vs.2/15), shorter ICI treatment cycles [3 (2, 6) vs. 6 (5, 8)], shorter time from ICI initiation to diabetes diagnosis [68 (31, 168) d vs. 162 (135, 235) d], and shorter time from the onset of diabetes symptoms to medical consultation [4 (2, 5) d vs. 8 (4, 26) d] (all P<0.05). The severe disease group also showed significantly higher blood glucose levels [43.0 (39.1, 57.3) mmol/L vs. 24.6 (19.6, 29.6) mmol/L] and a lower glycated hemoglobin level [6.8% (6.3%, 7.6%) vs. 7.9% (7.6%, 8.6%)], along with a higher incidence of fulminant T1D (8/9 vs. 2/15, all P<0.05). All patients received insulin injection therapy. After discharge, fasting C-peptide levels in 3 patients with mild disease showed a transient increase to 0.26, 0.43, 0.49 nmol/L but declined again after six months. Conclusions:ICI-T1D is characterized by acute onset and rapid progression. Older patients are more likely to develop severe disease. All patients require insulin therapy.