1.Practical exploration of ethical review in decentralized drug clinical trials
Xu ZUO ; Yingshuo HUANG ; Yue LI ; Lihan XING ; Chunxiu YANG ; Yan CUI
Chinese Medical Ethics 2025;38(1):40-45
ObjectiveTo explore the process and guidelines for ethical review in decentralized drug clinical trials, promote clinical trial progress, and ensure drug development progress. MethodsThe key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials, analyzing the advantages and challenges of decentralized drug clinical trials, and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials. ResultsRelevant laws and regulations were the basis for the ethical review, and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures. The ethics committee should focus on the feasibility, applicability, and rationality, the adequacy of informed consent, the protection of rights and interests and privacy of subjects, as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials. ConclusionDecentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations. Ethical review is also constantly being refined through exploration. It is necessary to supervise the implementation of responsibilities by all parties, pay attention to the rights and interests of subjects, and gradually promote the implementation of decentralized drug clinical trials.
2.Research on the prevalence of overweight and obesity among children
Xinyi LIANG ; Jingnan CHEN ; Xuelian ZHOU ; Ruimin CHEN ; Jingsi LUO ; Rongxiu ZHENG ; Chunxiu GONG ; Chunlin WANG ; Zhe SU ; Mireguli MAIMAITI ; Yan LIANG ; Hui YAO ; Haiyan WEI ; Hongwei DU ; Shaoke CHEN ; Yu YANG ; Feihong LUO ; Pin LI ; Min ZHU ; Wei WU ; Ke HUANG ; Guanping DONG ; Junfen FU
Chinese Journal of Pediatrics 2025;63(6):612-619
Objective:To investigate the prevalence and risk factors of overweight and obesity among Chinese children aged 3-18 years from 11 provinces, antonomous regions, or municipalities.Methods:This national cross-sectional community health survey utilized a multistage stratified cluster-random sampling method to recruit 193 997 nationally representative participants from 11 provinces, autonomous regions, or municipalities between January 2017 and December 2019. All participants underwent physical examinations, and their caregivers completed questionnaires assessing participants′ dietary, lifestyle, familial, and perinatal information. Multilevel multinomial logistic regression models were employed to identify the potential risk factors.Results:The cohort comprised 193 997 children (102 178 boys, 91 819 girls),aged (10±4) years. Overall prevalence rates were 30 574(15.8%)overweight children and 17 217(8.9%) obesity children. Boys exhibited higher overweight and obesity rates than girls (17.0% (17 368/102 178) vs. 14.4% (13 206/102 178), 11.3% (11 553/91 819) vs. 6.2% (5 664/91 819), χ2=249.12,1 578.69,both P<0.001). The detection rates of obesity in Tanner stage 2 and 3 were the highest in boys and girls, with 13.4%(2 231/16 665) and 8.6%(880/10 221) respectively. Risk factors for obesity included parental overweight (paternal OR=2.34 and maternal OR=2.29), annual household income of 100 000-200 000 yuan (compared with<100 000 yuan, OR=1.04), higher paternal education (compared with below high school,high school and a college education OR=1.09,1.14), birth weight >4.0 kg (≤5 and>5 years old OR=1.74, 1.44,respectively), and western food consumption≥1 time/month (compared with<1, 1-2, 3-4,>4 times/month OR=1.36, 1.30, 1.67(≤5 years), 1.19, 1.16, 1.15 (>5 years), respectively) (all P<0.05). Conversely, coarse grain intake≥1 times/week (compared with<1 times/week, every day, 3-4, 1-2 times/week OR=0.74, 0.80, 0.71 (≤5 years), 0.75, 0.87, 0.90(>5 years), respectively, all P<0.05) was associated with reduced obesity risk. Conclusions:Obesity epidemiology in children demonstrates significant heterogeneity across age, gender, geographic regions, and pubertal stages. It is necessary to establish a personalized prevention and control strategy.
3.Incidence, risk factors, and outcomes of falls among elderly in Beijing communities
Chunxiu WANG ; Shaochen GUAN ; Huihui LI ; Hongjun LIU ; Shimin HU ; Xiaoguang WU ; Yan ZHAO ; Chunxiao LIU ; Xujing BAI ; Xianghua FANG
Chinese Journal of Epidemiology 2025;46(6):994-1002
Objective:To investigate the incidence, risk factors, and outcomes of falls among the elderly community population in Beijing.Methods:A cross-sectional survey was conducted using stratified multistage random sampling to select urban and rural residents aged 65 years and older in Beijing. Mortality data was collected after the baseline survey for 5 years. The incidence of falls was weighted based on the composition ratios of age and gender from the 2010 Nation-wide Population Census of Beijing. A logistic regression model was used to analyze the impacts of demographic sociology of common chronic diseases on fall occurrence. The Cox proportional hazards regression model was used to analyze the fall and 5-year survival association.Results:A total of 2 968 participants completed the questionnaire, at cross-sectional survey, with an average age of (73.2±6.0) years, and 1 581 (53.8%) participants were female. Three hundred and sixty-one individuals experienced a fall within the past year. Among those who fell, 64 (17.7%) fell twice, and 95 (26.6%) fell three or more times. Of them, 14.4% (52) had post-fall fractures, with the wrist, knee, and hip being the most common fracture sites, accounting for 25.0%, 17.3%, and 15.4%, respectively. The weighted fall incidence was 12.4% (95% CI: 11.2%-13.5%). Aging, being female, and living in rural areas were more likely to fall. Logistic regression analysis showed that after adjusting for age, gender, and urban-rural status, the risk of falls for those living alone ( OR=1.48, 95% CI: 1.08-2.04) or living with children/grandchildren ( OR=1.51, 95% CI: 1.15-1.97) were significantly higher than those living with their spouse. In addition, the risk of falls was elevated significantly among the elderly with hypertension, diabetes, stroke, dementia, depression status, urinary incontinence, arthritis, insomnia, vision, and hearing loss, dependence on activities of daily living (ADL), general and poor self-rated health (SRH). The Cox proportional hazard regression model revealed that the 5-year risk of death increased by 65% ( HR=1.65, 95% CI: 1.29-2.11) for those who experienced a fall, which increased with fall frequency. This elevated risk persisted after adjusting for chronic conditions, ADL, and SRH. Conclusions:Ageing, female, living in rural regions, having common chronic diseases, dependence on ADL, general and poor SRH, living alone or living with children/grandchildren were associated with the elevated fall risk. The occurrence of fall was seasonal. The most common short-term adverse consequence after a fall was fractures, while the long-term effect was an increased risk of death.
4.Growth retardation and hepatopathy associated with single heterozygous mutations in the IARS1 gene: A case report
Yang LI ; Di MAO ; Liya WEI ; Chunxiu GONG
Journal of Clinical Hepatology 2025;41(4):731-735
Mutations in the IARS1 gene are rare in clinical practice, and up to now, only ten cases with detailed clinical and genetic data have been recorded in the literature. This article reports a case of growth retardation, intellectual developmental disorder, hypotonia, and hepatopathy (GRIDHH) associated with single heterozygous mutations in the IARS1 gene and summarizes the clinical and genetic features of GRIDHH, thereby expanding the genetic spectrum of GRIDHH.
5.Incidence, risk factors, and outcomes of falls among elderly in Beijing communities
Chunxiu WANG ; Shaochen GUAN ; Huihui LI ; Hongjun LIU ; Shimin HU ; Xiaoguang WU ; Yan ZHAO ; Chunxiao LIU ; Xujing BAI ; Xianghua FANG
Chinese Journal of Epidemiology 2025;46(6):994-1002
Objective:To investigate the incidence, risk factors, and outcomes of falls among the elderly community population in Beijing.Methods:A cross-sectional survey was conducted using stratified multistage random sampling to select urban and rural residents aged 65 years and older in Beijing. Mortality data was collected after the baseline survey for 5 years. The incidence of falls was weighted based on the composition ratios of age and gender from the 2010 Nation-wide Population Census of Beijing. A logistic regression model was used to analyze the impacts of demographic sociology of common chronic diseases on fall occurrence. The Cox proportional hazards regression model was used to analyze the fall and 5-year survival association.Results:A total of 2 968 participants completed the questionnaire, at cross-sectional survey, with an average age of (73.2±6.0) years, and 1 581 (53.8%) participants were female. Three hundred and sixty-one individuals experienced a fall within the past year. Among those who fell, 64 (17.7%) fell twice, and 95 (26.6%) fell three or more times. Of them, 14.4% (52) had post-fall fractures, with the wrist, knee, and hip being the most common fracture sites, accounting for 25.0%, 17.3%, and 15.4%, respectively. The weighted fall incidence was 12.4% (95% CI: 11.2%-13.5%). Aging, being female, and living in rural areas were more likely to fall. Logistic regression analysis showed that after adjusting for age, gender, and urban-rural status, the risk of falls for those living alone ( OR=1.48, 95% CI: 1.08-2.04) or living with children/grandchildren ( OR=1.51, 95% CI: 1.15-1.97) were significantly higher than those living with their spouse. In addition, the risk of falls was elevated significantly among the elderly with hypertension, diabetes, stroke, dementia, depression status, urinary incontinence, arthritis, insomnia, vision, and hearing loss, dependence on activities of daily living (ADL), general and poor self-rated health (SRH). The Cox proportional hazard regression model revealed that the 5-year risk of death increased by 65% ( HR=1.65, 95% CI: 1.29-2.11) for those who experienced a fall, which increased with fall frequency. This elevated risk persisted after adjusting for chronic conditions, ADL, and SRH. Conclusions:Ageing, female, living in rural regions, having common chronic diseases, dependence on ADL, general and poor SRH, living alone or living with children/grandchildren were associated with the elevated fall risk. The occurrence of fall was seasonal. The most common short-term adverse consequence after a fall was fractures, while the long-term effect was an increased risk of death.
6.Research on the prevalence of overweight and obesity among children
Xinyi LIANG ; Jingnan CHEN ; Xuelian ZHOU ; Ruimin CHEN ; Jingsi LUO ; Rongxiu ZHENG ; Chunxiu GONG ; Chunlin WANG ; Zhe SU ; Mireguli MAIMAITI ; Yan LIANG ; Hui YAO ; Haiyan WEI ; Hongwei DU ; Shaoke CHEN ; Yu YANG ; Feihong LUO ; Pin LI ; Min ZHU ; Wei WU ; Ke HUANG ; Guanping DONG ; Junfen FU
Chinese Journal of Pediatrics 2025;63(6):612-619
Objective:To investigate the prevalence and risk factors of overweight and obesity among Chinese children aged 3-18 years from 11 provinces, antonomous regions, or municipalities.Methods:This national cross-sectional community health survey utilized a multistage stratified cluster-random sampling method to recruit 193 997 nationally representative participants from 11 provinces, autonomous regions, or municipalities between January 2017 and December 2019. All participants underwent physical examinations, and their caregivers completed questionnaires assessing participants′ dietary, lifestyle, familial, and perinatal information. Multilevel multinomial logistic regression models were employed to identify the potential risk factors.Results:The cohort comprised 193 997 children (102 178 boys, 91 819 girls),aged (10±4) years. Overall prevalence rates were 30 574(15.8%)overweight children and 17 217(8.9%) obesity children. Boys exhibited higher overweight and obesity rates than girls (17.0% (17 368/102 178) vs. 14.4% (13 206/102 178), 11.3% (11 553/91 819) vs. 6.2% (5 664/91 819), χ2=249.12,1 578.69,both P<0.001). The detection rates of obesity in Tanner stage 2 and 3 were the highest in boys and girls, with 13.4%(2 231/16 665) and 8.6%(880/10 221) respectively. Risk factors for obesity included parental overweight (paternal OR=2.34 and maternal OR=2.29), annual household income of 100 000-200 000 yuan (compared with<100 000 yuan, OR=1.04), higher paternal education (compared with below high school,high school and a college education OR=1.09,1.14), birth weight >4.0 kg (≤5 and>5 years old OR=1.74, 1.44,respectively), and western food consumption≥1 time/month (compared with<1, 1-2, 3-4,>4 times/month OR=1.36, 1.30, 1.67(≤5 years), 1.19, 1.16, 1.15 (>5 years), respectively) (all P<0.05). Conversely, coarse grain intake≥1 times/week (compared with<1 times/week, every day, 3-4, 1-2 times/week OR=0.74, 0.80, 0.71 (≤5 years), 0.75, 0.87, 0.90(>5 years), respectively, all P<0.05) was associated with reduced obesity risk. Conclusions:Obesity epidemiology in children demonstrates significant heterogeneity across age, gender, geographic regions, and pubertal stages. It is necessary to establish a personalized prevention and control strategy.
7.Study on Clinical Profile,Treatment and Outcomes of Patients with Acute Cardio-cerebral Infarction
Xue LI ; Sufang XUE ; Chunxiu WANG
Journal of Medical Research 2024;53(1):131-135
Objective Cardio-cerebral infarction(CCI)is a severe clinical syndrome in which acute myocardial infarction(AMI)and acute ischemic stroke(AIS)occurs simultaneously(synchronous CCI,SCCI)or successively(metachronous CCI,MCCI).The study aims to explore its clinical profile,management and outcomes.Methods This is a single-center retrospective study of inpatients with CCI who presented to Xuanwu hospital from January 2014 to December 2021.The study collected and analyzed demographic informa-tion,clinical profile,management and outcomes(all-cause death,MACE events,mRS scores,bleeding events).Results Totally 137 patients with CCI were enrolled in the study,including 28 SCCI and 109 MCCI.Hypertension,smoking and diabetes were prominent risk factors for CCI.The heart function decreased significantly,including 42.9%suffered Killip Ⅲ-Ⅳ and 40.0%suffered decreased left ventricular ejection fraction.Large artery atherosclerosis was the most predominant etiology of AIS.The average NIHSS score was 11.24± 10.50.The rate of emergency reperfusion therapy was low(29.2%).Compared to the group that did not received emergence reperfusion therapy,the patients received emergency reperfusion therapy had a lower in-hospital mortality(P=0.042).All-cause mortality oc-curred in up to 27.0%,including 11.7%cardiovascular death.Heart failure(43.8%)was the most frequent MACE events.34.3%pa-tients had good neurological function(mRS 0-2)at discharge.27 patients(19.7%)experiencing major bleeding events,including 19 patients(13.9%)had the hemorrhagic transformation of AIS.Conclusion The CCI therapy still faces challenges,such as low reperfu-sion rate,differentiated antithrombotic options,and poor clinical prognosis.Large clinical research is need for promote the optimization of CCI treatment.
8.Prevalence and 5-year mortality of dementia and association with geriatric syndromes in elderly population in Beijing
Shimin HU ; Fang LI ; Shaochen GUAN ; Chunxiu WANG ; Xiaowei SONG ; Hongjun LIU ; Jinghong MA ; Yan ZHAO ; Chunxiao LIU ; Huihui LI ; Yanlei ZHANG ; Jian WU ; Xianghua FANG
Chinese Journal of Epidemiology 2024;45(11):1573-1581
Objective:To investigate the prevalence and mortality of dementia and assess the impact of geriatric syndromes (GS) on the risk for dementia and death in elderly population in Beijing.Methods:A cross-sectional survey was conducted in the elderly population aged ≥65 years and selected by a multi-stage sampling in Beijing during 2013-2015. Cognitive function was screened using the Chinese Revised Version of the Mini-Mental State Examination (MMSE). Then, neurological examination and psychiatric assessment were performed for those with the MMSE score lower than the cut-off value. The information about GS prevalence was also collected. The study also collected death records for all individuals from baseline until December 31, 2019. Based on the age and gender distribution from Beijing data of the 2010 Six th National Population Census, the dementia prevalence in the study population was directly standardized. Logistic regression analysis was used to evaluate the association of different forms of dementia with GS, and Cox proportional hazards regression model was used to estimate the hazard ratio ( HR) and 95% CI of death. Results:During 2013-2015, a total of 2 935 individuals completed dementia assessments, of which 167 were diagnosed with dementia. The standardized prevalence of dementia was 5.9% (95% CI: 5.0%-17.4%). The individuals with Alzheimer's disease (AD) and vascular dementia (VaD) accounted for 58.7% and 28.1% of total individuals with dementia, respectively. Aging, lower education level, urinary incontinence, and fall were risk factors for AD, while disability of activity of daily life dependence, hypertension, and stroke were found to be risk factors for VaD. After a median follow-up of 5.44 person-years, 399 deaths were recorded. The 5-year mortality risk was 2.87 (95% CI: 1.92-4.17) times and 4.93 (95% CI: 3.23-7.53) times higher for the elderly individuals with AD and VaD, respectively, compared to non-demented individuals. After adjusting for demographic, GS, and cardiovascular risk factors, the mortality risk in the elderly individuals with AD showed no significant difference compared with non-demented individuals ( HR=1.32, 95% CI: 0.89-1.97), while the mortality risk in those with VaD was 2.46 (95% CI: 1.49-4.05) times higher than that in non-demented individuals. Conclusions:The prevalence of dementia in Beijing increased significantly in the context of population aging, especially the prevalence of AD. The presence of GS increased the risks for AD and VaD, as well as the risk for death. Close attention needs to be paid to GS management in dementia prevention in elderly population.
9.Qualitative and Quantitative Analysis of Rehmanniae Radix and Its Decoction Pieces Based on Sugar Spectrum
Mengru DAI ; Chun LI ; Raorao LI ; Limei LIN ; Chunxiu SHEN ; Yongxin ZHANG ; Weihong FENG ; Zhimin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):157-163
ObjectiveTaking the oligosaccharides in Rehmanniae Radix(RR) as the research object, the content determination method based on high performance liquid chromatography-evaporative light scattering detection(HPLC-ELSD) and thin layer chromatography(TLC) identification method were established to explore the content and distribution of oligosaccharides in different RR herbs and decoction pieces. MethodA total of 10 batches of fresh and raw RR, 12 batches of RR decoction pieces and Rehmanniae Radix Praeparata(RRP) were collected. A TLC identification method for fructose, sucrose, manninotriose, raffinose and stachyose in RR was established by using silica gel G thin-layer plates with ethyl acetate-water-anhydrous formic acid-glacial acetic acid(12∶6∶5∶4) as the developing agent and 10% sulfuric acid-ethanol solution as chromogenic agent. A HPLC-ELSD was used to determine the contents of fructose, glucose, sucrose, melibiose, raffinose, manninotriose and stachyose in different RR herbs and decoction pieces. Then principal component analysis(PCA) and partial least squares-discriminant analysis(PLS-DA) were used to analyze the contents of 7 kinds of saccharides in RR herbs and decoction pieces, and the differential components were screened with the value of variable importance in the projection(VIP)>1. ResultThe results of TLC identification showed that fresh RR, raw RR and its decoction pieces showed spots of the same color on the corresponding positions with the control products of stachyose, raffinose and sucrose, while the TLC of RRP showed spots of the same color at corresponding positions to manninotriose and fructose controls. The results of methodological investigations of 7 analytes met the requirements of determination. Only glucose, sucrose, raffinose and stachyose were detected in 10 batches of fresh RR and 10 batches of raw RR herbs, the average contents of which were 0.84%, 4.62%, 2.42% and 57.90% in fresh samples, while those were 3.16%, 9.36%, 7.05% and 38.10% in raw samples, respectively. In 12 batches of RR decoction pieces, the contents of the above seven sugars(fructose, glucose, sucrose, melibiose, raffinose, manninotriose and stachyose) were 1.68%, 4.27%, 9.96%, 0.53%, 6.85%, 3.05% and 37.52%, respectively. In 12 batches of RRP, the contents of the above seven sugars were 10.62%, 11.01%, 1.25%, 3.35%, 1.12%, 28.16% and 6.39%, respectively. The results of multivariate statistical analysis showed that fresh RR, raw RR and RRP could be distinguished from each other by the contents of the 7 sugars, and the main differential components were stachyose, sucrose, raffinose and manninotriose. ConclusionIn terms of oligosaccharides, the contents and types of saccharides in different herbs and decoction pieces of RR are quite different, and the TLC identification method based on this can be used to distinguish raw RR from RRP, which can lay a foundation for improving the quality standard of RR and developing and applying oligosaccharides in different processed products of RR.
10.Study on the changes of chemical components of Aristolochia contorta before and after honey processing based on HPLC fingerprint and multivariate statistical analysis
Xiaoxia LIU ; Yongwei FENG ; Cuijie WEI ; Chunxiu WU ; Minyou HE ; Liye PAN ; Dongmei SUN ; Zhenyu LI
International Journal of Traditional Chinese Medicine 2024;46(11):1485-1492
Objective:To establish HPLC fingerprints of Aristolochia contorta and honey-processed Aristolochia contorta; To analyze the changes of chemical components before and after honey processing with multivariate statistics; To provide a reference for the study on the toxicity reduction of Aristolochia contorta.Methods:The fingerprints of 11 batches of Aristolochia contorta and honey-processed Aristolochia contorta were established through HPLC. Clustering analysis (HCA), principal component analysis (PCA), orthogonal partial least squares discriminant analysis (OPLS-DA) and independent sample t-test were used to compare the changes of chemical components of Aristolochia contorta before and after honey processing.Results:The results showed that there were 14 common peaks in the fingerprints of Aristolochia contorta and Aristolochia contorta. 7 common peaks were identified. Both HCA and PCA could clearly distinguish the samples of Aristolochia contorta before and after honey processing. OPLS-DA found and screened 7 differential markers, and the order of difference significance was peak 3 > peak 7 (7-hydroxy aristolochic acid A) > peak 5 (aristolochic acid C)> peak 8 (aristolochic acid D) > peak 6 > peak 2 (Magnolia alkaloid) > peak 14 (aristolochic acid Ⅰ). After honey processing, the content of chemical components represented by peaks 2, 3, 5, 6, 7, 8 and 14 decreased ( P<0.05). Conclusion:This method is simple and specific, which can be used for the fingerprint analysis of Aristolochia contorta and honey-processed Aristolochia contorta, and can effectively distinguish Aristolochia contorta and honey-processed Aristolochia contorta, and provide a reference for the processing research of toxicity reduction of Aristolochia contorta honey processing.

Result Analysis
Print
Save
E-mail