1.Efficacy of Zishen Huoxue Formula in treatment of molecular-targeted therapy-associated proteinuria in patients with primary liver cancer
Jing JING ; Aozhe ZHANG ; Simiao YU ; Xin WANG ; Yongqiang SUN ; Yiling WANG ; Ruixin GAO ; Yinying LU ; Xiaohe XIAO ; Ruilin WANG
Journal of Clinical Hepatology 2026;42(4):874-881
ObjectiveTo investigate the effect of Zishen Huoxue Formula (ZSXHF) on molecular-targeted therapy-associated proteinuria in patients with primary liver cancer (PLC), to assess the efficacy of ZSXHF in the treatment of molecular-targeted therapy-associated proteinuria, and to provide a basis for clinical medication. MethodsA retrospective cohort study was conducted among the PLC patients with molecular-targeted therapy-associated proteinuria who were diagnosed and treated in The Department of Hepatology of Chinese PLA General Hospital, from January 1, 2022 to July 1, 2025. With ZSXHF treatment as the exposure factor, the patients with a cumulative treatment duration of ≥9 weeks were enrolled as traditional Chinese medicine (TCM) group, while those without TCM treatment were enrolled as control group. Propensity score matching was performed for the two groups at a ratio of 1∶1 based on sex, age, 24-hour urinary protein, blood urea nitrogen, and serum creatinine. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test was used for comparison of categorical data between groups. Univariate and multivariate Logistic regression analyses were used to investigate the influencing factors for promoting the improvement of targeted-therapy-associated proteinuria. ResultsA total of 137 PLC patients with targeted-therapy-associated proteinuria were enrolled, with 34 patients in the TCM group and 103 in the control group. After follow-up for 6 months, the TCM group had a significant improvement in urinary protein grade compared with the control group (χ2=9.261, P=0.016). There were 25 patients in each group after propensity score matching, and after follow-up for 6 months, there were significant differences between the two groups in urinary protein grade (χ2=15.689, P<0.001) and 24-hour urinary protein (Z=-3.075, P=0.002). After cumulative treatment with ZSXHF for ≥9 weeks, the TCM group had a significantly greater change in 24-hour urinary protein from baseline compared with the control group (t=-2.514, P=0.016), while there were no significant differences in the changes in liver and renal function after ZSXHF intervention between the two groups (all P>0.05). The multivariate Logistic regression analysis showed that ZSXHF treatment (odds ratio=2.901, 95% confidence interval: 1.135 — 7.417, P=0.026) was an independent influencing factor for improvement in molecular-targeted therapy-associated proteinuria. ConclusionZSHXF can effectively alleviate molecular-targeted therapy-associated proteinuria in PLC patients with a favorable safety profile, which provides a new reference for TCM prevention and treatment of molecular-targeted therapy-associated adverse reactions in PLC patients.
2.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
FAN Yiling ; ZHU Ran ; YANG Yan ; JIANG Bo ; SONG Minghui ; WANG Jing ; LI Qiongqiong ; LI Gaomin ; WANG Shujuan ; SHAO Hong ; MA Shihong ; CAO Xiaoyun ; HU Changqin ; MA Shuangcheng, ; YANG Meicheng
Drug Standards of China 2025;26(1):093-098
Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.
3.A cohort study of lipid levels and recurrence risk of ischemic stroke in a community-based natural population in Songjiang District, Shanghai
Yangbo GENG ; Huayuan FEI ; Yunlong KAN ; Minhua TANG ; Yunhui WANG ; Jianguo YU ; Jiedong XU ; Yiling WU ; Genming ZHAO ; Yonggen JIANG ; Yan JIN
Shanghai Journal of Preventive Medicine 2025;37(7):562-568
ObjectiveTo investigate the recurrence of ischemic stroke (IS) and to analyze the association between four indices of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) and the risk of IS recurrence by analyzing the follow-up data related to IS in the community-based natural population of Songjiang District, Shanghai, so as to provide a scientific basis for improving the prognosis of stroke patients in the community and controlling IS recurrence. MethodsA prospective follow-up study was conducted among the IS patients in the community-based cohort population, collecting data about patient’s age, gender, disease history, biochemical indicators, and etc. Cox regression model and restricted cubic spline model were used to analyze the relationship between different levels of plasma lipids and the recurrence of IS in these patients. ResultsA total of 1 368 patients with IS were included. The total follow-up duration was 7 171.46 person-years, with a median follow-up time of 6.24 years. There were 420 cases of IS recurrence, resulting in a cumulative recurrence rate of 30.70%. The results of multivariate Cox regression analysis showed that the recurrence risk of IS was reduced when the baseline TC and LDL-C levels of IS patients were in the ranges of 4.65‒5.67 mmol·L-1 and 2.52‒3.46 mmol·L-1, respectively. The results of restricted cubic spline analysis showed a U-shaped relationship between baseline TC and LDL-C levels and the recurrence risk in IS patients. ConclusionThe cumulative recurrence rate of patients with IS in the community of Songjiang District in Shanghai is high, and the levels of TC and LDL-C at baseline survey are correlated with the recurrence of IS in these patients. It is suggested to pay more attention to the levels of LDL-C and TC in patients with IS, so as to improve the prognosis.
4.Development of a nomogram-based risk prediction model for chronic obstructive pulmonary disease incidence in community-dwelling population aged 40 years and above in Shanghai
Yixuan ZHANG ; Yiling WU ; Jinxin ZANG ; Xuyan SU ; Xin YIN ; Jing LI ; Wei LUO ; Minjun YU ; Wei WANG ; Qi ZHAO ; Qin WANG ; Genming ZHAO ; Yonggen JIANG ; Na WANG
Shanghai Journal of Preventive Medicine 2025;37(8):669-675
ObjectiveTo develop a nomogram-based risk prediction model for chronic obstructive pulmonary disease (COPD) incidence among the community-dwelling population aged 40 years old and above, so as to provide targeted references for the screening and prevention of COPD. MethodsBased on a natural population cohort in suburban Shanghai, a total of 3 381 randomly selected participants aged ≥40 years underwent pulmonary function tests between July and October 2021. Cox stepwise regression analysis was used to develop overall and gender-specific risk prediction models, along with the construction of corresponding risk nomograms. Model predictive performance was evaluated using the C-indice, area under the curve (AUC) values, and Brier score. Stability was assessed through 10-fold cross-validation and sensitivity analysis. ResultsA total of 3 019 participants were included, with a median follow-up duration of 4.6 years. The COPD incidence density was 17.22 per 1 000 person-years, significantly higher in males (32.04/1 000 person-years) than that in females (7.38/1 000 person-years) (P<0.001). The overall risk prediction model included the variables such as gender, age, education level, BMI, smoking, passive smoking, and respiratory comorbidities. The male-specific model incorporated the variables such as age, BMI, respiratory comorbidities, and smoking, while the female-specific model included age, marital status, respiratory comorbidities, and pulmonary tuberculosis history. The C-indices for the overall, male-specific, and female-specific models were 0.829, 0.749, and 0.807, respectively. The 5-year AUC values were 0.785, 0.658, and 0.811, with Brier scores of 0.103, 0.176, and 0.059, respectively. Both 10-fold cross-validated C-indices and sensitivity analysis (excluding participants with a follow-up duration of <6 months) yielded C-indices were above 0.740. ConclusionThis study developed concise and practical overall and gender-specific COPD risk prediction models and corresponding nomograms. The models demonstrated robust performance in predicting COPD incidence, providing a valuable reference for identifying high-risk populations and formulating targeted screening and personalized management strategies.
5.Clinical analysis of 16 cases of mucosal malignant melanoma in the nasal and paranasal sinuses without cervical lymph node metastasis
Huixi WANG ; Xiaohua LUO ; Xiang CHEN ; Yiling WANG
Chongqing Medicine 2025;54(7):1661-1666
Objective To investigate the clinical features,diagnosis,treatment and prognosis of sinon-asal mucosal melanoma(SNMM).Methods The clinical data of 16 cases of SNMM without cervical lymph node metastasis admitted to this hospital from June 2014 to July 2021 were retrospectively analyzed.Results The mean age of all 16 cases was(70.00±7.02)years.The mean survival period was 22.87 months in the treated group and 9.42 months in the untreated group,with significant difference in outcome(P=0.01).There was no significant difference in long-term prognosis between patients with bone destruction and those without bone destruction after treatment(P=0.085).There was also no significant difference in prognosis between T3 group and T4a group after treatment(P=0.119).Conclusion SNMM usually presents with mi-nor nasal bleeding as the initial symptom,and the overall prognosis is poor due to its propensity for metasta-sis.Surgical resection and postoperative individualized comprehensive therapy are the main treatments,and immunotherapy may improve survival.
6.Research progress of metabolomics in age-related macular degeneration
Feng WANG ; Chenghong LAN ; Yiling LIU ; Yi SHAO
International Eye Science 2025;25(5):760-764
Age-related macular degeneration(ARMD)is a common multifactorial disease among the elderly, which may lead to irreversible vision loss; however, the pathogenesis of ARMD is still unclear. Metabolomics is a relatively new “omics” technique that can provide qualitative and quantitative information about low molecular weight metabolites that make up biological systems, thereby revealing the physiological or pathological state of cell or tissue samples at specific time points. In recent years, increasing evidence suggests that metabolic dysfunction plays an important role in the development and progression of ARMD. Metabolic pathway dysregulation involves lipid metabolism, nucleotide metabolism, amino acid metabolism, and energy metabolism, which may play important roles in the occurrence and development of ARMD. The retina is one of the most metabolically active tissues in the human body, so using metabolomics techniques to measure molecular changes in ARMD will further enhance our understanding of the pathogenesis. This will provide important insights for the prevention and treatment of ARMD, This article reviews the application of metabolomics in ARMD.
7.The Ferroptosis-inducing Compounds in Triple Negative Breast Cancer
Xin-Die WANG ; Da-Li FENG ; Xiang CUI ; Su ZHOU ; Peng-Fei ZHANG ; Zhi-Qiang GAO ; Li-Li ZOU ; Jun WANG
Progress in Biochemistry and Biophysics 2025;52(4):804-819
Ferroptosis, a programmed cell death modality discovered and defined in the last decade, is primarily induced by iron-dependent lipid peroxidation. At present, it has been found that ferroptosis is involved in various physiological functions such as immune regulation, growth and development, aging, and tumor suppression. Especially its role in tumor biology has attracted extensive attention and research. Breast cancer is one of the most common female tumors, characterized by high heterogeneity and complex genetic background. Triple negative breast cancer (TNBC) is a special type of breast cancer, which lacks conventional breast cancer treatment targets and is prone to drug resistance to existing chemotherapy drugs and has a low cure rate after progression and metastasis. There is an urgent need to find new targets or develop new drugs. With the increase of studies on promoting ferroptosis in breast cancer, it has gradually attracted attention as a treatment strategy for breast cancer. Some studies have found that certain compounds and natural products can act on TNBC, promote their ferroptosis, inhibit cancer cells proliferation, enhance sensitivity to radiotherapy, and improve resistance to chemotherapy drugs. To promote the study of ferroptosis in TNBC, this article summarized and reviewed the compounds and natural products that induce ferroptosis in TNBC and their mechanisms of action. We started with the exploration of the pathways of ferroptosis, with particular attention to the System Xc--cystine-GPX4 pathway and iron metabolism. Then, a series of compounds, including sulfasalazine (SAS), metformin, and statins, were described in terms of how they interact with cells to deplete glutathione (GSH), thereby inhibiting the activity of glutathione peroxidase 4 (GPX4) and preventing the production of lipid peroxidases. The disruption of the cellular defense against oxidative stress ultimately results in the death of TNBC cells. We have also our focus to the realm of natural products, exploring the therapeutic potential of traditional Chinese medicine extracts for TNBC. These herbal extracts exhibit multi-target effects and good safety, and have shown promising capabilities in inducing ferroptosis in TNBC cells. We believe that further exploration and characterization of these natural compounds could lead to the development of a new generation of cancer therapeutics. In addition to traditional chemotherapy, we discussed the role of drug delivery systems in enhancing the efficacy and reducing the toxicity of ferroptosis inducers. Nanoparticles such as exosomes and metal-organic frameworks (MOFs) can improve the solubility and bioavailability of these compounds, thereby expanding their therapeutic potential while minimizing systemic side effects. Although preclinical data on ferroptosis inducers are relatively robust, their translation into clinical practice remains in its early stages. We also emphasize the urgent need for more in-depth and comprehensive research to understand the complex mechanisms of ferroptosis in TNBC. This is crucial for the rational design and development of clinical trials, as well as for leveraging ferroptosis to improve patient outcomes. Hoping the above summarize and review could provide references for the research and development of lead compounds for the treatment for TNBC.
8.Alleviation of Ulcerative Colitis by Shaoyaotang via Inhibiting Glycolysis Through SIRT6/HIF-1α Pathway
Yiling XIA ; Hui CAO ; Dongsheng WU ; Bo ZOU ; Erle LIU ; Yiwen WANG ; Shaijin JIANG ; Yiqian YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):10-19
ObjectiveTo investigate the role of silent information regulatory protein (SIRT6)/hypoxia-inducible factor-1α (HIF-1α) pathway in regulating the reprogramming of glucose metabolism in ulcerative colitis (UC) and the mechanism of intervention of Shaoyaotang. MethodsForty-eight c57bL/6 mice were randomly divided into a blank group, a model group, a Mesalazine group (0.42 g·kg-1), a Shaoyaotang group (31.08 g·kg-1), an inhibitor group (OSS-128167, 50 mg·kg-1), and an inhibitor + Shaoyaotang group (50 mg·kg-1 OSS-128167 + 31.08 g·kg-1 Shaoyaotang). A UC model was established by the administration of 2.5% dextran sulfate sodium (DSS) solution for mice in other groups for 7 d, except for the blank group. The mice in each group were treated with saline, Mesalazine, Shaoyaotang, inhibitor, and inhibitor + Shaoyaotang, respectively, for 7 d. The mice were necropsied 24 h after the last administration of the drug. The blood was collected from the orbital region, and colon tissue was taken. Hematoxylin-eosin (HE) staining was used to observe the pathological changes in colon tissue. Enzyme-linked immunosorbent assay (ELISA) was employed to detect serum interleukin (IL)-10, IL-17, and IL-6 levels. A biochemical method was used to detect glucose and lactate dehydrogenase A (LDHA) levels. Immunohistochemistry (IHC) was employed to detect IL-22 and transforming growth factor-β1 (TGF-β1) levels in colon tissue, and Western blot and real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) were used to detect relative protein and mRNA expressions of SIRT6, HIF-1α, and LDHA. ResultsCompared with those of the blank group, disease activity index (DAI) scores of mice in the model group and inhibitor group were significantly increased (P<0.01). The length of colon tissue was significantly shortened, and colon tissue was congested and eroded. The pathohistological scores were significantly increased (P<0.01). The levels of serum inflammatory factors IL-17 and IL-6 were significantly elevated, and the levels of IL-10 were significantly decreased (P<0.01). The protein expressions of IL-22 and TGF-β1 were significantly reduced in colon tissue (P<0.01). The relative protein and mRNA expressions of SIRT6 were significantly decreased (P<0.01), and the relative protein and mRNA expressions of HIF-1α and LDHA and the contents of glucose and lactate were significantly elevated (P<0.01). The level of inflammation in the colon of the mice in the inhibitor group was more severe than that in the model group (P<0.01). Compared with the model group, the Mesalazine group, the Shaoyaotang group, and the inhibitor + Shaoyaotang group showed reduced colonic injury, significant decrease in serum IL-17 and IL-6, significant increase in IL-10 (P<0.01), significant increase in the protein expressions of IL-22 and TGF-β1 in colon tissue (P<0.01), significant increase in the protein expressions of SIRT6 and the relative mRNA expressions (P<0.01), and significant reduction in the protein expressions of HIF-1α and LDHA, the relative mRNA expressions, and the contents of glucose and lactate (P<0.01). Compared with those in the Shaoyaotang group, the serum IL-17 and IL-6 were significantly increased, and IL-10 was significantly decreased in the inhibitor + Shaoyaotang group (P<0.01). The protein expressions of IL-22 and TGF-β1 in colon tissue were significantly decreased (P<0.01). The expressions of SIRT6 protein and the relative mRNA expressions were significantly decreased (P<0.01). The protein expressions of HIF-1α and LDHA, the relative mRNA expressions, and the contents of glucose and lactate were significantly elevated (P<0.01). However, the difference between the Shaoyaotang group and the Mesalazine group was not significant. ConclusionShaoyaotang can effectively treat DSS-induced mice with UC through the SIRT6/HIF-1α pathway, and its mechanism of action may be related to the regulation of the SIRT6/HIF-1α pathway and glucose metabolism reprogramming and the inhibition of glycolysis.
9.Analysis of Medication Patterns for Ancient Epidemic Treatment Based on Data Mining
Peipei JIN ; Tongxing WANG ; Liping CHANG ; Bin HOU ; Ningxin HAN ; Xiaoqi WANG ; Zhenhua JIA
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):287-294
ObjectiveExploring the formula rules of commonly used traditional Chinese medicines(TCMs) for epidemic treatment from the Qin and Han dynasties to the Qing dynasty through data mining, providing reference for the prevention and control of contemporary epidemics. MethodsThe articles on epidemic treatment in the electronic database of Chinese Medical Code V5.0 were systematically searched, and the contents such as source, dynasty, author, diagnosis, formula name, therapeutic method and efficacy, and composition of medicines from each article that met the inclusion criteria were extracted. Then, an Excel standardized database was established, and Python programs were used for data mining to summarize the frequency of commonly used medicines and perform hierarchical cluster analysis, Pearson correlation analysis, and association rule analysis. ResultsA total of 1 595 formulas were included, involving 558 TCMs. The efficacy of these medicines could be classified into two categories, namely, expeling pathogenic factors and reinforcing healthy Qi. According to the frequency deconstruction analysis, high-frequency medicines were mainly detoxification, Fu-organ dredging, aromatization and promoting blood circulation, followed by the medicines with the effect of treating the lungs, such as clearing the lungs and resolving phlegm, clearing heat and purging the lungs, relieving cough and asthma, and purging the lungs and relieving asthma. And the proportions of acrid-warm herbs and acrid-cold herbs varied in different periods. Hierarchical clustering and correlation analysis both suggested TCMs for expeling pathogenic factors and reinforcing healthy Qi often formed stable combinations with high association degrees. Association rule analysis showed that the core acrid-warm herb was mainly Ephedrae Herba, and the core acrid-cold herb was mainly Forsythiae Fructus, resulting in the core formulas of Maxing Shigantang and Yinqiaosan. ConclusionThroughout history, the prevention and control of epidemics have been based on the principle of "preserving healthy Qi and avoiding toxic Qi", focusing on the treatment of the causes and characteristics of epidemics through detoxification, Fu-organ dredging, and aromatization, emphasizing the use of Rhei Radix et Rhizoma and other herbs to dredge Fu-organ, eliminate toxins and pathogens, and playing the role of actively intervene with symptomatic medication. And based on the external manifestations of the body's struggle between evil and righteousness, diagnose and treatment according to syndrome differentiation was performed.
10.Alleviation of Ulcerative Colitis by Shaoyaotang via Inhibiting Glycolysis Through SIRT6/HIF-1α Pathway
Yiling XIA ; Hui CAO ; Dongsheng WU ; Bo ZOU ; Erle LIU ; Yiwen WANG ; Shaijin JIANG ; Yiqian YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):10-19
ObjectiveTo investigate the role of silent information regulatory protein (SIRT6)/hypoxia-inducible factor-1α (HIF-1α) pathway in regulating the reprogramming of glucose metabolism in ulcerative colitis (UC) and the mechanism of intervention of Shaoyaotang. MethodsForty-eight c57bL/6 mice were randomly divided into a blank group, a model group, a Mesalazine group (0.42 g·kg-1), a Shaoyaotang group (31.08 g·kg-1), an inhibitor group (OSS-128167, 50 mg·kg-1), and an inhibitor + Shaoyaotang group (50 mg·kg-1 OSS-128167 + 31.08 g·kg-1 Shaoyaotang). A UC model was established by the administration of 2.5% dextran sulfate sodium (DSS) solution for mice in other groups for 7 d, except for the blank group. The mice in each group were treated with saline, Mesalazine, Shaoyaotang, inhibitor, and inhibitor + Shaoyaotang, respectively, for 7 d. The mice were necropsied 24 h after the last administration of the drug. The blood was collected from the orbital region, and colon tissue was taken. Hematoxylin-eosin (HE) staining was used to observe the pathological changes in colon tissue. Enzyme-linked immunosorbent assay (ELISA) was employed to detect serum interleukin (IL)-10, IL-17, and IL-6 levels. A biochemical method was used to detect glucose and lactate dehydrogenase A (LDHA) levels. Immunohistochemistry (IHC) was employed to detect IL-22 and transforming growth factor-β1 (TGF-β1) levels in colon tissue, and Western blot and real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) were used to detect relative protein and mRNA expressions of SIRT6, HIF-1α, and LDHA. ResultsCompared with those of the blank group, disease activity index (DAI) scores of mice in the model group and inhibitor group were significantly increased (P<0.01). The length of colon tissue was significantly shortened, and colon tissue was congested and eroded. The pathohistological scores were significantly increased (P<0.01). The levels of serum inflammatory factors IL-17 and IL-6 were significantly elevated, and the levels of IL-10 were significantly decreased (P<0.01). The protein expressions of IL-22 and TGF-β1 were significantly reduced in colon tissue (P<0.01). The relative protein and mRNA expressions of SIRT6 were significantly decreased (P<0.01), and the relative protein and mRNA expressions of HIF-1α and LDHA and the contents of glucose and lactate were significantly elevated (P<0.01). The level of inflammation in the colon of the mice in the inhibitor group was more severe than that in the model group (P<0.01). Compared with the model group, the Mesalazine group, the Shaoyaotang group, and the inhibitor + Shaoyaotang group showed reduced colonic injury, significant decrease in serum IL-17 and IL-6, significant increase in IL-10 (P<0.01), significant increase in the protein expressions of IL-22 and TGF-β1 in colon tissue (P<0.01), significant increase in the protein expressions of SIRT6 and the relative mRNA expressions (P<0.01), and significant reduction in the protein expressions of HIF-1α and LDHA, the relative mRNA expressions, and the contents of glucose and lactate (P<0.01). Compared with those in the Shaoyaotang group, the serum IL-17 and IL-6 were significantly increased, and IL-10 was significantly decreased in the inhibitor + Shaoyaotang group (P<0.01). The protein expressions of IL-22 and TGF-β1 in colon tissue were significantly decreased (P<0.01). The expressions of SIRT6 protein and the relative mRNA expressions were significantly decreased (P<0.01). The protein expressions of HIF-1α and LDHA, the relative mRNA expressions, and the contents of glucose and lactate were significantly elevated (P<0.01). However, the difference between the Shaoyaotang group and the Mesalazine group was not significant. ConclusionShaoyaotang can effectively treat DSS-induced mice with UC through the SIRT6/HIF-1α pathway, and its mechanism of action may be related to the regulation of the SIRT6/HIF-1α pathway and glucose metabolism reprogramming and the inhibition of glycolysis.

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