1.Interpretation of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Wenxi PENG ; Meng QIAO ; Lianxin WANG ; Yuanyuan LI ; Xiuhui LI ; Xin CUI ; Zijia CHEN ; Xinyi CHEN ; Yi DENG ; Yanming XIE ; Zhifei WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):152-160
The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines (hereinafter referred to as the Guidelines) is first specialized in the field of drug safety for oral Chinese patent medicines (OCPMs) in China. Rooted in China's healthcare context, the Guidelines address the unique usage patterns and risk characteristics of OCPMs, filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines, and to promote the standardized development of pharmacovigilance practices for OCPMs, this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting, the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment, the Guidelines were examined from three dimensions of formulation components, medication behaviors, and population to address complex safety issues arising from medicinal constituents, irrational use, and individual susceptibility. In the area of risk control, the analysis focused on context-based interventions and dynamic closed-loop management strategies, exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore, this paper evaluated the applied value of the Guidelines and identified implementation challenges, such as insufficient capacity at the primary-care level and limited digital infrastructure. In response, the study proposed optimization strategies including establishing a dynamic updating mechanism, strengthening training at the grassroots level, and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders (including manufacturers), pharmaceutical distributors, healthcare institutions, and research organizations, ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.
2.Therapeutic efficacy of ruxolitinib combined with low-dose hormone in aGVHD after allogeneic hematopoietic stem cell transplantation
Yue HU ; Xupai ZHANG ; Sihan LAI ; Shan ZHANG ; Lei MA ; Xiao WANG ; Yan DENG ; Ying HAN ; Ying HE ; Guangcui HE ; Hai YI
Chinese Journal of Blood Transfusion 2026;39(4):506-512
Objective: To evaluate the efficacy and safety of ruxolitinib combined with low-dose hormone for patients with acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Methods: Thirty patients with aGVHD after allo-HSCT admitted to the Department of Hematology of the General Hospital of Western Theater Command from November 2021 to November 2024 were retrospectively analyzed. All patients were treated with low-dose hormone (methylprednisolone 0.3-1 mg kg
-d
) combined with ruxolitinib 5-10 mg d
. The efficacy and adverse reactions were observed during the follow-up period to analyze the survival outcomes of the patients. Results: A total of 30 patients with aGVHD after allo-HSCT were included in this study, consisting of 15 (50%) males and 15 (50%) females with a median age of 34 year-old (ranging from 14 to 62). Classification by disease type: there were 18 cases of acute myeloid leukemia, 4 cases of acute lymphoblastic leukemia, 4 cases of aplastic anemia, and 4 cases of myelodysplastic syndrome. Classification by aGVHD severity: there were 27 cases (90%) of Ⅱ-Ⅳ degree aGVHD and 11 cases (36.7%) of Ⅲ-Ⅳ degree aGVHD. Ruxolitinib in combination with low-dose glucocorticoid treatment yield responses in 28 (93.3%) patients, of which 27 (90%) achieved complete remission (CR), while 1 (3.3%) showed partial remission (PR). One patient (3.3%) had no response (NR), and 1 patient (3.3%) exhibited progressed disease (PD). Overall survival (OS) at 1 year of transplantation was 73.9% (95%CI 49.5% to 87.7%), progression-free survival (PFS) was 93.3% (95%CI 75.9% to 98.3%), non-relapse mortality (NRM) was 20.6% (95%CI 7.9% to 47.4%), and median survival time was 27.6 months. Conclusion: Ruxolitinib combined with low-dose hormones is safe and effective in the treatment of aGVHD after allo-HSCT.
3.Overview of Physical Biological Research on the Activation of Acupoint Effects by Acupuncture
Junyi LI ; Shiwei TU ; Yangyang LIU ; Baomin DOU ; Zezhi FAN ; Jiangjiang FU ; Jiangqi ZHOU ; Kaiyuan DENG ; Yanwei LI ; Yi GUO
Journal of Traditional Chinese Medicine 2026;67(10):1130-1136
By reviewing the physical biological research on the activation of acupoint effects by acupuncture, this paper explains the activation mechanism from the perspective of the generation and transmission of mechanical signals caused by acupuncture, and reveals the physical-chemical coupling processes in the acupoint microenvironment. Future research should focus on locally mechanosensitive cells, further exploring how acupuncture mechanical signals trigger dynamic changes in cells and molecules in the acupoints, and the physical-chemical information transduction mechanism, which will provide scientific evidence for the acupoint activation during acupuncture. Related studies will contribute to a deeper understanding of the scientific principles behind acupuncture and promote its clinical application and development.
4.Antibody levels of diphtheria and tetanus in healthy population in Pudong New Area, Shanghai, 2018-2024
Yu BAI ; Dandan YANG ; Wanran CHENG ; Rui ZHANG ; Pengfei DENG ; Caoyi XUE ; Laibao YANG ; Yi FEI
Journal of Public Health and Preventive Medicine 2026;37(3):52-55
Objective To understand the antibody levels of diphtheria and tetanus among healthy population in Shanghai Pudong New Area, and to provide a scientific basis for improving the vaccine immunization strategy. Methods Random sampling was used to select healthy people of all ages in 16 communities in Shanghai Pudong New Area from 2018 to 2024, and serum samples were collected and tested for serum anti-diphtheria and tetanus toxin IgG antibodies by enzyme-linked immunosorbent assay (ELISA) method to analyze the antibody positivity rate (≥0.1 IU/ml) and the geometric mean concentration (GMC) of antibodies. Results A total of 3 312 serum samples were included, with a male-to-female ratio of 0.76:1, and 53.77% were local residents. The seropositivity rates and geometric mean concentrations (GMC) of both diphtheria and tetanus antibodies generally declined with increasing age, but exhibited a transient rebound in the 7y-. A total of 1 175 individuals (35.48%) were seropositive for diphtheria, with a GMC of 0.054 IU/mL. For tetanus, 988 individuals (29.83%) were seropositive, with a GMC of 0.033 IU/mL. Significant differences in seropositivity rates (χ2diphtheria=950.005,χ2tetanus=1 324.393) and GMC (Hdiphtheria=1027.160,Htetanus=1 142.007) were observed among different age groups (P<0.001). Significant differences in seropositivity rates (χ2diphtheria=950.005,χ2tetanus=1324.393) and GMC (Hdiphtheria=1027.160,Htetanus=1142.007) were also found across different years (P<0.001). Conclusion The prevalence of diphtheria and tetanus antibodies in the healthy population of Pudong New Area is relatively low, particularly among adults over 20 years of age with inadequate immunization. This underscores the need to reinforce the National Immunization Program (NIP) vaccine specifications for children under 6 years of age and implement an immunization strategy for adolescents or adults against diphtheria and tetanus.
5.A New Perspective on Mental Health Assessment in Laboratory Animals: Stress Response Monitoring Based on Hair Characteristics
Hongman LI ; Yutong CHEN ; Yingpei SHI ; Yijing WANG ; Yan PAN ; Tong XU ; Yi ZHOU ; Qiyue DENG ; Xue LIU
Laboratory Animal and Comparative Medicine 2026;46(4):553-563
The mental health management of laboratory animals is a critical factor in ensuring the reliability of scientific research data. However, due to the subtle nature of mental state alterations and the limitations of current assessment methods, the mental health of laboratory animals is often overlooked by researchers. Therefore, there is an urgent need to explore a new, objective, simple, and practical method for evaluating mental health. Stress, as a primary factor inducing alterations in the mental state of animals, can influence experimental results across multiple research fields through the neuroendocrine-immune network. This paper first elucidates the necessity of mental health management in laboratory animals from three perspectives: factors contributing to stress, neural mechanisms of stress, and research areas affected by stress. It highlights that excluding animals with abnormal mental states before experiments can enhance the efficiency and reproducibility of biomedical studies. Second, this paper briefly summarizes existing methods for assessing the health of laboratory animals, pointing out that approaches such as behavioral tests and metabolomics have many limitations in evaluating stress responses. Existing methods struggle to meet the demand for simple, objective, and non-invasive assessment methods in animal management. Therefore, this paper focuses on hair, a biological sample with the advantages of cumulative information and non-invasive collection, and systematically describes the theoretical basis and technological advances in using hair characteristics as indicators of stress responses from three perspectives: hair traits, the levels of substances in hair, and artificial intelligence (AI). It proposes and supports an innovative technical pathway that combines hair traits with AI-based image analysis, with the aim of offering an improved solution for non-invasive and objective stress assessment, while providing theoretical support for improving the health management system of laboratory animals.
6.Protective Effect of Huayu Jiedu Prescription Against PC12 Cell Damage Induced by Combination of NETs and OGD
Wuchaonan LIU ; Ruiyu HUANG ; Qianru ZENG ; Mengge ZHANG ; Yunhao YI ; Tao GAO ; Dingxiang LI ; Yihui DENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):120-130
ObjectiveTo investigate the protective effect of Huayu Jiedu prescription against PC12 cell damage induced by a combination of neutrophil extracellular traps (NETs) and oxygen-glucose deprivation (OGD). MethodsFirst, dimethyl sulfoxide (DMSO) was used to induce the differentiation of the human promyelocytic leukemia cell line (HL-60) into neutrophil-like cells (dHL-60), and cell differentiation was assessed through Giemsa staining and flow cytometry. Next, phorbol myristate (PMA) was used to induce the formation of NETs in dHL-60 cells. The formation of NETs was assessed via SYTOX Green staining, and NETs were extracted by low-speed centrifugation. Finally, the NETs prepared through the conditioned medium were combined with OGD to induce a high-differentiation PC12 neuronal cell damage model through the co-culture method. This model was treated with the Huayu Jiedu prescription-containing serum. Cells were randomly allocated into a normal control group, a model (NETs + OGD) group, a traditional Chinese medicine (NETs + OGD + 5% Huayu Jiedu prescription-containing serum) group, and a NETosis inhibitor (100 mg·L-1 DNase I + NETs + OGD) group. The cell counting kit-8 (CCK-8) assay was used to evaluate cell viability and screen the optimal intervention concentrations of NETs and Huayu Jiedu Formula-containing serum, as well as the optimal intervention time for OGD. Enzyme-linked immunosorbent assay (ELISA) was adopted to measure the levels of myeloperoxidase-DNA complexes (MPO-DNA), citrullinated histone H3 (CitH3), and neutrophil elastase (NE). Western blot was employed to quantify the protein levels of CitH3 and cleaved Caspase-3. Terminal-deoxynucleotidyl transferase-mediated dUTP-biotin nick end labeling assay (TUNEL) staining and flow cytometry were employed to assess neuronal apoptosis. ResultsCompared with those in the normal control group, cells in the model group successfully differentiated into dHL60 cells after DMSO induction. Wright-Giemsa staining revealed that the cells in the model group had disappeared nucleoli, distinct reniform and lobulated changes of nuclei, highly condensed chromatin, and the cytoplasm containing pale purple fine granules. Flow cytometry showed that the mean fluorescence intensity (MFI) of CD11b in the model group was enhanced (P<0.01). Compared with those in the normal control group, dHL60 cells in the model group successfully generated NETs after PMA induction. SYTOX Green staining revealed loss of cell membrane integrity, with chromatin released from the cytoplasm to form abundant extracellular, cloud-like fibrillar structures, and a marked increase in fluorescence intensity (P<0.01). Through the CCK-8 assay for assessing the viability of highly differentiated PC12 cells, the optimal concentration for NETs was determined as 1 000 ng·L-1, the optimal concentration of Huayu Jiedu formula-containing serum as 5%, and the optimal duration for OGD as 2 h. Compared with the normal control group, the model group showed elevated levels of MPO-DNA, CitH3, and NE (P<0.01) and upregulated protein levels of CitH3 and cleaved Caspase-3 (P<0.01). Furthermore, TUNEL staining revealed an increased proportion of apoptotic cells (P<0.01) and flow cytometry showed an increased apoptosis rate (P<0.01) in the model group. Compared with the model group, the Huayu Jiedu formula-containing serum group and the NETosis inhibitor group exhibited declined levels of MPO-DNA, CitH3, and NE (P<0.05,P<0.01) and downregulated protein levels of CitH3 and cleaved Caspase-3 (P<0.01). In addition, TUNEL staining showed a decrease in the proportion of apoptotic cells (P<0.01), and flow cytometry revealed a decrease in the apoptosis rate (P<0.01). ConclusionHuayu Jiedu prescription may exert a protective effect against ischemic neuronal damage by inhibiting NET formation or alleviating NET-induced neurotoxicity
7.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.
8.High-throughput Sequencing of MET Mutational Landscape in Cancer Patients and the Value of IHC Screening for Targeted Therapy
Feicheng YANG ; Lixia JIANG ; Ruobing LIU ; Kai YANG ; Yewei LI ; Yi XIONG ; Hao DENG ; Jie HU
Journal of Sun Yat-sen University(Medical Sciences) 2026;47(1):172-181
ObjectiveTo investigate the mutation status of the MET gene in tumor patients, with a focus on its expression in lung cancer tissues and its impact on patient prognosis, providing theoretical basis and potential targets for precise diagnosis and treatment of the tumors. MethodsA total of 1,627 tumor patient samples were collected from January 2021 to September 2025. High-throughput sequencing technology was used to conduct DNA-level gene detection on 137 tumor patients with MET mutations. The distribution of mutation sites in exons and introns, as well as the occurrence frequencies of MET gene amplification and gene fusion were analyzed, with particular attention paid to the mutation frequencies of each exon and the high-frequency variant types. Immunohistochemical staining was performed to analyze the expression levels of c-MET protein in tumor tissues of the 137 patients. Immunohistochemical analysis was conducted on tumor tissues of 9 patients with MET gene exon 14 skipping mutations to study the association between c-MET protein expression and this specific mutation type. RNA sequencing results, immunohistochemical staining data, and follow-up prognosis of lung cancer from the GEPIA2 database and TCGA database were comprehensively analyzed to explore the potential relationship between MET gene expression in tumor tissues and patient prognosis. ResultsAmong 1,627 tumor patients, 137 MET mutation patients were detected, including 93 males with an average age of (66.85±9.61) years and 44 females with an average age of (59.43±11.08) years. Lung cancer was the most common tumor type (117 cases). MET gene expression was lower in breast cancer and glioblastoma multiforme, but higher in lung cancer and colorectal cancer as compared with the expression in normal tissues. Survival analysis showed that patients with high MET gene expression in lung adenocarcinoma had a shorter overall survival time than those with low expression. A total of 961 mutations were detected by next-generation sequencing, including 547 exon mutations and 374 intron mutations. MET gene amplification was found in 13 cases and gene fusion in 27 cases. The highest mutation frequency was in exon 2, followed by exon 5, exon 4, and exon 19. High-frequency variant types included c.2890C>A (p.L964M) on exon 4 and c.3028G>T (p.D1010Y) on exon 5. The c-MET protein expression was closely related to the type of gene mutation. Missense mutations often led to positive or strongly positive c-MET protein expression, while nonsense mutations often resulted in weak or absent c-MET protein expression. Among the 9 patients with MET gene exon 14 skipping mutations, the c-MET protein expression score was mostly 0 - 1, with only 1 case scoring 2. Among the 117 lung cancer patients, the incidence rate was higher in males than in females, and more common among stage Ⅲ-Ⅳ patients than among stage I-Ⅱ patients. Out of the 41 patients treated with surgery + targeted drugs (gutemitinib, savolitinib), 8 cases of recurrence or metastasis were found during follow-up. ConclusionMET gene mutations exhibit specific mutation characteristics in different tumor types, and its expression levels show significant differences between various tumor tissues and normal tissues. It is closely related to the poor prognosis of lung adenocarcinoma patients. We found that c-MET protein expression is closely related to the type of MET gene mutation, especially in patients with MET gene exon 14 skipping mutations, which presents a characteristic expression pattern. This provides an important basis for the preliminary screening using immunohistochemistry in clinical practice.
9.Protective Effect of Huayu Jiedu Prescription Against PC12 Cell Damage Induced by Combination of NETs and OGD
Wuchaonan LIU ; Ruiyu HUANG ; Qianru ZENG ; Mengge ZHANG ; Yunhao YI ; Tao GAO ; Dingxiang LI ; Yihui DENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):120-130
ObjectiveTo investigate the protective effect of Huayu Jiedu prescription against PC12 cell damage induced by a combination of neutrophil extracellular traps (NETs) and oxygen-glucose deprivation (OGD). MethodsFirst, dimethyl sulfoxide (DMSO) was used to induce the differentiation of the human promyelocytic leukemia cell line (HL-60) into neutrophil-like cells (dHL-60), and cell differentiation was assessed through Giemsa staining and flow cytometry. Next, phorbol myristate (PMA) was used to induce the formation of NETs in dHL-60 cells. The formation of NETs was assessed via SYTOX Green staining, and NETs were extracted by low-speed centrifugation. Finally, the NETs prepared through the conditioned medium were combined with OGD to induce a high-differentiation PC12 neuronal cell damage model through the co-culture method. This model was treated with the Huayu Jiedu prescription-containing serum. Cells were randomly allocated into a normal control group, a model (NETs + OGD) group, a traditional Chinese medicine (NETs + OGD + 5% Huayu Jiedu prescription-containing serum) group, and a NETosis inhibitor (100 mg·L-1 DNase I + NETs + OGD) group. The cell counting kit-8 (CCK-8) assay was used to evaluate cell viability and screen the optimal intervention concentrations of NETs and Huayu Jiedu Formula-containing serum, as well as the optimal intervention time for OGD. Enzyme-linked immunosorbent assay (ELISA) was adopted to measure the levels of myeloperoxidase-DNA complexes (MPO-DNA), citrullinated histone H3 (CitH3), and neutrophil elastase (NE). Western blot was employed to quantify the protein levels of CitH3 and cleaved Caspase-3. Terminal-deoxynucleotidyl transferase-mediated dUTP-biotin nick end labeling assay (TUNEL) staining and flow cytometry were employed to assess neuronal apoptosis. ResultsCompared with those in the normal control group, cells in the model group successfully differentiated into dHL60 cells after DMSO induction. Wright-Giemsa staining revealed that the cells in the model group had disappeared nucleoli, distinct reniform and lobulated changes of nuclei, highly condensed chromatin, and the cytoplasm containing pale purple fine granules. Flow cytometry showed that the mean fluorescence intensity (MFI) of CD11b in the model group was enhanced (P<0.01). Compared with those in the normal control group, dHL60 cells in the model group successfully generated NETs after PMA induction. SYTOX Green staining revealed loss of cell membrane integrity, with chromatin released from the cytoplasm to form abundant extracellular, cloud-like fibrillar structures, and a marked increase in fluorescence intensity (P<0.01). Through the CCK-8 assay for assessing the viability of highly differentiated PC12 cells, the optimal concentration for NETs was determined as 1 000 ng·L-1, the optimal concentration of Huayu Jiedu formula-containing serum as 5%, and the optimal duration for OGD as 2 h. Compared with the normal control group, the model group showed elevated levels of MPO-DNA, CitH3, and NE (P<0.01) and upregulated protein levels of CitH3 and cleaved Caspase-3 (P<0.01). Furthermore, TUNEL staining revealed an increased proportion of apoptotic cells (P<0.01) and flow cytometry showed an increased apoptosis rate (P<0.01) in the model group. Compared with the model group, the Huayu Jiedu formula-containing serum group and the NETosis inhibitor group exhibited declined levels of MPO-DNA, CitH3, and NE (P<0.05,P<0.01) and downregulated protein levels of CitH3 and cleaved Caspase-3 (P<0.01). In addition, TUNEL staining showed a decrease in the proportion of apoptotic cells (P<0.01), and flow cytometry revealed a decrease in the apoptosis rate (P<0.01). ConclusionHuayu Jiedu prescription may exert a protective effect against ischemic neuronal damage by inhibiting NET formation or alleviating NET-induced neurotoxicity
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.


Result Analysis
Print
Save
E-mail