1.Research Progress on the Mechanism of Lipocalin-2 in Neurological Diseases
Yongtai ZHOU ; Zhenyu YANG ; Yan LI ; Jiajing WU ; Bo ZHAO
Medical Journal of Peking Union Medical College Hospital 2025;16(2):330-337
Lipocalin-2 (LCN2), a member of the human lipocalin family, has been demonstrated to be closely associated with diabetes, cardiovascular diseases, and renal disorders. Recent studies have indicated that LCN2 plays a significant regulatory role in the pathogenesis and progression of various neurological diseases by mediating pathways such as inflammation, oxidative stress, and ferroptosis. This article reviews the research advancements on the mechanism of LCN2 in neurological disorders, including cerebrovascular diseases, cognitive impairment disorders, Parkinson's disease, depression, and anxiety disorders, aiming to enhance clinical understanding.
2.Reasons and suggestions for suspension and termination of domestic medical device and in vitro diag-nostic reagent clinical trials
Jiajing XIA ; Yan WANG ; Fei HUANG ; Guohua CHENG
Modern Hospital 2025;25(4):493-496
Objective To analyze the specific reasons for the suspension and termination of domestic medical device clinical trial projects.Based on the analysis results,provide reference suggestions and improvement measures for all parties in-volved in the trials.Methods Data collection method was used to collect samples of domestic medical device clinical trials,and visits were made to multiple medical institutions.For projects that were suspended or terminated,specific reasons were obtained through on-site interviews with research teams and clinical trial institution staff,reviewing"Project Suspension/Termination Let-ters"stored in the investigator's folder,and telephone consultations with clinical research associates(CRAs)of the projects.A contract research organization(CRO)commercial company was also visited,and specific reasons for project suspension or termi-nation were obtained through on-site interviews or telephone consultations with project managers,CRA-related personnel,etc.Descriptive analysis was used to summarize the reasons for suspension and termination and their rates.Results Statistical analy-sis showed that the suspension and termination rate of medical device clinical trials in China was 17.30%,with a rate of 16.04%in samples collected from medical institutions and 21.30%in samples collected from CRO companies.The reasons leading to the overall suspension and termination of domestic medical device clinical trials included sponsor strategy adjustments,medical insti-tution or research team issues,product or design defects,switching to registration using data from similar products,trial result-re-lated factors,third-party service provider issues,other reasons,safety-related factors,pandemic reasons,regulatory updates,and difficulties in obtaining informed consent.Conclusion The reasons for the suspension and termination of domestic medical de-vice clinical trial projects are complex and diverse,with a statistical analysis showing a rate of 17.30%in China.
3.Reasons and suggestions for suspension and termination of domestic medical device and in vitro diag-nostic reagent clinical trials
Jiajing XIA ; Yan WANG ; Fei HUANG ; Guohua CHENG
Modern Hospital 2025;25(4):493-496
Objective To analyze the specific reasons for the suspension and termination of domestic medical device clinical trial projects.Based on the analysis results,provide reference suggestions and improvement measures for all parties in-volved in the trials.Methods Data collection method was used to collect samples of domestic medical device clinical trials,and visits were made to multiple medical institutions.For projects that were suspended or terminated,specific reasons were obtained through on-site interviews with research teams and clinical trial institution staff,reviewing"Project Suspension/Termination Let-ters"stored in the investigator's folder,and telephone consultations with clinical research associates(CRAs)of the projects.A contract research organization(CRO)commercial company was also visited,and specific reasons for project suspension or termi-nation were obtained through on-site interviews or telephone consultations with project managers,CRA-related personnel,etc.Descriptive analysis was used to summarize the reasons for suspension and termination and their rates.Results Statistical analy-sis showed that the suspension and termination rate of medical device clinical trials in China was 17.30%,with a rate of 16.04%in samples collected from medical institutions and 21.30%in samples collected from CRO companies.The reasons leading to the overall suspension and termination of domestic medical device clinical trials included sponsor strategy adjustments,medical insti-tution or research team issues,product or design defects,switching to registration using data from similar products,trial result-re-lated factors,third-party service provider issues,other reasons,safety-related factors,pandemic reasons,regulatory updates,and difficulties in obtaining informed consent.Conclusion The reasons for the suspension and termination of domestic medical de-vice clinical trial projects are complex and diverse,with a statistical analysis showing a rate of 17.30%in China.
4.Mechanism of Fibroblast Growth Factor in Alzheimer's Disease
Jiajing WU ; Yan LI ; Yuxia LIANG ; Huijuan HUA ; Bo ZHAO
Medical Journal of Peking Union Medical College Hospital 2024;15(5):1131-1136
Alzheimer's disease(AD), the most common neurodegenerative disease, has shown an increasing incidence among younger people. With the onset of disease, most patients' cognitive function will show a progressive decline, bringing a heavy burden to the society and the family. Studies have shown that fibroblast growth factor (FGF) may be involved in the pathogenesis of AD through multiple mechanisms. This article reviews the mechanism of FGF in AD, with the hope of providing new ideas for elucidating the pathogenesis and early diagnosis of AD.
5.Association of psychological stress with wives’ hypertension across over 10 million Chinese married female population aged 20-49 years
Zhenyan ZHAO ; Jiajing JIA ; Xinyi LYU ; Lihua ZHANG ; Yuanyuan WANG ; Yuan HE ; Zuoqi PENG ; Ya ZHANG ; Hongguang ZHANG ; Qiaomei WANG ; Haiping SHEN ; Yiping ZHANG ; Donghai YAN ; Xu MA ; Ying YANG
Chinese Medical Journal 2024;137(13):1583-1591
Background::Psychological stress has been reported to be a potential risk factor for hypertension among females, but it remains unclear whether spousal chronic stress levels alter the risk of hypertension among women. We examined the associations between stress within the family and hypertension among married women.Methods::Reproductive-aged women who were planning for pregnancy and their husbands were recruited from the National Free Pre-pregnancy Checkup Projects (NFPCP) across 31 provinces in China in 2016 and 2017. Perceived stress of wives or husbands was measured with a 5-point Likert-type scale, and assessed from three domains: work/life-related stress, economic stress, and overall stress. Multivariable-adjusted logistic regression models were used to assess the associations between stress status and the prevalence of hypertension.Results::Of 10,027,644 couples, 261,098 (2.60%) women had hypertension. The results showed that higher stress levels among themselves or their husbands were associated with a higher prevalence of hypertension in women ( Pfor trend <0.001). Compared with non-stressed participants, female participants with the highest stress themselves were at a greater risk of hypertension, with adjusted odds ratio (OR) of 1.31 (95% confidence interval [CI]: 1.25-1.37); and compared with participants whose husbands had no stress, those whose husbands had the highest stress level were at a higher risk of hypertension with adjusted OR of 1.24 (95% CI: 1.20-1.29). Moreover, compared with non-stressed status for both couples, only-wife-stressed, only-husband-stressed, and both-stressed couples were found to be significantly associated with increased risks of wives’ hypertension, with adjusted ORs of 1.28 (95% CI: 1.25-1.31), 1.19 (95% CI: 1.17-1.21), and 1.28 (95% CI: 1.26-1.31), respectively. Conclusion::Moderate to severe stress in both spouses might be associated with female hypertension prevalence, which highlights the importance of paying attention to the psychological stresses of couples within the family.
6.Analysis of Subject Related Costs in Medical Research
Jiajing ZHANG ; Keying LI ; Zhendong WEI ; Jinhai YAN
Chinese Medical Ethics 2024;35(4):415-420
The development of medical research is completed by the cooperation of sponsors, investigators, subjects, and ethics committees. Clinically, it mainly includes clinical trials of medical devices, clinical medicine and new technology research. This paper analyzed the game and the relationship between rights, responsibilities and interests of relevant parties in medical research, combined with the relevant costs and sharing principles involved in medical research, and found that the use of the word "free" in the informed consent is easy to cause misunderstanding and the lack of relevant compensation costs in the informed consent, while the compensation and insurance costs had some problems, such as the imperfect subject compensation mechanism and the insufficient insurance purchase by the sponsor, which can not protect the basic rights and interests of the subjects. Therefore, in order to standardize the cost management of clinical medical research, it is necessary to standardize the process and content of informed consent, strengthen the supervision of medical research process, establish medical research damage compensation fund and research damage insurance system, so as to better protect the rights and interests of subjects.
7.Ethical Analysis of the Medical Science Experiments Targeting Humans
Jiajing ZHANG ; Keying LI ; Zhendong WEI ; Jinhai YAN
Chinese Medical Ethics 2023;36(3):277-283
With the continuous progress of medical technology, some violations of ethical principles often occur in science experimental research targeting humans. Taking the type of human experimental research as the starting point, through ethical analysis and evaluation of different types of human experimental research, this paper concluded that in human experimental research, it was necessary to adhere to humanitarian principles of human experimental research, fully respect the research participants’ right to informed consent, select research participants fairly, fully protect the research participants’ rights and interests, and supervise the whole research process. So as to better regulate the behavior of medical researchers in human experimental research and protect the rights and interests of research participants.
8.Effects of compatibility of Schisandra chinensis on Psoralea corylifolia -induced oxidative damage and endoplasmic reticulum stress in hepatocytes
Jingxi ZHANG ; Jia YIN ; Xiaolin QU ; Hui LIU ; Na WANG ; Jiajing YAN ; Chunsheng FU
China Pharmacy 2022;33(9):1088-1093
OBJECTIVE To study the effects of the compatibility of Schisandra chinensis on Psoralea corylifolia -induced oxidative damage and endoplasmic reticulum stress in L 02 hepatocytes,and to provide reference for clinical use of the compatibility attenuation of P. corylifolia -S. chinensis . METHODS L02 cells were divided into blank control group ,P. corylifolia model group (1 200 μg/mL P. corylifolia ,calculated by crude drug ),P. corylifolia -S. chinensis low-dose,medium-dose and high-dose groups (1 200 μg/mL P. corylifolia combined with 600,1 200,2 400 μg/mL S. chinensis ,respectively,calculated by crude drug ). After the cells in each group were cultured in culture medium or drug solution for 48 hours,the levels of aspartate aminotransferase(AST)and alanine aminotransferase (ALT)were detected ;the levels of glutathione (GSH),superoxide dismutase (SOD)and malondialdehyde (MDA)in cell culture medium were detected ;reactive oxygen species (ROS)level and mitochondrial membrane potential in cells were detected ;mRNA and protein expressions of glucose-regulated protein 78(GRP-78)and protein kinase R-like endoplasmic reticulum kinase (PERK)were detected. RESULTS Compared with blank control group ,the levels of AST,ALT,MDA and ROS ,mRNA and protein expressions of GRP- 78 and PERK were increased significantly in P. corylifolia model group (P<0.05 or P<0.01);while GSH and SOD levels ,mitochondrial membrane potential were decreased significantly (P<0.05 or P<0.01). Compared with P. corylifolia model group ,above indexes of P. corylifolia -S. chinensis low-dose, medium-dose and high-dose groups were all improved significantly (P<0.05 or P<0.01). CONCLUSIONS The compatibility of P. corylifolia -S. chinensis can alleviate P. corylifolia -induced oxidative damage and endoplasmic reticulum stress of L 02 cells.
9.Analysis of Subject Related Costs in Medical Research
Jiajing ZHANG ; Keying LI ; Zhendong WEI ; Jinhai YAN
Chinese Medical Ethics 2022;35(4):415-420
The development of medical research is completed by the cooperation of sponsors, investigators, subjects, and ethics committees. Clinically, it mainly includes clinical trials of medical devices, clinical medicine and new technology research. This paper analyzed the game and the relationship between rights, responsibilities and interests of relevant parties in medical research, combined with the relevant costs and sharing principles involved in medical research, and found that the use of the word "free" in the informed consent is easy to cause misunderstanding and the lack of relevant compensation costs in the informed consent, while the compensation and insurance costs had some problems, such as the imperfect subject compensation mechanism and the insufficient insurance purchase by the sponsor, which can not protect the basic rights and interests of the subjects. Therefore, in order to standardize the cost management of clinical medical research, it is necessary to standardize the process and content of informed consent, strengthen the supervision of medical research process, establish medical research damage compensation fund and research damage insurance system, so as to better protect the rights and interests of subjects.
10.Clinical features and GBA gene mutation in two siblings with typeⅢ Gaucher disease
Jian CHEN ; Yan MENG ; Xiuyu SHI ; Jiajing QIU ; Hui LI ; Liping ZHOU
Journal of Clinical Pediatrics 2015;33(5):462-465
Objective To report clinical manifestations, electroencephalogram (EEG), and the genotypes of two siblings with type Ⅲ Gaucher disease.Methods Two patients with different features were siblings. Their clinical data, signs, peripheral leukocytes acid β-glucosidase activity, andGBA gene were analyzed.Results (1) The proband was a boy. He visited us at the age of nine years old because of hepatosplenomegaly, thrombocytopenia and growth retardation without any neurologic symp-toms. He had normal intelligence but abnormal EEG ifndings. The activity of acid β-glucosidase in his leucocytes decreased to 1.5 nmol h-1·mg-1 Pr (normal range 6.0-16.7 nmol h-1·mg-1 Pr), supporting the diagnosis of type Ⅲ Gaucher disease. (2) The elder sister of the proband was 12 years old. She had tonic-clonic seizure and myoclonus seizure from the age of seven years old. Mild hepatomegaly, abnormal EEG, poor effect for antiepileptics, and progressive deterioration of psychomotor abilities were found. Her blood leucocytes acid β-glucosidase activity decreased to 1.8 nmol h-1·mg-1 Pr (normal range 6.0-16.7 nmol h-1·mg-1 Pr). Two heterozygous missense mutations, c.680A>G, (p.N188S) and c.1342G>C (p.D409H) were detected from the two siblings, respec-tively.Conclusions Patients with type Ⅲ Gaucher disease usually have the onset in childhood with typical features of Gaucher disease without neurologic involvement. Abnormal EEG may be helpful to the differential diagnosis of type I or type Ⅲ. On the other hand, neurologic manifestations could be presented as the ifrst symptom in some patients without viscera enlargement. The patients of type Ⅲ Gaucher disease with the same genotype could have different phenotypes, even between the siblings.

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