This paper summarizes Professor WANG Yaoxian's experience in treating diabetic kidney disease （DKD） from the perspective of spleen and stomach based on the "internal heat leading to concretions" theory. It is considered that internal heat leading to concretions constitutes the core pathogenesis of DKD， with the spleen and stomach serving as the source of internal heat； therefore， treatment should be based on regulating the spleen and stomach. In the early stage of DKD， dysfunction of the spleen and stomach leads to the initial generation of internal heat. Common syndrome patterns include gastrointestinal heat accumulation and constrained heat in the liver and stomach， for which modified Gegen Qinlian Decoction （葛根芩连汤） can be used to clear heat bind while modified Dachaihu Decoction （大柴胡汤） is used to clear stomach and soothe liver， respectively. In the middle stage of DKD， weakness of the spleen and stomach results in the initial formation of concretions and conglomerations. Common patterns include spleen deficiency with prevalence of dampness and deficiency of both the spleen and kidney. Treatment emphasizes strengthening the spleen and resolving dampness， raising yang and boosting the stomach with modified Shengyang Yiwei Decoction （升阳益胃汤）， or supplementing spleen and boosting kidney， dissipating bind and dispe-ring concretions with modified Shenqi Dihuang Decoction （参芪地黄汤）， respectively. In the late stage of DKD， it is characterized by spleen and stomach depletion， and rampant accumulation of turbidity and toxin， and the common syndrome patterns are damp-turbidity obstruction in the middle jiao （焦） and spleen-kidney yang deficiency. Treatment aims to remove turbidity and harmonize the stomach， or to warm the kidney and strengthen the spleen while elimina-ting turbidity， using modified Dahuang Gancao Decoction（大黄甘草汤） and Jupi Zhuru Decoction （橘皮竹茹汤） or modified Baoyuan Decoction （保元汤） and Lizhong Decoction （理中汤）， respectively. In clinical practice， appropriate formulas and medications are flexibly selected according to specific syndromes.

Objective:To explore the value of serum soluble E-cadherin (sEC) and cyclooxygenase-2 (COX-2) levels in predicting postoperative recurrence and metastasis of breast cancer.Methods:198 female breast cancer patients who underwent surgical treatment in Huai’an Hospital Affiliated to Xuzhou Medical University (Huai’an Second People’s Hospital) From Mar. 2023 to Mar. 2025 were selected and followed up for 3 years. The recurrence and metastasis were counted. Patients with recurrence and metastasis were included in the poor prognosis group, and patients without recurrence and metastasis were included in the good prognosis group. The general data, preoperative serum sEC and COX-2 levels were compared between the two groups. The influencing factors of recurrence and metastasis of breast cancer after operation were analyzed. The dose-response relationship and predictive value of serum sEC and COX-2 levels with recurrence and metastasis were analyzed. Logistic regression equation (LR) model 1 was constructed according to conventional influencing factors, and LR model 2 was constructed according to conventional influencing factors combined with serum sEC and COX-2. The predictive efficacy and accuracy of the two models were analyzed by receiver operating characteristic curve (ROC) and calibration curve. According to the ratio of 7∶3, another 85 female breast cancer patients who underwent surgical treatment in Huai’an Hospital Affiliated to Xuzhou Medical University (Huai’an Second People’s Hospital) from May. 2023 to May. 2025 were selected for external validation (validation set) .Results:Among 198 breast cancer patients who underwent postoperative follow-up for 3 years, 3 cases were lost to follow-up, and the recurrence and metastasis rate among the 195 patients who completed the 3-year postoperative follow-up was 26.15% (51/195). In the good prognosis group, the proportion of TNM stage III was 20.14%, the proportion of lymph node metastasis was 11.81%, the preoperative serum carbohydrate antigen 153 (CA153) level was (54.19±10.84) U/mL, the carbohydrate antigen 125 (CA125) level was (46.03±10.27) U/mL, the sEC level was (1987.65±191.37) ng/mL, and the COX-2 level was (17.85±5.21) ng/mL. In the poor prognosis group, the proportion of TNM stage III was 45.10%, the proportion of lymph node metastasis was 35.29%, the preoperative serum CA153 level was (65.87±12.23) U/mL, the CA125 level was (57.76±11.51) U/mL, the sEC level was (2 295.37±261.48) ng/mL, and the COX-2 level was (10.42±3.16) ng/mL. Compared with the good prognosis group, they were increased ( t/χ 2=12.00, 14.11, 6.39, 6.79, 8.92, 12.00, P<0.05). Multivariate Logistic regression analysis showed that TNM stage III ( OR=2.078, 95%CI =1.569-2.751, P<0.05), lymph node metastasis ( OR=2.435, 95 %CI=1.843-3.216, P<0.05), serum CA153 ( OR= 1.180,95 %CI=1.026-1.357, P<0.05), CA125 ( OR=1.206,95 %CI=1.033-1.408, P<0.05), sEC ( OR=1.011,95 %CI= 1.007-1.015, P<0.05), COX-2 ( OR=1.378,95 %CI=1.128-1.683, P<0.05) were independent risk factors for postoperative recurrence and metastasis of breast cancer. Restricted cubic spline (RCS) analysis showed that serum sEC and COX-2 levels were positively correlated with the risk of recurrence and metastasis of breast cancer ( P<0.05). ROC analysis showed that serum sEC (AUC=0.762,95 %CI=0.696-0.820, P<0.05) and COX-2 (AUC=0.757,95 %CI=0.691-0.815, P<0.05) could be used as biological indicators to predict postoperative recurrence and metastasis of breast cancer. The AUC of LR model 1 in predicting postoperative recurrence and metastasis of breast cancer was 0.862 (95 %CI=0.805-0.907, P<0.05). The AUC of LR model 2 in predicting postoperative recurrence and metastasis of breast cancer was 0.965 (95 %CI= 0.891-0.983, P<0.05), which was significantly larger than that of LR model 1 ( Z=2.015, P<0.05). The calibration curve analysis showed that the calibration degree of LR model 1 in predicting postoperative recurrence and metastasis of breast cancer was good, and the prediction results were in good agreement with the actual observation results. The calibration degree of LR model 2 was high, and the prediction results were in good agreement with the actual observation results. The results of external validation showed that the sensitivity of LR model 2 in predicting postoperative recurrence and metastasis of breast cancer was 82.61%, the specificity was 93.55%, the accuracy was 90.59%, and the Kappa value was 0.762 (95 %CI: 0.549-0.974) . Conclusions:Preoperative serum sEC and COX-2 levels are independent risk factors for postoperative recurrence and metastasis of breast cancer. They can be used as biological indicators to predict postoperative recurrence and metastasis of breast cancer. Combined with conventional indicators, they can significantly improve the predictive efficacy.

Objective:To explore the value of serum soluble E-cadherin (sEC) and cyclooxygenase-2 (COX-2) levels in predicting postoperative recurrence and metastasis of breast cancer.Methods:198 female breast cancer patients who underwent surgical treatment in Huai’an Hospital Affiliated to Xuzhou Medical University (Huai’an Second People’s Hospital) From Mar. 2023 to Mar. 2025 were selected and followed up for 3 years. The recurrence and metastasis were counted. Patients with recurrence and metastasis were included in the poor prognosis group, and patients without recurrence and metastasis were included in the good prognosis group. The general data, preoperative serum sEC and COX-2 levels were compared between the two groups. The influencing factors of recurrence and metastasis of breast cancer after operation were analyzed. The dose-response relationship and predictive value of serum sEC and COX-2 levels with recurrence and metastasis were analyzed. Logistic regression equation (LR) model 1 was constructed according to conventional influencing factors, and LR model 2 was constructed according to conventional influencing factors combined with serum sEC and COX-2. The predictive efficacy and accuracy of the two models were analyzed by receiver operating characteristic curve (ROC) and calibration curve. According to the ratio of 7∶3, another 85 female breast cancer patients who underwent surgical treatment in Huai’an Hospital Affiliated to Xuzhou Medical University (Huai’an Second People’s Hospital) from May. 2023 to May. 2025 were selected for external validation (validation set) .Results:Among 198 breast cancer patients who underwent postoperative follow-up for 3 years, 3 cases were lost to follow-up, and the recurrence and metastasis rate among the 195 patients who completed the 3-year postoperative follow-up was 26.15% (51/195). In the good prognosis group, the proportion of TNM stage III was 20.14%, the proportion of lymph node metastasis was 11.81%, the preoperative serum carbohydrate antigen 153 (CA153) level was (54.19±10.84) U/mL, the carbohydrate antigen 125 (CA125) level was (46.03±10.27) U/mL, the sEC level was (1987.65±191.37) ng/mL, and the COX-2 level was (17.85±5.21) ng/mL. In the poor prognosis group, the proportion of TNM stage III was 45.10%, the proportion of lymph node metastasis was 35.29%, the preoperative serum CA153 level was (65.87±12.23) U/mL, the CA125 level was (57.76±11.51) U/mL, the sEC level was (2 295.37±261.48) ng/mL, and the COX-2 level was (10.42±3.16) ng/mL. Compared with the good prognosis group, they were increased ( t/χ 2=12.00, 14.11, 6.39, 6.79, 8.92, 12.00, P<0.05). Multivariate Logistic regression analysis showed that TNM stage III ( OR=2.078, 95%CI =1.569-2.751, P<0.05), lymph node metastasis ( OR=2.435, 95 %CI=1.843-3.216, P<0.05), serum CA153 ( OR= 1.180,95 %CI=1.026-1.357, P<0.05), CA125 ( OR=1.206,95 %CI=1.033-1.408, P<0.05), sEC ( OR=1.011,95 %CI= 1.007-1.015, P<0.05), COX-2 ( OR=1.378,95 %CI=1.128-1.683, P<0.05) were independent risk factors for postoperative recurrence and metastasis of breast cancer. Restricted cubic spline (RCS) analysis showed that serum sEC and COX-2 levels were positively correlated with the risk of recurrence and metastasis of breast cancer ( P<0.05). ROC analysis showed that serum sEC (AUC=0.762,95 %CI=0.696-0.820, P<0.05) and COX-2 (AUC=0.757,95 %CI=0.691-0.815, P<0.05) could be used as biological indicators to predict postoperative recurrence and metastasis of breast cancer. The AUC of LR model 1 in predicting postoperative recurrence and metastasis of breast cancer was 0.862 (95 %CI=0.805-0.907, P<0.05). The AUC of LR model 2 in predicting postoperative recurrence and metastasis of breast cancer was 0.965 (95 %CI= 0.891-0.983, P<0.05), which was significantly larger than that of LR model 1 ( Z=2.015, P<0.05). The calibration curve analysis showed that the calibration degree of LR model 1 in predicting postoperative recurrence and metastasis of breast cancer was good, and the prediction results were in good agreement with the actual observation results. The calibration degree of LR model 2 was high, and the prediction results were in good agreement with the actual observation results. The results of external validation showed that the sensitivity of LR model 2 in predicting postoperative recurrence and metastasis of breast cancer was 82.61%, the specificity was 93.55%, the accuracy was 90.59%, and the Kappa value was 0.762 (95 %CI: 0.549-0.974) . Conclusions:Preoperative serum sEC and COX-2 levels are independent risk factors for postoperative recurrence and metastasis of breast cancer. They can be used as biological indicators to predict postoperative recurrence and metastasis of breast cancer. Combined with conventional indicators, they can significantly improve the predictive efficacy.

Objective To analyze the correlation between serum cystatin C (Cys-C) and bone turnover markers in elderly patients with type 2 diabetes mellitus (T2DM) and osteoporosis. Methods A retrospective analysis was conducted on the data of 320 elderly patients with T2DM admitted to Huai'an First People's Hospital from August 2021 to June 2024. Patients were divided into the osteoporosis group and the non-osteoporosis group according to whether they had osteoporosis. General information, bone turnover markers, and serum Cys-C levels were collected from all patients. The data were compared between the two groups to analyze the influencing factors of osteoporosis in elderly patients with T2DM and the correlation between serum Cys-C and bone turnover markers. Results The levels of total cholesterol and LDL-C in the osteoporosis group were higher than those in the non-osteoporosis group, and the bone mineral density was lower than that in the non-osteoporosis group (P<0.05). The levels of TPINP, β-CTX, and Cys-C in the osteoporosis group were higher than those in the non-osteoporosis group, and 25-OH-D3 level was lower than that in the non-osteoporosis group (P<0.05). Serum Cys-C was positively correlated with TPINP and β-CTX, and negatively correlated with 25-OH-D₃ (P<0.05). Multivariate logistic regression analysis found that total cholesterol, LDL-C, TPINP, β-CTX, 25-OH-D₃, and Cys-C were factors influencing osteoporosis in elderly patients with T2DM (P<0.05). Conclusion Serum Cys-C levels in elderly patients with T2DM and osteoporosis are elevated. There is a significant correlation between Cys-C level and bone turnover markers.

ObjectiveTo explore the possible mechanism of Yigan Fupi Prescription （抑肝扶脾方， YFP） in treating diarrhea-type irritable bowel syndrome （IBS-D） by investigating the AKT/mTOR signaling pathway. MethodsSixty SD rats were randomly divided into control group， model group， YFP low-， medium-， and high-dose group， and pinaverium bromide group， with 10 rats in each group. All groups but the control group， were subjected to 21 days of tail-clamping stimulation and 14 days of senna leaf gavage to establish a liver stagnation and spleen deficiency-type IBS-D rat model. After successful modeling， the YFP low-， medium-， and high-dose group were administered 0.96， 1.93， and 3.87 g/（kg·d） of the prescription， respectively. The pinaverium bromide group was given 13.5 mg/（kg·d）， while the control and model groups were given 10 ml/（kg·d） distilled water. All groups were administered once daily for 14 consecutive days. General conditions of the rats were recorded during the experiment， and after modeling and drug administration， body weight， Bristol stool score， abdominal withdrawal reflex （AWR） score， and histo pathology of colon tissue were observed under HE staining. ELISA was used to detect serum levels of tumor necrosis factor α （TNF-α）， interleukin-1β （IL-1β）， and interleukin-6 （IL-6）. Immunofluorescence was employed to detect the levels of AKT/mTOR pathway-related proteins including phosphorylated AKT （p-AKT）/AKT and phosphorylated mTOR （p-mTOR）/mTOR in the colon tissue. Western Blotting was used to detect the levels of autophagy-related proteins， including UNC-51-like kinase 1 （ULK1）， Beclin1 and LC3， and tight junction proteins including Occludin and ZO-1 in the colon tissue. ResultsAfter modeling， compared to the control group， the body weight of rats in the other groups decreased， and Bristol stool scores， as well as AWR scores under 20， 40， 60， and 80 mmHg increased （P＜0.05 or P＜0.01）. After drug administration， compared to the control group， the model group showed reduced body weight， decreased ULK1， Beclin1， LC3Ⅱ/LC3Ⅰ， Occludin， and ZO-1 protein levels in the colon tissue （P＜0.05 or P＜0.01）， and increased Bristol stool scores， AWR scores， serum TNF-α， IL-1β， and IL-6 levels， as well as p-AKT/AKT and p-mTOR/mTOR protein relative expression levels （P＜0.05 or P＜0.01）. Pathological results showed a significant reduction in goblet cells in the upper part of the glandular layer of the colon， with mild inflammatory cell infiltration. The submucosal collagen fibers were dissolved， with unclear boundaries， pale staining， and microvascular congestion and dilation. Compared with the model group， the YFP low-， medium-， and high-dose group and the pinaverium bromide group showed increased body weight， Beclin1， Occludin， and LC3Ⅱ/LC3Ⅰ protein levels （P＜0.05 or P＜0.01）， and decreased Bristol stool scores， AWR scores under 40， 60， and 80 mmHg， serum IL-1β， IL-6， TNF-α levels， and p-AKT/AKT， p-mTOR/mTOR protein relative expression levels （P＜0.05 or P＜0.01）. The pathological morphology of the rats in the YFP groups and pinaverium bromide group showed varying degrees of improvement. Compared with the pinaverium bromide group， the YFP low- and medium-dose group showed increased AWR scores under 20， 40， and 60 mmHg （P＜0.05）. The YFP low-dose group had reduced TNF-α， IL-1β， and IL-6 levels， and increased p-mTOR/mTOR protein relative expression levels occured in all YFP groups （P＜0.05）. Compared with the YFP low-dose group， the YFP high-dose group and pinaverium bromide group showed decreased AWR scores under different pressure levels and reduced p-AKT/AKT protein relative expression levels， while the YFP medium- and high-dose group had elevated serum TNF-α， IL-1β levels and reduced p-mTOR/mTOR protein relative expression levels （P＜0.05）. ConclusionYFP can effectively improve the pathological injury of colon tissue in IBS-D model rats with liver stagnation and spleen deficiency， reduce Bristol stool and AWR scores， and its mechanism may be related to reducing level of inflammatory factors and inhibiting AKT/mTOR pathway-related proteins in colon tissue， thereby enhancing the expression of autophagy-related proteins in the colon tissue.

The Huangdi Neijing proposes the " using bitter herbs to nourish or purge" theory to guide clinical prescription and formulation of herbal remedies based on the physiological characteristics and functions of the five zang viscera, along with the properties and flavors of medicinal herbs. This study explored diabetic kidney disease pathogenesis and treatment based on the " using bitter herbs to nourish or purge" theory. Kidney dryness is a key pathological factor in diabetic kidney disease, and the disharmony of kidney dryness is an essential aspect of its pathogenesis. Strengthening is the primary therapeutic principle, and kidney dryness is a persistent factor throughout the occurrence and progression of diabetic kidney disease. In the early stage, the pathogenesis involves heat-consuming qi and injuring yin, leading to kidney dryness. In the middle stage, the pathogenesis manifests as qi deficiency and blood stasis in the collaterals, resulting in turbidity owing to kidney dryness. In the late stage, the pathogenesis involves yin and yang deficiency, with kidney dryness and disharmony. This study proposes the staging-based treatment based on the " need for firmness" characteristic of the kidney. The aim is to provide new insights for clinical diagnosis and treatment in traditional Chinese medicine by rationally using pungent, bitter, and salty medicinal herbs to nourish and moisturize the kidney. This approach seeks to promote precise syndrome differentiation and personalized treatment for different stages of diabetic kidney disease, thereby enhancing clinical efficacy.

Fatigue driving is one of the leading causes of traffic accidents, posing a significant threat to drivers and road safety. Most existing methods focus on studying whole-brain multi-channel electroencephalogram (EEG) signals, which involve a large number of channels, complex data processing, and cumbersome wearable devices. To address this issue, this paper proposes a fatigue detection method based on frontal EEG signals and constructs a fatigue driving detection model using an asymptotic hierarchical fusion network. The model employed a hierarchical fusion strategy, integrating an attention mechanism module into the multi-level convolutional module. By utilizing both cross-attention and self-attention mechanisms, it effectively fused the hierarchical semantic features of power spectral density (PSD) and differential entropy (DE), enhancing the learning of feature dependencies and interactions. Experimental validation was conducted on the public SEED-VIG dataset. The proposed model achieved an accuracy of 89.80% using only four frontal EEG channels. Comparative experiments with existing methods demonstrate that the proposed model achieves high accuracy and superior practicality, providing valuable technical support for fatigue driving monitoring and prevention.
Humans ; Electroencephalography/methods* ; Automobile Driving ; Fatigue/diagnosis* ; Accidents, Traffic/prevention & control* ; Signal Processing, Computer-Assisted ; Neural Networks, Computer ; Algorithms ; Prefrontal Cortex/physiology*

Objective:To investigate the impact of ginseng alcohol extract(GEE)on improving sleep quality in the aged Drosophila model by regulating the redox balance,and to elucidate its associated mechanism.Methods:Thirty-two male drosophila melanogaster(7-days-old)were randomly selected as young group,while 64 male Drosophila melanogaster flies(35-days-old)were randomly assigned to aged model group(n=32)and GEE group(n=32).The sleep parameters,including total sleep duration,daytime sleep duration,night sleep duration,0-4 h of sleep duration after lights off(ZT0-4 sleep duration),deep sleep duration,sleep episodetimes,sleep fragmentation,and the activity parameters such as the total number of locomotor activity daytime locomotor activity amount and nighttime locomotor activity amount were analyzed using the DAM2 Drosophila behavioral analysis system 7 d after administration.The grouping of the drosophila was as above,and there were 100 drosophila ineach group.The differentially expressed proteins in drosophila brain tissue were screened,identified,and functionally analyzed using two-dimensional fluorescence difference gel electrophoresis(2D-DIGE)and matrix-assisted laser desorption/ionization time of flight mass spectrometry(MALDI-TOF/TOF-MS)proteomic methods.The grouping of the drosophila was as above,and there were 100 drosophila in each group.The activities of superoxide dismutase(SOD),catalase(CAT),and glutathione peroxidase(GSH-Px)and the levels of lipid peroxidation product(MDA)in brain tissue of the drosophila were determined using assay kits.Results:Compared with young group,the total sleep duration daytime sleep duration and night sleep cluration of the drosophila in agaed group were decreased(P<0.05 or P<0.01);and the sleep rhythm amplitude was shortened.Compared with aged group,the total sleep duration and daytime and nighttime sleep durations of the drosphila in GEE group were lengthened(P<0.01).Compared with young group,the ZT0-4 sleep duration deep sleep duration and sleep fragment of the drosophila in aged group were decreased(P<0.05 or P<0.01),and the sleep rhythm amplitude was shortened.Compared with young group,the ZT0-4 sleep duration,deep sleep duration,and single sleep fragment of the drosphila in GEE group were significantly prolonged(P<0.01),and the sleep amplitude was increased.Compared with young group,there was no significant difference in diurnal spontaneous activity or total spontaneous activity of the drosophila in aged group(P>0.05),while the nocturnal spontaneous activity was significantly increased(P<0.05).Compared with aged group,the diurnal spontaneous activity,nocturnal spontaneous activity,and total spontaneous activity of the drosophila in GEE group were significantly decreased(P<0.05 or P<0.01).A total of 47 differentially expressed proteins were selected in the 2D-DIGE electrophoretic mapping.Compared with young group,the expressions of 47 differentially expressed protein sites in aged group were down-regulated mainly including glutathione S-transferase,peroxiredoxin 1 and dihydrolipoic dehydrogenase,which were related to redox balance.Compared with young group,the activities of SOD,CAT and GSH-Px in brain tissue of the drosophila in aged group were decreased(P<0.05 or P<0.01),and the level of MDA was increased(P<0.01);compared with aged group,the activities of SOD,CAT and GSH-Px in brain tissue of the drosphila in GEE group were increased(P<0.05 or P<0.01),and the MDA level was decreased(P<0.05).Conclusion:GEE has improvement effect on the sleep quality of aged drosophila,and its possible mechanism may be related to upregulating the activities of antioxidant enzymes,inhibiting the accumulation of lipid peroxidation products,and maintaining redox balance.

Objective:To discuss the relationship between three proinflammatory factors and muscle mass(MM)in the elderly patients with sarcopenic obesity and diabetes,and to provide theoretical basis for the development of clinical treatment protocols in the elderly patients with sarcopenic obesity and diabetes.Methods:The elderly patients with diabetes who visited our hospital from January 2021 to May 2023 were selected,including 41 patients with obesity and diabetes(OD group)and 46 patients with sarcopenic obesity and diabetes(SOD group);80 healthy subjects(control group)and 62 subjects with simple obesity(SO group)who underwent physical examination in our hospital during the same period were included.The clinical data of the subjects in four groups were compared,and the correlations between proinflammatory factors and MM and fat mass(FM)were analyzed.All the subjects were divided into sarcopenia group and normal group based on the presence of sarcopenia.Logistic regression model was used to analyze the independent influencing factors of sarcopenia;receiver operating characteristic(ROC)curve was drawn to determine the predictive value of the above factors for sarcopenia.Results:Compared with control group,the body mass index(BMI),FM and body fat percentage(BFP)of the subjects in SOD,OD and SO groups were significantly increased(P＜0.05);compared with control group,OD group and SO group,the appendicular skeletal muscle mass(ASM),appendicular skeletal muscle mass index(ASMI)and grip strength(GS)of the subjects in SOD group were significantly decreased(P＜0.05),and the levels of serum interleukin-6(IL-6),C-reactive protein(CRP)and tumor necrosis factor-α(TNF-α)were significantly increased(P＜0.05).In all the subjects,the IL-6,CRP and TNF-α were negatively correlated with ASMI(r=-0.589,r=-0.621,r=-0.620;P＜0.05),and positively correlated with BFP(r=0.252,r=0.221,r=0.147;P＜0.05).Compared with normal group,the ASM,ASMI and GS of the subjects in sarcopenia group were significantly decreased(P＜0.05),and the levels of serum proinflammatory factors IL-6,CRP and TNF-α were significantly increased(P＜0.05).The univariate Logistic regression analysis results showed that IL-6,CRP and TNF-α were the influencing factors of sarcopenia(P＜0.05).The multivariate Logistic regression analysis results showed that the increased levels of IL-6 and TNF-α were the independent risk factors for sarcopenia(OR＞1,P＜0.05).The ROC curve results showed that the area under the curve(AUC)values of IL-6,CRP and TNF-α were all＞0.700,indicating that the above indicators had good predictive value for sarcopenia.Conclusion:The increased levels of proinflammatory factors IL-6,CRP and TNF-α are associated with the decrease of MM in the elderly patients with sarcopenic obesity and diabetes,and IL-6 and TNF-α are the independent risk factors for the sarcopenia.

BACKGROUND: Chronic kidney disease (CKD)-associated anemia (CKD-anemia) is associated with poor survival, and hemoglobin targets are often not achieved with current therapies. Phase 3 trials have demonstrated the treatment efficacy of roxadustat for CKD-anemia. This phase 4 study aims to evaluate the long-term (52-week) safety and effectiveness of roxadustat in a broad real-world patient population with CKD-anemia with and without dialysis in China. METHODS: This Phase 4 multicenter, open-label, prospective study, conducted from 24 November 2020 to 11 November 2022, evaluated the long-term safety and effectiveness of roxadustat for CKD-anemia in China. Patients aged ≥18 years with CKD-anemia with or without dialysis were included. The initial oral dose was 70-120 mg (weight-based followed by dose adjustment) over 52 weeks. The primary endpoint was safety based on adverse events (AEs). The secondary endpoints were hemoglobin changes from baseline and the proportion of patients who achieved mean hemoglobin ≥100 g/L. Effectiveness evaluable populations 1 (EE1) and EE2 included roxadustat-naïve and previously roxadustat-treated patients, respectively. The safety analysis set (SAF) included all patients who received ≥1 occasion. RESULTS: The EE1, EE2, and SAF populations included 1804, 193, and 2021 patients, respectively. In the SAF, the mean age was 50 ± 14 years, and 1087 patients (53.8%) were male. Mean baseline hemoglobin was 96.9 ± 14.0 g/L in EE1 and 100.3 ± 12.9 g/L in EE2. In EE1, the mean (95% confidence interval) hemoglobin changes from baseline over weeks 24-36 and 36-52 were 14.2 (13.5-14.9) g/L and 14.3 (13.5-15.0) g/L, respectively. Over weeks 24-36 and 36-52, 83.3% and 86.1% of patients in EE1 and 82.7% and 84.7% in EE2 achieved mean hemoglobin ≥100 g/L, respectively. In the SAF, 1643 (81.3%) patients experienced treatment-emergent AEs (TEAEs). Overall, 219 (10.8%) patients experienced drug-related TEAEs. Thirty-eight (1.9%) patients died of TEAEs (unrelated to the study drug). Vascular access thrombosis was uncommon. CONCLUSIONS: Roxadustat (52 weeks) increased hemoglobin and maintained the treatment target in Chinese patients with CKD-anemia with acceptable safety, supporting its use in real-world settings. REGISTRATION Chinese Clinical Trial Registry ( www.chictr.org.cn ) ChiCTR2100046322; CDE ( www.chinadrugtrials.org.cn ) CTR20201568.
Humans ; Male ; Female ; Anemia/etiology* ; Middle Aged ; Renal Insufficiency, Chronic/complications* ; Glycine/adverse effects* ; Isoquinolines/adverse effects* ; Aged ; Prospective Studies ; Adult ; Hemoglobins/metabolism* ; Treatment Outcome ; China ; Registries ; East Asian People