1.Characterization and Application of Moisture Absorption Kinetics of Traditional Chinese Medicines Based on Double Exponential Model:A Review
Yanting YU ; Lei XIONG ; Yan HE ; Wei LIU ; Jing YANG ; Yao ZHANG ; Jiali CHEN ; Xiaojian LUO ; Xiaoyong RAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):340-346
Hygroscopicity research has long been a key focus and hot topic in Chinese materia medica(CMM). Elucidating hygroscopic mechanisms plays a vital role in formulation design, process optimization, and storage condition selection. Hygroscopic models serve as essential tools for characterizing CMM hygroscopic mechanisms, with various types available. The double exponential model is a kinetic mathematical model constructed based on the law of conservation of energy and Fick's first law of diffusion, tailored to the physical properties of CMM extracts. In recent years, this model has been extensively applied to simulate the dynamic moisture absorption behavior of CMM extracts and solid dosage forms under varying humidity conditions. It has revealed the correlation between moisture absorption kinetic parameters and material properties, offering a new perspective for characterizing the moisture uptake behavior of CMM. This paper systematically reviews the application progress of this model in the field of CMM, analyzes its advantages, disadvantages, and challenges in this domain, and explores its potential application trends in other fields. It aims to provide references for elucidating the moisture absorption mechanisms of CMM and researching moisture-proofing technologies, while also offering insights for its broader application in food and polymer materials.
2.COLEC12high tumor-associated macrophages orchestrate lenvatinib resistance and cancer stemness in hepatocellular carcinoma via paracrine NRG1-HER2/HER3 signaling
Jianxing ZHANG ; Liang QIAO ; Zongfeng WU ; Dinglan ZUO ; Shanshan HUANG ; Shaoru LIU ; Zhenkun HUANG ; Yi ZENG ; Yu LI ; Yichuan YUAN ; Chenwei WANG ; Wei HE ; Jiliang QIU ; Yunfei YUAN ; Yi NIU ; Binkui LI
Clinical and Molecular Hepatology 2026;32(2):772-786
Background/Aims:
Lenvatinib resistance remains a critical barrier in advanced hepatocellular carcinoma (HCC) therapy. However, the underlying mechanisms and strategies for reversing resistance remain incompletely understood.
Methods:
Integrated transcriptomics of lenvatinib-resistant patient tumors and an acquired-resistance murine model identified a novel macrophage subpopulation. Functional validation employed CRISPR-SAM screening, conditioned medium (CM) assays, subcutaneous/orthotopic xenografts, patient-derived organoids (PDOs), and patient-derived xenografts (PDXs). Mechanistic studies included ChIP-qPCR, co-immunoprecipitation, and pharmacologic targeting. Clinical relevance was assessed in a retrospective cohort.
Results:
Resistant HCC exhibited significant enrichment of a COLEC12high TAM subset , which correlated with poor survival and treatment response. These TAMs secreted neuregulin-1 (NRG1) , activating HER2/HER3-AKT signaling in tumor cells to drive cancer stemness and lenvatinib resistance. Mechanistically, in TAMs COLEC12 sequestered STAT1 in the cytoplasm, preventing its phosphorylation, and thereby derepressing STAT3-mediated NRG1 transcription. Depletion of NRG1 reversed the stemness phenotypes and resensitized tumors to lenvatinib both in vitro and in vivo. Clinically, high NRG1 expression predicted an inferior lenvatinib response and shorter survival. Crucially, the bispecific anti-HER2/HER3 antibody zenocutuzumab restored lenvatinib efficacy in PDOs, PDXs, and murine models.
Conclusions
Our work establishes the COLEC12high TAM/NRG1 axis as a master regulator of therapeutic resistance and identifies NRG1 as a predictive biomarker, providing a clinically actionable strategy to overcome lenvatinib resistance in HCC.
3.The Clinical and Genetics Characteristics of Oculopharyngodistal Myopathy
Jiaxi YU ; Zhihao QUAN ; Yilei ZHENG ; Jing AN ; Jing LIU ; Qingqing WANG ; Lingchao MENG ; Meng YU ; Zhiying XIE ; Jianwen DENG ; He LYU ; Wei ZHANG ; Yun YUAN ; Zhaoxia WANG
JOURNAL OF RARE DISEASES 2026;5(2):164-174
To analyze the clinical and genetic features of oculopharyngodistal myopathy (OPDM) patients and compare the phenotypic differences among various causative genes. A total of 65 genetically confirmed OPDM patients from 43 unrelated families, who were admitted to the Department of Neurology, Peking University First Hospital between January 2008 and December 2025, were retrospectively included.The general demographic data, clinical manifestations, laboratory/auxiliary examinations, muscle pathology, and genetic test results were systematically collected and analyzed. The clinical and pathological characteristics among different OPDM subtypes were compared. Among the 65 patients(39 male and 26 female), the mean age of onset was (31.20±10.43) years (range: 14 to 63 years). The initial symptom was predominantly distal limb weakness (67.44%), which gradually progressed to involve the extraocular muscles, pharyngeal muscles, facial muscles and proximal limb muscles. Serum creatine kinase levels were mildly to moderately elevated. Muscle pathological examinations revealed rimmed vacuoles and intranuclear inclusions (within muscle fibers). The mean duration from onset to diagnosis was (12.33±7.88) years (range: 1 to 32 years). All probands had negative results on conventional next-generation whole-exome sequencing; pathogenic variants were identified through third-generation long-read sequencing or OPDM-targeted repeat-primed polymerase chain reaction(RP-PCR). Among the 43 families, OPDM2 subtype was the most common genetic subtype ( OPDM2 was the predominant subtype in this study. All subtypes share similar age of onset and muscular pathological changes, yet exhibit distinct disease progression patterns. Future multicenter prospective cohort studies are warranted to further elucidate the clinical characteristics, pathogenetic mechanisms, and prognostic differences among OPDM subtypes.
4.The Neural Circuit Characteristics of Repetitive Transcranial Magnetic Stimulation Over The Dorsolateral Prefrontal Cortex for The Treatment of Migraine
Chen-Xia JIN ; Bo-Lin TAN ; Yang YE ; Ji-Qing HE ; Ling-Yan WANG ; Zhong-Ming GAO ; Yu-Jun WANG ; Hui-Li LIU ; Yong-Xing YAN ; Xian-Wei CHE
Progress in Biochemistry and Biophysics 2026;53(7):1953-1968
ObjectiveMigraine is a leading neurological disorder and the fourth most common cause of years lived with disability worldwide, affecting nearly 116 million individuals. Although pharmacological treatments are available, their efficacy is often limited by side effects and variable response rates. Repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) offers a safe, non-invasive alternative for migraine management. However, the neurophysiological mechanisms, particularly how rTMS modulates local cortical excitability and distributed pain-related circuits, remain poorly understood. Elucidating these mechanisms is essential for optimizing treatment protocols and improving clinical outcomes. MethodsThis study employed concurrent transcranial magnetic stimulation and electroencephalography (TMS-EEG) to investigate neuroplastic and neurocircuitry mechanisms of DLPFC-rTMS in migraine. Study 1 compared 30 migraineurs and 28 healthy controls to identify abnormalities in TMS-evoked potentials (TEPs) and significant current density (SCD) within sensory-discriminative regions including the primary somatosensory cortex (S1) and posterior insula (pINS), cognitive-affective regions including the anterior insula (aINS) and midcingulate cortex (MCC), and a descending modulatory region, the periaqueductal gray (PAG). Study 2 used a single-blind, crossover, sham-controlled design in 34 healthy participants. Each participant received both active (10 Hz, 80% RMT, 1 500 pulses) and sham DLPFC-rTMS in counterbalanced order. TMS-EEG and cold pain tolerance were assessed before and after each session. ResultsIn Study 1, migraineurs showed a significantly less negative N120 amplitude compared to healthy controls (P=0.027, Cohen’s d=0.60), indicating local intracortical disinhibition. No group differences were observed for N40, P60, or P180 components. At the source level, migraineurs exhibited significantly higher SCD in the S1, pINS, aINS, and MCC (allQ<0.05), but not in the ventroposterior thalamus (vpTHAL), mediodorsal thalamus (mdTHAL), or PAG. In Study 2, active rTMS significantly reduced SCD from pre- to post-stimulation in the S1, aINS, and MCC (all Q<0.05). Sham stimulation also reduced SCD in the S1 (Q<0.05) but not in the aINS or MCC. Although no significant group-level analgesic effect was observed between active and sham conditions (P=0.107), correlation analyses revealed that greater SCD reductions in the S1 and MCC were significantly associated with higher post-rTMS pain tolerance (R=-0.487 and -0.495, both Q<0.01) and larger improvements in pain tolerance(R=-0.487 and -0.451, both Q<0.05). No such correlations were found following sham stimulation, suggesting that the behavioural relevance of neural changes is specific to active rTMS. ConclusionThis study provides novel evidence that migraineurs exhibit both local neuroplastic abnormalities (reduced N120 amplitude) and hyperactivity in key pain-processing regions (S1, pINS, aINS, MCC). A single session of DLPFC-rTMS reduced hyperactivity in the aINS, MCC, and S1. Notably, greater reductions in the S1 and MCC were associated with improved pain tolerance. These findings identify distinct cortical circuitries, particularly within the cognitive-affective pain network, that may serve as potential biomarkers for optimizing rTMS treatment in migraine and other chronic pain conditions. Future studies should validate these results in patient populations experiencing spontaneous migraine attacks and explore multi-session or accelerated rTMS protocols.
5.Mechanism of Shenling baizhu san in ameliorating ulcerative colitis via regulating flora metabolism-related proteins and TLR4/NF-κB/NLRP3 inflammatory axis
Jiajia XU ; Yu YOU ; Jiaoman WANG ; Yuhui LIU ; Shiyao CHANG ; Zhixian HE ; Ping LI ; Ziyan WANG ; Wei XIONG ; Fei HAN
China Pharmacy 2026;37(15):1992-1997
OBJECTIVE To investigate the mechanism of Shenling baizhu san (SLBZS) in ameliorating ulcerative colitis (UC). METHODS Mice were randomly divided into normal group, model group, and low-, medium-, high-dose SLBZS groups (3, 6, 12 g/kg), with 10 mice in each group. Except for the normal group, mice in other groups were given free access to 3% dextran sulfate sodium solution for 7 days to establish UC models. Simultaneously, mice in each group were intragastrically administered corresponding medicinal liquid or double-distilled water once a day for consecutive 7 days. After the last administration, the histopathological morphology of colon tissues was observed; the serum levels of inflammatory factors including tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β) and IL-18 were detected; the total bile acid contents in liver, gallbladder and colon tissues were determined; the expression level of NOD-like receptor family pyrin domain-containing protein 3 (NLRP3) in colon tissues was tested. The expression levels of flora metabolism-related proteins [G protein-coupled receptor 41(GPR41),GPR43,farnesoid X receptor (FXR), G protein-coupled bile acid receptor 1 (TGR5), flavin-containing monooxygenase 3 (FMO3), cytochrome P450 family 27 subfamily A member 1 (CYP27A1), CYP7A1] in liver or colon tissues, as well as the proteins related to Toll-like receptor 4 (TLR4)/nuclear factor-κB (NF-κB)/NLRP3 inflammatory axis [TLR4, NF-κB, phosphorylated NF-κB (p-NF-κB), myeloid differentiation factor 88 (MyD88), NLRP3, apoptosis-associated speck-like protein containing a CARD (ASC), caspase-1] in colon tissues were measured. RESULTS Compared with the model group, the colon tissue injury and inflammatory cell infiltration were alleviated in medium- and high-dose SLBZS groups. The serum levels of TNF-α, IL-1β and IL-18, total bile acid contents in liver and colon tissues, as well as the protein expression levels of FMO3 and CYP7A1 in liver tissues, TLR4, p-NF-κB, NF-κB, MyD88, NLRP3, ASC and caspase-1 in colon tissues were significantly decreased (P<0.05). Meanwhile, the total bile acid content in gallbladder, the protein expression levels of GPR41 and GPR43 in colon tissues, along with CYP27A1, FXR and TGR5 in liver tissues were significantly increased (P<0.05). CONCLUSIONS SLBZS may relieve colonic inflammatory injury and ameliorate UC by regulating the expression of flora metabolism-related proteins and inhibiting the abnormal activation of TLR4/NF-κB/NLRP3 inflammatory axis.
6.Advanced research on respiratory rehabilitation for patients with postoperative pulmonarycomplications after aortic dissection surgery
Nanxi ZHOU ; Zeruxin LUO ; Zhenghua XIAO ; Jiayuan HE ; Quan WEI ; Pengming YU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(09):1395-1402
Aortic dissection is a serious cardiovascular disease characterized by acute onset and high mortality rates. Although advancements in surgical techniques and anesthesia methods have significantly reduced surgical mortality, postoperative complications, particularly pulmonary complications, remain a challenge for the recovery of patients with aortic dissection. Existing studies indicate that respiratory rehabilitation plays a crucial role in preventing and alleviating postoperative pulmonary complications, and its application is gradually expanding. However, current understanding of respiratory rehabilitation treatment for patients with aortic dissection is still insufficient, and there is a lack of standardized protocols in clinical practice. This article aims to review the existing research evidence, comprehensively analyze common pulmonary complications after aortic dissection surgery, their pathogenesis, the latest advancements in perioperative respiratory rehabilitation, and the main challenges faced, in order to provide references for clinical practice and future research.
7.Mechanism of Shengxian Yixin Granule (升陷益心颗粒) in the Treatment of Heart Failure with Preserved Ejection Fraction Based on Macrophage-Mediated Inflammatory Response
Zhengwei DONG ; Rui YU ; Qiaozhi LI ; Huan ZHAO ; Jingjing WEI ; Genhao FAN ; Xinlu WANG ; He WANG ; Yongxia WANG ; Mingjun ZHU
Journal of Traditional Chinese Medicine 2026;67(19):2086-2094
ObjectiveTo investigate the effect and mechanism of Shengxian Yixin Granule (升陷益心颗粒, SYG) in treating heart failure with preserved ejection fraction (HFpEF). MethodsExperiment 1: Forty male C57BL/6 mice were randomly divided into control group, model group, low-dose [25 mg/(kg·d)], medium-dose [50 mg/(kg·d)], and high-dose [(75 mg/(kg·d)] SYG groups, with 8 mice per group. Except for the control group, HFpEF was induced by a high-fat diet combined with Nω-nitro-L-arginine methyl ester in drinking water for 16 weeks. After 10 weeks of modeling, treatment groups received corresponding doses of SYG by gavage, while the control group and model group received equal volume of normal saline, for 6 weeks. After 6 weeks of administration, the body weight, blood pressure including systolic blood pressure (SBP) and diastolic blood pressure (DBP), and heart weight-to-tibia length ratio (HW/TL) were recorded. Echocardiography was used to evaluate left ventricular ejection fraction (LVEF) and the ratio of early to late diastolic transmitral flow velocity (E/A). Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) and C-reactive protein (CRP) levels were measured by ELISA. The expression level of brain natriuretic peptide (BNP) in heart tissue was detected by qRT-PCR. Blood lipid levels, including low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and total cholesterol (TC), were determined by a biochemical analyzer. Splenic proportions of M1 macrophages, M2 macrophages, T helper 17 (Th17) cells, and regulatory T (Treg) cells were analyzed by flow cytometry. Experiment 2: RAW 264.7 cells were stimulated with lipopolysaccharide (LPS) to establish an M1 macrophage polarization model, and then treated with SYG-containing serum for 24 h. The cells were divided into four groups, including blank serum group, high-dose SYG-containing serum group, LPS group, and LPS plus high-dose SYG-containing serum group. Combined with asignal transducer and activator of transcription 3 (Stat3) inhibitor for 24 h, the cells were divided into a lipopolysaccharide group, a high-dose SYG-containing serum group, an inhibitor group, and high-dose SYG-containing serum plus inhibitor group. The expression levels of inducible nitric oxide synthase (iNOS) and interleukin-1β (IL-1β) in each group were detected by qRT-PCR. The protein levels of iNOS, IL-1β, Stat3, and phosphorylated Stat3 (p-Stat3) were detected by Western Blotting. ResultsExperiment 1: Compared to the control group, the model group showed significantly decreased E/A ratio, and increased cardiac BNP expression, plasma NT-proBNP,HW/TL ratio, body weight, TC, LDL-C, SBP, and DBP, as well as shortened exhaustion distance and exhaustion time (P<0.05 or P<0.01). Compared to the model group, the E/A ratio increased in the low-, medium-, and high-dose SYG groups; cardiac BNP expression decreased in the low- and high-dose groups, and plasma NT-proBNP levels decreased in the high-dose group; the HW/TL ratio and body weight decreased, while exhaustion distance and exhaustion time increased in the medium- and high-dose groups; TG levels decreased in the low- and medium-dose groups, and LDL-C levels decreased in the medium- and high-dose groups; SBP and DBP decreased in the low-, medium-, and high-dose groups (P<0.05 or P<0.01). Compared to the low-dose SYG group, body weight decreased, and both exhaustion distance and exhaustion time increased in the medium- and high-dose groups (P<0.05 or P<0.01). Compared to the medium-dose SYG group, the exhaustion time increased in the high-dose SYG group (P<0.01). Experiment 2: In the LPS‑induced M1 macrophage polarization model, compared to the blank serum group, the LPS group showed significantly increased mRNA and protein expression of iNOS and IL‑1β, as well as the p‑Stat3/Stat3 ratio (P<0.01). Compared to the LPS group, the high‑dose SYG-containing serum plus LPS group showed significantly decreased mRNA and protein expression of iNOS and IL‑1β, as well as the p‑Stat3/Stat3 ratio (P<0.05 or P<0.01). Compared to the LPS group, the inhibitor group also showed significantly reduced these parameters (P<0.05 or P<0.01). ConclusionSYG can improve cardiac function, ventricular remodeling, exercise capacity, and lipid metabolism in HFpEF mice, while inhibiting inflammatory responses. Its mechanism may be related to the regulation of the Stat3 signaling pathway and inhibition of M1 macrophage polarization.
8.Mechanism of Shengxian Yixin Granule (升陷益心颗粒) in the Treatment of Heart Failure with Preserved Ejection Fraction Based on Macrophage-Mediated Inflammatory Response
Zhengwei DONG ; Rui YU ; Qiaozhi LI ; Huan ZHAO ; Jingjing WEI ; Genhao FAN ; Xinlu WANG ; He WANG ; Yongxia WANG ; Mingjun ZHU
Journal of Traditional Chinese Medicine 2026;67(19):2086-2094
ObjectiveTo investigate the effect and mechanism of Shengxian Yixin Granule (升陷益心颗粒, SYG) in treating heart failure with preserved ejection fraction (HFpEF). MethodsExperiment 1: Forty male C57BL/6 mice were randomly divided into control group, model group, low-dose [25 mg/(kg·d)], medium-dose [50 mg/(kg·d)], and high-dose [(75 mg/(kg·d)] SYG groups, with 8 mice per group. Except for the control group, HFpEF was induced by a high-fat diet combined with Nω-nitro-L-arginine methyl ester in drinking water for 16 weeks. After 10 weeks of modeling, treatment groups received corresponding doses of SYG by gavage, while the control group and model group received equal volume of normal saline, for 6 weeks. After 6 weeks of administration, the body weight, blood pressure including systolic blood pressure (SBP) and diastolic blood pressure (DBP), and heart weight-to-tibia length ratio (HW/TL) were recorded. Echocardiography was used to evaluate left ventricular ejection fraction (LVEF) and the ratio of early to late diastolic transmitral flow velocity (E/A). Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) and C-reactive protein (CRP) levels were measured by ELISA. The expression level of brain natriuretic peptide (BNP) in heart tissue was detected by qRT-PCR. Blood lipid levels, including low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and total cholesterol (TC), were determined by a biochemical analyzer. Splenic proportions of M1 macrophages, M2 macrophages, T helper 17 (Th17) cells, and regulatory T (Treg) cells were analyzed by flow cytometry. Experiment 2: RAW 264.7 cells were stimulated with lipopolysaccharide (LPS) to establish an M1 macrophage polarization model, and then treated with SYG-containing serum for 24 h. The cells were divided into four groups, including blank serum group, high-dose SYG-containing serum group, LPS group, and LPS plus high-dose SYG-containing serum group. Combined with asignal transducer and activator of transcription 3 (Stat3) inhibitor for 24 h, the cells were divided into a lipopolysaccharide group, a high-dose SYG-containing serum group, an inhibitor group, and high-dose SYG-containing serum plus inhibitor group. The expression levels of inducible nitric oxide synthase (iNOS) and interleukin-1β (IL-1β) in each group were detected by qRT-PCR. The protein levels of iNOS, IL-1β, Stat3, and phosphorylated Stat3 (p-Stat3) were detected by Western Blotting. ResultsExperiment 1: Compared to the control group, the model group showed significantly decreased E/A ratio, and increased cardiac BNP expression, plasma NT-proBNP,HW/TL ratio, body weight, TC, LDL-C, SBP, and DBP, as well as shortened exhaustion distance and exhaustion time (P<0.05 or P<0.01). Compared to the model group, the E/A ratio increased in the low-, medium-, and high-dose SYG groups; cardiac BNP expression decreased in the low- and high-dose groups, and plasma NT-proBNP levels decreased in the high-dose group; the HW/TL ratio and body weight decreased, while exhaustion distance and exhaustion time increased in the medium- and high-dose groups; TG levels decreased in the low- and medium-dose groups, and LDL-C levels decreased in the medium- and high-dose groups; SBP and DBP decreased in the low-, medium-, and high-dose groups (P<0.05 or P<0.01). Compared to the low-dose SYG group, body weight decreased, and both exhaustion distance and exhaustion time increased in the medium- and high-dose groups (P<0.05 or P<0.01). Compared to the medium-dose SYG group, the exhaustion time increased in the high-dose SYG group (P<0.01). Experiment 2: In the LPS‑induced M1 macrophage polarization model, compared to the blank serum group, the LPS group showed significantly increased mRNA and protein expression of iNOS and IL‑1β, as well as the p‑Stat3/Stat3 ratio (P<0.01). Compared to the LPS group, the high‑dose SYG-containing serum plus LPS group showed significantly decreased mRNA and protein expression of iNOS and IL‑1β, as well as the p‑Stat3/Stat3 ratio (P<0.05 or P<0.01). Compared to the LPS group, the inhibitor group also showed significantly reduced these parameters (P<0.05 or P<0.01). ConclusionSYG can improve cardiac function, ventricular remodeling, exercise capacity, and lipid metabolism in HFpEF mice, while inhibiting inflammatory responses. Its mechanism may be related to the regulation of the Stat3 signaling pathway and inhibition of M1 macrophage polarization.
9.Clinical Efficacy of Yishen Jiangtang Decoction Combined with Conventional Western Medicine Treatment for Diabetic Kidney Disease with Pattern of Qi-Yin Deficiency Combined with Dampness-heat and Blood Stasis
Yunjie YANG ; Yasheng DENG ; Kaiying HE ; Qi ZHANG ; Yongxin YU ; Yaqing RUAN ; Zhuang HAN ; Qiwei CHEN ; Yi WEI ; Qiu CHEN ; Jing WU ; Mingqian JIANG ; Shiwei RUAN ; Jianting WANG ; Yuliang QIU ; Lixiang ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):157-167
ObjectiveTo observe the clinical efficacy and safety of Yishen Jiangtang decoction combined with conventional Western medicine treatment in managing stage G3A3 diabetic kidney disease (DKD) in the patients with the pattern of Qi-Yin deficiency combined with dampness-heat and blood stasis, and to explore its mechanism of inhibiting the endoplasmic reticulum stress (ERS)-apoptosis axis and delaying renal fibrosis (RF). MethodsA single-center, randomized, parallel-controlled clinical trial was conducted. A total of 78 patients diagnosed with stage G3A3 DKD and traditional Chinese medicine (TCM) pattern of Qi-Yin deficiency combined with dampness-heat and blood stasis and treated in the Department of Nephrology and the Department of Endocrinology of the People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine from March 2025 to February 2026 were enrolled. They were randomly assigned at a 1∶1 ratio into a control group (conventional Western medicine treatment) and an experimental group (Yishen Jiangtang decoction combined with conventional Western medicine treatment), with 39 patients in each group. The treatment lasted for 12 weeks. Basic demographic data and medical history were collected before and after treatment. The two groups before and after treatment were compared in terms of the following parameters: Blood urea nitrogen (BUN), serum creatinine (SCr), estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), fasting blood glucose (FBG), triglycerides (TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C). Enzyme-linked immunosorbent assay (ELISA) kits were used to measure serum glucose-regulated protein 78 (GRP78), serum cysteinyl aspartate-specific protease-3 (Caspase-3), and serum and urinary transforming growth factor-β1 (TGF-β1) levels before and after treatment. TCM symptom scores, TCM syndrome efficacy, and overall clinical efficacy were evaluated before and after treatment. Spearman correlation analysis was performed to explore the correlations of serum levels of GRP78 and Caspase-3, as well as serum and urinary levels of TGF-β1, with renal function, proteinuria, and glucose and lipid metabolism indicators in patients with DKD. In addition, safety indicators were also monitored. ResultsA total of 75 patients completed the study (38 in the control group and 37 in the experimental group). ① Baseline data: The two groups were comparable in terms of sex and age, with no statistically significant difference. ② Efficacy outcomes: Compared with baseline levels, both groups showed reductions in BUN, SCr, UACR, FBG, TG, TC, LDL-C, and TCM symptom scores (P<0.01) and increases in eGFR level (P<0.01). Moreover, the experimental group outperformed the control group in altering the indicators above (P<0.05). Regarding TCM syndrome efficacy, the total response rate in the experimental group was 83.78%, which was higher than that (57.89%) in the control group (P<0.05). Regarding overall clinical efficacy, the total response rate in the experimental group was 78.38%, which was higher than that (50.00%) in the control group (P<0.05). ③ Mechanism outcomes: Compared with baseline levels, both groups showed declined serum levels of GRP78, Caspase-3, and TGF-β1 and urinary level of TGF-β1 after treatment (P<0.01). Moreover, the experimental group showed greater declines than the control group (P<0.05). The serum levels of GRP78, Caspase-3,and TGF-β1 and the urinary level of TGF-β1 in DKD patients showed positive correlations with BUN, SCr, UACR, and FBG and negative correlations with eGFR (P<0.05). ④ Safety outcomes: Neither group showed drug-related adverse reactions, and laboratory safety parameters remained within normal ranges. ConclusionYishen Jiangtang decoction combined with conventional Western medicine treatment may safely and effectively alleviate clinical symptoms, correct glucose and lipid metabolism disorders, and protect the renal function in patients with stage G3A3 DKD and the pattern of Qi-Yin deficiency combined with dampness-heat and blood stasis. The mechanism may be associated with inhibition of the ERS-apoptosis axis and delay of the RF process.
10.Clinical Efficacy of Yishen Jiangtang Decoction Combined with Conventional Western Medicine Treatment for Diabetic Kidney Disease with Pattern of Qi-Yin Deficiency Combined with Dampness-heat and Blood Stasis
Yunjie YANG ; Yasheng DENG ; Kaiying HE ; Qi ZHANG ; Yongxin YU ; Yaqing RUAN ; Zhuang HAN ; Qiwei CHEN ; Yi WEI ; Qiu CHEN ; Jing WU ; Mingqian JIANG ; Shiwei RUAN ; Jianting WANG ; Yuliang QIU ; Lixiang ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):157-167
ObjectiveTo observe the clinical efficacy and safety of Yishen Jiangtang decoction combined with conventional Western medicine treatment in managing stage G3A3 diabetic kidney disease (DKD) in the patients with the pattern of Qi-Yin deficiency combined with dampness-heat and blood stasis, and to explore its mechanism of inhibiting the endoplasmic reticulum stress (ERS)-apoptosis axis and delaying renal fibrosis (RF). MethodsA single-center, randomized, parallel-controlled clinical trial was conducted. A total of 78 patients diagnosed with stage G3A3 DKD and traditional Chinese medicine (TCM) pattern of Qi-Yin deficiency combined with dampness-heat and blood stasis and treated in the Department of Nephrology and the Department of Endocrinology of the People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine from March 2025 to February 2026 were enrolled. They were randomly assigned at a 1∶1 ratio into a control group (conventional Western medicine treatment) and an experimental group (Yishen Jiangtang decoction combined with conventional Western medicine treatment), with 39 patients in each group. The treatment lasted for 12 weeks. Basic demographic data and medical history were collected before and after treatment. The two groups before and after treatment were compared in terms of the following parameters: Blood urea nitrogen (BUN), serum creatinine (SCr), estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), fasting blood glucose (FBG), triglycerides (TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C). Enzyme-linked immunosorbent assay (ELISA) kits were used to measure serum glucose-regulated protein 78 (GRP78), serum cysteinyl aspartate-specific protease-3 (Caspase-3), and serum and urinary transforming growth factor-β1 (TGF-β1) levels before and after treatment. TCM symptom scores, TCM syndrome efficacy, and overall clinical efficacy were evaluated before and after treatment. Spearman correlation analysis was performed to explore the correlations of serum levels of GRP78 and Caspase-3, as well as serum and urinary levels of TGF-β1, with renal function, proteinuria, and glucose and lipid metabolism indicators in patients with DKD. In addition, safety indicators were also monitored. ResultsA total of 75 patients completed the study (38 in the control group and 37 in the experimental group). ① Baseline data: The two groups were comparable in terms of sex and age, with no statistically significant difference. ② Efficacy outcomes: Compared with baseline levels, both groups showed reductions in BUN, SCr, UACR, FBG, TG, TC, LDL-C, and TCM symptom scores (P<0.01) and increases in eGFR level (P<0.01). Moreover, the experimental group outperformed the control group in altering the indicators above (P<0.05). Regarding TCM syndrome efficacy, the total response rate in the experimental group was 83.78%, which was higher than that (57.89%) in the control group (P<0.05). Regarding overall clinical efficacy, the total response rate in the experimental group was 78.38%, which was higher than that (50.00%) in the control group (P<0.05). ③ Mechanism outcomes: Compared with baseline levels, both groups showed declined serum levels of GRP78, Caspase-3, and TGF-β1 and urinary level of TGF-β1 after treatment (P<0.01). Moreover, the experimental group showed greater declines than the control group (P<0.05). The serum levels of GRP78, Caspase-3,and TGF-β1 and the urinary level of TGF-β1 in DKD patients showed positive correlations with BUN, SCr, UACR, and FBG and negative correlations with eGFR (P<0.05). ④ Safety outcomes: Neither group showed drug-related adverse reactions, and laboratory safety parameters remained within normal ranges. ConclusionYishen Jiangtang decoction combined with conventional Western medicine treatment may safely and effectively alleviate clinical symptoms, correct glucose and lipid metabolism disorders, and protect the renal function in patients with stage G3A3 DKD and the pattern of Qi-Yin deficiency combined with dampness-heat and blood stasis. The mechanism may be associated with inhibition of the ERS-apoptosis axis and delay of the RF process.

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