1.Danggui Shaoyaosan Regulates Nrf2/SLC7A11/GPX4 Signaling Pathway to Inhibit Ferroptosis in Rat Model of Non-alcoholic Fatty Liver Disease
Xinqiao CHU ; Yaning BIAO ; Ying GU ; Meng LI ; Tiantong JIANG ; Yuan DING ; Xiaping TAO ; Shaoli WANG ; Ziheng WEI ; Zhen LIU ; Yixin ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):35-42
ObjectiveTo investigate the effect of Danggui Shaoyaosan on ferroptosis in the rat model of non-alcoholic fatty liver disease (NAFLD) and explore the underlying mechanism based on the nuclear factor E2-related factor 2 (Nrf2)/solute carrier family 7 member 11 (SLC7A11)/glutathione peroxidase 4 (GPX4) signaling pathway. MethodsThe sixty SD rats were randomly grouped as follows: control, model, Yishanfu (0.144 g·kg-1), and low-, medium-, and high-dose (2.44, 4.88, and 9.76 g·kg-1, respectively) Danggui Shaoyaosan. A high-fat diet was used to establish the rat model of NAFLD. After 12 weeks of modeling, rats were treated with corresponding agents for 4 weeks. Then, the body weight and liver weight were measured, and the liver index was calculated. At the same time, serum and liver samples were collected. The levels or activities of total cholesterol (TC), triglycerides (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Fe2+ in the serum and TC, TG, free fatty acids (FFA), malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GPX), and Fe2+ in the liver were measured. Hematoxylin-eosin staining and oil red O staining were employed to observe the pathological changes in the liver. Immunofluorescence was used to assess the reactive oxygen species (ROS) content in the liver. Mitochondrial morphology was observed by transmission electron microscopy. The protein levels of Nrf2, SLC7A11, GPX4, transferrin receptor 1 (TFR1), and divalent metal transporter 1 (DMT1) in the liver were determined by Western blot. ResultsCompared with the control group, the model group showed increases in the body weight, liver weight, liver index, levels or activities of TC, TG, ALT, AST, and Fe2+ in the serum, levels of TC, TG, FFA, MDA, Fe2+, and ROS in the liver, and protein levels of TFR1 and DMT1 in the liver (P<0.01), and decreases in the activities of SOD, GPX and the protein levels of Nrf2, SLC7A11, and GPX4 in the liver (P<0.05, P<0.01). Meanwhile, the liver tissue in the model group presented steatosis, iron deposition, mitochondrial shrinkage, and blurred or swollen mitochondrial cristae. Compared with the model group, all doses of Danggui Shaoyaosan reduced the body weight, liver weight, liver index, levels or activities of TC, TG, ALT, AST, and Fe2+ in the serum, levels of TC, TG, FFA, MDA, Fe2+, and ROS in the liver, and protein levels of TFR1 and DMT1 in the liver (P<0.01), while increasing the activities of SOD and GPX and the protein levels of Nrf2, SLC7A11, and GPX4 in the liver (P<0.01). Furthermore, Danggui Shaoyaosan alleviated steatosis, iron deposition, and mitochondrial damage in the liver. ConclusionDanggui Shaoyaosan may inhibit lipid peroxidation and ferroptosis by activating the Nrf2/SLC7A11/GPX4 signaling pathway to treat NAFLD.
2.Associations between Pesticide Metabolites and Decreased Estimated Glomerular Filtration Rate Among Solar Greenhouse Workers: A Specialized Farmer Group.
Teng Long YAN ; Xin SONG ; Xiao Dong LIU ; Wu LIU ; Yong Lan CHEN ; Xiao Mei ZHANG ; Xiang Juan MENG ; Bin Shuo HU ; Zhen Xia KOU ; Tian CHEN ; Xiao Jun ZHU
Biomedical and Environmental Sciences 2025;38(2):265-269
3.Role of joint function screening and correction in preventing training injuries for new recruits:a randomized controlled trial
Enyu LEI ; Zhen CHEN ; Bing LI ; Ling ZHANG ; Honghui RONG ; Lu LU ; Chuanfen ZHENG ; Tao MENG ; Ji'an CHEN
Journal of Army Medical University 2025;47(9):1003-1009
Objective To investigate the effects of joint function screening and correction on intervention efficacy of prevention and assessment score of training injuries in new recruits.Methods A randomized controlled study was conducted on 265 new recruits subjected from two organizational units of an army unit with cluster sampling.Based on entire organizational unit,the participants were randomly divided into a control group(n=132)and an experimental group(n=133).The experimental group received joint function screening and corrective movement training,which was subsequently applied in the new recruit training,while the control group underwent training according to conventional methods.Joint function were collected before and after training.The demographic data,assessment score of training,and incidence of training injuries were collected through the participant's own organizational unit.Receiver operating characteristic(ROC)curve was plotted to evaluate the efficacy of joint function screening in predicting training injuries,and binary logistic regression and general linear regression analyses were applied to verify the correlation of joint function screening score with training injuries and assessment score of training.Results After new training,the score of joint function screening was significantly higher in the experimental group than the control group(16.62±1.87 vs 14.92±2.58,P<0.001).And the score was obviously increased in the experimental group(16.62±1.87 vs 12.82±1.98,P<0.001)and the control group(14.92±2.58 vs 12.95±1.81,P<0.001)when compared with the corresponding score before training.The area under the ROC curve(AUC)of joint function screening in predicting training injuries was 0.762(95%CI:0.694~0.830),indicating good predictive efficacy.During the new training process,the incidence of training injuries in the experimental group(13.53%)was significantly lower than that in the control group(24.24%,Chi-square=4.963,P=0.026).Binary logistic regression analysis showed that the pre-training assessment score of joint function screening was an important influencing factor for training injuries in new recruits(OR=0.552,95%CI:0.413~0.660,P<0.001).The experimental group obtained notably higher mean assessment score than the control group[733.00(716.00,752.75)vs 728.79(710.46,744.28),P=0.027].Linear regression analysis revealed a correlation between post-training score of joint function screening and the assessment score of newly trained personnel(P<0.001).Conclusion Joint function screening and correction for newly trained personnel can effectively prevent training-related injuries during the new training period,and correcting joint function through training can effectively improve the assessment score of newly trained personnel.
4.Network Meta-analysis of Chinese patent medicines in treatment of stable chronic obstructive pulmonary disease.
Yuan-Yuan ZHANG ; Meng-Zhen ZHANG ; Qian-Qian MA ; Ji-Hong ZHOU
China Journal of Chinese Materia Medica 2025;50(1):248-266
The efficacy and safety of different Chinese patent medicines in the treatment of stable chronic obstructive pulmonary disease(COPD) were evaluated by network Meta-analysis. The randomized controlled trial(RCT) of Chinese patent medicines for stable COPD were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, Web of Science, EMbase, and Cochrane Library with the time interval from inception to February 2024. The quality of the included RCT was evaluated by the Cochrane's risk of bias assessment tool. RevMan 5.4 and Stata 16.0 were used to establish the risk of bias diagram and perform the network Meta-analysis. A total of 113 RCTs were included, involving 8 265 patients and 14 Chinese patent medicines. The network Meta-analysis yielded the following results based on the surface under the cumulative ranking curve(SUCRA).(1) In terms of improving the forced expiratory volume in 1 second to forced vital capacity(FEV1/FVC) ratio, the top three treatments were Jingshuibao Capsules + conventional western medicine, Yupingfeng San + conventional western medicine, and Sanzi Zhike Capsules + conventional western medicine.(2) In terms of improving the clinical efficacy, the top three treatments were Yifei Capsules + conventional western medicine, Yupingfeng Granules + conventional western medicine, and Bufei Huoxue Capsules + conventional western medicine.(3) In terms of improving the percentage of predicted FEV1(FEV1%pred), the top three treatments were Jingshuibao Capsules + conventional western medicine, Bufei Granules + conventional western medicine, and Bailing Capsules + conventional western medicine.(4) In terms of improving the distance in 6 min walking test(6MWT), the top three treatments were Jingshuibao Capsules + conventional western medicine, Bailing Capsules + conventional western medicine, and Jianpi Yifei Oral Liquid + conventional western medicine.(5) In terms of reducing the COPD assessment test(CAT), the top three treatments were Bufei Granules + conventional western medicine, Yifei Capsules + conventional western medicine, and Yifei Huoxue Granules + conventional western medicine.(6) In terms of reducing the frequency of acute exacerbation of chronic obstructive pulmonary disease(AECOPD) within 1 year, the top three treatments were Yupingfeng Capsules + conventional western medicine, Yupingfeng San + conventional western medicine, and Jianpi Yifei Oral Liquid + conventional western medicine.(7) In terms of safety, 28 RCTs have reported adverse reactions, mainly involving the digestive system, circulatory system, and nervous system. The results showed that Chinese patent medicines combined with conventional western medicine improved FEV1/FVC, FEV1%pred, clinical efficacy, and 6MWT, while reducing CAT and the frequency of AECOPD within 1 year. However, due to the limitations of the included studies and the lack of direct comparisons between different interventions, these results need further validation.
Pulmonary Disease, Chronic Obstructive/physiopathology*
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Humans
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Drugs, Chinese Herbal/administration & dosage*
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Randomized Controlled Trials as Topic
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Nonprescription Drugs/therapeutic use*
5.Mechanism of Xiangmei Pills in treating ulcerative colitis based on UHPLC-Q-Orbitrap HRMS and 16S rDNA sequencing of intestinal flora.
Ya-Fang HOU ; Rui-Sheng WANG ; Zhen-Ling ZHANG ; Wen-Wen CAO ; Meng ZHAO ; Ya-Hong ZHAO
China Journal of Chinese Materia Medica 2025;50(4):882-895
The efficacy of Xiangmei Pills on rats with ulcerative colitis(UC) was investigated by characterizing the spectrum of the active chemical components of Xiangmei Pills. Rapid identification and classification of the main chemical components were performed,and the therapeutic effects of Xiangmei Pills on the proteins and intestinal flora of UC rats were analyzed to explore the mechanism of its action in treating UC. Fifty SD rats were acclimatized to feeding for 3 d and randomly divided into blank group, model group,mesalazine group(0. 4 g·kg~(-1)), low-dose group of Xiangmei Pills(1. 89 g·kg~(-1)), and high-dose group of Xiangmei Pills(5. 67 g·kg~(-1)), with 10 rats in each group. 5% dextrose sodium sulfate(DSS) was given by gavage to induce the male SD rat model with UC,and the corresponding medicinal solution was given by gavage after 10 days, respectively. The therapeutic effect of Xiangmei Pills on rats with UC was evaluated according to body mass, disease activity index(DAI), and hematoxylin-eosin(HE) staining, and the histopathological changes in the colon were observed. Ultra-high performance liquid chromatography-quadrupole/electrostatic field orbitrap high-resolution mass spectrometry(UHPLC-Q-Orbitrap HRMS) technique was used to rapidly and accurately identify the main chemical constituents of Xiangmei Pills. Immunohistochemistry was used to detect the expression of aryl hydrocarbon receptor(AhR),interferon-γ(IFN-γ), mucin-2(MUC-2), and cytochrome P450 1A1(CYP1A1) in colon tissue. Interleukin-22(IL-22) expression in colon tissue was detected by immunofluorescence. The 16S r DNA high-throughput sequencing technique was used to study the modulatory effects of Xiangmei Pills on the intestinal flora structure of rats with UC. Pharmacodynamic results showed that compared with that of the blank group, the colon tissue of the model group was congested, and ulcers were visible in the mucosa; compared with that in the model group, the histopathology of the colon of the rats with UC in the groups of Xiangmei Pills were improved, with scattered ulcers and reduced inflammatory cell infiltration. Chemical analysis showed that a total of 45 components were identified by mass spectrometry information, including 15 phenolic acids, 8 coumarins, 15 organic acids, 3 amino acids, 2 flavonoids, and 2 other components. Compared with those in the blank group, the levels of Ah R, CYP1A1, MUC-2, and IL-22 proteins in the colon tissue of rats in the model group were significantly decreased, and the level of IFN-γ protein was significantly increased; the intestinal flora of rats in the model group was disorganized, with a decrease in the abundance of the flora; the relative abundance of Bacteroidetes,unclassified genera of Ascomycetes, Prevotella of the Prevotella family, and Prevotella decreased significantly, and that of Firmicutes decreased, but the difference was not statistically significant. The relative abundance of Bacteroidetes, Bifidobacterium, and Lactobacillus increased significantly. Compared with those of the model group, the levels of Ah R, CYP1A1, MUC-2, and IL-22proteins in the colonic tissue of the groups of Xiangmei Pills were significantly higher, and the levels of IFN-γ proteins were significantly lower. The recovery of the intestinal flora was accelerated, and the diversity of the intestinal flora was significantly increased. The relative abundance of Bacteroidetes was significantly increased, and that of unclassified genera of Ascomycetes,Lactobacillus, Prevotella of the Prevotella family, and Prevotella was significantly increased. The relative abundance of Bacteroidetes and Bifidobacterium was significantly decreased. This study demonstrated that Xiangmei Pills can effectively treat UC, mainly through the phenolic acid and organic acid components to stimulate the intestinal barrier, regulate protein expression and the relative abundance and diversity of intestinal flora, and play a role in the treatment of UC.
Animals
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Colitis, Ulcerative/metabolism*
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Drugs, Chinese Herbal/chemistry*
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Rats, Sprague-Dawley
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Male
;
Rats
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Gastrointestinal Microbiome/genetics*
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Chromatography, High Pressure Liquid
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Humans
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Mass Spectrometry
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RNA, Ribosomal, 16S/genetics*
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Bacteria/drug effects*
6.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
7.Biomarkers of hepatotoxicity in rats induced by aqueous extract of Dictamni Cortex based on urine metabolomics.
Hui-Juan SUN ; Rui GAO ; Meng-Meng ZHANG ; Ge-Yu DENG ; Lin HUANG ; Zhen-Dong ZHANG ; Yu WANG ; Fang LU ; Shu-Min LIU
China Journal of Chinese Materia Medica 2025;50(9):2526-2538
This paper aimed to use non-targeted urine metabolomics to reveal the potential biomarkers of toxicity in rats with hepatic injury induced by aqueous extracts of Dictamni Cortex(ADC). Forty-eight SD rats were randomly assigned to a blank group and high-dose, medium-dose, and low-dose ADC groups, with 12 rats in each group(half male and half female), and they were administered orally for four weeks. The hepatic injury in SD rats was assessed by body weight, liver weight/index, biochemical index, L-glutathione(GSH), malondialdehyde(MDA), and pathological alterations. The qPCR was utilized to determine the expression of metabolic enzymes in the liver and inflammatory factors. Differential metabolites were screened using principal component analysis(PCA) and partial least squares-discriminant analysis(PLS-DA), followed by a metabolic pathway analysis. The Mantel test was performed to assess differential metabolites and abnormally expressed biochemical indexes, obtaining potential biomarkers. The high-dose ADC group showed a decrease in body weight and an increase in liver weight and index, resulting in hepatic inflammatory cell infiltration and hepatic steatosis. In addition, this group showed elevated levels of MDA, cytochrome P450(CYP) 3A1, interleukin-1β(IL-1β), and tumor necrosis factor-α(TNF-α), as well as lower levels of alanine transaminase(ALT) and GSH. A total of 76 differential metabolites were screened from the blank and high-dose ADC groups, which were mainly involved in the pentose phosphate pathway, tryptophan metabolism, purine metabolism, pentose and glucuronic acid interconversion, galactose metabolism, glutathione metabolism, and other pathways. The Mantel test identified biomarkers of hepatotoxicity induced by ADC in SD rats, including glycineamideribotide, dIDP, and galactosylglycerol. In summary, ADC induced hepatotoxicity by disrupting glucose metabolism, ferroptosis, purine metabolism, and other pathways in rats, and glycineamideribotide, dIDP, and galactosylglycerol could be employed as the biomarkers of its toxicity.
Animals
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Male
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Rats, Sprague-Dawley
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Rats
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Metabolomics
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Biomarkers/metabolism*
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Liver/metabolism*
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Drugs, Chinese Herbal/adverse effects*
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Female
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Chemical and Drug Induced Liver Injury/metabolism*
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Glutathione/metabolism*
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Humans
8.Bone loss in patients with spinal cord injury: Incidence and influencing factors.
Min JIANG ; Jun-Wei ZHANG ; He-Hu TANG ; Yu-Fei MENG ; Zhen-Rong ZHANG ; Fang-Yong WANG ; Jin-Zhu BAI ; Shu-Jia LIU ; Zhen LYU ; Shi-Zheng CHEN ; Jie-Sheng LIU ; Jia-Xin FU
Chinese Journal of Traumatology 2025;28(6):477-484
PURPOSE:
To investigate the incidence and influencing factors of bone loss in patients with spinal cord injury (SCI).
METHODS:
A retrospective case-control study was conducted. Patients with SCI in our hospital from January 2019 to March 2023 were collected. According to the correlation between bone mineral density (BMD) at different sites, the patients were divided into the lumbar spine group and the hip joint group. According to the BMD value, the patients were divided into the normal bone mass group (t > -1.0 standard deviation) and the osteopenia group (t ≤ -1.0 standard deviation). The influencing factors accumulated as follows: gender, age, height, weight, cause of injury, injury segment, injury degree, time after injury, start time of rehabilitation, motor score, sensory score, spasticity, serum value of alkaline phosphatase, calcium, and phosphorus. The trend chart was drawn and the influencing factors were analyzed. SPSS 26.0 was used for statistical analysis. Correlation analysis was used to test the correlation between the BMD values of the lumbar spine and bilateral hips. Binary logistic regression analysis was used to explore the influencing factors of osteoporosis after SCI. p < 0.05 was considered statistically significant.
RESULTS:
The incidence of bone loss in patients with SCI was 66.3%. There was a low concordance between bone loss in the lumbar spine and the hip, and the hip was particularly susceptible to bone loss after SCI, with an upward trend in incidence (36% - 82%). In this study, patients with SCI were divided into the lumbar spine group (n = 100) and the hip group (n = 185) according to the BMD values of different sites. Then, the lumbar spine group was divided into the normal bone mass group (n = 53) and the osteopenia group (n = 47); the hip joint group was divided into the normal bone mass group (n = 83) and the osteopenia group (n = 102). Of these, lumbar bone loss after SCI is correlated with gender and weight (p = 0.032 and < 0.001, respectively), and hip bone loss is correlated with gender, height, weight, and time since injury (p < 0.001, p = 0.015, 0.009, and 0.012, respectively).
CONCLUSIONS
The incidence of bone loss after SCI was high, especially in the hip. The incidence and influencing factors of bone loss in the lumbar spine and hip were different. Patients with SCI who are male, low height, lightweight, and long time after injury were more likely to have bone loss.
Humans
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Spinal Cord Injuries/complications*
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Male
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Female
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Retrospective Studies
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Incidence
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Adult
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Bone Density
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Middle Aged
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Case-Control Studies
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Osteoporosis/etiology*
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Lumbar Vertebrae
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Bone Diseases, Metabolic/etiology*
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Aged
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Risk Factors
9.Characteristics of Gut Microbiota Changes and Their Relationship with Infectious Complications During Induction Chemotherapy in AML Patients.
Quan-Lei ZHANG ; Li-Li DONG ; Lin-Lin ZHANG ; Yu-Juan WU ; Meng LI ; Jian BO ; Li-Li WANG ; Yu JING ; Li-Ping DOU ; Dai-Hong LIU ; Zhen-Yang GU ; Chun-Ji GAO
Journal of Experimental Hematology 2025;33(3):738-744
OBJECTIVE:
To investigate the characteristics of gut microbiota changes in patients with acute myeloid leukemia (AML) undergoing induction chemotherapy and to explore the relationship between infectious complications and gut microbiota.
METHODS:
Fecal samples were collected from 37 newly diagnosed AML patients at four time points: before induction chemotherapy, during chemotherapy, during the neutropenic phase, and during the recovery phase. Metagenomic sequencing was used to analyze the dynamic changes in gut microbiota. Correlation analyses were conducted to assess the relationship between changes in gut microbiota and the occurrence of infectious complications.
RESULTS:
During chemotherapy, the gut microbiota α-diversity (Shannon index) of AML patients exhibited significant fluctuations. Specifically, the diversity decreased significantly during induction chemotherapy, further declined during the neutropenic phase (P < 0.05, compared to baseline), and gradually recovered during the recovery phase, though not fully returning to baseline levels.The abundances of beneficial bacteria, such as Firmicutes and Bacteroidetes, gradually decreased during chemotherapy, whereas the abundances of opportunistic pathogens, including Enterococcus, Klebsiella, and Escherichia coli, progressively increased.Analysis of the dynamic changes in gut microbiota of seven patients with bloodstream infections revealed that the bloodstream infection pathogens could be detected in the gut microbiota of the corresponding patients, with their abundance gradually increasing during the course of infection. This finding suggests that bloodstream infections may be associated with opportunistic pathogens originating from the gut microbiota.Compared to non-infected patients, the baseline samples of infected patients showed a significantly lower relative abundance of Bacteroidetes (P < 0.05). Regression analysis indicated that Bacteroidetes abundance is an independent predictive factor for infectious complications (P < 0.05, OR =13.143).
CONCLUSION
During induction chemotherapy in AML patients, gut microbiota α-diversity fluctuates significantly, and the abundance of opportunistic pathogens increase, which may be associated with bloodstream infections. Patients with lower baseline Bacteroidetes abundance are more prone to infections, and its abundance can serve as an independent predictor of infectious complications.
Humans
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Gastrointestinal Microbiome
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Leukemia, Myeloid, Acute/microbiology*
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Induction Chemotherapy
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Feces/microbiology*
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Male
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Female
;
Middle Aged
10.Study design and rationale of the TXL-CAP trial: a randomized, double-blind, placebo-controlled, multicenter clinical trial assessing the effect of Tongxinluo capsules on the stability of coronary atherosclerotic plaques.
Mei NI ; Yun TI ; Yan QI ; Meng ZHANG ; Dayue Darrel DUAN ; Chen YAO ; Zhen-Hua JIA ; Yun ZHANG ; Pei-Li BU
Journal of Geriatric Cardiology 2025;22(7):615-624
Recent clinical trials have demonstrated a protective effect in using traditional Chinese medicine Tongxinluo (TXL) capsule to treat atherosclerosis. However, clinical evidence of the effects of TXL treatment on coronary plaque vulnerability is unavailable. In response, we developed this study to investigate the hypothesis that on the basis of statin therapy, treatment with TXL capsule may stabilize coronary lesions in patients with acute coronary syndrome (ACS). The TXL-CAP study was an investigator-initiated, randomized, double-blind clinical trial conducted across 18 medical centers in China. Patients with ACS aging from 18 to 80 years old who had a non-intervened coronary target lesion with a fibrous cap thickness (FCT) < 100 μm and lipid arc > 90° as defined by optical coherence tomography (OCT) were recruited. A total of 220 patients who met the selection criteria but did not meet the exclusion criteria will be finally recruited and randomized to receive treatment with TXL (n = 110) or placebo (n = 110) for a duration of 12 months. The primary endpoint was the difference in the minimum FCT of the coronary target lesion between TXL and placebo groups at the end of the 12-month follow-up. Secondary endpoints included: (1) changes of the maximum lipid arc and length of the target plaque, and the percentage of lipid, fibrous, and calcified plaques at the end of the 12-month period; (2) the incidence of composite cardiovascular events and coronary revascularization within the 12 months; (3) changes in the grade and scores of the angina pectoris as assessed using the Canadian Cardiovascular Society (CCS) grading system and Seattle angina questionnaire (SAQ) score, respectively; and (4) changes in hs-CRP serum levels. The results of the TXL-CAP trial will provide additional clinical data for revealing whether TXL capsules stabilizes coronary vulnerable plaques in Chinese ACS patients.

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