1.Xuefu Zhuyutang in Malignant Tumor Disease: A Review
Jiaqi JI ; Xiaoqing HU ; Yihan ZHAO ; Xuhang SUN ; Dandan WEI ; Junwen PEI ; Shiqing JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):321-330
Cancer has become a significant global public health issue, severely impacting public health and societal development. Despite advances in tumor treatment methods in recent years and a gradual decline in cancer mortality rates, drug-related adverse reactions and drug resistance remain substantial challenges. Traditional Chinese medicine (TCM) has demonstrated significant clinical efficacy in cancer treatment and small side effects, making it widely applied in the field of oncology. Xuefu Zhuyutang, derived from Yilin Gaicuo, is known for its abilities to invigorate blood circulation, dispel blood stasis, promote Qi flow, and alleviate pain. It was specifically formulated by the esteemed WANG Qingren of the Qing dynasty for the "blood stasis syndrome in the blood mansion" and is commonly used to treat Qi stagnation and blood stasis syndrome. Clinical studies have shown that Xuefu Zhuyutang, when combined with conventional Western medications, produces significant effects in the treatment of malignant tumors such as liver cancer, lung cancer, and cervical cancer. It substantially reduces the incidence of adverse reactions following Western treatments, including radiation esophagitis, radiation encephalopathy, radiation-induced oral mucositis, and edema. Additionally, it alleviates cancer-related pain and fever, blood hypercoagulability, and associated complications such as depression and anxiety, and also mitigates chemotherapy-induced side effects like hand-foot syndrome. Basic research has demonstrated its potential anti-tumor mechanisms, including the inhibition of Wnt/β-catenin signaling pathway activation, suppression of mitogen-activated protein kinase (MAPK) pathway activation, and anti-tumor angiogenesis. Pharmacological studies have revealed that its active components inhibit tumor cell proliferation and migration, induce tumor cell apoptosis, suppress tumor angiogenesis, enhance the cytotoxicity of natural killer cells against tumors, improve the tumor microenvironment, and regulate immune function. This paper reviewed the latest research progress on Xuefu Zhuyutang in the treatment of malignant tumors from four aspects: theoretical exploration, clinical studies, mechanisms of action, and pharmacological basis, aiming to provide insights and methods for the clinical diagnosis and treatment of malignant tumors.
2.Xuefu Zhuyutang in Malignant Tumor Disease: A Review
Jiaqi JI ; Xiaoqing HU ; Yihan ZHAO ; Xuhang SUN ; Dandan WEI ; Junwen PEI ; Shiqing JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):321-330
Cancer has become a significant global public health issue, severely impacting public health and societal development. Despite advances in tumor treatment methods in recent years and a gradual decline in cancer mortality rates, drug-related adverse reactions and drug resistance remain substantial challenges. Traditional Chinese medicine (TCM) has demonstrated significant clinical efficacy in cancer treatment and small side effects, making it widely applied in the field of oncology. Xuefu Zhuyutang, derived from Yilin Gaicuo, is known for its abilities to invigorate blood circulation, dispel blood stasis, promote Qi flow, and alleviate pain. It was specifically formulated by the esteemed WANG Qingren of the Qing dynasty for the "blood stasis syndrome in the blood mansion" and is commonly used to treat Qi stagnation and blood stasis syndrome. Clinical studies have shown that Xuefu Zhuyutang, when combined with conventional Western medications, produces significant effects in the treatment of malignant tumors such as liver cancer, lung cancer, and cervical cancer. It substantially reduces the incidence of adverse reactions following Western treatments, including radiation esophagitis, radiation encephalopathy, radiation-induced oral mucositis, and edema. Additionally, it alleviates cancer-related pain and fever, blood hypercoagulability, and associated complications such as depression and anxiety, and also mitigates chemotherapy-induced side effects like hand-foot syndrome. Basic research has demonstrated its potential anti-tumor mechanisms, including the inhibition of Wnt/β-catenin signaling pathway activation, suppression of mitogen-activated protein kinase (MAPK) pathway activation, and anti-tumor angiogenesis. Pharmacological studies have revealed that its active components inhibit tumor cell proliferation and migration, induce tumor cell apoptosis, suppress tumor angiogenesis, enhance the cytotoxicity of natural killer cells against tumors, improve the tumor microenvironment, and regulate immune function. This paper reviewed the latest research progress on Xuefu Zhuyutang in the treatment of malignant tumors from four aspects: theoretical exploration, clinical studies, mechanisms of action, and pharmacological basis, aiming to provide insights and methods for the clinical diagnosis and treatment of malignant tumors.
3.Construction and in vitro osteogenic activity study of magnesium-strontium co-doped hydroxyapatite mineralized collagen
WANG Meng ; SUN Yifei ; CAO Xiaoqing ; WEI Yiyuan ; CHEN Lei ; ZHANG Zhenglong ; MU Zhao ; ZHU Juanfang ; NIU Lina
Journal of Prevention and Treatment for Stomatological Diseases 2026;34(1):15-28
Objective:
To investigate the efficacy of magnesium-strontium co-doped hydroxyapatite mineralized collagen (MSHA/Col) in improving the bone repair microenvironment and enhancing bone regeneration capacity, providing a strategy to address the insufficient biomimetic composition and limited bioactivity of traditional hydroxyapatite mineralized collagen (HA/Col) scaffolds.
Methods:
A high-molecular-weight polyacrylic acid-stabilized amorphous calcium magnesium strontium phosphate precursor (HPAA/ACMSP) was prepared. Its morphology and elemental distribution were characterized by high-resolution transmission electron microscopy (TEM) and energy-dispersive spectroscopy. Recombinant collagen sponge blocks were immersed in the HPAA/ACMSP mineralization solution. Magnesium-strontium co-doped hydroxyapatite was induced to deposit within collagen fibers (experimental group: MSHA/Col; control group: HA/Col). The morphological characteristics of MSHA/Col were observed using scanning electron microscopy (SEM). Its crystal structure and chemical composition were analyzed by X-ray diffraction and Fourier transform infrared spectroscopy, respectively. The mineral phase content was evaluated by thermogravimetric analysis. The scaffold's porosity, ion release, and in vitro degradation performance were also determined. For cytological experiments, CCK-8 assay, live/dead cell staining, alkaline phosphatase staining, alizarin red S staining, RT-qPCR, and western blotting were used to evaluate the effects of the MSHA/Col scaffold on the proliferation, viability, early osteogenic differentiation activity, late mineralization capacity, and gene and protein expression levels of key osteogenic markers [runt-related transcription factor 2 (Runx2), collagen type Ⅰ (Col-Ⅰ), osteopontin (Opn), and osteocalcin (Ocn)] in mouse embryonic osteoblast precursor cells (MC3T3-E1).
Results:
HPAA/ACMSP appeared as amorphous spherical nanoparticles under TEM, with energy spectrum analysis showing uniform distribution of carbon, oxygen, calcium, phosphorus, magnesium, and strontium elements. SEM results of MSHA/Col indicated successful complete intrafibrillar mineralization. Elemental analysis showed the mass fractions of magnesium and strontium were 0.72% (matching the magnesium content in natural bone) and 2.89%, respectively. X-ray diffraction revealed characteristic peaks of hydroxyapatite crystals (25.86°, 31°-34°). Infrared spectroscopy results showed characteristic absorption peaks for both collagen and hydroxyapatite. Thermogravimetric analysis indicated a mineral phase content of 78.29% in the material. The scaffold porosity was 91.6% ± 1.1%, close to the level of natural bone tissue. Ion release curves demonstrated sustained release behavior for both magnesium and strontium ions. The in vitro degradation rate matched the ingrowth rate of new bone tissue. Cytological experiments showed that MSHA/Col significantly promoted MC3T3-E1 cell proliferation (130% increase in activity at 72 h, P < 0.001). MSHA/Col exhibited excellent efficacy in promoting osteogenic differentiation, significantly upregulating the expression of osteogenesis-related genes and proteins (Runx2, Col-Ⅰ, Opn, Ocn) (P < 0.01).
Conclusion
The MSHA/Col scaffold achieves dual biomimicry of natural bone in both composition and structure, and effectively promotes osteogenic differentiation at the genetic and protein levels, breaking through the functional limitations of pure hydroxyapatite mineralized collagen. This provides a new strategy for the development of functional bone repair materials
4.Inhibition of Epithelial-mesenchymal Transition Mechanism in Chronic Atrophic Gastritis Rats by Banxia Xiexintang via Regulating IL-17/ERK/C/EBPβ Signaling Pathway
Wenyu WU ; Xinyu ZENG ; Hao LI ; Weiqi SUN ; Jiahui REN ; Yang YU ; Tingting ZHOU ; Aili XU ; Wei WEI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):1-10
ObjectiveThis study aimed to investigate the action mechanism by which Banxia Xiexintang (BXT) inhibits epithelial-mesenchymal transition (EMT) in chronic atrophic gastritis (CAG) rats by regulating the interleukin-17(IL-17)/extracellular regulated protein kinases(ERK)/CCAAT enhancer binding protein β(C/EBPβ)signaling pathway, thereby providing new theoretical evidence for the treatment of CAG with classic traditional Chinese medicine formulas. MethodsA CAG rat model was established by using the combined factor method. After successful modeling, the rats were randomly divided into the model group, low-, medium-, and high-dose groups (0.549, 1.098, 2.196 g·kg-1, respectively) of BXT, and the positive drug group (vitacoenzyme, 0.3 g·kg-1). A normal control group was also set up. After 8 weeks of intervention, the pathological changes of gastric tissue were evaluated. The enzyme-linked immunosorbent assay (ELISA) was used to detect the contents of IL-17, tumor necrosis factor-α (TNF-α), cyclooxygenase-2 (COX-2), and C/EBPβ in serum, as well as the contents of EMT markers in gastric mucosal tissue including E-cadherin, N-cadherin, and vimentin. The immunohistochemistry method was employed to determine the localization and protein expression levels of IL-17, p-ERK, and C/EBPβ in gastric mucosal tissue. Western blot was used to detect the protein expressions of C/EBPβ, ERK, and its phosphorylated form (p)-ERK in gastric mucosa. Real-time polymerase chain reaction (Real-time PCR) was applied to measure the mRNA expression levels of ERK, COX-2, and C/EBPβ in gastric mucosa. ResultsCompared with those in the normal control group, the rats in the model group showed gastric mucosal glandular atrophy and inflammatory cell infiltration. The protein and their related mRNA expressions of C/EBPβ, ERK, and p-ERK in gastric mucosa were significantly increased (P<0.05,P<0.01). The levels of IL-17, TNF-α, COX-2, and C/EBPβ in serum were significantly increased (P<0.01). The contents of N-cadherin and vimentin in gastric mucosal tissue were significantly increased, while the content of E-cadherin was significantly decreased (P<0.01). Compared with the model group, after intervention with different doses of BXT, the pathological damage of the gastric mucosa was improved to varying degrees. The protein and mRNA expressions of C/EBPβ, ERK, and p-ERK in gastric mucosa were significantly reduced (P<0.05,P<0.01). The levels of IL-17, TNF-α, COX-2, and C/EBP β in serum were significantly decreased (P<0.01). The contents of N-cadherin and vimentin in gastric mucosa tissue were decreased, while the content of E-cadherin was increased (P<0.05,P<0.01). ConclusionBXT can effectively improve the pathological damage of gastric mucosal tissue in CAG rats. Its action mechanism may be related to reducing the levels of IL-17 and TNF-α in serum, regulating the IL-17/ERK/C/EBPβ signaling pathway and inhibiting the EMT process.
5.Methodological establishment of red blood cell lysis method for handling Rh typing double group samples
Lu LI ; Bin WANG ; Junjie WEI ; Xiaolin SUN ; Haiyun LIU ; Weixin WU ; Yinze ZHANG
Chinese Journal of Blood Transfusion 2026;39(1):114-117
Objective: To establish an accurate and rapid typing method for Rh typing of samples from patients who have received recent blood transfusions by utilizing the difference in osmotic fragility between fresh and old red blood cells. Methods: A lysing solution suitable for destroying old RBCs was prepared. Sixty-one samples collected in our hospital in 2024 with Rh typing of double groups were treated with the lysing solution to remove the old allogeneic red blood cells while preserving the patient's own fresh red blood cells, followed by repeat Rh typing tests. Results: For 61 samples with Rh typing in double groups, 41 were accurately detected identified through the red blood cell lysis method, yielding an identification rate of 67.21%. No significant difference was observed compared to the detection rate of the commonly used capillary centrifugation modified method (χ
=0.103, P>0.05). Conclusion: The red blood cell lysis method provides a novel and rapid experimental approach for clinical use in processing Rh-typed samples that are of double groups, thereby offering a basis for Rh compatibility blood transfusion.
6.Effects of Huanglian Jiedutang on Neutrophil Infiltration in Brain of MCAO Mice via Regulation of Chemokine Expression in Exosomes
Haojia ZHANG ; Kai WANG ; Zijin SUN ; Chunyu WANG ; Wei SHAO ; Kunjing LIU ; Liyang DONG ; Dan CHEN ; Wenxiu XU ; Chuanzun WANG ; Wen WANG ; Changxiang LI ; Xueqian WANG ; Fafeng CHENG ; Qingguo WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):42-53
ObjectiveTo investigate whether Huanglian Jiedutang can inhibit neutrophil infiltration in the brains of middle cerebral artery occlusion (MCAO) mice by regulating the expression of neutrophil-related chemokines in exosomes, thereby achieving therapeutic effects. MethodsA total of 130 male specific pathogen-free (SPF) C57BL/6J mice were randomly divided into four groups: Sham-operated group, MCAO model group, Huanglian Jiedutang group (6 g·kg-1), and Ginaton group (21.6 mg·kg-1), with 10 mice in the Ginaton group and 40 mice in each of the remaining three groups. Mice in the Huanglian Jiedutang group and the Ginaton group were administered the corresponding drugs by oral gavage once daily at a volume of 0.15 mL·(10 g)-1 for 7 consecutive days, while the sham-operated and model groups received an equal volume of saline via the same route. After 7 days, MCAO surgery was performed. The distal and proximal ends of the right common carotid artery (CCA) were ligated, a small incision was made between the two ligatures, and a silicone rubber-coated monofilament with a rounded tip was inserted into the lumen to occlude the CCA. The filament was left in place for 1 h to establish a focal cerebral ischemia model. At 24 h after modeling, mice were evaluated. Neurological function was assessed using the Longa score. Cerebral infarct volume was measured by 2,3,5-triphenyltetrazolium chloride (TTC) staining. Cerebral blood flow was observed by laser speckle imaging. Hematoxylin and eosin (HE) staining and Nissl staining were used to observe pathological changes in brain tissues. Exosomes were isolated from mouse plasma and brain tissues by ultracentrifugation and molecular size exclusion and identified by electron microscopy, particle size analysis, and protein blotting. Long-chain RNA libraries of exosomes were constructed and sequenced. Real-time quantitative reverse transcription polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of inflammatory factors and neutrophil-related chemokines in exosomes from plasma and brain tissues of each group. Enzyme-linked immunosorbent assay (ELISA) was used to detect the protein expression of inflammatory factors and neutrophil-related chemokines in exosomes from brain tissues of each group. Immunohistochemistry was used to detect the expression of the neutrophil-specific protein myeloperoxidase (MPO) in the brains of mice in each group. ResultsCompared with the sham-operated group, the model group showed decreased neurological function scores (P<0.01), obvious cerebral infarction (P<0.01), reduced cerebral blood flow (P<0.01), neuronal necrosis in the brain, and decreased numbers of Nissl bodies (P<0.01). The mRNA expression levels of IL-1β, MPO, CXCL1, CXCL2, CXCL3, CXCL10, CCL2, and CCL3 in exosomes from plasma and brain tissues were significantly increased (P<0.05, P<0.01). The protein expression levels of IL-1β, MPO, CXCL2, and CXCL10 in exosomes from brain tissues were increased (P<0.05, P<0.01), and MPO-positive rates and mean optical density values in brain tissues were elevated (P<0.01). Compared with the model group, the Huanglian Jiedutang group and the Ginaton group showed increased neurological function scores (P<0.05), reduced cerebral infarct volume (P<0.01), restored cerebral blood flow (P<0.01), reduced necrotic cells in the brain, and increased numbers of Nissl bodies (P<0.01). In the Huanglian Jiedutang group, the mRNA expression levels of IL-1β, MPO, CXCL1, CXCL2, CXCL3, CXCL10, CCL2, and CCL3 in exosomes from plasma and brain tissues were decreased (P<0.05, P<0.01). The protein expression levels of IL-1β, MPO, CXCL2, and CXCL10 in exosomes from brain tissues were reduced (P<0.05, P<0.01), and MPO-positive rates and mean optical density values in brain tissues were decreased (P<0.01). ConclusionHuanglian Jiedutang can effectively regulate the expression of neutrophil-related chemokines in exosomes from plasma and brain tissues of MCAO mice, thereby reducing neutrophil infiltration in the brain and achieving therapeutic effects.
7.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
8.Evaluation of photoreceptor cell lesions in age-related macular degeneration patients by adaptive optics scanning laser ophthalmoscope
Yuanrui SUN ; Cheng LI ; Jie XU ; Xue LI ; Wei LIU
International Eye Science 2026;26(4):674-682
AIM:To observe the morphological and structural changes of foveal cone photoreceptors in patients with age-related macular degeneration(ARMD)using adaptive optics scanning laser ophthalmoscopy(AOSLO)and to evaluate its application value in ARMD.METHODS:This was a retrospective cross-sectional study. Patients with ARMD who visited the Department of Ophthalmology, Army Medical Center of PLA, Army Medical University, and underwent AOSLO examination between September 2025 and October 2025 were enrolled as the experimental group(ARMD group). Age-matched individuals who underwent AOSLO examination during the same period and had either age-related cataract or pseudophakia with a normal macular region were selected as the control group(CON group). The AOSLO device was used to image a 2.4°×2.4° area of the fovea, and parameters including parafoveal cone photoreceptor density(PCPD), average inter-cell spacing, cell dispersion, and cell regularity were analyzed.RESULTS:A total of 53 participants(66 eyes)were included, comprising 24 patients(33 eyes)in the ARMD group [comprising 6 participants(6 eyes)in the intermediate ARMD group and 22 participants(27 eyes)in the late ARMD group(4 participants had one eye in the intermediate group and the other in the late ARMD group)], and 29 participants(33 eyes)in the CON group. The ARMD group included 13 males and 11 females, with a mean age of 69.36±9.79 y. The control group included 17 males and 12 females, with a mean age of 64.64±10.31 y. Compared to the CON group, the ARMD group exhibited significantly lower PCPD(31635±4887 vs 38524±3578 cells/mm2, P<0.01)and cell regularity(95.16%±0.75% vs 96.07%±0.67%, P<0.01), along with significantly greater average inter-cell spacing(4.43±0.26 vs 4.22±0.23 μm, P<0.01)and cell dispersion(20.23%±2.72% vs 16.47%±1.85%, P<0.01). Subgroup analysis within the ARMD group revealed that PCPD was significantly lower in the late ARMD subgroup(30831±4826 cells/mm2)compared to the intermediate ARMD subgroup(35254±3534 cells/mm2, P<0.05).CONCLUSION:Photoreceptor pathology in ARMD patients, as assessed by AOSLO, is characterized by decreased PCPD and cell regularity, as well as increased inter-cell spacing and dispersion. These structural alterations are closely associated with photoreceptor cell lesions. AOSLO, as a non-invasive and quantitative imaging modality, demonstrates promising application prospects in the clinical diagnosis of ARMD.
9.Effects of Huanglian Jiedutang on Neutrophil Infiltration in Brain of MCAO Mice via Regulation of Chemokine Expression in Exosomes
Haojia ZHANG ; Kai WANG ; Zijin SUN ; Chunyu WANG ; Wei SHAO ; Kunjing LIU ; Liyang DONG ; Dan CHEN ; Wenxiu XU ; Chuanzun WANG ; Wen WANG ; Changxiang LI ; Xueqian WANG ; Fafeng CHENG ; Qingguo WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):42-53
ObjectiveTo investigate whether Huanglian Jiedutang can inhibit neutrophil infiltration in the brains of middle cerebral artery occlusion (MCAO) mice by regulating the expression of neutrophil-related chemokines in exosomes, thereby achieving therapeutic effects. MethodsA total of 130 male specific pathogen-free (SPF) C57BL/6J mice were randomly divided into four groups: Sham-operated group, MCAO model group, Huanglian Jiedutang group (6 g·kg-1), and Ginaton group (21.6 mg·kg-1), with 10 mice in the Ginaton group and 40 mice in each of the remaining three groups. Mice in the Huanglian Jiedutang group and the Ginaton group were administered the corresponding drugs by oral gavage once daily at a volume of 0.15 mL·(10 g)-1 for 7 consecutive days, while the sham-operated and model groups received an equal volume of saline via the same route. After 7 days, MCAO surgery was performed. The distal and proximal ends of the right common carotid artery (CCA) were ligated, a small incision was made between the two ligatures, and a silicone rubber-coated monofilament with a rounded tip was inserted into the lumen to occlude the CCA. The filament was left in place for 1 h to establish a focal cerebral ischemia model. At 24 h after modeling, mice were evaluated. Neurological function was assessed using the Longa score. Cerebral infarct volume was measured by 2,3,5-triphenyltetrazolium chloride (TTC) staining. Cerebral blood flow was observed by laser speckle imaging. Hematoxylin and eosin (HE) staining and Nissl staining were used to observe pathological changes in brain tissues. Exosomes were isolated from mouse plasma and brain tissues by ultracentrifugation and molecular size exclusion and identified by electron microscopy, particle size analysis, and protein blotting. Long-chain RNA libraries of exosomes were constructed and sequenced. Real-time quantitative reverse transcription polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of inflammatory factors and neutrophil-related chemokines in exosomes from plasma and brain tissues of each group. Enzyme-linked immunosorbent assay (ELISA) was used to detect the protein expression of inflammatory factors and neutrophil-related chemokines in exosomes from brain tissues of each group. Immunohistochemistry was used to detect the expression of the neutrophil-specific protein myeloperoxidase (MPO) in the brains of mice in each group. ResultsCompared with the sham-operated group, the model group showed decreased neurological function scores (P<0.01), obvious cerebral infarction (P<0.01), reduced cerebral blood flow (P<0.01), neuronal necrosis in the brain, and decreased numbers of Nissl bodies (P<0.01). The mRNA expression levels of IL-1β, MPO, CXCL1, CXCL2, CXCL3, CXCL10, CCL2, and CCL3 in exosomes from plasma and brain tissues were significantly increased (P<0.05, P<0.01). The protein expression levels of IL-1β, MPO, CXCL2, and CXCL10 in exosomes from brain tissues were increased (P<0.05, P<0.01), and MPO-positive rates and mean optical density values in brain tissues were elevated (P<0.01). Compared with the model group, the Huanglian Jiedutang group and the Ginaton group showed increased neurological function scores (P<0.05), reduced cerebral infarct volume (P<0.01), restored cerebral blood flow (P<0.01), reduced necrotic cells in the brain, and increased numbers of Nissl bodies (P<0.01). In the Huanglian Jiedutang group, the mRNA expression levels of IL-1β, MPO, CXCL1, CXCL2, CXCL3, CXCL10, CCL2, and CCL3 in exosomes from plasma and brain tissues were decreased (P<0.05, P<0.01). The protein expression levels of IL-1β, MPO, CXCL2, and CXCL10 in exosomes from brain tissues were reduced (P<0.05, P<0.01), and MPO-positive rates and mean optical density values in brain tissues were decreased (P<0.01). ConclusionHuanglian Jiedutang can effectively regulate the expression of neutrophil-related chemokines in exosomes from plasma and brain tissues of MCAO mice, thereby reducing neutrophil infiltration in the brain and achieving therapeutic effects.
10.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.


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