1.Guidelines for Ethical Review Entrustment Contract of Life Science and Medical Research Involving Humans
Aijuan SHENG ; Meixia WANG ; Qiang LIU ; Zhongguang YU ; Hu CHEN ; Hui JIANG ; Jiyin ZHOU ; Xiaoqi WANG ; Haibin YU ; Mingjie ZI ; Yifeng JIANG ; Lei XU ; Tao SHI ; Guizhen SUN ; Dongxiang ZHENG
Chinese Medical Ethics 2023;36(5):492-498
The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.
2.Effect of resilience on association between job burnout and sleep disorders among workers in a petrochemical company
Hui WU ; Di WU ; Qingwei LYU ; Guizhen GU ; Wenhui ZHOU ; Shanfa YU
Journal of Environmental and Occupational Medicine 2023;40(4):426-432
Background The risks of unhealthy working mood and physical and mental health problems are high in the workers of petrochemical enterprises. Resilience is a positive psychological factor, which can provide positive ability to manage stress and job burnout, relieve tension, depression, anxiety, and other psychological discomfort. Objective To explore the moderating or mediating effect of resilience on the association between job burnout and sleep disorders in workers of petrochemical enterprises. Methods A survey with questionnaire of general information, resilience, job burnout (including exhaustion, cynicism, and professional efficacy), and sleep disorders was conducted among 1087 workers who were selected by cluster sampling from a petrochemical enterprise in Henan Province in April 2022. Mann-Whitney U test and Kruskal-Wallis H test were used to test the differences of scores among different demographic groups. Resilience, job burnout (including exhaustion, cynicism, and professional efficacy), and sleep disorder scores were analyzed by partial correlation analysis. The moderating effect of resilience was examined by linear regression analysis, and the mediating effect of resilience by Bootstrap method. Results A total of 861 questionnaires were collected, of which 857 were effective, and the effective rate was 99.5%. The M (P25, P75) of job burnout score was 1.24 (0.65, 2.22) and the incidence of job burnout was 36.4% (312/857); the scores [M (P25, P75)] of exhaustion, cynicism, and professional efficacy were 1.40 (0.80, 3.00), 1.00 (0.20, 1.60), and 5.50 (4.00, 6.00), respectively. The M (P25, P75) of resilience score was 36.00 (30.00, 41.00). The M (P25, P75) of sleep disorder score was 11.00 (7.00, 15.00). The partial correlation analysis results showed that job burnout, exhaustion, and cynicism were negatively correlated with resilience (r=−0.387, −0.248, −0.247, P<0.01), and positively correlated with sleep disorders (r=0.455, 0.445, 0.357, P<0.01); professional efficacy was positively correlated with resilience (r=0.366, P<0.01) and negatively correlated with sleep disorders (r=−0.184, P<0.01); resilience was negatively correlated with sleep disorders (r=−0.349, P<0.01). The linear regression analysis results found that job burnout, exhaustion, and cynicism elevated the risk of sleep disorders (P<0.01), resilience lowered the risk of sleep disorders (P<0.01); but the relationship between job burnout (exhaustion, cynicism, and professional efficacy) and sleep disorders was not moderated by resilience (P>0.05). The mediating effect test showed that resilience played a partial mediating role in the associations of job burnout, exhaustion, cynicism, and professional efficacy with sleep disorders, the mediating effects were 0.522 (95%CI: 0.283-0.777), 0.310 (95%CI: 0.188-0.453), 0.364 (95%CI: 0.228-0.524), −0.542 (95%CI: −0.741-−0.366) and the mediating effects accounted for 17.31%, 14.12%, 19.24%, and 64.72% of the total effects, respectively. Conclusion The relationship between job burnout and sleep disorders is partially mediated by resilience among workers in the selected petrochemical company, but no moderating effect is found.
3.The moderating and mediating effects of psychological capital in the relationship of job monotony and depressive symptoms
Hui WU ; Jianzhong SHAO ; Guizhen GU ; Furan LI ; Wenhui ZHOU ; Hongce XUE ; Shanfa YU
Chinese Journal of Behavioral Medicine and Brain Science 2022;31(11):1020-1025
Objective:To explore the moderating and mediating effects of psychological capital in the associations of job monotony and depressive symptoms.Methods:A convenient sampling method was used to sample 1 473 workers from a natural gas field in southwest China in October 2018.The sociodemographic characteristics, job monotony scale, PsyCap questionnaire and center of epidemiological survey, depression scale(CES-D) were conducted.Data were analyzed by SPSS 22.0 and Process v3.2 softwares.The statistical methods included t-test, one-way ANOVA, χ2 test, partial correlation analysis, multivariate regression analysis or Bootstrap method. Results:A total of 323 workers with depressive symptoms were detected, with a detection rate of 21.9%(323/1 473). The correlation analysis results showed that job monotony (13.67±1.38) was negatively correlated with self-efficacy (25.81±4.56), hope(25.91±4.55), resilience (26.80±3.80) and optimism (24.56±3.17) ( r=-0.26, -0.38, -0.36, -0.42 respectively, all P<0.01), and positively correlated with depressive symptoms ( r=0.50, P<0.01). Self-efficacy ( r=-0.38, P<0.05), hope ( r=-0.44, P<0.05), resilience ( r=-0.43, P<0.01) and optimism ( r=-0.47, P<0.01) were negatively correlated with depressive symptoms.The multivariate regression analysis results showed that self-efficacy and optimism had moderating effects on the associations of job monotony and depressive symptoms (both P<0.05), while hope and resilience had no moderating effects on the associations of job monotony and depressive symptoms (both P>0.05). The mediating effect test results showed that self-efficacy, hope, resilience and optimism played partial mediating roles in the associations of job monotony and depressive symptoms (all P<0.01), and the mediating effects were 0.139, 0.304, 0.232 and 0.339 respectively, and the proportion of mediating effect value to total effect was 12.2%, 23.3%, 18.8% and 25.3% respectively. Conclusion:Self-efficacy and optimism have moderating and mediating effects on the associations of job monotony and depressive symptoms, while hope and resilience have only mediating effects on the relationship between job monotony and depressive symptoms.
4.Hemodynamic Analysis on Proximal End of the Aortic Dissection with Different Rupture Shapes
Yu XUE ; Qingsong HAN ; Yongzhi GONG ; Guizhen BAO ; Shijie GUO ; Haiquan FENG ; Xiaotian WANG ; Wei WEI
Journal of Medical Biomechanics 2021;36(5):E751-E756
Objective To explore hemodynamic performance of the aortic dissection after lesions, so as to provide a more scientific basis for patient treatment. Methods Based on computed tomography angiography (CTA) image data from a patient with complex Stanford B-type aortic dissection, the personalized aortic dissection models with different rupture shapes (H-type, O-type, and V-type) at proximal end of the aortic dissection were established. Combined with computational fluid dynamics (CFD) and morphological analysis method, distributions of the velocity at rupture section, the blood flow, the wall pressure and the wall shear stress (WSS) were analyzed. Results The flow velocity, the highest pressure difference and the WSS proportion at entrance of the H-shaped rupture showed larger hemodynamic parameters than those of the other two types. The risk of dissection rupture for type H was the largest, while type V was in the middle, and type O was the smallest. Conclusions This study provides an effective reference for further numerical analysis the cases and formulation of treatment plans.
5.Degradation of SARS-CoV-2 receptor ACE2 by the E3 ubiquitin ligase Skp2 in lung epithelial cells.
Guizhen WANG ; Qun ZHAO ; Hui ZHANG ; Fan LIANG ; Chen ZHANG ; Jun WANG ; Zhenyin CHEN ; Ran WU ; Hong YU ; Beibei SUN ; Hua GUO ; Ruie FENG ; Kaifeng XU ; Guangbiao ZHOU
Frontiers of Medicine 2021;15(2):252-263
An unexpected observation among the COVID-19 pandemic is that smokers constituted only 1.4%-18.5% of hospitalized adults, calling for an urgent investigation to determine the role of smoking in SARS-CoV-2 infection. Here, we show that cigarette smoke extract (CSE) and carcinogen benzo(a)pyrene (BaP) increase ACE2 mRNA but trigger ACE2 protein catabolism. BaP induces an aryl hydrocarbon receptor (AhR)-dependent upregulation of the ubiquitin E3 ligase Skp2 for ACE2 ubiquitination. ACE2 in lung tissues of non-smokers is higher than in smokers, consistent with the findings that tobacco carcinogens downregulate ACE2 in mice. Tobacco carcinogens inhibit SARS-CoV-2 spike protein pseudovirions infection of the cells. Given that tobacco smoke accounts for 8 million deaths including 2.1 million cancer deaths annually and Skp2 is an oncoprotein, tobacco use should not be recommended and cessation plan should be prepared for smokers in COVID-19 pandemic.
Adult
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Animals
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COVID-19
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Epithelial Cells
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Humans
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Lung
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Mice
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Pandemics
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Peptidyl-Dipeptidase A
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SARS-CoV-2
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Spike Glycoprotein, Coronavirus
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Ubiquitin-Protein Ligases/genetics*
6.Relationship research among CDH23 gene and the risk of noise-induced hearing loss
Jie JIAO ; Guizhen GU ; Guoshun CHEN ; Huanling ZHANG ; Hui WU ; Yanhong LI ; Wenhui ZHOU ; Shanfa YU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2020;38(2):84-90
Objective:To explore the relationship among CDH23 gene variation and the risk of noise-induced hearing loss (NIHL) .Methods:The nested case-control study was performed and this study followed a cohort of 6297 noise-exposed workers in a steel factory of Henan province in China from January 1, 2006 to December 31, 2015. In July 2019, subjects whose average hearing threshold were more than 40 dB in high frequency were defined as the case group, and subjects whose average hearing threshold were less than 35 dB in high frequency and less than 25 dB in speech frequency were defined as the control group. A nested case-control study which included 572 subjects was carried out, in which subjects consisted of 286 cases and 286 controls. 18 single nucleotide polymorphisms (SNPs) in CDH23 were selected and genotyped, then we analyzed the association among SNPs in CDH23, haplotypes in CDH23 and NIHL risk. Logistic regression was performed to analyze the main effects of SNPs and the interactions between CNE and SNPs adjusting cumulative noise exposure (CNE) , smoking, drinking, physical exercise and hypertension. Moreover, the association between haplotypes in CDH23 and NIHL risk were also analyzed. We ananlyzed the relationship amongst different SNP groups and NIHL risk using the generalized multifactor dimensionality reduction (GMDR) method.Results:The results suggested that significant associations were observed for rs3802711, rs3752751, rs3752752, rs11592462, rs10762480, rs3747867 for NIHL overall and/or various CNE strata by adjusting CNE, smoking, drinking, physical exercise and blood pressure. For rs3802711, workers exposure to noise carrying the AA/GA genotype of rs3802711 increased risk of NIHL than those carrying GG genotype ( OR=3.121; 95% CI:1.054-9.239, P=0.035) in overall; In the stratified analysis of CNE (>97 dB (A) ·year at rs3802711 locus, workers exposure to noise carrying GA genotype ( OR=2.056; 95% CI:1.226~3.448, P=0.006) and GA+AA/GA genotype ( OR=2.221; 95% CI:1.340~3.681, P=0.002) increased NIHL risk. For rs11592462, workers exposure to noise carrying the GG genotype of rs11592462 increased risk of NIHL than those carrying CC genotype in overall ( OR=3.951; 95% CI:1.104-14.137, P=0.04) ; workers exposure to noise carrying the GG genotype of rs11592462 increased risk of NIHL than those carrying CG+CC genotype in overall ( OR=4.06; 95% CI:1.145-14.391, P=0.03) . After adjusting CNE, smoking, drinking, physical exercise and blood pressure, the haplotypes of CDH23 rs1227049, rs10999947, rs3752752, rs3752751, rs10762480, rs3802711, rs11592462, rs10466026, rs4747194, rs4747195 were not associated with the risk of NIHL. GMDR analysis showed no association between SNP combination and NIHL risk after adjusting CNE, smoking, drinking, physical exercise and blood pressure. Conclusion:Gene polymorphisms in CDH23 might associate significantly with the risk of NIHL.
7.Prediction of KCNQ4gene polymorphism varies with CNE or noise exposure duration on the Risk of NIHL-Cox model analysis based on cohort study
Wenhui ZHOU ; Guizhen GU ; Hui WU ; Yanhong LI ; Guoshun CHEN ; Huanling ZHANG ; Shanfa YU ; Yuxin ZHENG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2020;38(2):111-116
Objective:The purpose of this study was to explore the association between gene in the potassium recycling pathway 4 (KCNQ4) polymorphisms and the susceptibility to noise-induced hearing loss (NIHL) , and analysis the effect of cumulative noise exposure (CNE) and noise exposure duration on this association.Methods:A nested case-control study with 1∶1 matched was used based on the cohort of noise exposure in a steel factory. A total of 286 cases were selected as the group of hearing loss and 286 controls were chosen according to the matching standards of same gender, same type of work, age difference ≤ 5 years, noise exposure duration ≤ 2 years. The single nucleotide polymorphisms (SNPs) of rs4660468, rs4660470, rs34287852 in KCNQ4 were genotyped by SNPscan TM method. The codominant, dominant and recessive models were established to study KCNQ4 polymorphisms and the susceptibility to NIHL by single-factor conditional logistic regression analysis. The COX regression analysis was used to analyze the risk of developing NIHL in individuals with different genotypes along with the extending of noise exposure duration or CNE. Results:In the case of CNE≤96 dB (A) ·year, the risk of developing NIHL in individuals with TA genotype of rs4660470 was 2.197 times than individuals with TT genotypes (95% CI: 1.032~4.677) , and those with TA+AA and TT genotypes (HR=2.467, 95% CI: 1.025~5.934) With the increase of noise exposure duration, in rs4660470, individuals with TA genotype had a higher risk of suffering NIHL than those with TT genotype (HR=1.461, 95% CI: 1.061~2.011) , individuals with TA and/or AA genotype had a earlier risk of suffering NIHL than those with TT genotype. Conclusion:The mutant allele A of rs4660470 in KCNQ4 may be a risk factor for developing NIHL, CNE≤100 dB (A) ·year or the increase of noise exposure duration may further increase the risk of NIHL.
8.Association between GSTP1 gene polymorphisms and susceptibility to noise-induced hearing loss
Lulu YUAN ; Guoshun CHEN ; Jie JIAO ; Wenhui ZHOU ; Hui WU ; Guizhen GU ; Huanling ZHANG ; Yuxin ZHENG ; Shanfa YU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2020;38(2):101-107
Objective:To investigate the association between the single nucleotide polymorphisms (SNPS) at rs1695 and rs6591256 in glutathione S-transferase P1 (GSTP1) gene and susceptibility to noise-induced hearing loss in Chinese Han workers exposed to noise.Methods:Using the 1: 1 nested case-control study and taking 6297 workers exposed to noise in a steel plant in Henan province as the cohort study population in July 2019, we screened those who have been exposed to noise for ≥3 years and whose binaural high frequency (3000, 4000, 6000 Hz) average hearing threshold is ≥40 dB (A) into the case group. The control group was selected according to the matching criteria of the same sex, same type of work, and the age difference was not more than 5 years old, and the working age difference was not more than 2 years. 276 subjects were selected into the case group and the control group respectively. The medium and high throughout single nucleotide polymorphism typing technology (SNPscanTM technology) was used to detect the polymorphism of three nucleotide sites of GSR gene, and conditional logistic regression was used to analyze the relationship between single nucleotide polymorphism (SNP) and NIHL, and the relationship between different polymorphic sites and the risk of NIHL after adjusting covariates. After stratification with different cumulative noise exposure (CNE) , Conditional logistic regression analysis was used to analysis the risk of NIHL at different loci.Results:The mean and standard deviation of age of the selected subjects was (40.28±8.00) , the mean and standard deviation of noise-exposed working years was (18.7±8.92) years. The range of noise exposure levels and comulative noise exposure were 80.05-93.35dB (A) and 86.83-107.92 dB (A) ·year, respectively. Compared with the control group, there were no statistically significant differences in age, noise-exposured working years, intensity of noise exposure, CNE, gender, drinking, hypertension prevalence and noise exposure level in the hearing loss group ( P>0.05) , while there were statistically difference in smoking, binaural high-frequency average hearing threshold and binaural speech frequency ( P<0.05) . After adjusting for smoking, drinking, hypertension and other factors, in the co-dominant model, compared with GGgenotype, the risk of NIHL was higher in rs1002149 GT genotype and rs2251780 GA genotype ( OR=1.558, 95% CI: 1.028-2.361; OR=1.550, 95% CI: 1.020-2.355, P<0.05) ; compared with TT/GT genotype, the rs1002149 TT genotype has a higher risk of developing NIHL ( OR=1.494, 95% CI: 1.002-2.228, P<0.05) , while rs3779647 genotype had no relationship with the risk of NIHL ( P>0.05) . In the equivalent sound level (L Aeq) of noise >85 dB (A) stratification, compared with GG genotype, carrying rs1002149 GT genotype and rs2251780 GT genotype has higher risk of nihl ( OR=1.801, 95% CI: 1.093-2.967; OR=1.720, 95% CI: 1.050-2.817, P<0.05) . Haplotype analysis of two sites, rs1002149 and rs2251780, was not found to be related to NIIHL susceptibility. Conclusion:The allele G of rs1695 and rs6591256 may be risk factors of NIHL.
9.Association between GPX1 gene polymorphisms and noise-induced hearing loss
Jingyun LI ; Jie JIAO ; Guoshun CHEN ; Guizhen GU ; Huanling ZHANG ; Shanfa YU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2020;38(2):116-120
Objective:To identify association between genetic polymorphism in the Glutathione peroxidase 1 gene (GPX1) and noise-induced hearing loss (NIHL) .Methods:A nested case control study was conducted based on a cohort of noise-exposed subjects. 392 cases were selected from the steel factory in Henan Province, 392 matched control subjects for each case were designated on the basis of the matched criterion including same gender, age (±5years) and duration of exposure to noise (±2years) . Two single nucleotide polymorphisms (SNPs) of GPX1 were genotyped by SNPscanTM multiplex SNP genotyping kit. Hardy-Weinberg equilibrium (HWE) tests were performed using Pearson's χ 2 for each SNP among control group, effects of genotypes of GPX1 on NIHL were analyzed by logistic regression. Results:All two SNPs were in HWE. After adjustment for covariates including smoking status, rs1987628 polymorphism was statistically significantly associated with the NIHL risk under codominant and Dominant inheritance models; In the subjects carrying rs1987628 GA genotype had a higher NIHL risk than those carrying the GG genotype, the adjusted OR value was 1.803 (95% CI 1.215-2.676, P=0.003) . And meanwhile, rs1987628 GA+AA genotype had a higher NIHL risk than those carrying the GG genotype, the adjusted OR value was 1.762 (95% CI 1.197-2.593, P=0.004) . Conclusion:It was suggested that genetic polymorphism in the GPX1 gene might be the genetic susceptible factor for NIHL.
10.Retrospective investigation on explosive hearing loss of injured persons in explosion accidents involving a steel enterprise
Guoshun CHEN ; Huanling ZHANG ; Ruizhen LIU ; Guizhen GU ; Shanfa YU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2020;38(2):132-136
Objective:Through the investigation of the injured persons in explosion accidents, the impact of wearing the ear protectors device (anti-noise earplugs) on the auditory organs and hearing loss of the injured person was understood, which could provide reference for the clinical diagnosis, treatment and prevention of the explosive hearing impairment.Methods:A retrospective survey was conducted on 39 directly injured persons who were injured in 23 explosion accidents involving a steel plant from 1990 to 2016 as the explosive hearing loss, taking the time of the patient's injury and 3-6 months after the injury as the time of investigation and evidence collection, and according to whether to wear the ear protectors device for group comparison and statistical analysis.Results:There was no significant difference between the two groups in hearing loss, tinnitus, earache, headache, some patients with dizziness and craniocerebral injury, regardless of whether the injured person wore anti-noise earplugs or not ( P=0.444-1) , the shock (coma) patients in the non-protected group were more common (34.8%, 8/23) , and the difference was statistically significant ( P=0.012) ; Although auricle injury was detected in both groups and there was no significant difference between the two groups ( P=1) , but the external ear canal injury, tympanic membrane perforation were more common in the non-protected group, and there was no external ear canal and tympanic membrane perforation in the wearing earplug group, and the difference between the two groups was significant ( P=0.000) . After 3-6 months, the rehabilitation of auditory system and other symptoms in patients showed that the hearing loss, tinnitus, earache, headache, dizziness and other symptoms all disappeared in patients wearing earplugs, while the above symptoms in the non-protected group were improved but more persisted, and the difference between the two groups was statistically significant ( P=0.000-0.012) , and there was no significant difference in rehabilitation conditions such as craniocerebral injury between the two groups ( P=1) ; There were patients with unhealed auricle injury in both groups in 3-6 months after the injury, and there was no significant difference between the two groups ( P=1) , however, in the non-protected group, 69.57% (16/23) of the patients with external auditory canal injury were still unhealed and none of the patients with tympanic membrane perforation recovered, and the difference between the two groups was obvious ( P=0.000~0.001) ; Pure tone air conduction examination showed that the hearing of the earplugs wearers was well recovered at the time of the explosion, while irreversible hearing impairment was common in the non-protective group, the difference was statistically significant ( P=0.000) . Conclusion:Ear protector plays an important role in protecting the auditory organs and hearing of workers in explosion accident, and it is an effective protective measure to prevent and reduce the damage of external ear canal, perforation of tympanic membrane and explosive hearing loss caused by explosion accidents.

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