1.Evaluation of CARIFS Score and Negative Antigen Conversion Rate of Qingxuan Daozhi Formula in Treatment of Influenza in Children (Heat Accumulation in Lung and Stomach Syndrome):A Multi-center Randomized Controlled Clinical Study
Jing WANG ; Liqun WU ; Tiegang LIU ; Yongning CAO ; Jing QIU ; Jing LI ; Huaqing TAN ; Ying ZHANG ; Xulei GOU ; Jia WANG ; Jing LI ; Haipeng CHEN ; Xueying QIN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Lin JIANG ; Yingqi XU ; Jianping LIU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):188-196
ObjectiveThis paper aims to observe the syndrome improvement and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome). MethodsThrough a multi-center randomized controlled methodology design,confirmed influenza cases were collected from October 2022 to April 2023 in the pediatrics department of eight hospitals,such as Dongfang Hospital of Beijing University of Chinese Medicine. A total of 180 children with influenza and heat accumulation in the lung and stomach syndrome conforming to the standard were recruited through the clinic. The sick children meeting the inclusion criteria were randomly divided into groups by a block-randomized method. The children in the experimental group were treated with Qingxuan Daozhi formula for five days,and those in the control group were treated with Oseltamivir Phosphate Granules for five days. The primary efficacy indicator was the negative conversion rate of influenza antigen detection. Secondary efficacy indicators were the Canadian acute respiratory illness and flu scale (CARIFS) and the incidence of complications,severe cases, and critical cases. Follow-up observation was conducted on the day of enrollment,48 hours after medication,72 hours after medication, and (6+1) d after medication. ResultsOne hundred and eighty participants were randomly assigned to the experimental group (90 cases) or the control group (90 cases). All participants were followed up during the study. Comparison of influenza antigen detection results in the primary efficacy indicators showed that the average time of negative influenza antigen conversion in the experimental group was (5.29±1.25) d,and that in the control group was (5.40±1.68) d,without a statistically significant difference. After five days of intervention,52 cases in the experimental group and 51 cases in the control group converted to negative,without a statistically significant difference. CARIFS score results in the secondary efficacy indicators showed that during 72 hours after intervention,there were statistically significant differences between the experimental group and the control group in three dimensions, including headache,muscle soreness, and the need for extra care (P<0.05). On the (6+1) days after the intervention,the differences in both the experimental group and the control group were statistically significant in 10 dimensions, including sore throat,bad sleep,uncomfortable feeling,poor spirit and fatigue,crying more than usual,the need for extra care,symptom,function,influence on parents,and total score (P<0.05). The comparison results within the group in the dimensional scores of symptom, function, and influence on parents,as well as the CARIFS total score showed that with the delay of follow-up time,scores of both groups decreased significantly,with a statistically significant difference (P<0.01). Inter-group comparison results showed that the mean score of the experimental group was higher than that of the control group at the time of enrollment. With the progress of intervention,the score of the experimental group was significantly decreased compared with that of the control group. At the end of follow-up,the mean score of the experimental group was lower than that of the control group,with no statistically significant difference. In terms of the incidence of complications,severe cases, and critical cases, there were no complications,severe cases, and critical cases in the two groups,without a statistically significant difference. ConclusionThe symptom improvement effect and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome) are not inferior to Oseltamivir Phosphate granules, and children's acceptance is better. It can be more widely used in clinical treatment of influenza in children (heat accumulation in the lung and stomach syndrome).
2.Banxia Baizhu Tianmatang Regulates NLRP3 Inflammasomes to Ameliorate Cognitive Impairment in Epilepsy
Xingdan ZHU ; Yinhua KAI ; Rong TIAN ; Xin YANG ; Jiayi HE ; Xiangxin GUO ; Yadong MU ; Cui JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(14):308-316
ObjectiveTo explore the mechanism through which Banxia Baizhu Tianmatang ameliorates cognitive impairment in epileptic rats induced by lithium chloride-pilocarpine by regulating the neuroinflammatory reaction mediated by NOD-like receptor protein 3 (NLRP3) inflammasomes. MethodsSixty male SD rats were randomly allocated into blank, model, carbamazepine (0.125 g·kg-1·d-1), Banxia Baizhu Tianmatang (1.04 g·kg-1·d-1), and carbamazepine (0.125 g·kg-1·d-1) + Banxia Baizhu Tianmatang (1.04 g·kg-1·d-1) groups (n=12). After the modeling of epilepsy, rats were administrated with corresponding agents by gavage for 12 weeks. At the 6th and 12th week of the intervention, the rats’ hyper-excited behavior was evaluated by the stylus experiment, and at the 12th week of intervention, the cognitive function was evaluated by Barnes maze. At the same time, the seizure frequency and severity grade (Racine score) were recorded. The serum and hippocampus tissue samples were collected after anesthesia for the following tests. Nissl staining was used to evaluate the degree of neuronal damage in the hippocampal CA1 area. The content of malondialdehyde (MDA) in the hippocampus was determined by the thiobarbituric acid (TBA) method. Serum levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-18 (IL-18) were quantified by enzyme-linked immunosorbent assay (ELISA). Immunohistochemical method was adopted to detect the expression of apoptosis-associated speck-like protein containing a card (ASC) in the hippocampus. Western blot was employed to quantitatively analyze the protein levels of NLRP3, cysteinyl aspartate-specific proteinase-1 (Caspase-1), and brain-derived neurotrophic factor (BDNF) in the hippocampus. ResultsThe model group showed increased stylus scores at the 6th and 12th week after modeling, a decreased Barnes maze strategy score at the 12th week, a prolonged incubation period (P<0.05), elevated serum levels of inflammatory factors (P<0.05), decreased neurons with scattered arrangement and large gaps in the hippocampus, increased content of MDA in the hippocampus (P<0.05), an increased positive expression of ASC, and up-regulated protein levels of Caspase-1, NLRP3, and BDNF (P<0.05). Compared with the model group, the intervention with Banxia Baizhu Tianmatang for 12 weeks was accompanied by a decreased stylus score, epileptic seizures with a decreased score, a decreased number, and shortened duration, an increased Barnes maze strategy score, shortened escape latency (P<0.01), declined serum levels of inflammatory factors (P<0.05), regular morphology of hippocampal neurons, reduced MDA content in the hippocampus (P<0.05), a decreased positive expression of ASC, and down-regulated protein levels of Caspase-1, NLRP3, and BDNF (P<0.05, P<0.01). In addition, compared with the carbamazepine group, Banxia Baizhu Tianmatang + carbamazepine showed improved performance in controlling the seizure, improved the cognitive behavior score and morphology of hippocampal neurons, alleviated the oxidative stress products, lowered the levels of inflammatory factors, reduced the positive expression of ASC in the hippocampus, and down-regulated the expression of Caspase-1, NLRP3 and BDNF, with no significant differences. ConclusionBanxia Baizhu Tianmatang may reduce neuroinflammation, control epileptic seizures, and ameliorate cognitive impairment by inhibiting the expression of NLRP3 inflammasomes.
3.Integrating Transcriptomics and 3D Organoids to Investigate Mechanism of Periplaneta americana Extract Against Lung Adenocarcinoma
Qiong MA ; Chunxia HUANG ; Jiawei HE ; Yuting BAI ; Xingyue LIU ; Yuxuan XIONG ; Yang ZHONG ; Hengzhou LAI ; Yuling JIANG ; Xueke LI ; Qian WANG ; Yifeng REN ; Xi FU ; Funeng GENG ; Taoqing WU ; Ping XIAO ; Fengming YOU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):124-132
ObjectiveTo evaluate the antitumor activity of Periplaneta americana extract(PAE) against human-derived lung adenocarcinoma organoids(LUAD-PDOs) and to elucidate its potential mechanism based on transcriptomics. MethodsFresh tumor and adjacent normal tissues from patients with LUAD were collected to construct LUAD-PDOs and normal lung organoid(Nor-PDOs) models using 3D organoid culture technology. The effective intervention concentration of PAE was determined using the cell counting kit-8(CCK-8) assay. Experimental groups included the model group(LUAD-PDOs), normal group, model administration group(LUAD-PDOs+PAE), and normal administration group(Nor-PDOs+PAE). Hematoxylin-eosin(HE) staining was used to observe the pathological structures of PDOs, immunohistochemistry(IHC) was performed to detect the expressions of the proliferation marker Ki-67 and lung adenocarcinoma differentiation markers cytokeratin-7(CK-7) and Napsin A, TUNEL staining was applied to detect cell apoptosis. RNA sequencing(RNA-Seq) was conducted to identify differentially expressed genes(DEGs), followed by Gene Ontology(GO), Kyoto Encyclopedia of Genes and Genomes(KEGG), and Gene Set Enrichment Analysis(GSEA), alongside protein-protein interaction(PPI) network analysis to screen core mechanisms. Finally, key targets were validated by integrating external database analysis with immunofluorescence(IF). ResultsNor-PDOs and LUAD-PDOs that highly recapitulated the pathological characteristics of the primary tissues were successfully established. The CCK-8 assay determined that the effective intervention concentration of PAE was 16 g·L-1. Morphological observation showed that Nor-PDOs exhibited lumen-forming structures, whereas LUAD-PDOs displayed dense, solid structures. CCK-8 and TUNEL assays revealed that, compared with the model group, PAE intervention inhibited the proliferation of LUAD-PDOs and promoted apoptosis in LUAD cells, while showing no significant effect on the viability of Nor-PDOs. Transcriptomic analysis identified 719 DEGs that were significantly reversed after PAE intervention(347 up-regulated and 372 down-regulated)(P<0.05). GO enrichment analysis indicated that DEGs in the model administration group were significantly enriched in biological processes related to cell cycle regulation compared to the model group. KEGG pathway analysis revealed that PAE affected pathways related to proliferation and metabolism, including pathways in cancer and the p53 signaling pathway. GSEA further confirmed that PAE significantly enhanced the activity of the p53 signaling pathway(P<0.05). PPI network analysis indicated that breast cancer type 1 susceptibility protein(BRCA1) and checkpoint kinase 1(CHEK1) were the core down-regulated targets in the p53 pathway. IF verified the high expression of BRCA1 and CHEK1 in LUAD-PDOs and their significant downregulation after PAE intervention(P<0.05). Furthermore, survival analysis based on The Cancer Genome Atlas(TCGA) database indicated that low expression of BRCA1 and CHEK1 was significantly associated with prolonged overall survival in patients with LUAD(P<0.05). ConclusionPAE effectively inhibits proliferation of LUAD-PDOs and promotes their apoptosis, its anti-tumor mechanism is potentially associated with the activation of the p53 signaling pathway, with BRCA1 and CHEK1 genes likely serving as key downstream targets for the effects of PAE.
4.Construction and Application of "Source-Pivot-Convergence" Pattern Identification and Treatment Model for Malignant Tumors
Yuling JIANG ; Jiawei HE ; Yang ZHONG ; Chunxia HUANG ; Qiong MA ; Chuan ZHENG ; Xi FU ; Fengming YOU
Journal of Traditional Chinese Medicine 2026;67(9):956-960
Based on LI Gao's Academic Thought, focusing on the process of qi transformation and taking the regulation and restoration of metabolism and immunity as the entry point, a "source-pivot-convergence" diagnostic and therapeutic model for malignant tumors is constructed. In this model, spleen and stomach internal injury is the source of malignant tumor occurrence, while the disorder of ascending and descending is the pivot of the disease development, and the generation of yin fire is the convergence of malignant tumor progression. Based on this, the three major therapeutic methods of clearing the source, harmonizing the pivot, and resolving the convergence are established. To fortify spleen and boost qi, consolidate the root and clear the source, modified Buzhong Yiqi Decoction(补中益气汤)can be used. To raise the clear and direct the turbid downward, regulate qi and harmonize the pivot, modified Shengyang Yiwei Decoction (升阳益胃汤) is suggested. To restore balance and promote circulation, disperse accumulation and resolve convergence, modified Shengyang Sanhuo Decoction (升阳散火汤) is selected. In clinical practice, these formulas can be used in combination according to the complexity of the pathogenesis, and further adapted with prescriptions for promoting dispersion and penetrating pathogenic factors, resolving phlegm and promoting circulation, activating blood and eliminating concretions, which can provide a reference for the prevention and treatment of tumor diseases.
5.Construction and Application of "Source-Pivot-Convergence" Pattern Identification and Treatment Model for Malignant Tumors
Yuling JIANG ; Jiawei HE ; Yang ZHONG ; Chunxia HUANG ; Qiong MA ; Chuan ZHENG ; Xi FU ; Fengming YOU
Journal of Traditional Chinese Medicine 2026;67(9):956-960
Based on LI Gao's Academic Thought, focusing on the process of qi transformation and taking the regulation and restoration of metabolism and immunity as the entry point, a "source-pivot-convergence" diagnostic and therapeutic model for malignant tumors is constructed. In this model, spleen and stomach internal injury is the source of malignant tumor occurrence, while the disorder of ascending and descending is the pivot of the disease development, and the generation of yin fire is the convergence of malignant tumor progression. Based on this, the three major therapeutic methods of clearing the source, harmonizing the pivot, and resolving the convergence are established. To fortify spleen and boost qi, consolidate the root and clear the source, modified Buzhong Yiqi Decoction(补中益气汤)can be used. To raise the clear and direct the turbid downward, regulate qi and harmonize the pivot, modified Shengyang Yiwei Decoction (升阳益胃汤) is suggested. To restore balance and promote circulation, disperse accumulation and resolve convergence, modified Shengyang Sanhuo Decoction (升阳散火汤) is selected. In clinical practice, these formulas can be used in combination according to the complexity of the pathogenesis, and further adapted with prescriptions for promoting dispersion and penetrating pathogenic factors, resolving phlegm and promoting circulation, activating blood and eliminating concretions, which can provide a reference for the prevention and treatment of tumor diseases.
6.Targeting ER lipid raft-associated 1 reveals a coordinated cholesterol-dependent vulnerability in hepatocellular carcinoma
Yiming ZHANG ; Yushan HOU ; Xinxin WANG ; Kaikun XU ; Pei JIANG ; Siqi WANG ; Huimin KANG ; Hu ZHANG ; Jingzhuo JIN ; Xiaofen HUANG ; Zifeng LIU ; Songpeng YANG ; Jiaqi LIU ; Lingqiang ZHANG ; Fuchu HE ; Chunyan TIAN ; Aihua SUN
Clinical and Molecular Hepatology 2026;32(2):866-883
Background/Aims:
Dysregulated cholesterol metabolism is a hallmark of hepatocellular carcinoma (HCC) that drives tumor initiation and progression. However, clinical targeting of cholesterol metabolism has yielded limited benefits due to stringent feedback in tumor cells. Identifying a central mediator capable of restoring cholesterol homeostasis within the cell’s intrinsically fine-tuned regulatory framework is urgently needed.
Methods:
We integrated a proteomic dataset from patients with cholesterol-dysregulated HCC into a global cholesterol metabolic regulatory network to identify potential therapeutic targets for disrupted cholesterol homeostasis. The prognostic significance of the candidate targets was further validated in an independent cohort through immunohistochemistry. Functional and mechanistic studies were conducted in vitro using HCC cell lines and in vivo using mouse models. The pharmacological efficacy of the candidate agent was evaluated in both subcutaneous and orthotopic HCC mouse models.
Results:
ER lipid raft-associated 1 (ERLIN1), a pivotal regulator of cholesterol metabolism reprogramming, was identified as an independent favorable prognostic indicator in HCC. ERLIN1 constrains HCC progression both in vitro and in vivo by stabilizing the INSIG1–SCAP–SREBP2 axis and maintaining the metabolic balance of intracellular cholesterol. Under hypoxia, impaired factor-inhibiting hypoxia-1-dependent hydroxylation of ASB11 at asparagine residues 90 and 92 enhances ASB11-mediated ERLIN1 degradation. Pharmacological targeting of this axis using zoledronic acid (ZoA) attenuated HCC progression by weakening the ASB11–ERLIN1 interaction and restoring cholesterol homeostasis.
Conclusions
ERLIN1 represents a druggable metabolic vulnerability in cholesterol-dysregulated HCC. Targeting the ASB11–ERLIN1 axis with the clinically approved ZoA reestablishes cholesterol homeostasis and offers a promising therapeutic strategy to overcome the current limitations of cholesterol-targeted HCC therapies.
7.Analysis of soil-borne nematode infection status among rural communities in Yubei, Chongqing
Dan JIANG ; Yong-dong HAO ; Sen-ping YANG ; Xiao-yuan SU ; Hua-jun BAI ; Bo LYU ; Ya-ling RAN ; He-yi GUAN ; Ling HU
Acta Parasitologica et Medica Entomologica Sinica 2026;33(2):85-89
Objective To analyze the infection status and epidemic trends of soil-borne nematode infections in Yubei, Chongqing City, in 2010,2021, and 2022. Methods The local populations from four survey sites of four towns in 2010 and five sites of five towns in 2021 and 2022 were surveyed regarding their basic information using a unified form. Fecal samples of the participants were collected and tested for soil-borne nematode infections using the modified Kato-Katz thick smear method. Results In 2010, 2 049 participants were surveyed, followed by 1 000 participants in 2021 and 2022. The overall prevalence of parasitic infections declined significantly from 3.86% to 0.20%. In 2010, soil-transmitted nematode included hookworms(3.81%) and roundworms(0.29%). In 2021, the infection rates of roundworms and hookworms were 1.70% and 0.10% respectively. Notably, only Ascaris was identified in 2022(0.20%). The≥60 age group consistently exhibited the highest infection rates across all surveys, followed by the 40-59 age group. The infection rates of males in the three surveys were 3.31%,1.92%, and 0.20% respectively, and those of females were 4.37%, 1.46%, and 0.20% respectively. There was no statistically significant difference in the infection rates between males and females. Educational attainment was inversely associated with infection; in 2010, the highest prevalence was observed among those with primary education or below, whereas in 2021, illiterate or semi-literate individuals showed the highest susceptibility. The occupational distribution of infections in 2010 indicated that retirees (8.33%), farmers(4.86%), and homemakers or unemployed individuals(3.45%)were the most affected. However, in 2021 and 2022, farmers emerged as the predominant occupational group with soil-transmitted nematode infections. Conclusions The infection rate of soil-borne nematodes showed a decreasing trend in Yubei, and the infection species changed from hookworms in 2010 to Ascaris in 2022. Farmers, the elderly, and people with low education levels should continue to be the focus of preventive and control efforts.
8.Traditional Chinese Medicine Modulates Endoplasmic Reticulum Stress for Prevention and Treatment of Neuropathic Pain: A Review
Fengjiao YANG ; Yingye LIANG ; Peng YANG ; Yuling JIANG ; Gangyun WANG ; Yufeng HE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(17):291-300
Neuropathic pain (NP) is a chronic pain syndrome resulting from injury, inflammation, or dysfunction of the somatosensory nervous system. Its pathogenesis is complex and intimately associated with peripheral sensitization and maladaptive neuroplasticity within the central nervous system. The core clinical manifestations, including spontaneous pain, allodynia, and paresthesia, severely compromise patients’ quality of life and pose substantial challenges to clinical management. Endoplasmic reticulum stress (ERS), a critical cellular defense mechanism against disrupted intracellular homeostasis, is primarily initiated and modulated through three canonical branches of the unfolded protein response (UPR): the protein kinase RNA-like endoplasmic reticulum kinase (PERK) pathway, the inositol-requiring transmembrane kinase/endonuclease 1α (IRE1α) pathway, and the activating transcription factor 6 (ATF6) pathway. These signaling cascades play a pivotal role in the pathological progression of NP. Traditional Chinese medicine (TCM) exhibits unique advantages in the treatment of NP. Leveraging its hallmark characteristics of multi-target, multi-pathway, and holistic regulation, TCM can systematically modulate the ERS signaling network to inhibit neuronal apoptosis, attenuate neuroinflammatory infiltration, and rectify autophagic dysfunction, ultimately promoting the repair and regeneration of damaged neural tissue. This review systematically summarizes the core role of ERS in the occurrence and development of NP. It focuses on the latest research progress regarding ERS pathway modulation in NP amelioration by representative TCM interventions, including potential core bioactive components (e.g., tanshinoneⅡA, catalpol, and formononetin), classic and empirical compound formulas (e.g., Huangqi Guizhi Wuwu decoction, Compound Qiying granules, and Tangluoning), and TCM external therapies (e.g., electroacupuncture, moxibustion with seed-sized moxa cone, and acupotomy). Through an in-depth analysis of the functional characteristics and mechanisms of these TCM interventions, particularly their bidirectional regulation and multi-target synergy, this review aims to provide a solid theoretical foundation for further optimizing TCM-based strategies for NP prevention and treatment and to delineate future directions for clinical translation of related research achievements and targeted drug development.
9.Chinese clinical expert consensus on multi-arm robotic-assisted uniportal pulmonary resection
Deping ZHAO ; Xuefei HU ; Chenlu YANG ; Ye NING ; Yuming ZHU ; Lei JIANG ; Wenxin HE ; Chang CHEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(09):1370-1374
Multi-arm robotic-assisted uniportal pulmonary resection is an emerging minimally invasive technique that enables anatomical pulmonary resection through a single incision using a multi-arm robotic platform. This consensus was initiated by Shanghai Pulmonary Hospital and developed through a multidisciplinary national expert panel. Using evidence-based methodology and expert survey, it provides a comprehensive overview of the clinical application of this technique, including its definition, indications and contraindications, technical considerations, and learning curve. As the first expert consensus focused on multi-arm robotic-assisted uniportal pulmonary resection, this consensus highlights the feasibility and developmental potential of the technique, which integrates existing robotic systems with uniportal minimally invasive principles. The consensus also offers theoretical and practical guidance for the standardized and safe implementation of the technique.
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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