1.Clinical trial of Xianling Gubao capsules combined with Jintiange capsules in treating patients with primary osteoporosis
The Chinese Journal of Clinical Pharmacology 2024;40(12):1723-1727
Objective To explore the clinical efficacy of Xianling Gubao capsules combined with Jintiange capsules in primary osteoporosis and their effects on bone density,bone metabolism,and osteosclerosis protein levels.Methods Patients with primary osteoporosis were randomly divided into control and treatment groups using a random number table.The control group received chewable calcium carbonate with vitamin D3,2 tablets per dose(each containing 600 mg of calcium carbonate),qd;simultaneously,they took Jintiange capsules orally,1.2 g per dose,bid.The treatment group received Xianling Gubao capsules orally,in addition to the treatment received by the control group,1.5 g per dose,bid,for a duration of 6 months.The clinical efficacy,bone density,bone metabolism,and osteosclerosis protein levels before and after treatment were compared between the two groups.Results Four patients dropped out during the trial,and finally,63 patients were included in each of the treatment and control groups.After treatment,the total effective rate in the treatment group were 87.30%(55 cases/63 cases)and in the control group were 71.43%(45 cases/63 cases),with statistically significant difference(P<0.05).After treatment,the lumbar spine L2-4 density in the treatment and control groups were(0.73±0.09)and(0.96±0.10)g·cm-3;the femoral neck density were(0.68±0.07)and(0.78±0.10)g·cm-3;blood calcium levels were(1.25±0.30)and(1.56±0.41)mmol·L-1;bone calcium levels were(25.51±2.23)and(35.91±5.30)ng·mL-1;alkaline phosphatase levels were(97.54±7.34)and(79.50±6.23)U·L-1;osteosclerosis protein levels were(13.87±4.95)and(10.11±2.99)pg·mL-1,respectively.The comparison of these indicators between the treatment and control groups showed statistically significant differences(all P<0.05).The main adverse drug reactions in the treatment group were allergic reactions,gastrointestinal reactions,and general fatigue;while in the control group,they were allergic reactions,gastrointestinal reactions,and peripheral edema.The total incidence of adverse drug reactions in the treatment and control groups were 9.52%and 7.94%,respectively,with no statistically significant difference(P>0.05).Conclusion Xianling Gubao capsules combined with Jintiange capsules can significantly improve the clinical efficacy of patients with primary osteoporosis,increase bone density,and enhance bone metabolism levels.
2.Effects of low-energy red light on choroidal thickness and spherical equivalent and axial length in myopic children
Zhi-Ming GU ; Chang-Jun LAN ; Wei-Qi ZHONG ; Gui-Mei ZHOU ; Xuan LIAO
International Eye Science 2023;23(5):791-796
AIM: To systematically evaluate the effects of low-energy red light on choroidal thickness(ChT), spherical equivalent(SE), and axial length(AL)in myopic children.METHODS: A total of 8 databases, including Pubmed, Embase, Cochrane Library, Web of Science, CNKI, WanFang Database, VIP Database and China Biomedical Literature Database, were electronically retrieved to collect the clinical randomized controlled trial(RCT)of low-energy red light in myopia, with red light intervention as an experimental group and glasses as a control group. The retrieval time limit is from the establishment of the database to January 2023. According to the recommendation of the Cochrane Handbook, literature quality and risk of bias were evaluated. Revman5.4 software was used for Meta-analysis.RESULTS: Totally 8 RCT about red-light treatment with myopia were included. The sample size for ChT analysis contained 407 eyes in the red-light group and 425 eyes in the control group; SE analysis included 490 eyes in the red-light group and 518 eyes in the control group; sample size for AL analysis were 518 eyes in the red-light group and 539 eyes in the control group. The differences in ChT, SE and AL between the groups were statistically significant(ChT: WMD=37.81, 95%CI: 21.55~54.07, P<0.001; SE: WMD=0.58, 95%CI: 0.46~0.71, P<0.001; AL: WMD=-0.31, 95%CI: -0.39~-0.24, P<0.001).CONCLUSION: Specific red light can promote the increase of ChT while inhibit SE and AL. However, its long-term efficacy and side effects remain unclear. The above conclusions need to be further clarified by more RCT with large samples.
3.Developmental effects of TCIPP and TnBP on zebrafish (Danio rerio) embryos.
Shu Yi ZHANG ; Shao Ping ZHANG ; Zi Jin SHAO ; Yuan Zheng FU ; Wen GU ; Hong ZHI ; Jian KONG ; Fu Chang DENG ; Wen Yan YAN ; Juan LIU ; Chao WANG ; Song TANG
Chinese Journal of Preventive Medicine 2023;57(5):693-700
Objective: To investigate the toxicity of tris (2-chloropropyl) phosphate (TCIPP) and tributyl phosphate (TnBP) on the growth and development of zebrafish embryos, as well as to explore the underlying mechanisms at the transcriptional level. Methods: With zebrafish as a model, two hpf zebrafish embryos were exposed to TCIPP and TnBP (0.1, 1, 10, 100, 500, and 1 000 μmol/L) using the semi-static method, and their rates of lethality and hatchability were determined. The transcriptome changes of 120 hpf juvenile zebrafish exposed to environmentally relevant concentrations of 0.1 and 1 μmol/L were measured. Results: The 50% lethal concentrations (LC50) of TCIPP and TnBP for zebrafish embryos were 155.30 and 27.62 μmol/L (96 hpf), 156.5 and 26.05 μmol/L (120 hpf), respectively. The 72 hpf hatching rates of TCIPP (100 μmol/L) and TnBP (10 μmol/L) were (23.33±7.72)% and (91.67±2.97)%, which were significantly decreased compared with the control group (P<0.05). Transcriptome analysis showed that TnBP had more differential genes (DEGs) than TCIPP, with a dose-response relationship. These DEGs were enriched in 32 pathways in total, including those involved in oxidative stress, energy metabolism, lipid metabolism, and nuclear receptor-related pathways, using the IPA pathway analysis. Among them, three enriched pathways overlapped between TCIPP and TnBP, including TR/RXR activation and CAR/RXR activation. Additionally, DEGs were also mapped onto pathways of LXR/RXR activation and oxidative stress for TnBP exposure only. Conclusion: Both TCIPP and TnBP have growth and developmental toxicities in zebrafish embryos, with distinct biomolecular mechanisms, and TnBP has a stronger effect than TCIPP.
Animals
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Zebrafish/metabolism*
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Embryo, Nonmammalian/metabolism*
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Transcriptome
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Oxidative Stress
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Water Pollutants, Chemical/metabolism*
4.Incidence and prognosis of olfactory and gustatory dysfunctions related to infection of SARS-CoV-2 Omicron strain: a national multi-center survey of 35 566 population.
Meng Fan LIU ; Rui Xia MA ; Xian Bao CAO ; Hua ZHANG ; Shui Hong ZHOU ; Wei Hong JIANG ; Yan JIANG ; Jing Wu SUN ; Qin Tai YANG ; Xue Zhong LI ; Ya Nan SUN ; Li SHI ; Min WANG ; Xi Cheng SONG ; Fu Quan CHEN ; Xiao Shu ZHANG ; Hong Quan WEI ; Shao Qing YU ; Dong Dong ZHU ; Luo BA ; Zhi Wei CAO ; Xu Ping XIAO ; Xin WEI ; Zhi Hong LIN ; Feng Hong CHEN ; Chun Guang SHAN ; Guang Ke WANG ; Jing YE ; Shen Hong QU ; Chang Qing ZHAO ; Zhen Lin WANG ; Hua Bin LI ; Feng LIU ; Xiao Bo CUI ; Sheng Nan YE ; Zheng LIU ; Yu XU ; Xiao CAI ; Wei HANG ; Ru Xin ZHANG ; Yu Lin ZHAO ; Guo Dong YU ; Guang Gang SHI ; Mei Ping LU ; Yang SHEN ; Yu Tong ZHAO ; Jia Hong PEI ; Shao Bing XIE ; Long Gang YU ; Ye Hai LIU ; Shao wei GU ; Yu Cheng YANG ; Lei CHENG ; Jian Feng LIU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(6):579-588
Objective: This cross-sectional investigation aimed to determine the incidence, clinical characteristics, prognosis, and related risk factors of olfactory and gustatory dysfunctions related to infection with the SARS-CoV-2 Omicron strain in mainland China. Methods: Data of patients with SARS-CoV-2 from December 28, 2022, to February 21, 2023, were collected through online and offline questionnaires from 45 tertiary hospitals and one center for disease control and prevention in mainland China. The questionnaire included demographic information, previous health history, smoking and alcohol drinking, SARS-CoV-2 vaccination, olfactory and gustatory function before and after infection, other symptoms after infection, as well as the duration and improvement of olfactory and gustatory dysfunction. The self-reported olfactory and gustatory functions of patients were evaluated using the Olfactory VAS scale and Gustatory VAS scale. Results: A total of 35 566 valid questionnaires were obtained, revealing a high incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain (67.75%). Females(χ2=367.013, P<0.001) and young people(χ2=120.210, P<0.001) were more likely to develop these dysfunctions. Gender(OR=1.564, 95%CI: 1.487-1.645), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), oral health status (OR=0.881, 95%CI: 0.839-0.926), smoking history (OR=1.152, 95%CI=1.080-1.229), and drinking history (OR=0.854, 95%CI: 0.785-0.928) were correlated with the occurrence of olfactory and taste dysfunctions related to SARS-CoV-2(above P<0.001). 44.62% (4 391/9 840) of the patients who had not recovered their sense of smell and taste also suffered from nasal congestion, runny nose, and 32.62% (3 210/9 840) suffered from dry mouth and sore throat. The improvement of olfactory and taste functions was correlated with the persistence of accompanying symptoms(χ2=10.873, P=0.001). The average score of olfactory and taste VAS scale was 8.41 and 8.51 respectively before SARS-CoV-2 infection, but decreased to3.69 and 4.29 respectively after SARS-CoV-2 infection, and recovered to 5.83and 6.55 respectively at the time of the survey. The median duration of olfactory and gustatory dysfunctions was 15 days and 12 days, respectively, with 0.5% (121/24 096) of patients experiencing these dysfunctions for more than 28 days. The overall self-reported improvement rate of smell and taste dysfunctions was 59.16% (14 256/24 096). Gender(OR=0.893, 95%CI: 0.839-0.951), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), history of head and facial trauma(OR=1.180, 95%CI: 1.036-1.344, P=0.013), nose (OR=1.104, 95%CI: 1.042-1.171, P=0.001) and oral (OR=1.162, 95%CI: 1.096-1.233) health status, smoking history(OR=0.765, 95%CI: 0.709-0.825), and the persistence of accompanying symptoms (OR=0.359, 95%CI: 0.332-0.388) were correlated with the recovery of olfactory and taste dysfunctions related to SARS-CoV-2 (above P<0.001 except for the indicated values). Conclusion: The incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain is high in mainland China, with females and young people more likely to develop these dysfunctions. Active and effective intervention measures may be required for cases that persist for a long time. The recovery of olfactory and taste functions is influenced by several factors, including gender, SARS-CoV-2 vaccination status, history of head and facial trauma, nasal and oral health status, smoking history, and persistence of accompanying symptoms.
Female
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Humans
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Adolescent
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SARS-CoV-2
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Smell
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COVID-19/complications*
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Cross-Sectional Studies
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COVID-19 Vaccines
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Incidence
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Olfaction Disorders/etiology*
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Taste Disorders/etiology*
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Prognosis
5.Research progress of Kelch-like ECH-associated protein 1-nuclear factor erythroid 2-related factor 2 signaling pathway regulated retinal oxidative stress
Zhi-Ming GU ; Wei-Qi ZHONG ; Chang-Jun LAN ; Xuan LIAO
International Eye Science 2023;23(11):1840-1843
Oxidative stress(OS)is a major reason for body damage. Studies have shown that a variety of factors, such as ischemia and hypoxia, excessive light and hyperglycemia can cause the increase of reactive oxygen species and free radicals in the retina, thus inducing OS, damaging retina and affecting the normal visual function. Kelch-like ECH-associated protein 1(KEAP1)and nuclear factor erythroid 2 related factor 2(NRF2), which together constitute the main antioxidant stress signaling pathway in the body, play an antioxidant role by regulating retinal energy metabolism and cell proliferation, apoptosis and autophagy through various ways, so as to reduce retinal damage caused by OS. In this paper, the role and mechanism of the KEAP1-NRF2 signaling pathway regulation of OS in the retinal are briefly reviewed, aiming to provide ideas for subsequent research.
6.Influencing factors for prognosis in patients with ST-segment elevation myocardial infarction with cardiogenic shock treated with extracorporeal membrane oxygenation combined with percutaneous coronary intervention
Li-Fang SU ; Wei ZHI ; Heng-Bo GAO ; Hao XIAO ; Chang-Chang LIU ; Qing ZHOU ; Yan-Bo WANG ; Xin-Shun GU
Chinese Journal of Interventional Cardiology 2023;31(12):904-910
Objective To investigate the influencing factors for prognosis in patients with ST-segment elevation myocardial infarction(STEMI)with cardiogenic shock(CS)treated with extracorporeal membrane oxygenation(ECMO)combined with percutaneous coronary intervention(PCI).Methods The clinical data of patients with STEMI and CS who received ECMO combined with PCI treatment in the cardiology department of our hospital from May 2019 to July 2023 were retrospectively analyzed.According to the clinical outcome,the patients were divided into death group and survival group.The clinical data of the two groups was compared.Results The study analyzed a total of 37 patients,including 34 males with an average age of(52.4±11.7)years.There were 15 survivors and 22 deaths,with a survival rate of 40.5%.Compared with the death group,the survival group had higher systolic blood pressure[(100.6±17.7)mmHg vs.(84.6±22.0)mmHg,P=0.025]and diastolic blood pressure[(64.5±11.8)mmHg vs.(54.3±16.0)mmHg,P=0.043]at admission,and longer time from shock to ECMO support[4.0(3.0,10.0)h vs.2.8(1.9,5.1)h,P=0.048]and shorter time from ECMO support to passage of guide wire[1.5(0.5,3.0)h vs.3.8(2.3,7.0)h,P=0.008].The proportion of thrombolysis in myocardial infarction(TIMI)blood flow classification reaching level Ⅲ in the first frame is higher[9(60.0%)vs.5(22.7%),P=0.038].The level of serum alanine aminotransferase[261.8(100.1,944.9)U/L vs.106.6(27.4,193.3)U/L,P=0.033]and shorter time from aspartate aminotransferase[753.6(432.7,1533.0)U/L vs.244.7(113.7,594.3)U/L,P=0.009]in the death group are significantly higher than that in the survival group.Conclusions This study suggests that the time from ECMO support and ECMO support to passage of guide wire,and the first frame TIMI blood flow grading are important factors affecting the prognosis of STEMI patients with CS treated with ECMO combined with PCI.
7.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
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East Asian People
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Neoplasms/pathology*
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Antibodies, Monoclonal, Humanized/therapeutic use*
8.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
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East Asian People
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Neoplasms/pathology*
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Antibodies, Monoclonal, Humanized/therapeutic use*
9.Meta-analysis of the effect of different concentrations of atropine inhibiting spherical equivalent degree and axial length of myopia in children
Zhi-Ming GU ; Chang-Jun LAN ; Wei-Qi ZHONG ; Xiao-Yu LI ; Xiao-Ling XIANG ; Xuan LIAO
International Eye Science 2022;22(10):1671-1677
AIM: To systematically evaluate the effects of 0.01%, 0.025% and 0.05% ophthalmic atropine on the change of spherical equivalent(SE)degree and axial length(AL)of myopic children. METHODS: PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang Database, VIP and CBM were searched for all publications related to 0.01%, 0.025% and 0.05% atropine to control myopia simultaneously. The publication time is from the database construction to May 2022. The Cochrane handbook was used to evaluate the risk of bias and quality of the included literature, STATA12.0 was used to detect publication bias and Revman5.4 software was used for Meta-analysis. RESULTS: A total of 6 literatures(1 239 eyes)were included, with 5 randomized controlled trials and 1 case-control study. Meta-analysis results showed that 0.025% atropine had better inhibitory effect on SE and AL than 0.01% atropine(SE: WMD=-0.15, 95%CI: -0.23--0.06, P<0.001; AL: WMD=0.07, 95%CI: 0.03-0.10, P<0.001). The inhibitory effect of 0.05% atropine on SE and AL was better than 0.01% atropine(SE: WMD=-0.35, 95%CI: -0.44--0.26, P<0.001; AL: WMD=0.16, 95%CI: 0.12-0.20, P<0.001). The inhibitory effect of 0.05% atropine on SE and AL increase was better than 0.025% atropine(SE: WMD=-0.20, 95%CI: -0.28--0.11, P<0.001; AL: WMD=0.09, 95%CI: 0.06-0.12, P<0.001). CONCLUSION: The concentration of 0.05% atropine is superior to 0.01% and 0.025% atropine in the control of SE and AL. However, the side effects of long-term use remain to be observed.
10.Correlation analysis of age and microbial characteristics in saliva and feces of high-risk population of upper gastrointestinal cancer.
Min Juan LI ; Dan Tong SHAO ; Jia Chen ZHOU ; Jian Hua GU ; Zhi Yuan FAN ; Jun Jie QIN ; Xin Qing LI ; Chang Qing HAO ; Wen Qiang WEI
Chinese Journal of Preventive Medicine 2022;56(12):1759-1766
Objective: To explore the correlation between age and diversity and microbial composition in saliva and feces microbiota in high-risk population of upper gastrointestinal cancer. Methods: Based on the national project on early diagnosis and early treatment of upper gastrointestinal cancer, 38 participants were enrolled in Linzhou in Henan province in August 2019. The participant information was collected by questionnaire. Saliva and feces specimens were collected from each participant for 16S rRNA sequencing and bioinformatics analysis. Spearman rank correlation was used to analyze the correlation between age and α diversity (Observed ASVs and Shannon index) and relative abundance of microbiota (phyla, genera, and species) in saliva and feces. Results: The median age (age range) of 38 participants was 54 (43-60) years old, and there were 16 males (42.1%). The Observed ASVs of saliva was negatively correlated with age (rs=-0.35, P<0.05), but the observed ASVs of feces was not correlated with age. In saliva, the relative abundance of Treponema (rs=‒0.44, P<0.05), Alloprevotella (rs=‒0.42, P<0.05), and Porphyromonas (rs=‒0.41,P<0.05) were significantly negatively correlated with age. At the species level, the relative abundance of Porphyromonas endodontalis, Alloprevotella tannerae, Haemophilus influenza, Moraxella bovoculi, Prevotella sp.oral clone ID019, and Prevotella sp.oral clone ASCG10 in saliva were significantly negatively correlated with age, and the rs values were -0.50, -0.40, -0.38, -0.35, -0.33 and -0.33 (P<0.05), respectively. In feces, the relative abundance of Enterobacteria (rs=-0.35, P<0.05), Escherichia (rs=-0.33, P<0.05), and Bifidobacteria (rs=0.33, P<0.05) were correlated with age. At the species level, the relative abundance of Romboutsia sedimentorum, Citrobacter murliniae, and bacteroides uniformis in feces were correlated with age, and the rs values were -0.42, -0.37 and 0.36 (P<0.05), respectively. Conclusion: Age of the high-risk population of upper gastrointestinal cancer is correlated with the relative abundance of microbiota in saliva and feces.
Male
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Humans
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Adult
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Saliva/microbiology*
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RNA, Ribosomal, 16S/genetics*
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Feces/microbiology*
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Microbiota
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Gastrointestinal Neoplasms

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