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.Clinical observation of lamellar keratectomy and corneal collagen crosslinking in the treatment of superficial fungal keratitis
Limei LIU ; Xinhong HAN ; Chunxiu MING ; Pengfei ZHANG ; Chao WANG
International Eye Science 2025;25(5):802-807
AIM:To evaluate the clinical efficacy of lamellar keratectomy and corneal collagen crosslinking(LKCCC)in treating superficial fungal keratitis.METHODS: Retrospective analysis. Totally 79 patients(79 eyes)with superficial fungal keratitis who underwent LKCCC in our hospital from January 2014 to October 2023 were included. After admission, routine antifungal drug treatment for 7 d showed no obvious improvement or progressive aggravation. The maximum diameter of corneal lesions in all patients was ≤7 mm, the maximum depth was no more than 50% of the corneal thickness at the location, and the remaining healthy corneal thickness was ≥300 μm. The follow-up time was 90 to 112 d.RESULTS:Among the included 79 eyes, the lesions were located in the central region of the cornea in 6 eyes, in the paracentral region in 61 eyes, and in the peripheral region in 12 eyes. Hypopyon was observed in 5 cases. LKCCC was successfully administered in 79 eyes, cured in 76 eyes(96%), and failed in 3 eyes(4%). The healing time of corneal epithelium in 76 cured eyes was 3-15 d, of which 51 eyes(67%)healed within 7 d and 24 eyes(32%)healed within 3 d. The uncorrected visual acuity(UCVA)and best corrected visual acuity(BCVA)of 76 eyes of cured patients were statistically significant compared with those preoperatively(P<0.0167). Two of the 3 failed eyes were located at the edge of the lesion and recovered after re-keratectomy. One eye was located in the center of the lesion and recovered after being covered by bulbar conjunctival flap. At the last follow-up, no other complications were observed in all patients except superficial cloud and thinning of cornea.CONCLUSION:LKCCC is a rapid and effective treatment for superficial fungal keratitis and can be considered a new treatment option.
3.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.
4.Dynamic changes of HBsAb and its predictive value in patients with chronic hepatitis B receiving antiviral therapy for clinical cure
Haiyan YANG ; Kunyan HAO ; Xieer LIANG ; Zhihong LIU ; Chunxiu ZHONG ; Junhua YIN ; Ya XU ; Leyuan WU ; Yuecheng YU ; Jinlin HOU ; Rong FAN
Chinese Journal of Hepatology 2025;33(6):551-559
Objective:To explore the predictive value of hepatitis B surface antibody (HBsAb) quantitative level for achieving hepatitis B surface antigen (HBsAg) seroclearance and serological conversion in patients with chronic hepatitis B (CHB) treated with nucleos(t)ide analogs (NAs) or interferon (IFN).Methods:A two-center prospective cohort study was conducted, including CHB patients from Nanfang Hospital Southern Medical University and Eastern Theater General Hospital treated with NAs and IFN. All patients were followed up once every three to six months. Basic clinical information and test results were collected at each follow-up. The presence or absence of HBsAg seroclearance and serological conversion rate was evaluated. HBsAg serological conversion was defined as HBsAg quantification continuously below the detection limit (<0.05 IU/mL) at two detection time points at least six months apart. HBsAg serological conversion was defined as HBsAb positivity (≥10 IU/L) at the same time as the first HBsAg seroclearance. The Kruskal-Wallis test was used to compare the quantitative data of multiple groups, and the Wilcoxon rank-sum test was used to compare the data between groups. The chi-square test was used for the count data, and the Fisher exact test was used when the chi-square test was not met. Univariate and multivariate Cox analysis was used to determine the predictors of the study endpoints, and stepwise regression was used for variable screening.Results:A total of 2 266 CHB cases were included, of which 86.5% (1 959/2 266) were NA antiviral-received population. The median treatment duration before baseline was 10.5 (2.5, 37.6) months, and the baseline HBsAg quantification was 3.1 (2.6, 3.5) log 10 IU/mL. A total of 68 cases (3.0%) had HBsAg seroclearance, and 44 cases (1.9%) achieved serological conversion after 85.0 (62.7, 97.3) months of prospective follow-up. The level and positivity rate of HBsAb showed a progressive increase 36 months before and significantly after HBsAg seroclearance. Cox regression analysis results showed that baseline HBsAb level was an independent predictor of HBsAg serological conversion ( HR=2.26, P=0.002) in the overall population, especially in the subgroup with HBsAg between 100 and 1 000 IU/mL, suggesting HBsAb level had important predictive value. In addition, the serological conversion development rate was significantly higher in the GOLDEN model favourable patients than in the unfavourable patients (11.5% vs. 0, P<0.001). Conclusion:The baseline HBsAb quantitative level can predict HBsAg seroclearance and serological conversion for patients with CHB receiving antiviral treatment, which is of significant value in long-term treatment monitoring.
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 the Expression of KDM1A and UCHL3 in Thyroid Cancer Tissue and Relationship with the Clinical Pathological Features and Prognosis
Mingyang WANG ; Zhongchao CAO ; Yanchao WANG ; Chunxiu LIU
Journal of Modern Laboratory Medicine 2025;40(1):105-109,115
Objective The purpose of this study is to investigate the expression of histone lysine-specific demethylase 1 (KDM1A) and ubiquitin carboxyl-terminal hydrolase L3 (UCHL3) in thyroid cancer (TC) tissue and its relationship with clinical features and prognosis. Methods 94 TC patients diagnosed and treated at the Third Hospital of Heilongjiang Province from January 2017 to January 2019 were retrospectively selected as the study subjects. Immunohistochemistry was used to detect the expression of KDM1A and UCHL3 in tissues. Spearman correlation analysis was used to investigate the correlation between KDM1A and UCHL3. Kaplan-Meier survival curve was used to analyze the relationship between the levels of KDM1A and UCHL3 and the 5-year progression-free survival rate of TC patients. Multivariate COX regression model was used to analyze the prognostic factors of TC patients. Results The positive rates of KDM1A (68.09%) and UCHL3 (65.96%) in cancer tissues were higher than those in adjacent tissues(10.64%,8.51%),and the differences were statistically significant(x2=64.984,66.369,all P<0.001). The protein expression of KDM1A and UCHL3 was significant protein correlation (r=0.714,P<0.001). The positive rates of KDM1A (87.50%,90.91%) and UCHL3 (85.00%,87.88%) in TNM stage Ⅲ~Ⅳ and lymph node metastatic TC cancer tissues were higher than those in stage Ⅰ~Ⅱ(53.70%,53.85%)and non-lymph node metastatic(55.74%,54.10%) cancer tissues,and the differences were statistically significant(x2=9.985~12.191,all P<0.001). The 5-year progression-free survival rates of TC patients in the KDM1A positive and negative groups were 62.50% (40/64) and 86.67% (26/30),with significant differences,the 5-year progression-free survival rates of UCHL3 positive and negative patients were 58.06% (36/62) and 90.63% (29/32),with significant differences (Log-Rankx2=5.670,9.724,P=0.017,0.002). KDM1A positive,UCHL3 positive,TNM stage Ⅲ~Ⅳ,lymph node metastasis were risk factors affecting the prognosis of TC patients (Waldx2=1.315~1.697,all P<0.001). Conclusion KDM1A and UCHL3 are upregulated in TC,and played a pro-cancer role. They are new tumor markers for evaluating the prognosis of TC patients.
8.Pathogenesis,syndrome differentiation,and treatment of chronic prostatitis based on the"host-guest interaction-collateral disease"theory
Yi WEI ; Zhiming HONG ; Junfeng QIU ; Zilong CHEN ; Shengjie WANG ; Wenshuo CHEN ; Lianqin ZHANG ; Chunxiu CHEN
Journal of Beijing University of Traditional Chinese Medicine 2025;48(7):979-984
Chronic prostatitis,a common condition in andrology,is clinically characterized by a prolonged course,resistance to treatment,and frequent recurrence.In traditional Chinese medicine,it is classified under the categories of"turbid sperm,""overstrain strangury,"and"vaginal pain."Based on the"host-guest interaction-collateral disease"theory,we believe that healthy qi deficiency,latent pathogenic factors,and collateral obstruction are the primary pathological factors of this disease,which run through the entire process of chronic prostatitis occurrence and development.Accordingly,we propose that obstruction of collaterals and apathesia of the semen chamber are the core pathogenesis.The disease progression can be divided into three pathological stages:"deficiency,depression,and blood stasis."Spleen and kidney deficiency and malnutrition of collaterals form the pathological foundation.In the deficiency stage,treatment strategies involve reinforcing qi and nourishing the collaterals,using Fuzheng Yangrong Decoction.During disease progression,dampness and heat invasion,as well as collateral stagnation qi,are key contributors to disease progression.Thus,treatment focuses on clearing heat and dampness,promoting qi flow,and smoothing the collaterals,achieved with a modified Qiantongding Decoction.In the final stage,blood stasis and collateral obstruction dominate,warranting therapeutic strategies aimed at tonifying and removing blood stasis,addressing both the body and the collaterals simultaneously using the modified Guiling Huayu Decoction.Overall,the clinical treatment generally focuses on the concept of function through free flow,combination of unblocking and tonifying.This study provides a novel perspective and reference for clinical differentiation and treatment of chronic prostatitis.
9.Aerobic exercise promotes remodeling of the energy metabolism network in the skeletal muscle of mice with sarcopenic obesity
Cong CHEN ; Huijuan WU ; Yue HU ; Huanghao ZHOU ; Chunxiu HUANG
Chinese Journal of Tissue Engineering Research 2025;29(17):3596-3604
BACKGROUND:Sarcopenia obesity is characterized by the coexistence of sarcopenia and obesity with a continuously increasing prevalence.Aerobic exercise can alleviate the progression of sarcopenic obesity,but the overall metabolic changes in skeletal muscle after exercise are still unclear.OBJECTIVE:To investigate the effects of exercise on various aspects of the energy metabolic pathways in the skeletal muscle of mice with sarcopenic obesity.METHODS:Male C57BL/6J mice were randomly divided into normal control(normal diet)and model(high-fat diet)groups.After 12 weeks of feeding,sarcopenic obesity model mice were screened by body mass and behavior assessments.The sarcopenia obesity mice were then divided into the sedentary and exercise groups.Mice in the exercise group were subjected to treadmill training on the basis of a high-fat diet.After 8 weeks of intervention,body mass,lipid metabolism,muscle volume of calf muscle group of the hind limb,skeletal muscle morphology,and expressions of energy metabolic pathway-related genes were detected.RESULTS AND CONCLUSION:Compared with the normal control group,the levels of triglycerides,total cholesterol,and free fatty acid in the sedentary group were significantly increased,along with significantly increased lipid droplets in skeletal muscle(P<0.05).Compared with the sedentary group,all of the above indicators in the exercise group showed a significant decreasing trend(P<0.05).Compared with the normal control group,grip strength and fatigue latency time,muscle volume,and fiber cross-sectional area were significantly decreased in the sedentary group,but the mRNA expression of Atrogin-1 and Murf-1 was elevated(P<0.05).Compared with the sedentary group,grip strength and fatigue latency time,muscle volume,and fiber cross-sectional area were significantly improved in the exercise group(P<0.05),while the mRNA expression of Atrogin-1 and Murf-1 was reduced(P<0.05).Compared with the normal control group,the mRNA expression of intramuscular transcription factors Pparα and Pgc-1α was decreased in the sedentary group(P<0.05),the mRNA expression of fatty acid synthesis-related enzymes Srebp1c and Fasn was elevated(P<0.05),and the mRNA expression of the β-oxidation system Cpt1β,Acox1,Acox3 and fatty acid metabolism Arf1 and Plin3 was decreased(P<0.05).Compared with the sedentary group,the abnormal expression of the above genes was significantly reversed in the exercise group(P<0.05).To conclude,aerobic exercise can alleviate lipid deposition and improve muscle quality and strength of sarcopenic obesity mice by regulating the expression of genes in the intramuscular energy metabolism network.
10.Defining fertility preservation based on Rodgers' evolutionary concept analysis method
Lei XIA ; Chunxiu ZHOU ; Min HUANG ; Xuemei FAN ; Zhu ZHU
Chinese Journal of Modern Nursing 2025;31(33):4611-4616
Objective:To analyze and elaborate on the concept connotation of fertility preservation, so as to provide guidance for clinical nursing practice.Methods:Research on fertility preservation was retrieved from databases including China National Knowledge Infrastructure, Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, and CINAHL. The search period was from the establishment of the database to January 31, 2025. Literature was selected based on inclusion criteria and analyzed using Rodgers' evolutionary concept analysis method.Results:A total of 43 articles were included. The conceptual attributes of fertility preservation encompassed five aspects, including targeting individuals with reproductive needs, prioritizing prevention, covering multi-level medical interventions, relying on assisted reproductive technologies for preservation, and being oriented toward enhancing fertility capacity and quality. The implementation of fertility preservation was influenced by demographic factors, disease factors, medical resources, and cultural factors. The anticipated outcomes included not only delayed childbirth but also improved in patients' mental health, quality of life, and interpersonal relationships. However, this may also raise ethical concerns.Conclusions:Fertility preservation plays a vital role in maintaining birth rates and enhancing population quality. Defining the concept of fertility preservation helps healthcare providers understand its essence and provides a reference for developing scientifically grounded fertility preservation programs.

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