1.Necessity of blood hemocompatibility evaluation in medical devices with indirect contact with blood
Chun-xia QIAO ; Qiu-jin QU ; Li HOU ; Zeng-lin ZHAO ; Xiang-yu CHU ; Xiao-xia SUN
Chinese Medical Equipment Journal 2025;46(8):44-49
Objective To study the need for blood compatibility evaluation of medical devices that come into indirect contact with blood in order to accurately evaluate the risk of their interaction with blood.Methods Seven medical devices with indirect contact with blood were selected as samples including extension tubes of central venous catheters,port bodies of implantable drug delivery devices,infusion sets,receiving lines of dialysis equipment,auxiliary lines of left ventricular assist devices,blood monitors and catheter holders,with high-density polyethylene as the negative control,glass beads as the positive control and blank whole blood or plasma for the blank control.Partial thromboplastin time(PTT)test,platelet count test and hematology test(white blood cell and red blood cell count)were performed by direct contact method and indirect contact method,respectively.In the direct contact method,whole blood or plasma was in direct contact with the sample;while in the indirect contact method,whole blood or plasma was not in direct contact with the extraction solution,with no direct contact with the sample.Results With the indirect contact method the ratios(expressed as a percentage)of the PTT,platelate,WBC and RBC counts of the samples,positive and negative controls to those of the blank control were all higher than those with the direct contact method,and the indirect contact method had the sensitivity lower than that of the direct contact method.Conclusion Medical devices indirectly contacting blood have low risks for causing coagulation and platelet and hematologic adverse reactions,which are suggested to be evaluated for hemolysis testing only in case of the history of safe clinical use.[Chinese Medical Equipment Journal,2025,46(8):44-49]
2.Necessity of blood hemocompatibility evaluation in medical devices with indirect contact with blood
Chun-xia QIAO ; Qiu-jin QU ; Li HOU ; Zeng-lin ZHAO ; Xiang-yu CHU ; Xiao-xia SUN
Chinese Medical Equipment Journal 2025;46(8):44-49
Objective To study the need for blood compatibility evaluation of medical devices that come into indirect contact with blood in order to accurately evaluate the risk of their interaction with blood.Methods Seven medical devices with indirect contact with blood were selected as samples including extension tubes of central venous catheters,port bodies of implantable drug delivery devices,infusion sets,receiving lines of dialysis equipment,auxiliary lines of left ventricular assist devices,blood monitors and catheter holders,with high-density polyethylene as the negative control,glass beads as the positive control and blank whole blood or plasma for the blank control.Partial thromboplastin time(PTT)test,platelet count test and hematology test(white blood cell and red blood cell count)were performed by direct contact method and indirect contact method,respectively.In the direct contact method,whole blood or plasma was in direct contact with the sample;while in the indirect contact method,whole blood or plasma was not in direct contact with the extraction solution,with no direct contact with the sample.Results With the indirect contact method the ratios(expressed as a percentage)of the PTT,platelate,WBC and RBC counts of the samples,positive and negative controls to those of the blank control were all higher than those with the direct contact method,and the indirect contact method had the sensitivity lower than that of the direct contact method.Conclusion Medical devices indirectly contacting blood have low risks for causing coagulation and platelet and hematologic adverse reactions,which are suggested to be evaluated for hemolysis testing only in case of the history of safe clinical use.[Chinese Medical Equipment Journal,2025,46(8):44-49]
3.Observation on the Clinical Efficacy of Yifei Fumai Tang Combined with Comprehensive Western Medicine Treatment in the Treatment of Difficulty Offline and Intensive Care Unit-Acquired Weakness
Chun-ping ZOU ; Wen-shui LOU ; Yan HU ; Zong-lin RAO ; Lu GAN ; Qiu-xia GUAN
Progress in Modern Biomedicine 2025;25(19):3147-3153,3161
Objective:To observe the application value of Yifei Fumai Tang in the treatment of difficulty offline and intensive care unit-acquired weakness(ICU-AW).Methods:Used random number table method,60 patients with difficulty offline and ICU-AW who were admitted to our hospital from June 2022 to June 2024 were divided into control group(received conventional Western medicine comprehensive treatment,n=30)and study group(received Yifei Fumai Tang treatment in addition to the control group,n=30).Medical Research Council(MRC),Barthel Index(BI)scores,clinical indicators(total mechanical ventilation time,weaning success rate,secondary intubation rate,ICU stay,and mobilization time),diaphragm thickness,diaphragm mobility,and incidence of adverse reactions between two groups were compared.Results:Compared with the control group at 7 d after treatment and 14 d after treatment,the MRC and BI scores in the study group were higher(P<0.05).Compared with the control group,the study group had lower rate of secondary intubation rate,shorter total mechanical ventilation time,ICU stay time,and mobilization time,higher weaning success rate,and greater diaphragm thickness,diaphragm mobility(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:Yifei Fumai Tang combined with Western Medicine in the treatment of Difficulty Offline and ICU-AW,can effectively improve the prognosis of patients,shorten total mechanical ventilation time,ICU stay,mobilization time,increase weaning success rate,and improve respiratory function.
4.Observation on the Clinical Efficacy of Yifei Fumai Tang Combined with Comprehensive Western Medicine Treatment in the Treatment of Difficulty Offline and Intensive Care Unit-Acquired Weakness
Chun-ping ZOU ; Wen-shui LOU ; Yan HU ; Zong-lin RAO ; Lu GAN ; Qiu-xia GUAN
Progress in Modern Biomedicine 2025;25(19):3147-3153,3161
Objective:To observe the application value of Yifei Fumai Tang in the treatment of difficulty offline and intensive care unit-acquired weakness(ICU-AW).Methods:Used random number table method,60 patients with difficulty offline and ICU-AW who were admitted to our hospital from June 2022 to June 2024 were divided into control group(received conventional Western medicine comprehensive treatment,n=30)and study group(received Yifei Fumai Tang treatment in addition to the control group,n=30).Medical Research Council(MRC),Barthel Index(BI)scores,clinical indicators(total mechanical ventilation time,weaning success rate,secondary intubation rate,ICU stay,and mobilization time),diaphragm thickness,diaphragm mobility,and incidence of adverse reactions between two groups were compared.Results:Compared with the control group at 7 d after treatment and 14 d after treatment,the MRC and BI scores in the study group were higher(P<0.05).Compared with the control group,the study group had lower rate of secondary intubation rate,shorter total mechanical ventilation time,ICU stay time,and mobilization time,higher weaning success rate,and greater diaphragm thickness,diaphragm mobility(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:Yifei Fumai Tang combined with Western Medicine in the treatment of Difficulty Offline and ICU-AW,can effectively improve the prognosis of patients,shorten total mechanical ventilation time,ICU stay,mobilization time,increase weaning success rate,and improve respiratory function.
5.Analysis on international experience and development trends of health emergency drills
Shuo QIU ; Yu WANG ; Chun XU ; Peng ZHAO ; Yuehui LIU ; Lin LI
Military Medical Sciences 2025;49(7):529-534
This study analyzed the practical experience of the World Health Organization,the European Union,the United States,and Japan,to reveal the characteristics of health emergency drills in terms of institutional construction,technological integration,and international collaboration.The health emergency drills present three major development trends:paradigm shift driven by social demand,efficiency improvement empowered by intelligent technology,and deepening international cooperation under the global governance framework.In response to the construction needs of China's public health emergency system,policy recommendations were proposed to establish a hierarchical classification system,a full-cycle training strategy for major infectious diseases,a dual wheel drive mechanism by both techniques and qualified personnel,and a path for global governance participation.
6.Prognostic value of abnormal myocardial perfusion assessed by SPECT myocardial perfusion imaging before hematopoietic stem cell transplantation in patients with malignant hematologic diseases
Ke LI ; Yuetao WANG ; Weiying GU ; Chun QIU ; Dongyan WANG ; Feifei ZHANG ; Dan JIANG ; Baosheng MENG ; Yan LIN ; Jianfeng WANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2025;45(8):475-481
Objective:To assess the presence of chemotherapy-induced abnormal myocardial perfusion using SPECT myocardial perfusion imaging (MPI) in patients with malignant hematologic diseases before hematopoietic stem cell transplantation (HSCT), and to explore its predictive value for mid-to-long-term mortality risk after transplantation.Methods:From March 2016 to August 2022, 139 patients with malignant hematologic diseases (80 males, 59 females; age (45.7±13.0) years) who underwent resting MPI to assess the presence of chemotherapy-induced abnormal myocardial perfusion before HSCT at the First People′s Hospital of Changzhou were prospectively included. Baseline-data were collected and patients were followed up for mid-to-long-term (≥100d) adverse outcomes after transplantation. Overall survival (OS) of each patient was recorded. The χ2 test and independent-sample t test were used for data analysis. Cox regression analysis was utilized to identify independent risk factors affecting OS. Kaplan-Meier method and log-rank test were used for survival analysis. Results:The median follow-up time of 139 patients was 41.6(19.5, 65.6) months, with all-cause mortality of 28.8%(40/139), and the cardiovascular mortality was 42.5%(17/40). The prior cardiotoxic therapies rate (anthracycline dose ≥250mg/m 2) was higher in the death group compared to that in the survival group (15.0% (6/40) vs 5.1% (5/99); χ2=3.87, P=0.049). Pre-transplant abnormal myocardial perfusion rate was also higher in the death group compared to that in the survival group (55.0%(22/40) vs 22.2%(22/99); χ2=15.19, P<0.001). But pre-transplant left ventricular ejection fraction (LVEF) was lower in the death group compared to that in the survival group ((60.4±5.2)% vs (62.9±3.9)%; t=-3.07, P=0.003). Cox multivariate regression analysis showed that the abnormal myocardial perfusion indicated by MPI before transplantation was an independent risk factor affecting OS after HSCT in patients with malignant hematologic diseases (hazard rate ( HR)=2.70, 95% CI: 1.33-5.46, P=0.006). Kaplan-Meier analysis showed the 1-, 2-, 5-year OS rates of patients with the abnormal myocardial perfusion and the normal myocardial perfusion were 73.5%, 69.1%, 49.2% and 94.6%, 89.9%, 81.6%, respectively, with significant difference ( χ2=17.01, P<0.001). Conclusions:Patients with abnormal myocardial perfusion detected by MPI before HSCT for malignant hematologic diseases have a poorer prognosis, characterized by lower post-transplantation OS rates. The utilization of MPI for assessing abnormal myocardial perfusion before transplantation in patients with malignant hematologic diseases can aid in predicting the mid-to-long-term mortality risk after transplantation.
7.Prognostic value of abnormal myocardial perfusion assessed by SPECT myocardial perfusion imaging before hematopoietic stem cell transplantation in patients with malignant hematologic diseases
Ke LI ; Yuetao WANG ; Weiying GU ; Chun QIU ; Dongyan WANG ; Feifei ZHANG ; Dan JIANG ; Baosheng MENG ; Yan LIN ; Jianfeng WANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2025;45(8):475-481
Objective:To assess the presence of chemotherapy-induced abnormal myocardial perfusion using SPECT myocardial perfusion imaging (MPI) in patients with malignant hematologic diseases before hematopoietic stem cell transplantation (HSCT), and to explore its predictive value for mid-to-long-term mortality risk after transplantation.Methods:From March 2016 to August 2022, 139 patients with malignant hematologic diseases (80 males, 59 females; age (45.7±13.0) years) who underwent resting MPI to assess the presence of chemotherapy-induced abnormal myocardial perfusion before HSCT at the First People′s Hospital of Changzhou were prospectively included. Baseline-data were collected and patients were followed up for mid-to-long-term (≥100d) adverse outcomes after transplantation. Overall survival (OS) of each patient was recorded. The χ2 test and independent-sample t test were used for data analysis. Cox regression analysis was utilized to identify independent risk factors affecting OS. Kaplan-Meier method and log-rank test were used for survival analysis. Results:The median follow-up time of 139 patients was 41.6(19.5, 65.6) months, with all-cause mortality of 28.8%(40/139), and the cardiovascular mortality was 42.5%(17/40). The prior cardiotoxic therapies rate (anthracycline dose ≥250mg/m 2) was higher in the death group compared to that in the survival group (15.0% (6/40) vs 5.1% (5/99); χ2=3.87, P=0.049). Pre-transplant abnormal myocardial perfusion rate was also higher in the death group compared to that in the survival group (55.0%(22/40) vs 22.2%(22/99); χ2=15.19, P<0.001). But pre-transplant left ventricular ejection fraction (LVEF) was lower in the death group compared to that in the survival group ((60.4±5.2)% vs (62.9±3.9)%; t=-3.07, P=0.003). Cox multivariate regression analysis showed that the abnormal myocardial perfusion indicated by MPI before transplantation was an independent risk factor affecting OS after HSCT in patients with malignant hematologic diseases (hazard rate ( HR)=2.70, 95% CI: 1.33-5.46, P=0.006). Kaplan-Meier analysis showed the 1-, 2-, 5-year OS rates of patients with the abnormal myocardial perfusion and the normal myocardial perfusion were 73.5%, 69.1%, 49.2% and 94.6%, 89.9%, 81.6%, respectively, with significant difference ( χ2=17.01, P<0.001). Conclusions:Patients with abnormal myocardial perfusion detected by MPI before HSCT for malignant hematologic diseases have a poorer prognosis, characterized by lower post-transplantation OS rates. The utilization of MPI for assessing abnormal myocardial perfusion before transplantation in patients with malignant hematologic diseases can aid in predicting the mid-to-long-term mortality risk after transplantation.
8.Analysis of the current situation of skin test for β-lactam antibiotics in medical institutions in Beijing
Ying-qiu YING ; Yi-feng DING ; Yin-chu CHENG ; Ming LU ; Jia-jia ZHENG ; Chao LIN ; Ning SHEN ; Chun-yan LI ; Juan DU ; Yi-heng YANG ; Suo-di ZHAI
The Chinese Journal of Clinical Pharmacology 2024;40(22):3323-3327
Objective To investigate the current situation of skin tests for β-lactams in 155 hospitals in Beijing.Methods The questionnaires were sent to medical institutions in Beijing to statistically described the current situation of β-lactams skin test,and the relevant influencing factors were analyzed by Fisher exact test,and Chi-square test.Results A total of 3 097 questionnaires were received from 155 medical institutions,of which 3 057 were valid questionnaires(effective rate is 98.71%).In this study,122 hospitals conducted skin test before using intravenous penicillins,accounting for 99.19%of 123 hospitals with intravenous penicillins.Hospitals with infectious disease pharmacists conducted more skin tests before using intravenous penicillins(98.59%vs 88.46%,P<0.001),and some hospitals didn't conduct skin tests before using oral penicillins.Seventy hospitals(45.16%)had not yet cancelled skin tests for cephalosporins,more hospitals with infectious disease pharmacists cancelled routine skin test(59.74%vs 50.00%,P<0.05),and more tertiary hospitals cancelled cephalosporin skin test(80.65%vs 51.40%,29.41%,all P<0.01).After the promulgation of the"Guiding Principle for Skin Test of β-lactams(2021 edition)",more primary hospitals have developed or updated the rules or regulation for skin test of β-lactams according to the Guiding Principle,compared with secondary hospitals(72.22%vs 41.18%,P<0.05).Hospitals with infectious disease pharmacists developed or updated the rules or regulation for skin test of β-lactams in their hospitals(78.57%vs 60.00%,P<0.05).Infectious disease pharmacists had promoting effect on the publicity of the rules or regulation of skin test in the hospital(92.65%vs 80.46%,P<0.05).Conclusion Many hospitals in Beijing have not cancelled cephalosporins skin test,and the current situation of cancelling cephalosporins skin test in tertiary hospitals is better than that in primary and secondary hospitals.
9.Design and finite element analysis of experimental device for simulating interface micro motion of bone trabecular prosthesis
Guang-Hui SHI ; Xiao-Guang ZHANG ; Xuan LI ; Lin-Wei LYU ; Chun-Qiu ZHANG
Chinese Medical Equipment Journal 2024;45(1):25-30
Objective To design an experimental device for simulating the interface micro motion of bone trabecular prosthesis and carry out the finite element analysis.Methods The experimental device was composed of a screw-in cylinder with threads,a flexible hinge,a micro-motion rod,a trabecular prosthesis,a connecting rod and a fixation post.A model of the experimental device was constructed with SolidWorks software,and then imported into ABAQUS software to establish a finite element model.An axial displacement load was applied to the femur to analyze the effects of the position of the flexible hinge,the gap between the prosthesis and the femur and the length of the connecting rod on the micro motion.Results The interface micro motion produced by the experimental device increased with the distance of the flexible hinge from the lower end of the screwed-in cylinder;the gap between the prosthesis and the femur did not affect the interface micro motion when the gap was not lower than 20 μm;the interface micro motion rose with the length of the connecting rod.Conclusion The experimental device can accurately simulate the micro motion of different bone trabecular prosthesis interfaces,and can be used for studying the effect of the interface micro motion on osseointegration.[Chinese Medical Equipment Journal,2024,45(1):25-30]
10.Study on anti-myocardial ischemia active components and mechanism of Xinkeshu tablets based on network pharmacology and zebrafish model
Lin-Hua HOU ; Hua-Zheng ZHANG ; Shuo GAO ; Yun ZHANG ; Qiu-Xia HE ; Ke-Chun LIU ; Chen SUN ; Jian-Heng LI ; Qing XIA
Chinese Pharmacological Bulletin 2024;40(5):964-974
Aim To study the active ingredients and mechanism of action of Xinkeshu tablets against myo-cardial ischemia by network pharmacology and ze-brafish model.Methods The anti-myocardial ische-mia activity of Xinkeshu tablets was evaluated by iso-prenaline hydrochloride(ISO)-induced zebrafish myo-cardial ischemia model and H2O2-induced H9c2 dam-age model.The active ingredients of Xinkeshu tablets were retrieved using databases such as TCMSP.The potential targets were predicted by PharmaMapper data-base.Myocardial ischemic disease targets were searched by OMIM database.The potential therapeutic targets of Xinkeshu tablets against myocardial ischemia were analyzed.GO and KEGG enrichment analysis were conducted on core targets.The active ingredients were verified by zebrafish and cell model.qRT-PCR was used to detect the expression of key targets.Re-sults Xinkeshu tablets could significantly alleviate ISO-induced pericardial edema and bradycardia.It al-so could increase sinus venous-bulb aortic(SV-BA)distance and improve the cell viability.The 30 poten-tial active ingredients of Xinkeshu tables mainly acted on 30 core targets,including ALB,AKT1 and MAPK1,to regulate 627 GO items,including protein phosphorylation,negative regulation of apoptosis and positive regulation of PI3K signal transduction.KEGG results showed that 117 signaling pathways,including PI3K/Akt,FOXO and Ras,exerted anti-myocardial ischemia effect.Salvianolic acid A,lithospermic acid,rosmarinic acid,salvianolic acid D,salvianolic acid B,ginsenoside Rg2,hyperoside,3'-methoxypuerarin,3'-hydroxypuerarin and ginsenoside Rg1 could alleviate ISO-induced zebrafish myocardial ischemia and im-prove the cell viability.Xinkeshu tablets could upregu-late the expression of genes such as ras and akt1,and downregulate the expression of genes such as mapk1 and mapk8.Conclusion The active ingredients,in-cluding salvianolic acid A in Xinkeshu tablets,exert anti-myocardial ischemia effects by targeting targets,such as AKT1,MAPK1,and regulating signaling path-ways,such as PI3K/Akt,MAPK and Ras.

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