1.Interpretation of ISO 10555-1:2023 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements
Shan FENG ; Zi-xiang HONG ; Xi-yun DANG ; Jun KE ; Xue BAI
Chinese Medical Equipment Journal 2025;46(10):65-70
The overall revision of ISO 10555-1:2023 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements was introduced,which was compared with YY 0285.1-2017 Intravascular catheters—Sterile and sing-use catheters—Part 1:General requirements in terms of terminology definition,requirements and identification of nominal size.The new and changed contents of ISO 10555-1:2023 were interpreted,and references were provided for the develop-ment,inspection and testing and supervision of related products and for the future revision of YY 0285.1-2017 standard.[Chinese Medical Equipment Journal,2025,46(10):65-70]
2.Interpretation of ISO 10555-1:2023 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements
Shan FENG ; Zi-xiang HONG ; Xi-yun DANG ; Jun KE ; Xue BAI
Chinese Medical Equipment Journal 2025;46(10):65-70
The overall revision of ISO 10555-1:2023 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements was introduced,which was compared with YY 0285.1-2017 Intravascular catheters—Sterile and sing-use catheters—Part 1:General requirements in terms of terminology definition,requirements and identification of nominal size.The new and changed contents of ISO 10555-1:2023 were interpreted,and references were provided for the develop-ment,inspection and testing and supervision of related products and for the future revision of YY 0285.1-2017 standard.[Chinese Medical Equipment Journal,2025,46(10):65-70]
3.Low-air-pressure clean room system: A flexible, high-quality model for assisted reproduction laboratories
Minh Tam LE ; Trung Van NGUYEN ; Thai Thanh Thi NGUYEN ; Hong Nhan Thi DANG ; Quoc Huy Vu NGUYEN
Clinical and Experimental Reproductive Medicine 2025;52(1):56-64
Objective:
This study aimed to develop a configurable clean room paradigm with low air pressure for assisted reproductive technology (ART) clinics and demonstrate the concept’s efficacy using in vitro fertilization (IVF) treatment.
Methods:
A high-standard clean room system with positive pressure (13 Pa) was built using accessible materials and equipment for ART laboratories. Methods for controlling and evaluating the clean room’s characteristics were developed and implemented for quality assessment and calibration to maximize efficiency. The feasibility of the flexible clean room concept was assessed by analyzing the key performance indicators of embryo culture and IVF treatment.
Results:
After 3 weeks of testing, the concentration of particles ≥0.5 μm was 6.04 times lower than the International Organization for Standardization (ISO) class 5 standard (3,520 particles/m3) in the IVF laboratory. Air pressure, noise, temperature, and humidity were controlled stably and appropriately. Five days after installation and handover, the volatile organic compound concentration dropped to 0.00 ppm. With blastocysts and a respectable blastocyst rate, embryonic culture with female patients younger than 40 matched the criteria (63.5% and 38.9%, respectively). After vitrified blastocysts were transferred, the pregnancy and implantation rates were 58.5% and 36.2%, respectively, demonstrating a high degree of treatment success.
Conclusion
Our customizable, high-quality, low-air-pressure clean room model can be implemented to achieve positive outcomes for infertility treatment.
4.Low-air-pressure clean room system: A flexible, high-quality model for assisted reproduction laboratories
Minh Tam LE ; Trung Van NGUYEN ; Thai Thanh Thi NGUYEN ; Hong Nhan Thi DANG ; Quoc Huy Vu NGUYEN
Clinical and Experimental Reproductive Medicine 2025;52(1):56-64
Objective:
This study aimed to develop a configurable clean room paradigm with low air pressure for assisted reproductive technology (ART) clinics and demonstrate the concept’s efficacy using in vitro fertilization (IVF) treatment.
Methods:
A high-standard clean room system with positive pressure (13 Pa) was built using accessible materials and equipment for ART laboratories. Methods for controlling and evaluating the clean room’s characteristics were developed and implemented for quality assessment and calibration to maximize efficiency. The feasibility of the flexible clean room concept was assessed by analyzing the key performance indicators of embryo culture and IVF treatment.
Results:
After 3 weeks of testing, the concentration of particles ≥0.5 μm was 6.04 times lower than the International Organization for Standardization (ISO) class 5 standard (3,520 particles/m3) in the IVF laboratory. Air pressure, noise, temperature, and humidity were controlled stably and appropriately. Five days after installation and handover, the volatile organic compound concentration dropped to 0.00 ppm. With blastocysts and a respectable blastocyst rate, embryonic culture with female patients younger than 40 matched the criteria (63.5% and 38.9%, respectively). After vitrified blastocysts were transferred, the pregnancy and implantation rates were 58.5% and 36.2%, respectively, demonstrating a high degree of treatment success.
Conclusion
Our customizable, high-quality, low-air-pressure clean room model can be implemented to achieve positive outcomes for infertility treatment.
5.Low-air-pressure clean room system: A flexible, high-quality model for assisted reproduction laboratories
Minh Tam LE ; Trung Van NGUYEN ; Thai Thanh Thi NGUYEN ; Hong Nhan Thi DANG ; Quoc Huy Vu NGUYEN
Clinical and Experimental Reproductive Medicine 2025;52(1):56-64
Objective:
This study aimed to develop a configurable clean room paradigm with low air pressure for assisted reproductive technology (ART) clinics and demonstrate the concept’s efficacy using in vitro fertilization (IVF) treatment.
Methods:
A high-standard clean room system with positive pressure (13 Pa) was built using accessible materials and equipment for ART laboratories. Methods for controlling and evaluating the clean room’s characteristics were developed and implemented for quality assessment and calibration to maximize efficiency. The feasibility of the flexible clean room concept was assessed by analyzing the key performance indicators of embryo culture and IVF treatment.
Results:
After 3 weeks of testing, the concentration of particles ≥0.5 μm was 6.04 times lower than the International Organization for Standardization (ISO) class 5 standard (3,520 particles/m3) in the IVF laboratory. Air pressure, noise, temperature, and humidity were controlled stably and appropriately. Five days after installation and handover, the volatile organic compound concentration dropped to 0.00 ppm. With blastocysts and a respectable blastocyst rate, embryonic culture with female patients younger than 40 matched the criteria (63.5% and 38.9%, respectively). After vitrified blastocysts were transferred, the pregnancy and implantation rates were 58.5% and 36.2%, respectively, demonstrating a high degree of treatment success.
Conclusion
Our customizable, high-quality, low-air-pressure clean room model can be implemented to achieve positive outcomes for infertility treatment.
6.Benign Versus Malignant Solid Liver Lesions: How Can Apparent Diffusion Coefficient Value Be Added to the Differentiation?
Hong Phuong Dung TRAN ; Ngoc Thanh HOANG ; Cam Nhung DANG ; Thanh Thao NGUYEN ; Trong Binh LE
Investigative Magnetic Resonance Imaging 2025;29(4):216-224
Purpose:
To determine the efficacy of apparent diffusion coefficient (ADC) values and ratios (lesion/liver tissue, lesion/splenic tissue, lesion/paraspinal muscle) in differentiating benign from malignant solid liver lesions.
Materials and Methods:
This study retrospectively analyzed data from 115 patients with solid liver lesions who underwent abdominal magnetic resonance imaging (MRI) at a single institution between January 2023 and December 2024. Lesions were classified as benign or malignant based on biochemical tests as well as radiographic and/or histopathologic findings. ADC values and ratios were determined using a 1.5 T MRI scanner.Quantitative variables are presented as mean ± standard deviation or median (interquartile range). Receiver operating characteristic (ROC) analysis was used to determine the cut-off values for ADC value and ratio, for which associated areas under the ROC curve were calculated.
Results:
The present analysis included 115 lesions—36 benign and 79 malignant. The median ADC value of the benign lesions was significantly higher than that of malignant lesions: 1744.5 × 10-6 mm2 /s vs. 1168.0 × 10-6 mm2 /s, respectively. The average lesion-toliver ADC (rADC l), lesion-to-spleen ADC (rADCsp), and lesion-to-paraspinal muscle ADC (rADC m) ratios for the benign lesions were significantly higher than those of malignant lesions: 1.79 vs. 1.09, 2.31 vs. 1.44, and 1.19 vs 0.80, respectively. A threshold of 1416 × 10-6 mm2 /s was used to differentiate benign vs. malignant lesions, with a sensitivity of 83.3% and a specificity of 78.5%. The cut-off values for rADC l, rADCsp, and rADC m were 1.55, 1.95, and 0.97, respectively, with sensitivities of 69.4%, 69.4%, and 83.3% and specificities of 87.3%, 91.1%, and 79.9%, respectively.
Conclusion
ADC metrics obtained from diffusion-weighted MRI effectively distinguished benign from malignant solid liver lesions.
7.Association of digit ratio with polymorphisms at three loci of matrix metalloproteinase 9 gene in Ningxia Han youths
Meng-Yi YANG ; Jin ZHANG ; Shi-Bo NIU ; Jie DANG ; Zhan-Bing MA ; Hong LU ; Zheng-Hao HUO ; Yu XU ; Dan SHEN
Acta Anatomica Sinica 2025;56(1):74-79
Objective To investigate the association of digit ratio with single nucleotide polymorphism(SNP)at three loci(rs17576,rs3918249,rs9509)of matrix metallopeptidase 9(MMP-9)gene.Methods A total of 804 Ningxia Han youths(399 males and 405 females)were used as the study subjects.A digital camera was used to take frontal photographs of the hands,and image analysis software was used to mark the anatomical points and measure the lengths of each finger of both hands(2D,3D,4D,5D);Multiplexed PCR was used to detect the three polymorphic sites of the MMP-9 gene,SPSS 25.0 and R Studio software were used for data analysis and plotting.Results The 2D/3D(P<0.05)and 2D/4D(left,P<0.01,right,P<0.05)of both hands,2D/5D(P<0.01),3D/5D,4D/5D(P<0.05)of the right hand,and 3D/4D(P<0.05)of the left hand in female youths of Ningxia Han were significantly higher than those in males,Differences in genotypes and allele frequencies at all 3 loci of the MMP-9 gene were not statistically significant between genders(P>0.05).Right hand 2D/4D was significantly associated with genotypes at the rs17576 and rs3918249 loci in male youths(P<0.05).Conclusion MMP-9 gene SNPs(rs17576 and rs3918249)may be associated with the formation of 2D/4D of Ningxia Han male youths.
8.Mitochondria: The Target of Ionizing Radiation Damage
Lian-Chen TIAN ; Ya-Yi YUAN ; Xu-Hong DANG
Progress in Biochemistry and Biophysics 2025;52(4):836-844
In recent years, due to the development of radiotherapy technology and nuclear energy, people have paid more and more attention to the various effects of ionizing radiation on organisms. Ionizing radiation can induce protein, DNA and other biological macromolecules to damage, resulting in apoptosis, senescence, cancer and a series of changes. For a long time, it has been believed that the main target of ionizing radiation damage is DNA in the nucleus. However, it has been reported in recent years that ionizing radiation has both direct and indirect effects, and the theory of ROS damage in the indirect effects believes that ionizing radiation has target uncertainty, so it is not comprehensive enough to evaluate only the DNA damage in the nucleus. It has been reported that ionizing radiation can cause damage to organelles as well as damage to cells. Mitochondria are important damaged organelles because mitochondria occupy as much as 30% of the entire cell volume in the cytoplasm, which contains DNA and related enzymes that are closely related to cellular ATP synthesis, aerobic respiration and other life activities. What is more noteworthy is that mitochondria are the only organelles in which DNA exists in the human body, which makes researchers pay attention to various damage to mitochondrial DNA caused by ionizing radiation (such as double-strand breaks, base mismatching, and fragment loss). Although these damages also occur in the nucleus, mitochondrial DNA is more severely damaged than nuclear DNA due to its lack of histone protection, so mitochondria are important targets of ionizing radiation damage in addition to the nucleus. Mitochondrial DNA is not protected by histones and has little repair ability. When exposed to ionizing radiation, common deletions occur at an increased frequency and are passed on to offspring. For large-scale mitochondrial DNA damage, mitochondria indirectly compensate for the amount of damaged DNA by increasing the number of DNA copies and maintaining the normal function of mitochondrial DNA. Mitochondria are in a state of oxidative stress after exposure to ionizing radiation, and this oxidative stress will promote the change in mitochondrial function. When mitochondria are damaged, the activity of proteins related to aerobic respiration decreases, and oxidative respiration is inhibited to a certain extent. At the same time, a large amount of active superoxide anions are continuously produced to stimulate mitochondrial oxidative stress, and the signal of such damage is transmitted to the surrounding mitochondria, resulting in a cascade of damage reaction, which further activates the signalling pathway between mitochondria and nucleus. The cell nucleus is also in a state of oxidative stress, and finally, the level of free radicals is high, causing secondary damage to the genetic material DNA of mitochondria and nucleus. In this paper, the damage effects of ionizing radiation on mitochondria are reviewed, to provide a new idea for radiation protection.
9.Therapeutic effect of Ziziphi Spinosae Semen extracts on chronic unpredictable mild stress-induced depression and insomnia-like behavior in mice.
Hong-Bo CHENG ; Xian LIU ; Hui-Ying SHANG ; Rong GAO ; Wan-Yun DANG ; Ye-Hui GAO ; Cheng-Rong XIAO ; Yue GAO ; Zeng-Chun MA
China Journal of Chinese Materia Medica 2025;50(7):1817-1829
This paper aims to study the effect of Ziziphi Spinosae Semen extracts on chronic unpredictable mild stress(CUMS)-induced depression-like and insomnia behavior models of mice. The CUMS-induced depression-like and insomnia behavior model of mice was established by CUMS treatment for three weeks. The mice were randomly divided into control group, model group, positive drug diazepam group(2 mg·kg~(-1)), as well as low-dose group(1.95 g·kg~(-1)), medium-dose group(3.9 g·kg~(-1)), and high-dose group(7.8 g·kg~(-1)) of Ziziphi Spinosae Semen extracts, with 18 mice in each group. On the 15th day of modeling, the drug was administered intragastrically once a day for one week. Then, the pentobarbital sodium cooperative righting experiment, open field experiment, and elevated plus maze experiment were carried out, respectively. The contents of neurotransmitters 5-hydroxytryptamine(5-HT) and 5-hydroxyindoleacetic acid(5-HIAA) in serum and thalamus of mice, as well as the levels of corticotropin releasing hormone(CRH), adrenocorticotropic hormone(ACTH), and corticosterone(CORT) in serum, were determined by enzyme-linked immunosorbent assay(ELISA). The neuron damage in the hippocampus of mice was observed by hematoxylin-eosin(HE) staining and Nissl staining. Western blot was used to detect the expressions of tryptophan hydroxylase 2(TPH2), serotonin transporter(SERT), monoamine oxidase A(MAOA), five prime repressors under dual repression binding protein 1(Freud1), synaptic plasticity-related proteins [cellular gene FOS(C-FOS), postsynaptic density protein 95(PSD95), synapsin 1(SYN1), and activity-regulated cytoskeleton-associated gene(ARC)], blood-brain barrier(BBB) permeability-related proteins [zonula occludens 1(ZO-1), occludin, and claudin 1], inflammatory factors [NOD-, LRR-and pyrin domain-containing protein 3(NLRP3), apoptosis-associated speck-like protein(ASC), gasdermin D(GSDMD), caspase-3, and caspase-8], and antioxidant factors [nuclear factor erythroid 2-related factor 2(NRF2) and heme oxygenase 1(HO1)] in thalamic tissue of mice. The results indicated that compared with that in the model group, the sleep latency was significantly shortened, and the sleep duration was significantly prolonged in each dose group of Ziziphi Spinosae Semen extracts. The number of visits to the central area of the open field and the distance and time of visits were significantly increased in each dose group of Ziziphi Spinosae Semen extracts. In addition, the proportion of distance and time of entering the open arm area of the elevated plus maze was significantly increased in each dose group of Ziziphi Spinosae Semen extracts. The contents of 5-HT and 5-HIAA in serum and thalamus of mice increased to varying degrees in each dose group of Ziziphi Spinosae Semen extracts; the contents of CRH, ACTH, and CORT in serum of mice were significantly decreased. The protein expression of TPH2 was significantly increased. The protein expression of MAOA, SERT, and Freud1 was significantly decreased. Ziziphi Spinosae Semen extracts could also significantly reduce the protein expression of C-FOS but significantly increase the protein expression of PSD95, ARC, and SYN1. They could reduce the pathological damage of the hippocampus in mice and significantly increase the protein expression of ZO-1, occluding, and claudin 1. The protein expression of NLRP3, GSDMD, ASC, caspase-3, and caspase-8 in the thalamic tissue of mice was significantly decreased, and the protein expression of HO1 and NRF2 was significantly increased. In conclusion, Ziziphi Spinosae Semen extracts could effectively improve sleep disorders and depression-like behaviors in CUMS-induced model mice, which may be related to regulating the 5-HT anabolism process and hypothalamic-pituitary-adrenal(HPA) axis-related hormone levels, reducing pathological damage in the hippocampus, improving synaptic plasticity, repairing BBB integrity, and alleviating inflammatory response and oxidative stress damage.
Animals
;
Ziziphus/chemistry*
;
Mice
;
Male
;
Depression/psychology*
;
Drugs, Chinese Herbal/administration & dosage*
;
Sleep Initiation and Maintenance Disorders/psychology*
;
Stress, Psychological/complications*
;
Behavior, Animal/drug effects*
;
Humans
;
Disease Models, Animal
10.Prevalence of frailty and importance of influencing factors in adults in Shaanxi Province
Zongkai LI ; Yan HUANG ; Ziping WANG ; Hui JING ; Yuxin TENG ; Yezhou LIU ; Yuan SHEN ; Qiang LI ; Baibing MI ; Jiaomei YANG ; Hong YAN ; Shaonong DANG
Chinese Journal of Epidemiology 2025;46(1):131-139
Objective:To understand the prevalence of frailty and the importance of its influencing factors in adult population in Shaanxi Province.Methods:The data were from Shaanxi baseline survey of natural population cohort study in northwest China during 2018-2019. The frailty index (FI) was constructed to evaluate the frailty status of the population, and XGboost model combined with Shapley method was used to analyze the importance of the sociodemographic and life behavior factors affecting the prevalence of frailty by gender and age.Results:A total of 25 079 subjects were included, in whom 964 (3.8%) had frailty, and there was no significant difference in the overall prevalence of frailty between women (3.9%) and men (3.8%) ( P=0.629), but there was a gender specific difference in the distribution of FI ( P<0.001), and the proportion of the pre-frailty in men was higher than that in women. The prevalence of frailty increased with age ( P<0.001), the prevalence of frailty were 1.3%, 2.5% and 7.8% in young, middle-aged and elderly women, respectively, and 1.9%, 2.7% and 5.5% in young, middle-aged and elderly men, respectively. Sociodemographic characteristics and lifestyle patterns were both influencing factors for the prevalence of frailty, but their importance varied with gender and age. The top five contributing factors were education level, staying up late, annual family income level, sedentary time and marital status in young women, and staying up late, smoking, annual family income level, sedentary time and drinking in young men. The top five contributing factors were education level, annual family income level, passive exposure to smoking, staying up late, and sedentary time in middle-aged women, and annual family income level, education level, sedentary time, staying up late and drinking in middle-aged men. The top five contributing factors were annual family income level, passive exposure to smoking, sedentary time, marital status, and smartphone use in elderly women, and education level, annual family income level, smoking, smartphone use and sedentary time in elderly men. Conclusions:There are gender specific differences in the distribution of FI in Shaanxi. The prevalence of frailty increased with age, but young and middle-aged people also have frailty risk. The prevalence of frailty in young men was mainly related to unhealthy life behaviors, such as staying up late, smoking, sedentary behavior and drinking, while the prevalence of frailty in middle-aged and elderly men and women were more affected by sociodemographic factors, such as education level, economic status and marital status.

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