Study on Influencing Factors of Environmental Testing Quality of Medical Device Manufacturers Clean Workshops / 中国医疗器械杂志

OBJECTIVE@#Improve the quality of testing in medical device manufacturers clean workshops to ensure the authenticity and reliability of testing data.@*METHODS@#Analyze the problems and influencing factors found in the process of testing of medical device manufacturers clean workshops from 2016 to 2020, and put forward reasonable suggestions to ensure the quality of testing.@*RESULTS@#In the process of testing, there are six factors that affect the quality of testing, including testing personnel, instruments and equipment, testing consumables, testing methods, testing environment and actual operation.@*CONCLUSIONS@#To improve the quality of testing, should strengthen the training of testing personnel, continuously improve the testing quality management system, establish an effective information communication mechanism, find out the influencing factors in time, provide objective, real and effective testing data for medical device manufacturing enterprises, and provide technical support for the production and supervision of medical devices.

Impact of obstructive sleep apnea on the long-term cardiovascular outcomes in patients with acute coronary syndrome / 中华心血管病杂志

Objective: To investigate the impact of obstructive sleep apnea (OSA) on long-term cardiovascular outcomes in patients with acute coronary syndrome (ACS). Methods: This is a single-center, prospective cohort study. Between June 2015 to January 2020, consecutive ACS patients hospitalized at Beijing Anzhen Hospital, Capital Medical University were enrolled. All patients underwent portable sleep breathing monitoring, and they were then divided into moderate/severe OSA group (apnea-hypopnea index (AHI)≥15 events/hour) and no/mild OSA group (AHI<15 events/hour). The primary endpoint was major adverse cardiac and cerebrovascular event (MACCE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, ischemia-driven revascularization and hospital admission for unstable angina or heart failure. MACCE were compared yearly by the log-rank test. Multivariable Cox regression analyses were performed to determine the independent predictors of MACCE. Results: A total of 1 927 patients with ACS were enrolled, including 1 629 males (84.5%), aged (56.4±10.5) years. Moderate/severe OSA was present in 1 014 (52.6%) patients. Compared with no/mild OSA group, moderate/severe OSA group exhibited a higher body mass index (P<0.05). Hypertension, prior PCI were more prevalent in moderate/severe OSA group (both P<0.05). The difference of ACS category between the two groups was statistically significant (P=0.021). The rate of patients who underwent PCI and the number of stents were higher in the moderate/severe OSA group. During a 5-year follow-up (median 2.9 years (IQR 1.5-3.6 years)), the cumulative incidence of MACCE was significantly higher in the moderate/severe OSA group than in the no/mild OSA group (34.0% vs. 24.0%, HR=1.346, 95%CI 1.100-1.646, log-rank P=0.004). The cumulative incidence of MACCE remained statistically higher at 4 and 5 year in the moderate/severe OSA group as compared to the no/mild OSA group (33.3% vs. 22.9%, HR=1.397, 95%CI 1.141-1.710, log-rank P=0.001; 34.0% vs. 24.0%, HR=1.341, 95%CI 1.096-1.640, log-rank P=0.004, respectively). Multivariate analysis showed that moderate/severe OSA (HR=1.312, 95%CI 1.054-1.631, P=0.015) was an independent predictor of long-term MACCE in ACS patients. Conclusions: Moderate/severe OSA is observed in more than 52% ACS patients. Moderate/severe OSA is an independent predictor of long-term MACCE.

Application and Evaluation of Chemiluminescence Immunoassay in Blood Screening / 中国实验血液学杂志

OBJECTIVE@#To explore the application of blood screening method based on chemiluminescence immunoassay（CLIA）and to evaluate its officacy.@*METHODS@#Screening HBsAg, anti-HCV, anti-HIV and TP was performed on 3,530 voluntary blood donors by ELISA and CLIA, and then all the specimens with ELISA and ELISA/CLIA were further confirmed by NAT; TP single and double positive specimens by ELISA or CLIA were further confirmed by TPPA.@*RESULTS@#The results of CLIA method was well consistent with NAT results, displaying better repeatability and higher sensitivity than ELISA method. For CLIA/ELISA specimens there was a certain false-negative result obtained by ELISA method, especially for blood donors with low virus biter concentration or "window period".@*CONCLUSION@#ELISA and CLIA have complementary advantages in blood screening, which can improve the sensitivity of blood screening, reduce the missed detection and shorten detection time. The introduction of CLIA for blood screening is of great importance for ensuring the quality of blood and the safety of clinical transfusion.

Stress, Stressors And Coping Strategies Among University Nursing Students

@#Literature has documented that student nurses undergo stress in their academic and clinical setting. This raises concerns because stress during undergraduate training may result in psychological or emotional impairment during the nurses’ professional life and ultimately affect the quality of patient care. The Objective of the study was to study the prevalence of stress, and the association between sociodemographic factors, stressors and coping strategies with stress. This was a cross-sectional study on 96-year 1-3 nursing students from a government university done between 2015-2018. Bahasa Malaysia translated The General Health Questionnaire, Stressors in Nursing Student Scale Questionnaire and Brief COPE Questionnaire was used in this study. This study had Malay (95.9%) and female (91.7%) dominated population. The prevalence of stress in student nurses was 25%. No association was reported between sociodemographic factors and stress. Among the 4 stressors educational, clinical, confidence and financial, clinical stressor scored the highest mean 6.40 (SD±3.66). Confidence stressor (AOR=1.26 95% CI 1.04-1.53) was the only stressor associated with stress. The top 3 coping strategies practiced by the student nurses were religion (praying), acceptance and planning. Self-blame (AOR 8.18 95% CI 1.86-35.91) was the only coping strategy associated with stress. Stress management programmes, and workshops on stress and coping strategies should be conducted yearly to ensure a well-balanced environment for good learning experiences and prevent stress related health problems and improved academic performance.

Complete Mitochondrial Genome of Echinostoma hortense (Digenea: Echinostomatidae)

Echinostoma hortense (Digenea: Echinostomatidae) is one of the intestinal flukes with medical importance in humans. However, the mitochondrial (mt) genome of this fluke has not been known yet. The present study has determined the complete mt genome sequences of E. hortense and assessed the phylogenetic relationships with other digenean species for which the complete mt genome sequences are available in GenBank using concatenated amino acid sequences inferred from 12 protein-coding genes. The mt genome of E. hortense contained 12 protein-coding genes, 22 transfer RNA genes, 2 ribosomal RNA genes, and 1 non-coding region. The length of the mt genome of E. hortense was 14,994 bp, which was somewhat smaller than those of other trematode species. Phylogenetic analyses based on concatenated nucleotide sequence datasets for all 12 protein-coding genes using maximum parsimony (MP) method showed that E. hortense and Hypoderaeum conoideum gathered together, and they were closer to each other than to Fasciolidae and other echinostomatid trematodes. The availability of the complete mt genome sequences of E. hortense provides important genetic markers for diagnostics, population genetics, and evolutionary studies of digeneans.

Osteoblastic behavior to zirconium coating on Ti-6Al-4V alloy

PURPOSE: The purpose of this study was to assess the surface characteristics and the biocompatibility of zirconium (Zr) coating on Ti-6Al-4V alloy surface by radio frequency (RF) magnetron sputtering method. MATERIALS AND METHODS: The zirconium films were developed on Ti-6Al-4V discs using RF magnetron sputtering method. Surface profile, surface composition, surface roughness and surface energy were evaluated. Electrochemical test was performed to evaluate the corrosion behavior. Cell proliferation, alkaline phosphatase (ALP) activity and gene expression of mineralized matrix markers were measured. RESULTS: SEM and EDS analysis showed that zirconium deposition was performed successfully on Ti-6Al-4V alloy substrate. Ti-6Al-4V group and Zr-coating group showed no significant difference in surface roughness (P>.05). Surface energy was significantly higher in Zr-coating group than in Ti-6Al-4V group (P<.05). No difference in cell morphology was observed between Ti-6Al-4V group and Zr-coating group. Cell proliferation was higher in Zr-coating group than Ti-6Al-4V group at 1, 3 and 5 days (P<.05). Zr-coating group showed higher ALP activity level than Ti-6Al-4V group (P<.05). The mRNA expressions of bone sialoprotein (BSP) and osteocalcin (OCN) on Zr-coating group increased approximately 1.2-fold and 2.1-fold respectively, compared to that of Ti-6Al-4V group. CONCLUSION: These results suggest that zirconium coating on Ti-6Al-4V alloy could enhance the early osteoblast responses. This property could make non-toxic metal coatings on Ti-6Al-4V alloy suitable for orthopedic and dental implants.

Direct inhibitory effects of 153Sm-DTPA-c(CGRRAGGSC) on human prostate cancer PC-3 cells / 中华核医学杂志

Objective To investigate the direct inhibitory effects of 153Sm- DTPA-c (Cys-Gly-Arg-Arg-Ala-Gly-Gly-Ser-Cys) NH2 ( 153 Sm-DTPA-c (CGRRAGGSC)) on human prostate cancer PC-3 cells. Methods 153Sm-DTPA-c(CGRRAGGSC) was synthesized by the reaction of 153SmCl3 with DTPA-c(CGRRAGGSC) using indirect synthesis method. PC-3 cells in vitro culture were divided into four study groups, groug A ( the control, with PBS only), group B with 1.5 mg/L c ( CGRRAGGSC), group C with 370 kBq 153 SmCl3 and group D with 370 kBq 153Sm-DTPA-c(CGRRAGGSC). PC-3 cell growth was assayed by 3-(4, 5-dimethylthiazol-2-yl ) -2, 5-diphenyltetrazolium bromide (MTT) method. Cell cycle and apoptosis were analyzed by flow cytometry. The expression changes of interleukin 11 (IL11 ) and IL11 receptor (IL1 1 R) in PC-3 cells were examined by Western Blot. One way analysis of variance (ANOVA) and paired-t test were applied for statistic analysis. Results The labeling yield of 153Sm-DTPA-c (CGRRAGGSC) was 85% and the radiochemical purity was 95.8%. The specific activity of 153Sm-DTPA-c(CGRRAGGSC) was 1.32 × 105 MBq/μmol. Significant inhibitory effects on the growth of PC-3 cells were found in both group C and D, with a time-dependent manner. However, no obvious inhibition was found either in group A or in group B. After 48 h,significant differences of sub-G1 peak area were found among groups, (0. 98 ± 0. 18)%, (0. 35 ±0. 10)%, (4.05 ±0.28)% and (13.38 ±0. 89)% for group A, B, C and D, respectively. Furthermore,sexpression of ILl 1R in group D was significantly lower than that in group B and C with absorbance values 0. 339 ~ 0.014, 0.338 ~ 0.019, 0.226 ~ 0. 015 for group B, C and D, respectively. Absorbance values in groups B and C were not significantly different after treatment, compared with those before treatment; however, there was difference between absorbance values after and before treatment in group D ( t = 0. 405,1. 163,135.989,P>0.05 >0.05, <0.05). Conchluion 153Sm-DTPA-c(CGRRAGGSC) can directly in hibit the cell growth and expression of human prostate cancer cells PC-3.

Correlation between renal artery resistance index and serum creatinine level early after renal transplantation / 南方医科大学学报

<p><b>OBJECTIVE</b>To investigate the relationship between the resistance index (RI) of the renal artery and serum creatinine (Cr) level in patients early (within one month) after renal transplantation.</p><p><b>METHODS</b>A total of 123 patients receiving renal transplantation underwent examinations by color Doppler ultrasound for measurement of the RI of the renal artery within one month after the operation. According to the results of RI measurement, the patients were divided into RI≥0.75 and RI<0.75 groups for analyzing the correlation between RI and serum Cr level measured at the same time points.</p><p><b>RESULTS</b>The RI and Cr levels in patients with RI≥0.75 showed a significant positive correlation (P<0.05), whereas they showed an inverse correlation in patients with RI<0.75 (P<0.05). The patients with RI≥0.75 had significantly lower RI of the renal artery and Cr level than those with RI≥0.75.</p><p><b>CONCLUSION</b>RI is significantly correlated to Cr, and may serve as an indicator for predicting renal graft function after transplantation.</p>

p38 mitogen-activated protein kinase inhibitor suppresses the expression of pro-inflammatory cytokines in liver from brain dead rats / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To observe the suppressive effect on the expression of pro-inflammatory cytokines in liver from brain dead (BD) rats through inhibition of p38 mitogen-activated protein kinase (MAPK) signaling pathway by SB203580.</p><p><b>METHODS</b>A total of 30 male Wistar rats weighing from 180 to 200 g were randomly divided into 3 experimental groups: (1) BD group (n = 10): brain death was induced in rats; (2) BD+SB203580 group (n = 10): brain death was successfully induced and SB203580 (10 mg/kg) was given through dorsal vein of penis. After brain death artificial ventilation was maintained for 6 hours and only those with mean arterial blood pressure more than 80 mm Hg (1 mm Hg = 0.133 kPa) were accepted as BD donors. (3) Control group (n = 10): living healthy rats. The expressions of TNFalpha and IL-1beta mRNA in liver tissues were analyzed by RT-PCR and the protein expressions of TNFalpha, IL-1beta and phosphorylated p38MAPK were detected by Western blot.</p><p><b>RESULTS</b>The phosphorylated p38MAPK detected in the liver in BD group was significantly increased compared with the control group (q = 172.53, P < 0.01), and the expressions of TNFalpha and IL-1beta mRNA and proteins in liver were also significantly increased in BD group compared with the control group (q = 123.99, 135.35, 243.09 and 192.23, respectively, P < 0.01). The phosphorylated p38MAPK was decreased in BD+SB203580 group and significantly decreased compared with the BD group (q = 63.90, P is less than 0.05), but higher than that in control group (q = 108.63, P < 0.01). The expressions of TNFalpha and IL-1beta mRNA and proteins in liver were significantly decreased in BD+SB203580 group compared with the BD group (q = 55.11, 98.13, 61.03 and 50.85, respectively, P < 0.01), but higher than that in control group (q = 68.89, 37.22, 182.06 and 141.38, respectively, P < 0.01). SB203580 can suppress the expression of pro-inflammatory cytokines in the liver of brain dead rats through the inhibition of p38MAPK signaling pathway which may reduce the immunogenicity of donor livers.</p>

A novel 99Tcm labelled polypeptide analogue for interleukin-11 receptor imaging in a bone metastases model for prostate cancer / 中华核医学杂志

Objective To assess the feasibility of a novel 99Tcm labelled polypeptide analogue for interleukin-11 receptor ( IL11R) imaging in a bone metastases model for prostate cancer. Methods A novel circular polypeptide analogue of IL11 ( c( CGRRAGGSC ) ) was indirectly labeled with 99Tcm and the product was named as 99Tcm-DTPA-IL11 RR. The labeling efficiency, radiochemical purity and stability of the product were measured with paper chromatography and high performance liquid chromatography (HPLC). The biodistribution of 99Tcm-DTPA-IL11RR was investigated in 28 ICR normal mice. The organ radioactivity was measured as percentage activity of injection dose per gram of tissue ( %ID/g). The models of bone metastases from prostate cancer were established at the tibias of BALB/c nude mice bearing human prostate cancer PC-3 cells. The tumor bearing ( n= 5 ) and standard closed fracture nude mice models underwent both 99Tcm-DTPA-IL11RR and 99Tcm-methylene diphosphonate (MDP) scintigraphy study. The images were acquired at 0.5, 1,2, 4, 6, 8, 24 h after intravenous injection of the tracers. The competitive inhibition imaging was perfomed in three tumor bearing mice. One-way variance analysis was used. Results The labeling efficiency was 90.7%. The radiochemical purity of 99Tcm-DTPA-IL11RR in normal saline solution was (99.57 ±0.09)%, (99.29 ±0.18)%, (98.95 ±0.78)%, (98.67 ±0.11)%, (96.53 ±0.91)%, (95.20±0.70)%, (88.38 ±0.22)% and (36.17±1.29)% at room temperature after0, 1,2, 3, 4, 6, 8 and 24 h, respectively. The tracer radiochemical purity in the blood of ICR mice remained over 90% at 37 C for 6 h. The labeling compounds were excreted mainly through kidney. The peak uptake of bone ( ( 1.910 ±0.109) %ID/g) and liver ( (0.366 ±0.030) %ID/g) was at 4 h after injection. In the tumor bearing mice, the uptake of spine marrow and large joints of extremities was mild. The highest uptake at tumor region was at 4 h and persistent at 6-8 h after injection. The tumor to non-tumor ratios (T/NT) were 1.17 ±0.17, 2.20 ±0.29, 3.20 ±0.15, 3.67 ±0.23, 13.61±0.85, 9.45 ±0.37 and 3.33 ±0.30 at 0.5,1, 2, 4, 6, 8 and 24 h, respectively (F=621.54, P＜0.05). In the standard closed fracture models,high uptake of 99Tcm-MDP was shown at the fracture site, with no increased 99Tcm-DTPA-IL11RR uptake noted. The tumor uptake was significantly depressed after a pre-injection of the unlabeled polypeptide analogue. Conclusions The synthesis of 99Tcm-DTPA-IL11RR is stable and the labeling efficiency is high. It may be a potential molecular probe in metastatic bone imaging for prostate cancer.

Prevalence and risk factors for posttraumatic stress disorder among survivors from a coal mining accident after 2 and 10 months / 中南大学学报(医学版)

OBJECTIVE@#To investigate the prevalence of posttraumatic stress disorder (PTSD) among survivors from a coal mining accident after 2 and 10 months and factors related to PTSD.@*METHODS@#To estimate the prevalence of PTSD, 104 miners were surveyed through the PTSD Checklist-Civilian Version (PCL-C). Forty survivors including 24 severe PTSD patients and 24 non-PTSD subjects were evaluated thoroughly.@*RESULTS@#The current prevalence rate among survivors from the coal mining accident at 2 months was 50%. There were significant differences in PTSD symptoms, anxiety and depression, personality, and memory performance between the PTSD patients and non-PTSD controls. State anxiety, time to renew the work, depression, neuroticism, and the place they were staying, and length of service were predictors of PTSD. After 10 months of the accident, 30.6% survivors still met the criterion of PTSD. Compared with 2 months after the accident, PTSD symptoms, anxiety, and memory performance improved clearly, while the depressive symptoms had no significant difference. The state anxiety, time to renew the work, positive coping, emotional balance, and length of service were the factors of PTSD symptom healing.@*CONCLUSION@#The current prevalence of PTSD among survivors from coal mining accident is high. The mining accident has great influence on victims, and psychological or medication interventions are necessary. There are lots of risk factors for the prevalence of PTSD, such as state anxiety, depression, neuroticism, and shorter duration of service. Positive coping may be a beneficial factor for PTSD recovery.

Effect of 5-HT and postsynaptic 5-HT1 A on the mood and recogniztion of the repeated restraint stress in rats / 中南大学学报(医学版)

OBJECTIVE@#To explore the role of 5-HT and postsynaptic 5-HT1A receptors in the stress adaptation.@*METHODS@#p-PCA was used to deplete the 5-HT in rats. The 5-HT1A agonist 8-OH-DPAT and antagonist WAY100635 were used to determine the effect of postsynaptic 5-HT1A receptors on the ratso behaviors in the Elevated Plus-Maze test, the Forced Swimming test, and the Morris Water Maze test.@*RESULTS@#Compared with the intact rats, the 5-HT depleted rats showed more seriously anxious behaviors in the Elevated Plus-Maze test and more obvious learned helplessness in the Forced Swimming test. After having been stressed the 5-HT depleted rats showed significantly impaired learning and memory compared with the intact rats according to Morris Water Maze test. Activation of postsynaptic 5-HT1A receptors by 8-OH-DPAT in the 5-HT depleted rats or the 5-HT depleted stress rats significantly decreased the symptoms of anxiety and learned helplessness behaviors which were prevented by the treatment of WAY100635. The 8-OH-DPAT and WAY100635 had no obvious effect on the 5-HT depletion or 5-HT depleted stress rats in the Morris Water Maze test.@*CONCLUSION@#Deficiency of 5-HT in rats may suppress its ability to stress adaptation. Activation of post-synaptic 5-HT1A receptors can attenuate the anxiety and depressive behavior symptoms, and facilitate rats to adapt stress.

Cephalometric study with Steiner analysis on normal occlusion of Korean adults in Yanbian China / 华西口腔医学杂志

<p><b>OBJECTIVE</b>The aim of the study was to establish a cephalometric normal standard value for Korean in Yanbian China by means of Steiner analysis.</p><p><b>METHODS</b>72 cases of Korean adults in Yanbian with normal occlusion were selected, standard lateral cranial X-ray films were taken and cephalometric Steiner analysis was performed. The data was compared with Korean in Soul of Republic of Korea with normal occlusion.</p><p><b>RESULTS</b>1) Cephalometric Steiner normal standard values, standard deviation and Cheveron analysis chart were established. 2) 1-NB angle of male was significantly bigger than that of female, while GoGn-SN angle of female was significantly bigger than that of male (P<0.05), respectively. 3) There were significant differences on SNA, SNB, ANB, SND, [symbol: see text]-NA (mm),1-NB (except woman) compared with same age group Korean presented by In-Chool Park (P<0.05).</p><p><b>CONCLUSION</b>There is a significantly different between male and female Koreans with normal occlusions in Yanbian China. This experiment filled in the blank of stomatology research in Yanbian Korean autonomous region. In the mean while, it completed and supplemented the normal occlude data of different nations in China. The present paper also provided the reference for clinic and scientific research on orthognathic surgeon. At the same time, the experiment provided the evidence for the further research.</p>

A case of vertebral traumatic pseudoaneurysm / 华西口腔医学杂志

Pseudoaneurysm often occurred after trauma and infection. It was seen commonly on limb arteries but rarely on vertebral artery. The case was diagnosed two months after trauma. The pulsatile mass and vascular murmur found through preoperative examination confirmed from the vertebral artery. No complication was observed after surgery.