1.Clinical Observation of Modified Zhigancao Tang in Treating Patients with Liver and Kidney Deficiency of Parkinson's Disease and Its Effect on Neuronal Signal-related Proteins
Yifo WEI ; Furong LYU ; Jia YAO ; Guonian LI ; Xianyi LUO ; Meng LUO ; Zhengzheng WEN ; Qiuqi LI ; Yihan LIU ; Linlin YANG ; Rui ZUO ; Wenxin DANG ; Fang MI ; Xiaoyan WANG ; Zhigang CHEN ; Fan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):166-173
ObjectiveMicrotube associated protein-2 (MAP-2), alpha-tubulin (α-tubulin), and synaptophysin (SYP) are important proteins in neuronal signal communication. This paper observed the effects of modified Zhigancao Tang on the expression of serum α-Synuclein (α-Syn) and its oligomers, MAP-2, α-tubulin, and SYP of patients with liver and kidney deficiency of Parkinson's disease (PD), analyzed their correlation, and evaluated the therapeutic effect of modified Zhigancao Tang in patients with liver and kidney deficiency of PD based on α-Syn transmission pathway mediated by neuronal communication in vivo. MethodsA total of 60 patients with PD who met the inclusion criteria were randomly divided into a treatment group (30 cases) and a control group (30 cases). Both groups were treated on the basis of PD medicine, and the treatment group was treated with modified Zhigancao Tang. Both groups were treated for 12 weeks. The changes in UPDRS score, TCM syndrome score, and expression of serum α-Syn and its oligomers, MAP-2, α-tubulin, and SYP were observed before and after 12 weeks of treatment in each group. The correlation between the above-mentioned serum biological indexes and the levels of serum α-Syn and its oligomers was analyzed. ResultsAfter treatment, the TCM syndrome score, UPDRS score, UPDRS-Ⅱ score, and UPDRS-Ⅲ score of the treatment group were significantly decreased (P<0.05, P<0.01). The UPDRS score, UPDRS-Ⅱ score, and UPDRS-Ⅲ scores in the treatment group were significantly decreased compared with those in the control group after treatment (P<0.05). After treatment, the total effective rate of the control group was 63.3% (19/30), and that of the treatment group was 86.7% (26/30). The clinical effect of the observation group was better than the control group (Z=-2.03, P<0.05). The total effective rate of the observation group was better than that of the control group, and the difference was statistically significant (χ2=5.136, P<0.05). After treatment, the oligomer level of serum α-Syn and MAP-2 level in the treatment group were significantly decreased (P<0.05, P<0.01). The levels of serum α-Syn and its oligomers, as well as α-tubulin in the treatment group, were significantly decreased compared with those in the control group after treatment (P<0.05, P<0.01). Serum α-Syn was correlated with serum MAP-2 and α-Syn oligomer in patients with PD (P<0.05, P<0.01) but not correlated with serum SYP . Serum α-Syn oligomers of patients with PD were correlated with serum MAP-2 and α-tubulin (P<0.05, P<0.01) but not correlated with serum SYP level. Serum SYP of patients with PD was correlated with serum MAP-2 (P<0.05). ConclusionModified Zhigancao Tang has a therapeutic effect on patients with liver and kidney deficiency of PD by inhibiting the production of α-Syn oligomers and intervening α-Syn microtubule transport pathway in vivo.
2.Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis
Jian LIU ; Hongchun ZHANG ; Chengxiang WANG ; Hongsheng CUI ; Xia CUI ; Shunan ZHANG ; Daowen YANG ; Cuiling FENG ; Yubo GUO ; Zengtao SUN ; Huiyong ZHANG ; Guangxi LI ; Qing MIAO ; Sumei WANG ; Liqing SHI ; Hongjun YANG ; Ting LIU ; Fangbo ZHANG ; Sheng CHEN ; Wei CHEN ; Hai WANG ; Lin LIN ; Nini QU ; Lei WU ; Dengshan WU ; Yafeng LIU ; Wenyan ZHANG ; Yueying ZHANG ; Yongfen FAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):182-188
The Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis (GS/CACM 337-2023) was released by the China Association of Chinese Medicine on December 13th, 2023. This expert consensus was developed by experts in methodology, pharmacy, and Chinese medicine in strict accordance with the development requirements of the China Association of Chinese Medicine (CACM) and based on the latest medical evidence and the clinical medication experience of well-known experts in the fields of respiratory medicine (pulmonary diseases) and pediatrics. This expert consensus defines the application of Qinbaohong Zhike oral liquid in the treatment of cough and excessive sputum caused by phlegm-heat obstructing lung, acute bronchitis, and acute attack of chronic bronchitis from the aspects of applicable populations, efficacy evaluation, usage, dosage, drug combination, and safety. It is expected to guide the rational drug use in medical and health institutions, give full play to the unique value of Qinbaohong Zhike oral liquid, and vigorously promote the inheritance and innovation of Chinese patent medicines.
3.Effect of Gynostemma pentaphyllum Alcohol Extract on Glucose and Lipid Metabolism Disorders in db/db Mice Based on Transcriptomics and Gut Microbiota
Yifei ZHU ; Lei DING ; Wei LIU ; Yahui SUN ; Lingling QIN ; Lili WU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):80-89
ObjectiveTo investigate the efficacy and underlying mechanisms of Gynostemma pentaphyllum alcohol extract in improving glucose and lipid metabolism disorders in db/db mice through transcriptomics and gut microbiota analysis. MethodsEighteen db/db mice were randomly assigned to the model(DM) group, metformin(MET) group, and G. pentaphyllum alcohol extract(GP) group, with six mice in each group, based on stratification of fasting blood glucose and body weight. An additional six db/m mice were selected as the normal control(NC) group. Mice in the NC and DM groups were administered deionized water (10 mL·kg-1) daily. The MET group received metformin (0.195 g·kg-1) by gavage. The GP group was treated with G. pentaphyllum alcohol extract (3.9 g·kg-1) by gavage for six weeks. Fasting blood glucose was measured every two weeks. After six weeks of intervention, serum levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (CREA), and blood urea nitrogen (BUN) were assessed. Enzyme-linked immunosorbent assay (ELISA) was used to measure insulin (FINS), adiponectin (ADP), and tumor necrosis factor-α (TNF-α). Hematoxylin-eosin (HE) staining was used to observe liver histomorphology, periodic acid-Schiff (PAS) staining was employed to assess hepatic glycogen synthesis, and Oil Red O staining was used to detect hepatic lipid deposition. Liver transcriptomic data were used to identify differentially expressed genes in the liver and conduct enrichment analysis. Real-time PCR was employed to verify the expression levels of adiponectin gene (Adipoq), peroxisome proliferator-activated receptor gamma coactivator-1α (PGC-1α), AMP-activated protein kinase (AMPK), peroxisome proliferator-activated receptor α (PPARα), glucokinase (GCK), forkhead box (Fox)O1, FoxO3, phosphoenolpyruvate carboxykinase (PEPCK), and glucose-6-phosphatase (G6PC). Metagenomic sequencing was conducted to analyze changes in gut microbiota composition. ResultsCompared with the NC group, the DM group exhibited significantly elevated fasting blood glucose (P<0.01), serum AST, ALT, TC, TG, LDL-C, and HDL-C (P<0.01). FINS, homeostatic model assessment for insulin resistance (HOMA-IR), and the inflammatory cytokine TNF-α were significantly increased (P<0.01), while ADP was significantly decreased (P<0.05). Histological analysis confirmed severe hepatic steatosis and excessive lipid accumulation in the DM group, along with markedly reduced glycogen synthesis. Compared with the DM group, the GP group showed significantly decreased fasting blood glucose (P<0.01), reduced serum TC, LDL-C, and HDL-C levels (P<0.05), significantly decreased serum TG and AST levels (P<0.01), significantly reduced FINS, HOMA-IR, and TNF-α levels (P<0.01), and significantly increased ADP (P<0.01). Hepatic steatosis and lipid deposition were significantly alleviated, while glycogen synthesis was markedly enhanced. Transcriptomic differential and enrichment analyses suggested that the mechanisms by which G. pentaphyllum alcohol extract improved hepatic glucose and lipid metabolism in db/db mice may involve regulation of the AMPK and FoxO signaling pathways. Real-time PCR results confirmed that expression of PGC-1α, PEPCK, G6PC, FoxO1, and FoxO3 was significantly downregulated following treatment with G. pentaphyllum alcohol extract (P<0.05, P<0.01), whereas mRNA expression of Adipoq, PPARα, GCK, and AMPK was significantly upregulated (P<0.05, P<0.01). Metagenomic analysis showed that the relative abundance of Lactobacillus, Alistipes, and Akkermansia species was higher in the GP group than in the DM group. ConclusionG. pentaphyllum alcohol extract may improve glucose and lipid metabolism disorders in db/db mice by regulating the hepatic AMPK/PPARα pathway to suppress lipid deposition and alleviate hepatic steatosis, by inhibiting gluconeogenesis through the AMPK/PGC-1α and FoxO pathways to lower fasting blood glucose, and by increasing the abundance of beneficial gut bacteria such as Lactobacillus, Alistipes, and Akkermansia to restore gut microbiota balance.
4.Effect of Gynostemma pentaphyllum Alcohol Extract on Glucose and Lipid Metabolism Disorders in db/db Mice Based on Transcriptomics and Gut Microbiota
Yifei ZHU ; Lei DING ; Wei LIU ; Yahui SUN ; Lingling QIN ; Lili WU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):80-89
ObjectiveTo investigate the efficacy and underlying mechanisms of Gynostemma pentaphyllum alcohol extract in improving glucose and lipid metabolism disorders in db/db mice through transcriptomics and gut microbiota analysis. MethodsEighteen db/db mice were randomly assigned to the model(DM) group, metformin(MET) group, and G. pentaphyllum alcohol extract(GP) group, with six mice in each group, based on stratification of fasting blood glucose and body weight. An additional six db/m mice were selected as the normal control(NC) group. Mice in the NC and DM groups were administered deionized water (10 mL·kg-1) daily. The MET group received metformin (0.195 g·kg-1) by gavage. The GP group was treated with G. pentaphyllum alcohol extract (3.9 g·kg-1) by gavage for six weeks. Fasting blood glucose was measured every two weeks. After six weeks of intervention, serum levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (CREA), and blood urea nitrogen (BUN) were assessed. Enzyme-linked immunosorbent assay (ELISA) was used to measure insulin (FINS), adiponectin (ADP), and tumor necrosis factor-α (TNF-α). Hematoxylin-eosin (HE) staining was used to observe liver histomorphology, periodic acid-Schiff (PAS) staining was employed to assess hepatic glycogen synthesis, and Oil Red O staining was used to detect hepatic lipid deposition. Liver transcriptomic data were used to identify differentially expressed genes in the liver and conduct enrichment analysis. Real-time PCR was employed to verify the expression levels of adiponectin gene (Adipoq), peroxisome proliferator-activated receptor gamma coactivator-1α (PGC-1α), AMP-activated protein kinase (AMPK), peroxisome proliferator-activated receptor α (PPARα), glucokinase (GCK), forkhead box (Fox)O1, FoxO3, phosphoenolpyruvate carboxykinase (PEPCK), and glucose-6-phosphatase (G6PC). Metagenomic sequencing was conducted to analyze changes in gut microbiota composition. ResultsCompared with the NC group, the DM group exhibited significantly elevated fasting blood glucose (P<0.01), serum AST, ALT, TC, TG, LDL-C, and HDL-C (P<0.01). FINS, homeostatic model assessment for insulin resistance (HOMA-IR), and the inflammatory cytokine TNF-α were significantly increased (P<0.01), while ADP was significantly decreased (P<0.05). Histological analysis confirmed severe hepatic steatosis and excessive lipid accumulation in the DM group, along with markedly reduced glycogen synthesis. Compared with the DM group, the GP group showed significantly decreased fasting blood glucose (P<0.01), reduced serum TC, LDL-C, and HDL-C levels (P<0.05), significantly decreased serum TG and AST levels (P<0.01), significantly reduced FINS, HOMA-IR, and TNF-α levels (P<0.01), and significantly increased ADP (P<0.01). Hepatic steatosis and lipid deposition were significantly alleviated, while glycogen synthesis was markedly enhanced. Transcriptomic differential and enrichment analyses suggested that the mechanisms by which G. pentaphyllum alcohol extract improved hepatic glucose and lipid metabolism in db/db mice may involve regulation of the AMPK and FoxO signaling pathways. Real-time PCR results confirmed that expression of PGC-1α, PEPCK, G6PC, FoxO1, and FoxO3 was significantly downregulated following treatment with G. pentaphyllum alcohol extract (P<0.05, P<0.01), whereas mRNA expression of Adipoq, PPARα, GCK, and AMPK was significantly upregulated (P<0.05, P<0.01). Metagenomic analysis showed that the relative abundance of Lactobacillus, Alistipes, and Akkermansia species was higher in the GP group than in the DM group. ConclusionG. pentaphyllum alcohol extract may improve glucose and lipid metabolism disorders in db/db mice by regulating the hepatic AMPK/PPARα pathway to suppress lipid deposition and alleviate hepatic steatosis, by inhibiting gluconeogenesis through the AMPK/PGC-1α and FoxO pathways to lower fasting blood glucose, and by increasing the abundance of beneficial gut bacteria such as Lactobacillus, Alistipes, and Akkermansia to restore gut microbiota balance.
5.Modified Buwangsan Ameliorates Cognitive Dysfunction in Rat Model of Type 2 Diabetes Mellitus by Regulating Autophagy in Hippocampus via PI3K/Akt/mTOR Pathway
Jie YANG ; Tonghua LIU ; Wei LIU ; Lili WU ; Lingling QIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):104-113
ObjectiveTo evaluate the therapeutic effects of modified Buwangsan on cognitive dysfunction in the rat model of type 2 diabetes mellitus with mild cognitive impairment (T2DM-MCI) and explore the underlying mechanism. MethodsThirty-six 5-week-old SPF-grade SD rats were randomly assigned into 6 groups: Normal (Con, fed with a normal diet), model (DM, fed with a high-sugar and high-fat diet), low-dose modified Buwangsan (L-BWS, 1.86 g·kg-1), medium-dose modified Buwangsan (M-BWS, 3.72 g·kg-1), high-dose modified Buwangsan (H-BWS,7.44 g·kg-1), and huperzine A (SSJJ, 0.018 mg·kg-1). The rats were treated by gavage once a day for 12 weeks. The body weight and blood glucose level were monitored dynamically. Morris water maze was employed to test the cognitive function of rats. Hematoxylin-eosin and Nissl staining were employed to observe the pathological changes of the hippocampus. The levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6) in the serum and hippocampus were assessed by enzyme-linked immunosorbent assay. Western blotting was employed to determine the expression levels of key autophagy-related proteins including microtubule-associated protein 1 light chain 3 (LC3), type Ⅲ phosphatidylinositol 3-kinase complex regulatory subunit (Beclin1), and phosphorylated UNC-51-like kinase (p-ULK) 1/2 in the hippocampus. Immunofluorescence staining was employed to observe the regulation of p-PI3K/PI3K, p-mTOR/mTOR, and p-Akt/Akt ratios. ResultsCompared with the DM group, the L-BWS, M-BWS, H-BWS, and SSJJ groups showed increases in body weight at the end of the experiment (P<0.05), and the M-BWS, H-BWS and SSJJ groups showed declines in fasting blood glucose level (P<0.05). In the water maze test, compared with the DM group, the M-BWS, H-BWS, and SSJJ groups presented shortened escape latency (P<0.001). The L-BWS, M-BWS, H-BWS, and SSJJ group showcased regularly arranged cells in the hippocampus and cortex, markedly increased number of neurons, and significantly recovered Nissl bodies. Compared with the DM group, the L-BWS, M-BWS, H-BWS, and SSJJ groups had reductions in the levels of IL-1β and IL-6 in the serum and hippocampus (P<0.05), increases in the LC3-II/LC3-I ratio and expression level of beclin1 in the hippocampus (P<0.05) and the p-ULK level (P<0.05). The p-PI3K/PI3K, p-Akt/Akt, and p-mTOR/mTOR ratios in the hippocampus decreased in the M-BWS, H-BWS, and SSJJ groups (P<0.01). ConclusionModified Buwangsan significantly ameliorates cognitive dysfunction and neurological damage in the rat model of T2DM through multiple mechanisms. It regulates metabolic disorders, lowers the blood glucose level, improves lipid metabolism, and alleviates oxidative stress. It promotes the protection and repair of neurons by inhibiting inflammatory responses and activating the autophagy pathway in the hippocampus. At the same time, modified Buwangsan relieves autophagy inhibition by regulating the PI3K/Akt/mTOR signaling pathway to alleviate the brain tissue injury.
6.Modified Buwangsan Ameliorates Cognitive Dysfunction in Rat Model of Type 2 Diabetes Mellitus by Regulating Autophagy in Hippocampus via PI3K/Akt/mTOR Pathway
Jie YANG ; Tonghua LIU ; Wei LIU ; Lili WU ; Lingling QIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):104-113
ObjectiveTo evaluate the therapeutic effects of modified Buwangsan on cognitive dysfunction in the rat model of type 2 diabetes mellitus with mild cognitive impairment (T2DM-MCI) and explore the underlying mechanism. MethodsThirty-six 5-week-old SPF-grade SD rats were randomly assigned into 6 groups: Normal (Con, fed with a normal diet), model (DM, fed with a high-sugar and high-fat diet), low-dose modified Buwangsan (L-BWS, 1.86 g·kg-1), medium-dose modified Buwangsan (M-BWS, 3.72 g·kg-1), high-dose modified Buwangsan (H-BWS,7.44 g·kg-1), and huperzine A (SSJJ, 0.018 mg·kg-1). The rats were treated by gavage once a day for 12 weeks. The body weight and blood glucose level were monitored dynamically. Morris water maze was employed to test the cognitive function of rats. Hematoxylin-eosin and Nissl staining were employed to observe the pathological changes of the hippocampus. The levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6) in the serum and hippocampus were assessed by enzyme-linked immunosorbent assay. Western blotting was employed to determine the expression levels of key autophagy-related proteins including microtubule-associated protein 1 light chain 3 (LC3), type Ⅲ phosphatidylinositol 3-kinase complex regulatory subunit (Beclin1), and phosphorylated UNC-51-like kinase (p-ULK) 1/2 in the hippocampus. Immunofluorescence staining was employed to observe the regulation of p-PI3K/PI3K, p-mTOR/mTOR, and p-Akt/Akt ratios. ResultsCompared with the DM group, the L-BWS, M-BWS, H-BWS, and SSJJ groups showed increases in body weight at the end of the experiment (P<0.05), and the M-BWS, H-BWS and SSJJ groups showed declines in fasting blood glucose level (P<0.05). In the water maze test, compared with the DM group, the M-BWS, H-BWS, and SSJJ groups presented shortened escape latency (P<0.001). The L-BWS, M-BWS, H-BWS, and SSJJ group showcased regularly arranged cells in the hippocampus and cortex, markedly increased number of neurons, and significantly recovered Nissl bodies. Compared with the DM group, the L-BWS, M-BWS, H-BWS, and SSJJ groups had reductions in the levels of IL-1β and IL-6 in the serum and hippocampus (P<0.05), increases in the LC3-II/LC3-I ratio and expression level of beclin1 in the hippocampus (P<0.05) and the p-ULK level (P<0.05). The p-PI3K/PI3K, p-Akt/Akt, and p-mTOR/mTOR ratios in the hippocampus decreased in the M-BWS, H-BWS, and SSJJ groups (P<0.01). ConclusionModified Buwangsan significantly ameliorates cognitive dysfunction and neurological damage in the rat model of T2DM through multiple mechanisms. It regulates metabolic disorders, lowers the blood glucose level, improves lipid metabolism, and alleviates oxidative stress. It promotes the protection and repair of neurons by inhibiting inflammatory responses and activating the autophagy pathway in the hippocampus. At the same time, modified Buwangsan relieves autophagy inhibition by regulating the PI3K/Akt/mTOR signaling pathway to alleviate the brain tissue injury.
7.Clinical Efficacy of Xiaoji Hufei Formula in Protecting Children with Close Contact Exposure to Influenza: A Multicenter,Prospective, Non-randomized, Parallel, Controlled Trial
Jing WANG ; Jianping LIU ; Tiegang LIU ; Hong WANG ; Yingxin FU ; Jing LI ; Huaqing TAN ; Yingqi XU ; Yanan MA ; Wei WANG ; Jia WANG ; Haipeng CHEN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Liqun WU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):223-230
ObjectiveTo evaluate the efficacy and safety of Xiaoji Hufei Formula in protecting children with close contact exposure to influenza, and to provide reference and evidence-based support for better clinical prevention and treatment of influenza in children. MethodsA multicenter, prospective, non-randomized, parallel, controlled trial was conducted from October 2021 to May 2022 in five hospitals, including Dongfang Hospital of Beijing University of Chinese Medicine. Confirmed influenza cases and influenza-like illness (ILI) cases were collected, and eligible children with close contact exposure to these cases were recruited in the outpatient clinics. According to whether the enrolled close contacts were willing to take Xiaoji Hufei formula for influenza prevention, they were assigned to the observation group (108 cases) or the control group (108 cases). Follow-up visits were conducted on days 7 and 14 after enrollment. The primary outcomes were the incidence of ILI and the rate of laboratory-confirmed influenza. Secondary outcomes included traditional Chinese medicine (TCM) symptom score scale for influenza, influenza-related emergency (outpatient) visit rate, influenza hospitalization rate, and time to onset after exposure to influenza cases. ResultsA total of 216 participants were enrolled, with 108 in the observation group and 108 in the control group. Primary outcomes: (1) Incidence of ILI: The incidence was 12.0% (13/108) in the observation group and 23.1% (25/108) in the control group, with the observation group showing a significantly lower incidence (χ2=4.6, P<0.05). (2) Influenza confirmation rate: 3.7% (4/108) in the observation group and 4.6% (5/108) in the control group, with no statistically significant difference. Secondary outcomes: (1) TCM symptom score scale: after onset, nasal congestion and runny nose scores differed significantly between the two groups (P<0.05), while other symptoms such as fever, sore throat, and cough showed no significant differences. (2) Influenza-related emergency (outpatient) visit rate: 84.6% (11 cases) in the observation group and 96.0% (24 cases) in the control group, with no significant difference. (3) Time to onset after exposure: The median onset time after exposure to index patients was 7 days in the observation group and 4 days in the control group, with a statistically significant difference (P<0.05). ConclusionIn previously healthy children exposed to infectious influenza cases under unprotected conditions, Xiaoji Hufei formula prophylaxis significantly reduced the incidence of ILI. Xiaoji Hufei Formula can be recommended as a specific preventive prescription for influenza in children.
8.Clinical Efficacy of Xiaoji Hufei Formula in Protecting Children with Close Contact Exposure to Influenza: A Multicenter,Prospective, Non-randomized, Parallel, Controlled Trial
Jing WANG ; Jianping LIU ; Tiegang LIU ; Hong WANG ; Yingxin FU ; Jing LI ; Huaqing TAN ; Yingqi XU ; Yanan MA ; Wei WANG ; Jia WANG ; Haipeng CHEN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Liqun WU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):223-230
ObjectiveTo evaluate the efficacy and safety of Xiaoji Hufei Formula in protecting children with close contact exposure to influenza, and to provide reference and evidence-based support for better clinical prevention and treatment of influenza in children. MethodsA multicenter, prospective, non-randomized, parallel, controlled trial was conducted from October 2021 to May 2022 in five hospitals, including Dongfang Hospital of Beijing University of Chinese Medicine. Confirmed influenza cases and influenza-like illness (ILI) cases were collected, and eligible children with close contact exposure to these cases were recruited in the outpatient clinics. According to whether the enrolled close contacts were willing to take Xiaoji Hufei formula for influenza prevention, they were assigned to the observation group (108 cases) or the control group (108 cases). Follow-up visits were conducted on days 7 and 14 after enrollment. The primary outcomes were the incidence of ILI and the rate of laboratory-confirmed influenza. Secondary outcomes included traditional Chinese medicine (TCM) symptom score scale for influenza, influenza-related emergency (outpatient) visit rate, influenza hospitalization rate, and time to onset after exposure to influenza cases. ResultsA total of 216 participants were enrolled, with 108 in the observation group and 108 in the control group. Primary outcomes: (1) Incidence of ILI: The incidence was 12.0% (13/108) in the observation group and 23.1% (25/108) in the control group, with the observation group showing a significantly lower incidence (χ2=4.6, P<0.05). (2) Influenza confirmation rate: 3.7% (4/108) in the observation group and 4.6% (5/108) in the control group, with no statistically significant difference. Secondary outcomes: (1) TCM symptom score scale: after onset, nasal congestion and runny nose scores differed significantly between the two groups (P<0.05), while other symptoms such as fever, sore throat, and cough showed no significant differences. (2) Influenza-related emergency (outpatient) visit rate: 84.6% (11 cases) in the observation group and 96.0% (24 cases) in the control group, with no significant difference. (3) Time to onset after exposure: The median onset time after exposure to index patients was 7 days in the observation group and 4 days in the control group, with a statistically significant difference (P<0.05). ConclusionIn previously healthy children exposed to infectious influenza cases under unprotected conditions, Xiaoji Hufei formula prophylaxis significantly reduced the incidence of ILI. Xiaoji Hufei Formula can be recommended as a specific preventive prescription for influenza in children.
9.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
10.Spicy food consumption and risk of vascular disease: Evidence from a large-scale Chinese prospective cohort of 0.5 million people.
Dongfang YOU ; Dianjianyi SUN ; Ziyu ZHAO ; Mingyu SONG ; Lulu PAN ; Yaqian WU ; Yingdan TANG ; Mengyi LU ; Fang SHAO ; Sipeng SHEN ; Jianling BAI ; Honggang YI ; Ruyang ZHANG ; Yongyue WEI ; Hongxia MA ; Hongyang XU ; Canqing YU ; Jun LV ; Pei PEI ; Ling YANG ; Yiping CHEN ; Zhengming CHEN ; Hongbing SHEN ; Feng CHEN ; Yang ZHAO ; Liming LI
Chinese Medical Journal 2025;138(14):1696-1704
BACKGROUND:
Spicy food consumption has been reported to be inversely associated with mortality from multiple diseases. However, the effect of spicy food intake on the incidence of vascular diseases in the Chinese population remains unclear. This study was conducted to explore this association.
METHODS:
This study was performed using the large-scale China Kadoorie Biobank (CKB) prospective cohort of 486,335 participants. The primary outcomes were vascular disease, ischemic heart disease (IHD), major coronary events (MCEs), cerebrovascular disease, stroke, and non-stroke cerebrovascular disease. A Cox proportional hazards regression model was used to assess the association between spicy food consumption and incident vascular diseases. Subgroup analysis was also performed to evaluate the heterogeneity of the association between spicy food consumption and the risk of vascular disease stratified by several basic characteristics. In addition, the joint effects of spicy food consumption and the healthy lifestyle score on the risk of vascular disease were also evaluated, and sensitivity analyses were performed to assess the reliability of the association results.
RESULTS:
During a median follow-up time of 12.1 years, a total of 136,125 patients with vascular disease, 46,689 patients with IHD, 10,097 patients with MCEs, 80,114 patients with cerebrovascular disease, 56,726 patients with stroke, and 40,098 patients with non-stroke cerebrovascular disease were identified. Participants who consumed spicy food 1-2 days/week (hazard ratio [HR] = 0.95, 95% confidence interval [95% CI] = [0.93, 0.97], P <0.001), 3-5 days/week (HR = 0.96, 95% CI = [0.94, 0.99], P = 0.003), and 6-7 days/week (HR = 0.97, 95% CI = [0.95, 0.99], P = 0.002) had a significantly lower risk of vascular disease than those who consumed spicy food less than once a week ( Ptrend <0.001), especially in those who were younger and living in rural areas. Notably, the disease-based subgroup analysis indicated that the inverse associations remained in IHD ( Ptrend = 0.011) and MCEs ( Ptrend = 0.002) risk. Intriguingly, there was an interaction effect between spicy food consumption and the healthy lifestyle score on the risk of IHD ( Pinteraction = 0.037).
CONCLUSIONS
Our findings support an inverse association between spicy food consumption and vascular disease in the Chinese population, which may provide additional dietary guidance for the prevention of vascular diseases.
Humans
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Male
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Female
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Prospective Studies
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Middle Aged
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Aged
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Vascular Diseases/etiology*
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Risk Factors
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China/epidemiology*
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Adult
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Proportional Hazards Models
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Cerebrovascular Disorders/epidemiology*
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East Asian People


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