1.Mechanism of Xiezhuo Jiedu Prescription in Treatment of Ulcerative Colitis by Inhibiting Ferroptosis and Alleviating Intestinal Mucosal Injury Based on Nrf2/SLC7A11/GPX4 Signaling Pathway
Qiang CHUAI ; Wenjing ZHAI ; Sujie JIA ; Xiaomeng LANG ; Jie REN ; Xin KANG ; Shijie REN ; Xingchi LIU ; Xin LIU ; Xiaohong JIANG ; Jianping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):160-169
ObjectiveTo investigate the mechanism of Xiezhuo Jiedu prescription in the treatment of ulcerative colitis (UC) by inhibiting ferroptosis and alleviating intestinal mucosal injury based on the nuclear factor E2 related factor 2/solute carrier family 7 member/glutathione peroxidase 4 (Nrf2/SLC7A11/GPX4) signaling pathway. MethodsA total of 60 male SD rats were divided into a normal group, a model group, high- and low-dose Xiezhuo Jiedu prescription groups (26.64 and 13.32 g·kg-1, respectively), a ferroptosis inhibitor group (Ferrostatin-1, 0.005 g·kg-1), and a mesalazine group (0.27 g·kg-1), with 10 rats in each group. A UC rat model was established by intrarectal administration of trinitrobenzene sulfonic acid (TNBS)-ethanol. The normal group and the model group were intragastrically administered normal saline. The other groups were given intragastric administration according to the corresponding dosage for 7 d. The general condition, disease activity index (DAI) score, colon length, and mucosal injury index (CDMI) score were observed in each group. The pathological changes of colon tissue in each group were observed by hematoxylin-eosin (HE) staining. The intestinal mucosa and mitochondrial morphology in each group were observed by transmission electron microscopy. The expression levels of Occludin, Claudin-1, mucin 2 (MUC2), and E-cadherin in intestinal tissue were detected by immunofluorescence (IF). Enzyme-linked immunosorbent assay (ELISA) was used to detect the expression levels of serum tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-10 (IL-10) in each group, and a lactic acid assay kit or ELISA was employed to detect the expression levels of reactive oxygen species (ROS), ferrous ions (Fe2+), glutathione (GSH), malondialdehyde (MDA), 4-hydroxynonenal (4-HNE), diamine oxidase (DAO), and D-lactate (D-LA). Real-time quantitative polymerase chain reaction (Real-time PCR) was applied to detect the mRNA expression levels of Nrf2, SLC7A11, GPX4, Occludin, Claudin-1, MUC2, and E-cadherin in each group, and Western blot was adopted to detect the protein expression levels of Nrf2, p-Nrf2, SLC7A11, and GPX4 in each group. ResultsCompared with the normal group, rats in the model group exhibited listlessness, sluggish response, and mucopurulent and bloody stools. The model group also showed significantly increased DAI score, colon length, CDMI score, and expression levels of TNF-α, IL-6, ROS, Fe2+, MDA, 4-HNE, DAO, and D-LA (P<0.01). In addition, it presented significantly decreased IF values of Occludin, Claudin-1, MUC2, and E-cadherin and mRNA and protein expression levels of IL-10, GSH, Nrf2, p-Nrf2, SLC7A11, and GPX4 (P<0.01). There were different degrees of improvement in each administration group after treatment, and the improvement was the most significant in the high-dose Xiezhuo Jiedu prescription group (P<0.01). ConclusionXiezhuo Jiedu prescription may alleviate intestinal mucosal injury by inhibiting ferroptosis of intestinal epithelial cells via regulating the Nrf2/SLC7A11/GPX4 signaling pathway, thereby exhibiting efficacy in the treatment of UC.
2.Tangbikang Granules Improve Diabetic Peripheral Neuropathy by Inhibiting Ferroptosis via AMPK/Nrf2 Signaling Pathway
Zehong YANG ; Tonghua LIU ; Xiaohong MU ; Yaqi ZHANG ; Huizhong BAI ; Lingling QIN ; Xiaolei JIA
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):52-60
ObjectiveTo explore the mechanism by which Tangbikang granules improve diabetic peripheral neuropathy based on ferroptosis mediated by the adenosine monophosphate-activated protein kinase/nuclear factor erythroid 2-related factor 2 (AMPK/Nrf2) signaling pathway. MethodsA diabetes model was established using spontaneous male Zucker diabetic fatty (ZDF) rats. After successful modeling, the rats were divided into a normal group, a model group, high-, medium-, and low-dose Tangbikang granules groups, and a metformin hydrochloride group. The high-, medium-, and low-dose Tangbikang granules groups were administered by gavage at doses of 2.5, 1.25, 0.625 g·kg-1, respectively. The metformin hydrochloride group received 0.135 g·kg-1 by gavage, while the remaining groups received an equal volume of deionized water. Administration continued for 12 weeks. Blood glucose levels were measured after administration, and at 4, 8, 12 weeks. Following the 12-week intervention, the thermal pain threshold and the sciatic nerve conduction velocity (SNCV) were measured. The levels of malondialdehyde (MDA), superoxide dismutase (SOD), and adenosine triphosphate (ATP) in the sciatic nerve were measured using enzyme-linked immunosorbent assay (ELISA). Morphological changes in the sciatic nerve were observed using hematoxylin and eosin (HE) staining, and the ultrastructural changes were examined using transmission electron microscopy. The levels of glutathione peroxidase 4 (GPx4) were detected using immunofluorescence (IF) assay. The protein expression levels of p-AMPK, Nrf2, GPx4, and acyl-CoA synthetase long-chain family member 4 (ACSL4) were detected using Western blot. ResultsCompared with the normal group, the model group had significantly higher blood glucose levels after administration and at weeks 4, 8 and 12 (P<0.01). The thermal pain threshold was significantly prolonged (P<0.01), and the SNCV was significantly slowed down (P<0.01). The SOD and ATP levels significantly decreased (P<0.01), while the MDA levels significantly increased (P<0.01). Pathologically, the sciatic nerve fibers in the model group showed a dispersed structure, disordered and sparse arrangement, axonal atrophy, irregular myelin sheath halo, increased and swollen Schwann cell nuclei, obvious endoneurial fibrosis, and collagen hyperplasia. Immunofluorescence assay revealed fragmented red fluorescence and significantly reduced expression of GPx4 (P<0.01). Western blot analysis showed significantly decreased protein expression levels of p-AMPK, Nrf2, and GPx4 (P<0.01), and significantly increased expression of ACSL4 (P<0.01) in the model group. Compared with the model group, fasting blood glucose level decreased significantly in the high-dose Tangbikang granules group at weeks 4 and 12 (P<0.05). The thermal pain threshold was significantly shortened in the high- and medium-dose Tangbikang granules groups (P<0.01). The SNCV was significantly accelerated in the high- and medium-dose Tangbikang granules groups (P<0.01). The SOD levels were significantly elevated in the high-dose Tangbikang granules group (P<0.01). The MDA levels significantly decreased in all Tangbikang granules groups (P<0.01). Both the metformin hydrochloride group and the high-dose Tangbikang granules group exhibited relatively orderly and densely arranged sciatic nerve fibers with more regular myelin sheath halos. The GPx4 expression significantly increased in both the metformin hydrochloride group and all Tangbikang granules groups (P<0.01). The protein expression levels of p-AMPK, Nrf2, and GPx4 were significantly increased (P<0.01), while ACSL4 protein expression significantly decreased (P<0.01). ConclusionTangbikang granules may improve peripheral neuropathy by suppressing ferroptosis through the regulation of the AMPK/Nrf2 signaling pathway.
3.Evaluation of CARIFS Score and Negative Antigen Conversion Rate of Qingxuan Daozhi Formula in Treatment of Influenza in Children (Heat Accumulation in Lung and Stomach Syndrome):A Multi-center Randomized Controlled Clinical Study
Jing WANG ; Liqun WU ; Tiegang LIU ; Yongning CAO ; Jing QIU ; Jing LI ; Huaqing TAN ; Ying ZHANG ; Xulei GOU ; Jia WANG ; Jing LI ; Haipeng CHEN ; Xueying QIN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Lin JIANG ; Yingqi XU ; Jianping LIU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):188-196
ObjectiveThis paper aims to observe the syndrome improvement and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome). MethodsThrough a multi-center randomized controlled methodology design,confirmed influenza cases were collected from October 2022 to April 2023 in the pediatrics department of eight hospitals,such as Dongfang Hospital of Beijing University of Chinese Medicine. A total of 180 children with influenza and heat accumulation in the lung and stomach syndrome conforming to the standard were recruited through the clinic. The sick children meeting the inclusion criteria were randomly divided into groups by a block-randomized method. The children in the experimental group were treated with Qingxuan Daozhi formula for five days,and those in the control group were treated with Oseltamivir Phosphate Granules for five days. The primary efficacy indicator was the negative conversion rate of influenza antigen detection. Secondary efficacy indicators were the Canadian acute respiratory illness and flu scale (CARIFS) and the incidence of complications,severe cases, and critical cases. Follow-up observation was conducted on the day of enrollment,48 hours after medication,72 hours after medication, and (6+1) d after medication. ResultsOne hundred and eighty participants were randomly assigned to the experimental group (90 cases) or the control group (90 cases). All participants were followed up during the study. Comparison of influenza antigen detection results in the primary efficacy indicators showed that the average time of negative influenza antigen conversion in the experimental group was (5.29±1.25) d,and that in the control group was (5.40±1.68) d,without a statistically significant difference. After five days of intervention,52 cases in the experimental group and 51 cases in the control group converted to negative,without a statistically significant difference. CARIFS score results in the secondary efficacy indicators showed that during 72 hours after intervention,there were statistically significant differences between the experimental group and the control group in three dimensions, including headache,muscle soreness, and the need for extra care (P<0.05). On the (6+1) days after the intervention,the differences in both the experimental group and the control group were statistically significant in 10 dimensions, including sore throat,bad sleep,uncomfortable feeling,poor spirit and fatigue,crying more than usual,the need for extra care,symptom,function,influence on parents,and total score (P<0.05). The comparison results within the group in the dimensional scores of symptom, function, and influence on parents,as well as the CARIFS total score showed that with the delay of follow-up time,scores of both groups decreased significantly,with a statistically significant difference (P<0.01). Inter-group comparison results showed that the mean score of the experimental group was higher than that of the control group at the time of enrollment. With the progress of intervention,the score of the experimental group was significantly decreased compared with that of the control group. At the end of follow-up,the mean score of the experimental group was lower than that of the control group,with no statistically significant difference. In terms of the incidence of complications,severe cases, and critical cases, there were no complications,severe cases, and critical cases in the two groups,without a statistically significant difference. ConclusionThe symptom improvement effect and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome) are not inferior to Oseltamivir Phosphate granules, and children's acceptance is better. It can be more widely used in clinical treatment of influenza in children (heat accumulation in the lung and stomach syndrome).
4.Mitochondrial mechanism of resting energy metabolic rate changes induced by corticosterone and effects of kidney tonifying prescriptions in mice
Yuxin JIA ; Dandan CHEN ; Jimeng HU ; Xiaohong DENG ; Jianhua HUANG
Acta Laboratorium Animalis Scientia Sinica 2025;33(7):1043-1052
Objective To explore the change trend and related mechanism of resting metabolic rate induced by corticosterone in mice,and observe the intervention effects of Zhibai Dihuang Pill and Jinkui Shenqi pill.Methods Sixty-four mice were randomly divided into short-term and long-term groups,and each group was randomly divided into four groups.Mice in CORT group,ZBDH group and JKSQ group were given sterile drinking water containing corticosterone,and mice in Ctrl group were given sterile drinking water containing 1%anhydrous ethanol.Mice in ZBDH group and JKSQ group were given Chinese medicine by gavage.RMR of mice in each group was dynamically monitored during modeling and Chinese medicine intervention.The morphology of mitochondria in liver and muscle were observed by transmission electron microscope.The TR expression level in liver and muscle tissues of each group was observed by immunofluorescence,and MDA and ATP levels were detected in liver and muscle tissues of each group.levels of ACTH,TSH,INS,T3,T4,FT3,FT4,8-OHdG,FGF-21,GDF-15,L-lactic acid and pyruvic acid in serum were also detected.Results Compared with Ctrl group,the mitochondrial morphology of liver and muscle tissues in CORT group was damaged,and the expression of TR was decreased.In short-term(Day 8),RMR,ATP in liver,serum T4,ACTH and INS levels were significantly increased in the CORT group,while serum FGF-21,TSH levels and MDA in liver were significantly decreased.In long term(Day 56),RMR,serum 8-OhdG,INS,and ATP in liver and muscle were significantly decreased in the CORT group,serum FGF-21,GDF-15,T3,T4,FT3,FT4,MDA in liver and muscle were significantly increased.Compared with CORT group,in short term,RMR,serum L(+)-lactate in ZBDH group were significantly decreased,while serum 8-OHdG and the expression of TRα in muscle were significantly increased.In JKSQ group,the mitochondrial morphology of muscle tissue was improved,the expression of TRα and serum FGF-21 were significantly increased,while serum L(+)-lactic acid,FT4 and ATP in liver were significantly decreased.In long term,serum FGF-21 was significantly lower in ZBDH group,and in JKSQ group,RMR,ATP in liver tissue and TRα expression in muscle were significantly increased,while the levels of FGF-21,GDF-15,T3,FT4 in serum and MDA in muscle tissue were significantly decreased.Conclusion CORT induced RMR to increase first and then decrease with the intervention time.In the short term,Zhibai Dihuang Pill significantly decreased RMR in mice,while in the long term,Jinkui Shenqi Pill significantly increased RMR.The mechanism may be related to mitochondrial injury,thyroxine secretion and thyroxine receptor expression.
5.Mitochondrial mechanism of resting energy metabolic rate changes induced by corticosterone and effects of kidney tonifying prescriptions in mice
Yuxin JIA ; Dandan CHEN ; Jimeng HU ; Xiaohong DENG ; Jianhua HUANG
Acta Laboratorium Animalis Scientia Sinica 2025;33(7):1043-1052
Objective To explore the change trend and related mechanism of resting metabolic rate induced by corticosterone in mice,and observe the intervention effects of Zhibai Dihuang Pill and Jinkui Shenqi pill.Methods Sixty-four mice were randomly divided into short-term and long-term groups,and each group was randomly divided into four groups.Mice in CORT group,ZBDH group and JKSQ group were given sterile drinking water containing corticosterone,and mice in Ctrl group were given sterile drinking water containing 1%anhydrous ethanol.Mice in ZBDH group and JKSQ group were given Chinese medicine by gavage.RMR of mice in each group was dynamically monitored during modeling and Chinese medicine intervention.The morphology of mitochondria in liver and muscle were observed by transmission electron microscope.The TR expression level in liver and muscle tissues of each group was observed by immunofluorescence,and MDA and ATP levels were detected in liver and muscle tissues of each group.levels of ACTH,TSH,INS,T3,T4,FT3,FT4,8-OHdG,FGF-21,GDF-15,L-lactic acid and pyruvic acid in serum were also detected.Results Compared with Ctrl group,the mitochondrial morphology of liver and muscle tissues in CORT group was damaged,and the expression of TR was decreased.In short-term(Day 8),RMR,ATP in liver,serum T4,ACTH and INS levels were significantly increased in the CORT group,while serum FGF-21,TSH levels and MDA in liver were significantly decreased.In long term(Day 56),RMR,serum 8-OhdG,INS,and ATP in liver and muscle were significantly decreased in the CORT group,serum FGF-21,GDF-15,T3,T4,FT3,FT4,MDA in liver and muscle were significantly increased.Compared with CORT group,in short term,RMR,serum L(+)-lactate in ZBDH group were significantly decreased,while serum 8-OHdG and the expression of TRα in muscle were significantly increased.In JKSQ group,the mitochondrial morphology of muscle tissue was improved,the expression of TRα and serum FGF-21 were significantly increased,while serum L(+)-lactic acid,FT4 and ATP in liver were significantly decreased.In long term,serum FGF-21 was significantly lower in ZBDH group,and in JKSQ group,RMR,ATP in liver tissue and TRα expression in muscle were significantly increased,while the levels of FGF-21,GDF-15,T3,FT4 in serum and MDA in muscle tissue were significantly decreased.Conclusion CORT induced RMR to increase first and then decrease with the intervention time.In the short term,Zhibai Dihuang Pill significantly decreased RMR in mice,while in the long term,Jinkui Shenqi Pill significantly increased RMR.The mechanism may be related to mitochondrial injury,thyroxine secretion and thyroxine receptor expression.
6.Effects of 12 weeks of low-intensity resistance training combined with blood flow restriction training on body composition,muscle strength,and arterial elastic function in young adults
Yuexin JIA ; Saisai TIAN ; Xiaohong QI ; Suqin ZHANG
Chinese Journal of Tissue Engineering Research 2025;29(12):2521-2527
BACKGROUND:High-intensity resistance training effectively improves muscle strength,but with a high risk of arteriosclerosis;high-intensity resistance training combined with aerobic exercise effectively reduces the level of arteriosclerosis;low-intensity resistance combined with blood flow restriction training does not require high load strength to stimulate muscles,which may be a scientific training method to improve muscle strength and maintain arterial elasticity.OBJECTIVE:To explore the effects of 12 weeks of low-intensity resistance training combined with blood flow restriction training on body composition,muscle strength,and arterial elasticity in young people,thereby providing theoretical support for the development of personalized training programs.METHODS:Fifty-five college students were randomly recruited and divided by drawing lots into high-intensity resistance training group,high-intensity resistance training combined with aerobic exercise group,and low-intensity resistance training combined with blood flow restriction training group. All participants were subjected to 12 weeks of high-intensity resistance training,high-intensity resistance training combined with aerobic exercise,or low-intensity resistance training combined with blood flow restriction training,and their body composition,muscle strength,and arterial elasticity were tested after training. RESULTS AND CONCLUSION:After 12 weeks of training intervention,the lean body mass of the high-intensity resistance training group and the low-intensity resistance training combined with blood flow restriction training group significantly increased (P<0.05). The one-repetition maximum and knee isokinetic muscle strength significantly increased in all the three groups (P<0.05). The arterial elasticity of the high-intensity resistance training combined with aerobic exercise group and the low-intensity resistance training combined with blood flow restriction training group significantly improved (P<0.05). These findings indicate that 12 weeks of high-intensity resistance training and low-intensity resistance training combined with blood flow restriction training significantly improve body composition;all the three training programs can increase muscle strength;12 weeks of high-intensity resistance training combined with aerobic exercise and low-intensity resistance training combined with blood flow restriction training both improve arterial elasticity,and the effect of low-intensity resistance training combined with blood flow restriction training is superior to that of high-intensity resistance training combined with aerobic exercise. Therefore,it is recommended that low-intensity resistance training combined with blood flow restriction training be used as the preferred training method to improve arterial elasticity,thus reducing the risk of arteriosclerosis.
7.Nigella sativa L. seed extract alleviates oxidative stress-induced cellular senescence and dysfunction in melanocytes.
Ben NIU ; Xiaohong AN ; Yongmei CHEN ; Ting HE ; Xiao ZHAN ; Xiuqi ZHU ; Fengfeng PING ; Wei ZHANG ; Jia ZHOU
Chinese Journal of Natural Medicines (English Ed.) 2025;23(2):203-213
Nigella sativa L. seeds have been traditionally utilized in Chinese folk medicine for centuries to treat vitiligo. This study revealed that the ethanolic extract of Nigella sativa L. (HZC) enhances melanogenesis and mitigates oxidative stress-induced cellular senescence and dysfunction in melanocytes. In accordance with established protocols, the ethanol fraction from Nigella sativa L. seeds was extracted, concentrated, and lyophilized to evaluate its herbal effects via 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assays, tyrosinase activity evaluation, measurement of cellular melanin contents, scratch assays, senescence-associated β-galactosidase (SA-β-gal) staining, enzyme-linked immunosorbent assay (ELISA), and Western blot analysis for expression profiling of experimentally relevant proteins. The results indicated that HZC significantly enhanced tyrosinase activity and melanin content while notably increasing the protein expression levels of Tyr, Mitf, and gp100 in B16F10 cells. Furthermore, HZC effectively mitigated oxidative stress-induced cellular senescence, improved melanocyte condition, and rectified various functional impairments associated with melanocyte dysfunction. These findings suggest that HZC increases melanin synthesis in melanocytes through the activation of the MAPK, PKA, and Wnt signaling pathways. In addition, HZC attenuates oxidative damage induced by H2O2 therapy by activating the nuclear factor E2-related factor 2-antioxidant response element (Nrf2-ARE) pathway and enhancing the activity of downstream antioxidant enzymes, thus preventing premature senescence and dysfunction in melanocytes.
Oxidative Stress/drug effects*
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Melanocytes/cytology*
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Cellular Senescence/drug effects*
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Nigella sativa/chemistry*
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Plant Extracts/pharmacology*
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Seeds/chemistry*
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Mice
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Animals
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Melanins/metabolism*
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Monophenol Monooxygenase/metabolism*
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Humans
8.Cloning, prokaryotic expression, and functional validation of flavonoid 3-O-glycosyltransferase gene (Rh3GT) from Rhododendron hybridum Hort.
Yicheng YAN ; Zehang WU ; Yuhang JIANG ; Gaoyuan HU ; Yujie YANG ; Xiaohong XIE ; Yueyan WU ; Yonghong JIA
Chinese Journal of Biotechnology 2025;41(2):881-895
Flavonoid 3-O-glucosyltransferase (3GT) is a key enzyme in the glucosidation of anthocyanins. To investigate the 3GT gene in rhododendron, we cloned an open reading frame (ORF) of 3GT gene (named Rh3GT) from Rhododendron hybridum Hort (Red cultivar) and then characterized this gene and the deduced protein in terms of the biochemical characteristics, expression level, and enzymatic function. The results showed that Rh3GT had a full length of 993 bp and encoded 330 amino acid residues. The deduced protein was hydrophilic, stable, weak acid, belonging to the glycosyltransferase family (GT-B type), with glutamine (Q) at position 44 in the PSPG box. The phylogenetic analysis showed that Rh3GT was most closely related to Vc3GT from Vaccinium corymbosum and Vm3GT from Vaccinium myrtillus. Rh3GT was expressed in the stems, leaves, and flowers and almost not expressed in the roots, with the highest expression level in petals during full blooming stage. Introduction of pCAMBIAL1302-Rh3GT into petals significantly up-regulated the expression level of Rh3GT and increased the total anthocyanin accumulation. Rh3GT was successfully expressed in Escherichia coli BL21 in the form of inclusion bodies with a size of about 36 kDa. The results of HPLC showed that the recombinant Rh3GT after denaturation, purification, and dilution could catalyze the synthesis of cyanidin and UDP-glucose to synthesize cyanidin 3-O-glucoside, indicating that the expressed protein had 3GT activity. This study provides basic data for further studying the molecular regulation mechanism of anthocyanin biosynthesis and theoretical support for molecular breeding of rhododendron.
Rhododendron/classification*
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Glucosyltransferases/metabolism*
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Cloning, Molecular
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Escherichia coli/metabolism*
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Recombinant Proteins/biosynthesis*
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Anthocyanins/biosynthesis*
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Phylogeny
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Plant Proteins/metabolism*
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Amino Acid Sequence
9.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.
10.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.

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