1.Correlation analysis of inflammatory markers (NLR/PLR/SII) with the severity of intrauterine adhesions
Ying WANG ; Xuan XU ; Longyu ZHANG ; Rong WU ; Jingjing HU ; Wenjuan YANG ; Xiao WU ; Zhaolian WEI
Acta Universitatis Medicinalis Anhui 2026;61(1):146-150
ObjectiveTo investigate the correlation between neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII) and the severity of intrauterine adhesions (IUA). MethodsThe retrospective study included 380 patients who underwent transcervical resection of adhesions (TCRA) from December 2019 to March 2025. Based on the American Fertility Society (AFS) classification, patients were divided into mild (n=61), moderate (n=225), and severe (n=94) groups. NLR, PLR, and SII were calculated from preoperative blood tests. Statistical analyses included Kruskal-Wallis test and ordinal Logistic regression. ResultsNLR, PLR, and SII were significantly higher in the severe IUA group compared to the mild group (P<0.05), with SII showing the strongest predictive ability (OR=1.004, P=0.001). The number of intrauterine procedures was an independent risk factor (OR=1.27/level, P=0.016). The predictive model [Logit(P)=-0.676+0.241×operation times+0.004×SII] effectively identified severe IUA cases. ConclusionInflammatory markers (particularly SII) are correlated with IUA severity and may serve as non-invasive tools for clinical assessment.
2.Exploring Anti-inflammatory Synergistic Mechanism of Atractylodis Macrocephalae Rhizoma Processed with Aurantii Fructus Immaturus Juice Based on Differential Component Tracking Strategy
Hongda XUAN ; Shengnan SHEN ; Linlin LI ; Jingjing LIAO ; Xianyu XU ; Xiaoxia LIU ; Haining LYU ; Fang WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):228-237
ObjectiveTaking Aurantii Fructus Immaturus juice(AFI)-processed Atractylodis Macrocephalae Rhizoma(AMR) as an example, this study aims to systematically compare the volatile and non-volatile components of AMR and its processed products, investigate the key differential components, evaluate their anti-inflammatory activities, and elucidate the synergistic mechanism of processing. MethodsThe chemical compositions of volatile and non-volatile components in AMR and AFI-processed AMR were systematically characterized using gas chromatography-mass spectrometry(GC-MS) and ultra-performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(UPLC-Q-TOF-MS), with relative mass fractions and response values determined separately. Volatile components were identified through searches in the National Institute of Standards and Technology(NIST)17 database, comparison with retention index(RI) and fragmentation pattern matching. Non-volatile components were identified by searching Waters Traditional Chinese Medicine (TCM) spectral library, in conjunction with PubChem and MassBank, characteristic fragmentation patterns and response values were also used to support identification. Differential components were screened using principal component analysis(PCA), orthogonal partial least squares-discriminant analysis(OPLS-DA), with variable importance in the projection(VIP) value >1. Components with high log2fold change(FC) among major differential groups were selected as those exhibiting significant changes before and after processing. The anti-inflammatory activity of the differential compounds was evaluated by assessing their effects on nitric oxide(NO) production in a lipopolysaccharide(LPS)-induced RAW264.7 macrophage model. Enzyme-linked immunosorbent assay(ELISA) was used to detect the effects of the differential components on tumor necrosis factor(TNF)-α, interleukin(IL)-1β, IL-6, and monocyte chemotactic protein(MCP)-1 levels, and immunofluorescence(IF) was employed to assess their effects on nuclear transcription factor(NF)-κB p65 translocation, thereby elucidating the underlying molecular mechanisms. ResultsA total of 36 compounds were identified in the volatile components of AMR and AFI-processed AMR, among which, sesquiterpenes and monoterpenes were significantly increased after processing. In the non-volatile components, 36 compounds were identified, and the main differential components were flavonoids, sesquiterpenoids, and triterpenoids. Flavonoids were the primary differential components distinguishing AMR from its processed products, representing compounds directly introduced during processing. Five compounds, including atractylenolide Ⅲ, tangeritin, nobiletin, hesperidin and narirutin, were selected as representatives of three classes based on their most prominent differential expression among different compound types for subsequent anti-inflammatory activity studies. The results showed that 100 μmol·L-1 tangerine and narirutin could significantly inhibit LPS-induced NO production(P<0.01) in a concentration-dependent manner. Tangeritin was able to significantly inhibit the levels of TNF-α and MCP-1 secreted by RAW264.7(P<0.05), while narirutin significantly inhibited the levels of TNF-α, IL-1β, MCP-1 and IL-6(P<0.01). IF revealed that both tangeritin and narirutin significantly blocked the translocation of NF-κB p65 from the cytoplasm to the nucleus. ConclusionAFI-processed AMR significantly alters the chemical composition profile of AMR, and the newly introduced flavonoid components during processing may be key to its enhanced anti-inflammatory effects.
3.Issues and recommendations in the implementation of mutual recognition for ethical review outcomes in multicenter clinical research: a case study of 10 contracting institutions in Guangdong province
Xu LU ; Feng CAO ; Xuan DUAN ; Junrong LIU
Chinese Medical Ethics 2026;39(1):64-70
ObjectiveTo investigate the current situation of mutual recognition for ethical review outcomes in multicenter clinical research across 10 contracting medical institutions in Guangdong Province, analyze existing issues and propose improvement recommendations, thereby promoting the standardized management of mutual recognition for ethical review outcomes in medical institutions. MethodsData from 381 multicenter clinical studies conducted in these 10 medical institutions from January 24 to October 31, 2024, were collected. Text visualization was performed using Python and the WordCloud library, and statistical analyses were conducted with SPSS 25.0. ResultsOf the 381 studies investigated, industry-sponsored clinical trials (ISTs) accounted for 51.71%, while investigator-initiated clinical trials (IITs) constituted 48.29%. The proportions of ethical committees serving as primary reviewers and collaborative reviewers were 33.33% and 66.67%, respectively. The confirmation methods of mutual recognition outcomes were primarily expedited reviews (50.66%) and meeting reviews (49.34%), and no cases of “direct confirmation” were found. The Chi-square test revealed statistically significant differences in review confirmation methods based on project type (χ²=14.851, P<0.001) and ethics committee role (χ²= 69.435, P<0.001). The frequency distribution trend of the contingency table showed that IST projects and primary ethics committees preferred to employ meeting review (58.88% and 79.53% respectively, both higher than the average level of 49.34%), while IIT projects and the collaborative ethics committees more frequently utilized expedited review (60.87% and 65.75% respectively, both higher than the average level of 50.66%). ConclusionThe confirmation methods of mutual recognition for ethical review outcomes in multicenter clinical research are significantly associated with the role of the ethics committee and the type of project. It is recommended to improve management systems, enhance information construction and personnel training, as well as clarify mutual recognition responsibilities and strengthen supervision. This aims to ensure review quality while improving mutual recognition efficiency, thereby safeguarding the rights and interests of research participants.
4.Study on Reducing Hepatotoxicity and Retaining Anti-osteoporosis Activity of Psoraleae Fructus Though Salt Processing Based on Zebrafish
Yiqi LIU ; Xuan WANG ; Qiqi FAN ; Zehua CHANG ; Shuo FAN ; Na WANG ; Zheng LI ; Xinfang XU ; Chongjun ZHAO ; Xiangri LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):79-90
ObjectiveTo investigate the mechanism of salt processing of Psoraleae Fructus (PF) through modern analytical techniques and biotechnology, focusing on its effects related to hepatotoxicity and anti-osteoporosis activity. MethodsThe zebrafish model was utilized to evaluate the impact of PF and salt-processed Psoraleae Fructus (SPF) on the hepatotoxicity (using 134.17 , 178.89, 268.34 mg·L-1 as low, medium, and high dose groups of PF, 135.04, 180.06, 270.08 mg·L-1 as low, medium, and high dose groups of SPF, respectively) and anti-osteoporotic activity (using 33.54 , 67.08 and 134.17 mg·L-1 as low, medium, and high dose groups of PF, 33.76, 67.52, 135.04 mg·L-1 as low, medium, and high dose groups of SPF, respectively), which was using alizarin red skull staining of zebrafish as an indicator of different batches of PF. The specific dosage of a batch of PF was taken as an example. Then ultra-performance liquid chromatography-quadrupole-time of flight-mass spectrometry(UPLC-Q-TOF-MS) analysis was employed to identify the chemical composition of PF before and after salt processing, and PCA, OPLS-DA, and independent sample t-test were used to elucidating the compositional changes associated with the effects of salt processing on hepatotoxicity and anti-osteoporosis activity. ResultsUnder specific conditions, PF induced notable hepatotoxicity in zebrafish while simultaneously demonstrating protective effect against prednisolone-induced osteoporosis. In comparison to PF, SPF showed alleviated hepatotoxicity while retaining significant anti-osteoporosis activity. UPLC-Q-TOF-MS analysis revealed that after salt processing, the overall chemical composition of PF showed a downward trend, with 69 components showing a decrease in content, represented by psoralen, and 13 components showing an increase, represented by 4′-O-methyl psoralen B. Further multivariate statistical analysis revealed 11 key differential components before and after salt processing of PF, including psoralen and bakuchiol. ConclusionSalt processing effectively diminishes hepatotoxicity without impairing therapeutic efficacy against osteoporosis of PF, which may be related to the compositional changes before and after salt processing of PF and provides key evidence to reveal the scientific significance of salt processing of PF.
5.In Vitro Anti-psoriatic Effect of Kangfuxin Liquid via Inhibiting Cell Proliferation and Migration Ability and Blocking JAK3/STAT3 Signaling Pathway
Shuai LI ; Xuan LIU ; Wenyan TANG ; Zhenqi WU ; Chunhui CHEN ; Dadan QIU ; Yi XU ; Chenggui ZHANG ; Jianquan ZHU ; Jiali ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):123-133
ObjectiveThis paper aims to explore the in vitro anti-psoriasis activity and potential mechanism of Kangfuxin liquid (KFX liquid), providing experimental evidence for the anti-psoriasis effect of KFX liquid. MethodsFirstly, the uninduced human immortalized keratinocyte cells (HaCaT cells) were divided into seven groups, namely the control group and KFX liquid groups with different doses (5, 10, 20, 40, 80, 160 g·L-1). After being treated with different concentrations of KFX liquid, the effect of KFX liquid on the normal cell proliferation was detected by using the cell counting kit-8 (CCK-8) method. Secondly, the uninduced HaCaT cells were divided into six groups, namely the control group and recombinant human interleukin-7A (rh-IL-7A) groups with different doses (5, 10, 50, 100, 120 g·L-1). After being treated with different concentrations of recombinant human interleukin-17A (rh IL-17A) liquid, the effect of rh IL-17A on cell proliferation was detected. The optimal induction concentration was screened. Then, normal HaCaT cells were divided into a control group and KFX liquid groups with different doses (5, 10, 20, 40, 80, 160 g·L-1). Except for the control group, the other groups established psoriasis cell models with the optimal induction concentration of rh IL-17A. After being treated with different concentrations of KFX liquid, the effects of KFX liquid on the psoriasis-like HaCaT cell proliferation were investigated. Finally, the uninduced HaCaT cells were divided into six groups, namely the control group, rh IL-17A group, methotrexate (MTX) group, and KFX liquid groups with different doses (20, 40, 80 g·L-1). Except for the control group, the other groups used the optimal induction concentration of rh IL-17A to establish psoriasis cell models. After being treated with different drugs, the cell migration levels were detected through scratch assays, and real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect the relative mRNA expression levels of Ki-67 antigen (Ki67), S100 calcium-binding protein A7 (S100A7), S100 calcium-binding protein A8 (S100A8), and S100 calcium-binding protein A9 (S100A9), thereby comprehensively evaluating the in vitro anti-psoriasis activity of KFX liquid. By detecting the relative mRNA expression levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and chemokine-20 (CXCL-20) inflammatory-related factors in psoriasis-like HaCaT cells and the protein expression levels of Janus kinase 3 (JAK3), phosphorylated Janus kinase 3 (p-JAK3), signal transducer and activator of transcription 3 (STAT3), and phosphorylated signal transducer and activator of transcription 3 (p-STAT3), the mechanism was explored. ResultsCompared with that of control group, when treated with 80 g·L-1 KFX liquid for 72 h (P<0.05) and at different times with 160 g·L-1 KFX liquid, the HaCaT cell proliferation activity was significantly affected (P<0.01), while the other concentrations of KFX liquid had no significant differences in cell morphology and cell proliferation activity at different times, indicating that the KFX liquid is relatively safe for HaCaT cells and has no obvious toxic side effects. Compared with that of control group, when treated with different concentrations of rh IL-17A for 24 h, the HaCaT cell proliferation activity was significantly enhanced, and the cell activity was the strongest when the concentration was 100 μg·L-1 (P<0.05), with a density close to 100% and intact cell morphology, indicating that 100 μg·L-1 is the optimal concentration for inducing HaCaT cell proliferation. The results of the KFX liquid treatment on rh IL-17A-induced psoriasis-like cells show that the KFX liquid not only effectively inhibits the rh IL-17A-induced psoriasis-like HaCaT cell proliferation activity (P<0.01), but also significantly reduces the migration ability of rh IL-17A-induced psoriasis-like HaCaT cells (P<0.01), and the relative mRNA expression levels of Ki67, S100A7, S100A8, and S100A9 (P<0.01). Moreover, the KFX liquid can significantly reduce the relative mRNA expression levels of IL-1β, IL-6, and CXCL-20 in rh IL-17A-induced psoriasis-like cells (P<0.01), and significantly inhibit the phosphorylation levels of JAK3 and STAT3 proteins (P<0.05, P<0.01). ConclusionThe KFX liquid has no obvious toxicity to uninduced HaCaT cells. It can inhibit rh IL-17A-induced psoriasis-like HaCaT cell proliferation, reduce the cell migration ability, and has good in vitro anti-psoriasis activity. Its action mechanism may be related to downregulating the expression levels of inflammation-related cytokines in the JAK3/STAT3 signaling pathway and inhibiting the phosphorylation levels of JAK3 and STAT3 proteins.
6.In Vitro Anti-psoriatic Effect of Kangfuxin Liquid via Inhibiting Cell Proliferation and Migration Ability and Blocking JAK3/STAT3 Signaling Pathway
Shuai LI ; Xuan LIU ; Wenyan TANG ; Zhenqi WU ; Chunhui CHEN ; Dadan QIU ; Yi XU ; Chenggui ZHANG ; Jianquan ZHU ; Jiali ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):123-133
ObjectiveThis paper aims to explore the in vitro anti-psoriasis activity and potential mechanism of Kangfuxin liquid (KFX liquid), providing experimental evidence for the anti-psoriasis effect of KFX liquid. MethodsFirstly, the uninduced human immortalized keratinocyte cells (HaCaT cells) were divided into seven groups, namely the control group and KFX liquid groups with different doses (5, 10, 20, 40, 80, 160 g·L-1). After being treated with different concentrations of KFX liquid, the effect of KFX liquid on the normal cell proliferation was detected by using the cell counting kit-8 (CCK-8) method. Secondly, the uninduced HaCaT cells were divided into six groups, namely the control group and recombinant human interleukin-7A (rh-IL-7A) groups with different doses (5, 10, 50, 100, 120 g·L-1). After being treated with different concentrations of recombinant human interleukin-17A (rh IL-17A) liquid, the effect of rh IL-17A on cell proliferation was detected. The optimal induction concentration was screened. Then, normal HaCaT cells were divided into a control group and KFX liquid groups with different doses (5, 10, 20, 40, 80, 160 g·L-1). Except for the control group, the other groups established psoriasis cell models with the optimal induction concentration of rh IL-17A. After being treated with different concentrations of KFX liquid, the effects of KFX liquid on the psoriasis-like HaCaT cell proliferation were investigated. Finally, the uninduced HaCaT cells were divided into six groups, namely the control group, rh IL-17A group, methotrexate (MTX) group, and KFX liquid groups with different doses (20, 40, 80 g·L-1). Except for the control group, the other groups used the optimal induction concentration of rh IL-17A to establish psoriasis cell models. After being treated with different drugs, the cell migration levels were detected through scratch assays, and real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect the relative mRNA expression levels of Ki-67 antigen (Ki67), S100 calcium-binding protein A7 (S100A7), S100 calcium-binding protein A8 (S100A8), and S100 calcium-binding protein A9 (S100A9), thereby comprehensively evaluating the in vitro anti-psoriasis activity of KFX liquid. By detecting the relative mRNA expression levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and chemokine-20 (CXCL-20) inflammatory-related factors in psoriasis-like HaCaT cells and the protein expression levels of Janus kinase 3 (JAK3), phosphorylated Janus kinase 3 (p-JAK3), signal transducer and activator of transcription 3 (STAT3), and phosphorylated signal transducer and activator of transcription 3 (p-STAT3), the mechanism was explored. ResultsCompared with that of control group, when treated with 80 g·L-1 KFX liquid for 72 h (P<0.05) and at different times with 160 g·L-1 KFX liquid, the HaCaT cell proliferation activity was significantly affected (P<0.01), while the other concentrations of KFX liquid had no significant differences in cell morphology and cell proliferation activity at different times, indicating that the KFX liquid is relatively safe for HaCaT cells and has no obvious toxic side effects. Compared with that of control group, when treated with different concentrations of rh IL-17A for 24 h, the HaCaT cell proliferation activity was significantly enhanced, and the cell activity was the strongest when the concentration was 100 μg·L-1 (P<0.05), with a density close to 100% and intact cell morphology, indicating that 100 μg·L-1 is the optimal concentration for inducing HaCaT cell proliferation. The results of the KFX liquid treatment on rh IL-17A-induced psoriasis-like cells show that the KFX liquid not only effectively inhibits the rh IL-17A-induced psoriasis-like HaCaT cell proliferation activity (P<0.01), but also significantly reduces the migration ability of rh IL-17A-induced psoriasis-like HaCaT cells (P<0.01), and the relative mRNA expression levels of Ki67, S100A7, S100A8, and S100A9 (P<0.01). Moreover, the KFX liquid can significantly reduce the relative mRNA expression levels of IL-1β, IL-6, and CXCL-20 in rh IL-17A-induced psoriasis-like cells (P<0.01), and significantly inhibit the phosphorylation levels of JAK3 and STAT3 proteins (P<0.05, P<0.01). ConclusionThe KFX liquid has no obvious toxicity to uninduced HaCaT cells. It can inhibit rh IL-17A-induced psoriasis-like HaCaT cell proliferation, reduce the cell migration ability, and has good in vitro anti-psoriasis activity. Its action mechanism may be related to downregulating the expression levels of inflammation-related cytokines in the JAK3/STAT3 signaling pathway and inhibiting the phosphorylation levels of JAK3 and STAT3 proteins.
7.Plasma exchange and intravenous immunoglobulin prolonged the survival of a porcine kidney xenograft in a sensitized, brain-dead human recipient.
Shuaijun MA ; Ruochen QI ; Shichao HAN ; Zhengxuan LI ; Xiaoyan ZHANG ; Guohui WANG ; Kepu LIU ; Tong XU ; Yang ZHANG ; Donghui HAN ; Jingliang ZHANG ; Di WEI ; Xiaozheng FAN ; Dengke PAN ; Yanyan JIA ; Jing LI ; Zhe WANG ; Xuan ZHANG ; Zhaoxu YANG ; Kaishan TAO ; Xiaojian YANG ; Kefeng DOU ; Weijun QIN
Chinese Medical Journal 2025;138(18):2293-2307
BACKGROUND:
The primary limitation to kidney transplantation is organ shortage. Recent progress in gene editing and immunosuppressive regimens has made xenotransplantation with porcine organs a possibility. However, evidence in pig-to-human xenotransplantation remains scarce, and antibody-mediated rejection (AMR) is a major obstacle to clinical applications of xenotransplantation.
METHODS:
We conducted a kidney xenotransplantation in a brain-dead human recipient using a porcine kidney with five gene edits (5GE) on March 25, 2024 at Xijing Hospital, China. Clinical-grade immunosuppressive regimens were employed, and the observation period lasted 22 days. We collected and analyzed the xenograft function, ultrasound findings, sequential protocol biopsies, and immune surveillance of the recipient during the observation.
RESULTS:
The combination of 5GE in the porcine kidney and clinical-grade immunosuppressive regimens prevented hyperacute rejection. The xenograft kidney underwent delayed graft function in the first week, but urine output increased later and the single xenograft kidney maintained electrolyte and pH homeostasis from postoperative day (POD) 12 to 19. We observed AMR at 24 h post-transplantation, due to the presence of pre-existing anti-porcine antibodies and cytotoxicity before transplantation; this AMR persisted throughout the observation period. Plasma exchange and intravenous immunoglobulin treatment mitigated the AMR. We observed activation of latent porcine cytomegalovirus toward the end of the study, which might have contributed to coagulation disorder in the recipient.
CONCLUSIONS
5GE and clinical-grade immunosuppressive regimens were sufficient to prevent hyperacute rejection during pig-to-human kidney xenotransplantation. Pre-existing anti-porcine antibodies predisposed the xenograft to AMR. Plasma exchange and intravenous immunoglobulin were safe and effective in the treatment of AMR after kidney xenotransplantation.
Transplantation, Heterologous/methods*
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Kidney Transplantation/methods*
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Heterografts/pathology*
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Immunoglobulins, Intravenous/administration & dosage*
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Graft Survival/immunology*
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Humans
;
Animals
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Sus scrofa
;
Graft Rejection/prevention & control*
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Kidney/pathology*
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Gene Editing
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Species Specificity
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Immunosuppression Therapy/methods*
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Plasma Exchange
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Brain Death
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Biopsy
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Male
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Aged
8.Research advance on the role of gut microbiota and its metabolites in juvenile idiopathic arthritis.
Ao-Hui PENG ; You-Jia CHEN ; Jin-Xuan GU ; Zhi-Gang JIN ; Xu-Bo QIAN
Acta Physiologica Sinica 2025;77(3):587-601
Juvenile idiopathic arthritis (JIA) is the most common condition of chronic rheumatic disease in children. JIA is an autoimmune or autoinflammatory disease, with unclear mechanism and limited treatment efficacy. Recent studies have found a number of alterations in gut microbiota and its metabolites in children with JIA, which are related to the development and progression of JIA. This review focuses on the influence of the gut microbiota and its metabolites on immune function and the intestinal mucosal barrier and discuss the key role of the gut-joint axis in the pathogenesis of JIA and emerging treatment methods based on gut microbiota and its metabolites. This review could help elucidate the pathogenesis of JIA and identify the potential therapeutic targets for the prevention and treatment of JIA.
Humans
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Arthritis, Juvenile/physiopathology*
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Gastrointestinal Microbiome/physiology*
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Child
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Intestinal Mucosa
9.Medication rules of Astragali Radix in ancient Chinese medical books based on "disease-medicine-dose" pattern.
Jia-Lei CAO ; Lü-Yuan LIANG ; Yi-Hang LIU ; Zi-Ming XU ; Xuan WANG ; Wen-Xi WEI ; He-Jia WAN ; Xing-Hang LYU ; Wei-Xiao LI ; Yu-Xin ZHANG ; Bing-Qi WEI ; Xian-Qing REN
China Journal of Chinese Materia Medica 2025;50(3):798-811
This study employed the "disease-medicine-dose" pattern to mine the medication rules of traditional Chinese medicine(TCM) prescriptions containing Astragali Radix in ancient Chinese medical books, aiming to provide a scientific basis for the clinical application of Astragali Radix and the development of new medicines. The TCM prescriptions containing Astragali Radix were retrieved from databases such as Chinese Medical Dictionary and imported into Excel 2020 to construct the prescription library. Statical analysis were performed for the prescriptions regarding the indications, syndromes, medicine use frequency, herb effects, nature and taste, meridian tropism, dosage forms, and dose. SPSS statistics 26.0 and IBM SPSS Modeler 18.0 were used for association rules analysis and cluster analysis. A total of 2 297 prescriptions containing Astragali Radix were collected, involving 233 indications, among which sore and ulcer, consumptive disease, sweating disorder, and apoplexy had high frequency(>25), and their syndromes were mainly Qi and blood deficiency, Qi and blood deficiency, Yin and Yang deficiency, and Qi deficiency and collateral obstruction, respectively. In the prescriptions, 98 medicines were used with the frequency >25 and they mainly included Qi-tonifying medicines and blood-tonifying medicines. Glycyrrhizae Radix et Rhizoma, Angelicae Sinensis Radix, Ginseng Radix et Rhizoma, Atractylodis Macrocephalae Rhizoma, and Citri Reticulatae Pericarpium were frequently used. The medicines with high frequency mainly have warm or cold nature, and sweet, pungent, or bitter taste, with tropism to spleen, lung, heart, liver, and kidney meridians. In the treatment of sore and ulcer, Astragali Radix was mainly used with the dose of 3.73 g and combined with Glycyrrhizae Radix et Rhizoma to promote granulation and heal up sores. In the treatment of consumptive disease, Astragali Radix was mainly used with the dose of 37.30 g and combined with Ginseng Radix et Rhizoma to tonify deficiency and replenish Qi. In the treatment of sweating disorder, Astragali Radix was mainly used with the dose of 3.73 g and combined with Glycyrrhizae Radix et Rhizoma to consolidate exterior and stop sweating. In the treatment of apoplexy, Astragali Radix was mainly used with the dose of 7.46 g and combined with Glycyrrhizae Radix et Rhizoma to dispell wind and stop convulsions. Astragali Radix can be used in the treatment of multiple system diseases, with the effects of tonifying Qi and ascending Yang, consolidating exterior and stopping sweating, and expressing toxin and promoting granulation. According to the manifestations of different diseases, when combined with other medicines, Astragali Radix was endowed with the effects of promoting granulation and healing up sores, tonifying deficiency and Qi, consolidating exterior and stopping sweating, and dispelling wind and replenishing Qi. The findings provide a theoretical reference and a scientific basis for the clinical application of Astragali Radix and the development of new medicines.
Drugs, Chinese Herbal/history*
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Humans
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Medicine, Chinese Traditional/history*
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History, Ancient
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Astragalus Plant/chemistry*
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China
;
Astragalus propinquus
10.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
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Child
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Child, Preschool
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Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome

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