1.Signal mining and analysis of adverse events of basiliximab used in solid organ transplantation based on FAERS database
Saisai CHENG ; Feng ZHU ; Bi ZHOU
Chinese Journal of Pharmacoepidemiology 2025;34(5):515-523
Objective Based on the US Food and Drug Administration(FDA)adverse event Reporting System(FAERS),to explore the signal of adverse events of basiliximab in solid organ transplantation,and to provide reference for its clinical safety.Methods The adverse drug event(ADE)signals of basiliximab in solid organ transplantation from the first quarter of 2004 to the second quarter of 2024 were retrospectively analyzed in the FAERS database of the FDA.The reporting odds ratio(ROR)method and Bayesian confidence propagation neural network(BCPNN)method were used for signal mining.Results A total of 1,581 ADE reports related to the use of basiliximab were obtained,involving 27 system/organ classifications.A total of 460 ADE signals were identified.The top 5 PT signals in terms of report frequency were mainly elevated serum creatinine,fever,cytomegalovirus infection,decreased hemoglobin,and decreased lymphocyte count.The top 5 PT signals in terms of signal intensity were mainly cytomegalovirus infection,elevated serum creatinine,decreased lymphocyte count,increased neutrophil count,and thrombotic microangiopathy.New ADE signals identified included decreased lymphocyte count,thrombotic microangiopathy,eye organ diseases,Kaposi's sarcoma,elevated blood lactate dehydrogenase,elevated transaminases,and shock.Conclusion Data mining using FAERS database is helpful to find new ADE signals of basiliximab in solid organ transplantation.Clinicians should focus on new severe ADE signals such as coagulation function,ocular organ diseases,elevated transaminase,shock and so on.
2.Association of blood selenium exposure with sex hormones among men aged 18-79 years in China
Zheng LI ; Yingli QU ; Yawei LI ; Saisai JI ; Haocan SONG ; Qi SUN ; Miao ZHANG ; Wenli ZHANG ; Jiayi CAI ; Liang DING ; Ying ZHU ; Feng ZHAO ; Zhaojin CAO ; Yuebin LYU ; Lu WANG ; Xiaoming SHI
Chinese Journal of Preventive Medicine 2025;59(10):1632-1639
Objective:To investigate the association between blood selenium levels and sex hormones in Chinese men aged 18-79 years.Methods:Data were derived from the China National Human Biomonitoring survey conducted in 2017-2018, with a final sample size of 5 414 men. General demographic characteristics, behavioral habits, and dietary frequency were collected through questionnaires and physical examinations. Fasting blood samples were collected to measure blood lead, serum testosterone, and estradiol levels. Complex sampling linear regression models were used to analyze the associations between blood selenium levels and testosterone, estradiol, and the testosterone/estradiol ratio, adjusting for confounding factors including age, education level, marital status, smoking status, alcohol consumption, seafood intake, soy product intake, protein supplement intake, BMI, and diabetes status.Results:The mean age of the 5 414 participants was (46.85±27.91) years; 4 774 (91.65%) were of Han ethnicity and 4 505 (86.68%) were married. The median ( Q1, Q3) blood selenium concentration in men was 97.80 (80.64, 116.99) μg/L. After adjusting for confounding factors, the complex sampling linear regression model revealed negative associations between blood selenium levels and both testosterone levels and the testosterone/estradiol ratio, with a significant linear trend ( Ptrend<0.05). Compared with the Q1 group, the β (95% CI) values for testosterone in the Q2, Q3, and Q4 groups were -0.02 (-0.06 to 0.02), -0.03 (-0.08 to 0.01), and -0.06 (-0.09 to -0.02), respectively. Similarly, the β (95% CI) values for the testosterone/estradiol ratio in the Q2, Q3, and Q4 groups were -0.01 (-0.03 to 0.02), -0.01 (-0.04 to 0.04), and -0.03 (-0.06 to -0.01), respectively. Subgroup analysis indicated stronger associations between blood selenium levels and testosterone/estradiol levels in non-smoking and obese men (BMI≥28 kg/m2). Conclusion:Blood selenium levels are negatively associated with testosterone levels and the testosterone/estradiol ratio in Chinese adult males.
3.Association of cadmium internal exposure levels with blood lipid in adults aged 18 to 79 years in China
Haocan SONG ; Saisai JI ; Zheng LI ; Yawei LI ; Feng ZHAO ; Yingli QU ; Yifu LU ; Yingying HAN ; Junxin LIU ; Jiayi CAI ; Tian QIU ; Wenli ZHANG ; Xiao LIN ; Junfang CAI ; Yuebin LYU ; Xiaoming SHI
Chinese Journal of Preventive Medicine 2025;59(8):1254-1263
Objective:To explore the association of blood and urinary cadmium levels with lipid profile levels and dyslipidemia in Chinese adults aged 18 to 79 years.Methods:Based on the China National Human Biomonitoring (CNHBM) program, a cross-sectional survey was conducted from 2017 to 2018 using a multi-stage stratified random sampling method, including a total of 10 713 adults aged 18 to 79 years. Data was obtained through questionnaires, physical examinations, biological sample collection, and laboratory testing. Multiple linear mixed effect model (MLMM) and generalized linear mixed effect model (GLMM) were used to analyze the association of blood and creatinine-corrected urinary cadmium levels with lipid profile levels as well as dyslipidemia among adults.Results:The age of 10 713 participants was (47.23±0.24) years, with 5 372 males accounting for 61.3% of the national population. The weighted mean±standard error (SE) of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) was (5.21±0.03), (1.86±0.03), (2.96±0.03), and (1.43±0.01) mmol/L, respectively. The prevalence rate of hypercholesterolemia, hypertriglyceridemia, mixed hyperlipidemia, low HDL-C, and high LDL-C was 16.0%, 21.6%, 6.6%, 13.5%, and 10.0%, respectively. MLMM showed that, after adjusting for relevant confounders, log-transformed blood cadmium levels were positively associated with increased levels of TC, TG and LDL-C ( P<0.05). When blood cadmium levels were categorized into quartiles, compared to the lowest exposure group ( Q1), participants in the highest blood cadmium exposure group ( Q4) had increases of 0.19 (95% CI: 0.06, 0.32) mmol/L in TC and 0.25 (95% CI: 0.08, 0.43) mmol/L in TG. GLMM indicated that, after adjusting for confounders, higher blood cadmium exposure levels were associated with increased risks of hypercholesterolemia, hypertriglyceridemia, mixed hyperlipidemia, and high LDL-C ( P<0.05). Further analysis by quartiles showed that, compared to the blood cadmium Q1 exposure group, the OR value (95% CI) for the Q4 group was 1.53 (1.12, 2.08) for hypercholesterolemia, 1.54 (1.09, 2.17) for hypertriglyceridemia, 2.24 (1.47, 3.40) for mixed hyperlipidemia, and 1.49 (1.07, 2.09) for high LDL-C. Conclusion:The cadmium internal exposure levels are associated with blood lipid profile levels as well as the incidence of dyslipidemia in Chinese adults aged 18 to 79.
4.Association of blood selenium exposure with sex hormones among men aged 18-79 years in China
Zheng LI ; Yingli QU ; Yawei LI ; Saisai JI ; Haocan SONG ; Qi SUN ; Miao ZHANG ; Wenli ZHANG ; Jiayi CAI ; Liang DING ; Ying ZHU ; Feng ZHAO ; Zhaojin CAO ; Yuebin LYU ; Lu WANG ; Xiaoming SHI
Chinese Journal of Preventive Medicine 2025;59(10):1632-1639
Objective:To investigate the association between blood selenium levels and sex hormones in Chinese men aged 18-79 years.Methods:Data were derived from the China National Human Biomonitoring survey conducted in 2017-2018, with a final sample size of 5 414 men. General demographic characteristics, behavioral habits, and dietary frequency were collected through questionnaires and physical examinations. Fasting blood samples were collected to measure blood lead, serum testosterone, and estradiol levels. Complex sampling linear regression models were used to analyze the associations between blood selenium levels and testosterone, estradiol, and the testosterone/estradiol ratio, adjusting for confounding factors including age, education level, marital status, smoking status, alcohol consumption, seafood intake, soy product intake, protein supplement intake, BMI, and diabetes status.Results:The mean age of the 5 414 participants was (46.85±27.91) years; 4 774 (91.65%) were of Han ethnicity and 4 505 (86.68%) were married. The median ( Q1, Q3) blood selenium concentration in men was 97.80 (80.64, 116.99) μg/L. After adjusting for confounding factors, the complex sampling linear regression model revealed negative associations between blood selenium levels and both testosterone levels and the testosterone/estradiol ratio, with a significant linear trend ( Ptrend<0.05). Compared with the Q1 group, the β (95% CI) values for testosterone in the Q2, Q3, and Q4 groups were -0.02 (-0.06 to 0.02), -0.03 (-0.08 to 0.01), and -0.06 (-0.09 to -0.02), respectively. Similarly, the β (95% CI) values for the testosterone/estradiol ratio in the Q2, Q3, and Q4 groups were -0.01 (-0.03 to 0.02), -0.01 (-0.04 to 0.04), and -0.03 (-0.06 to -0.01), respectively. Subgroup analysis indicated stronger associations between blood selenium levels and testosterone/estradiol levels in non-smoking and obese men (BMI≥28 kg/m2). Conclusion:Blood selenium levels are negatively associated with testosterone levels and the testosterone/estradiol ratio in Chinese adult males.
5.Association of cadmium internal exposure levels with blood lipid in adults aged 18 to 79 years in China
Haocan SONG ; Saisai JI ; Zheng LI ; Yawei LI ; Feng ZHAO ; Yingli QU ; Yifu LU ; Yingying HAN ; Junxin LIU ; Jiayi CAI ; Tian QIU ; Wenli ZHANG ; Xiao LIN ; Junfang CAI ; Yuebin LYU ; Xiaoming SHI
Chinese Journal of Preventive Medicine 2025;59(8):1254-1263
Objective:To explore the association of blood and urinary cadmium levels with lipid profile levels and dyslipidemia in Chinese adults aged 18 to 79 years.Methods:Based on the China National Human Biomonitoring (CNHBM) program, a cross-sectional survey was conducted from 2017 to 2018 using a multi-stage stratified random sampling method, including a total of 10 713 adults aged 18 to 79 years. Data was obtained through questionnaires, physical examinations, biological sample collection, and laboratory testing. Multiple linear mixed effect model (MLMM) and generalized linear mixed effect model (GLMM) were used to analyze the association of blood and creatinine-corrected urinary cadmium levels with lipid profile levels as well as dyslipidemia among adults.Results:The age of 10 713 participants was (47.23±0.24) years, with 5 372 males accounting for 61.3% of the national population. The weighted mean±standard error (SE) of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) was (5.21±0.03), (1.86±0.03), (2.96±0.03), and (1.43±0.01) mmol/L, respectively. The prevalence rate of hypercholesterolemia, hypertriglyceridemia, mixed hyperlipidemia, low HDL-C, and high LDL-C was 16.0%, 21.6%, 6.6%, 13.5%, and 10.0%, respectively. MLMM showed that, after adjusting for relevant confounders, log-transformed blood cadmium levels were positively associated with increased levels of TC, TG and LDL-C ( P<0.05). When blood cadmium levels were categorized into quartiles, compared to the lowest exposure group ( Q1), participants in the highest blood cadmium exposure group ( Q4) had increases of 0.19 (95% CI: 0.06, 0.32) mmol/L in TC and 0.25 (95% CI: 0.08, 0.43) mmol/L in TG. GLMM indicated that, after adjusting for confounders, higher blood cadmium exposure levels were associated with increased risks of hypercholesterolemia, hypertriglyceridemia, mixed hyperlipidemia, and high LDL-C ( P<0.05). Further analysis by quartiles showed that, compared to the blood cadmium Q1 exposure group, the OR value (95% CI) for the Q4 group was 1.53 (1.12, 2.08) for hypercholesterolemia, 1.54 (1.09, 2.17) for hypertriglyceridemia, 2.24 (1.47, 3.40) for mixed hyperlipidemia, and 1.49 (1.07, 2.09) for high LDL-C. Conclusion:The cadmium internal exposure levels are associated with blood lipid profile levels as well as the incidence of dyslipidemia in Chinese adults aged 18 to 79.
6.Signal mining and analysis of adverse events of basiliximab used in solid organ transplantation based on FAERS database
Saisai CHENG ; Feng ZHU ; Bi ZHOU
Chinese Journal of Pharmacoepidemiology 2025;34(5):515-523
Objective Based on the US Food and Drug Administration(FDA)adverse event Reporting System(FAERS),to explore the signal of adverse events of basiliximab in solid organ transplantation,and to provide reference for its clinical safety.Methods The adverse drug event(ADE)signals of basiliximab in solid organ transplantation from the first quarter of 2004 to the second quarter of 2024 were retrospectively analyzed in the FAERS database of the FDA.The reporting odds ratio(ROR)method and Bayesian confidence propagation neural network(BCPNN)method were used for signal mining.Results A total of 1,581 ADE reports related to the use of basiliximab were obtained,involving 27 system/organ classifications.A total of 460 ADE signals were identified.The top 5 PT signals in terms of report frequency were mainly elevated serum creatinine,fever,cytomegalovirus infection,decreased hemoglobin,and decreased lymphocyte count.The top 5 PT signals in terms of signal intensity were mainly cytomegalovirus infection,elevated serum creatinine,decreased lymphocyte count,increased neutrophil count,and thrombotic microangiopathy.New ADE signals identified included decreased lymphocyte count,thrombotic microangiopathy,eye organ diseases,Kaposi's sarcoma,elevated blood lactate dehydrogenase,elevated transaminases,and shock.Conclusion Data mining using FAERS database is helpful to find new ADE signals of basiliximab in solid organ transplantation.Clinicians should focus on new severe ADE signals such as coagulation function,ocular organ diseases,elevated transaminase,shock and so on.
7.Construction of gut microbial culture banks: advances, methods and perspectives.
Saisai FENG ; Liping LIU ; Liangliang ZHANG ; Jianguo XU
Chinese Journal of Biotechnology 2023;39(11):4463-4481
Recently, the gut microbiota-based live biotherapeutics (LBPs) development, the interaction between gut microbial species and the host, and the mining of new antimicrobial peptides, enzymes and metabolic pathway have received increasing attention. Culturing gut microbial species is therefore of great importance. This review systemically compared the construction advances of gut microbial culture banks and also analyzed the differences of methods used by research groups to give insight into the construction and enrichment of gut microbial resources. Presently, the gut microbial culture banks have included more than 1 000 bacterial species, belonging to 12 phyla, 22 classes, 39 orders, 96 families, and 358 genera. Among these, Firmicutes, Proteobacteria, Bacteroidota, and Actinomycetota exhibited the greatest diversities at the species level. The sequencing data showed that there are more than 2 000 species inhibited in the human gut. Therefore, the cultured gut microbial species are far from saturation. In terms of the construction method, the stool samples were pre-treated with ethanol or directly spread and cultured in the non-selective nutritional rich medium (represented by Gifu anaerobic medium) to obtain single colony. Then single colony was further purified. Generally, a simplified isolation and culture method is sufficient to obtain the most common and important intestinal bacterial species, such as Bifidobacteria-Lactobacillus, Akkermansia muciniphila, Faecalibacterium prausnitzii, Prevotella and S24-7 family strains. Finally, microbial resources with great diversities at the strain level are required for further functional research and product development. Samples covering hosts with distinct physiological status, diets or regions are necessary.
Humans
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Gastrointestinal Microbiome
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Microbiota
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Bacteria
8.Association of urinary nickel levels with insulin resistance, islet function, and diabetes in adults aged 18 years and above in China
Yingli QU ; Zheng LI ; Saisai JI ; Qi SUN ; Yawei LI ; Jiayi CAI ; Zhuona ZHANG ; Haocan SONG ; Wenli ZHANG ; Feng ZHAO ; Ying ZHU ; Yuebin LYU ; Zhaojin CAO ; Xiaoming SHI
Chinese Journal of Epidemiology 2023;44(11):1717-1723
Objective:To investigate the effects of urinary nickel exposure on insulin resistance, islet function and diabetes risk in adults aged 18 years and above in China.Methods:Based on the China National Human Biomonitoring from 2017 to 2018, a total of 500 diabetes patients were randomly selected as the case group, and the matched euglycemic control were selected by 1∶1 matching ratio. The urinary and venous blood samples of the subjects were collected, and the urinary nickel levels and serum glucose metabolism indexes such as fasting blood glucose and fasting insulin were detected, and the insulin resistance index (HOMA-IR), β cell function index (HOMA-β), and adjusted HOMA-β were calculated by using homeostasis model assessment. A multivariate logistic regression model was used to analyze the association between urinary nickel level and diabetes risk. Multiple linear regression models were used to evaluate the association of urinary nickel level with HOMA-IR, HOMA-β and adjusted HOMA-β.Results:The sex ratio of controls and cases was 1∶1. The multivariate logistic regression model showed that after adjusting for factors such as education level, smoking status, alcohol consumption, rice and meat intakes, family history of diabetes, BMI, total cholesterol level, hypertension, and urinary creatinine, compared with T1 group, the ORs of diabetes risk in the T2 and T3 groups were 1.36 (95% CI: 0.98-1.89) and 1.60 (95% CI: 1.14-2.24), respectively. The multiple linear regression model showed a positive association between urinary nickel levels and the elevated HOMA-IR, the β value of HOMA-IR in the T3 group was 0.12 (95% CI: 0.01-0.25) compared with the T1 group and each one-unit increase in the log-transformed urinary nickel level (2.71 μg/L) was associated with a 0.06 elevation in HOMA-IR (95% CI: 0.02-0.10). Meanwhile, the urinary nickel levels were negative associated with the adjusted HOMA-β, the β value of adjusted HOMA-β in the T3 group were -0.26 compared with the T1 group (95% CI: -0.41- -0.11), and each one-unit increase in the log-transformed urinary nickel level (2.71 μg/L) was associated with a -0.09 decrease in adjusted HOMA-β(95% CI: -0.14- -0.04). Conclusion:Higher urinary nickel level is positively correlated with elevated insulin resistance and diabetes risk while negatively correlated with the function of pancreatic islet β cells in adults in China.
9.Association of blood oxidative stress level with hypertriglyceridemia in the elderly aged 65 years and older in 9 longevity areas of China
Qiyue TAN ; Yuebin LYU ; Jinhui ZHOU ; Mingyuan ZHANG ; Chen CHEN ; Feng ZHAO ; Chengcheng LI ; Yingli QU ; Saisai JI ; Feng LU ; Yingchun LIU ; Heng GU ; Bing WU ; Zhaojin CAO ; Shuhua ZHAO ; Xiaoming SHI
Chinese Journal of Preventive Medicine 2021;55(1):18-24
Objective:To investigate the association of blood oxidative stress level with hypertriglyceridemia in the elderly aged 65 years and older in China.Methods:A total of 2 393 participants aged 65 years and older were recruited in 9 longevity areas from Heathy Aging and Biomarkers Cohort Study, during 2017 to 2018. Information on demographics characteristic, life style and health status were collected by questionnaire and physical examination, and venous blood was collected to detect the levels of blood oxidative stress and hypertriglyceridemia. The linear or non-linear association between oxidative stress and hypertriglyceridemia was described by restrictive cubic splines (RCS) fitting multiple linear regression model. The generalized linear mixed effect model was conducted to assess the association between oxidative stress and hypertriglyceridemia.Results:A total of 2 393 participants, mean age was 84.6 years, the youngest was 65 and the oldest was 112, the male was 47.9%(1 145/2 393), the triglyceride level was (1.4±0.8) mmol/L. The hypertriglyceridemia detection rate was 9.99%(239/2 393). The results of multiple linear regression model with restrictive cubic spline fitting showed that MDA level was linear association with triglyceride level; SOD level was nonlinear association with triglyceride level. MDA level had significantly association with hypertriglyceridemia, and the corresponding OR value was 1.063 (95% CI: 1.046,1.081) with 1 nmol/ml increment of blood MDA; SOD level had significantly association with hypertriglyceridemia, and the corresponding OR value was 0.986(95% CI: 0.983,0.989) with 1 U/ml increment of blood SOD. Conclusion:Among the elderly aged 65 and older in 9 longevity areas in China, MDA and SOD levels were associated with the risk of hypertriglyceridemia.
10.Association of sleep duration with cognitive impairment among older adults aged 65 years and older in China
Saisai JI ; Yuebin LYU ; Yingli QU ; Chen CHEN ; Chengcheng LI ; Jinhui ZHOU ; Zheng LI ; Wenli ZHANG ; Yawei LI ; Yingchun LIU ; Feng ZHAO ; Huijuan ZHU ; Xiaoming SHI
Chinese Journal of Preventive Medicine 2021;55(1):31-38
Objective:The study is to examine association of sleep duration and cognitive impairment in the older adults aged 65 years and older in China.Methods:We analyzed data from 2017-2018 wave of Chinese Longitudinal Healthy Longevity Survey (CLHLS). A total of 14 966 participants were included in the analysis. Data with respect to socioeconomic status, community involvement, behavior pattern, diet, life style, family structure, disease condition, mental health and cognitive function were collected. Cognitive function was measured with Mini-mental State Examination (MMSE). We conducted generalized linear mixed models to examine associations of sleep duration with cognitive impairment, and subgroup analyses of sex and age were conducted.Results:Among 14 966 participants, the percentage of participants aged 65 to 79 years, 80 to 89 years, 90 to 99 years and 100 years and older was 5 148 (4.40%), 3 777 (25.24%), 3 322 (22.20%) and 2 719 (18.16%), respectively. A total of 2 704 participants reported sleep duration of 5 h and less, and 3 883 reported 9 h and more, accounting for 18.94% and 27.19%, respectively. In total, 3 748 were defined with cognitive impairment, accounting for 25.04%. The results of generalized linear mixed models showed that both short (≤5 h) and long (≥ 9 h) sleep duration were associated with cognitive impairment compared with sleep duration of 7 h, with OR(95% CI) of 1.35(1.09-1.68) and 1.70(1.39-2.07), respectively. The association of sleep duration with cognitive impairment was more obvious in males and individuals aged 65 to 79 years old. Conclusion:Short or long sleep duration was responsible for increased risk of cognitive impairment in older Chinese.

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