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Objective@#To establish an analytical method for serum prolactin (PRL) based on the photoinduced chemiluminescence technology, and evaluate its performance. @*Methods@#A pair of PRL monoclonal antibodies were labeled with luminescent nanospheres and biotin respectively, and the double antibody sandwich detection system was formed with the serum prolactin and streptavidin-labeled photosensitive microspheres (universal photosensitive solution) under homogeneous conditions. The performance index and correlation of the detection system were evaluated. @*Results@#The precision of intra-assay and within-day (coefficient of variation) of the developed assay were 4.60% and 5.25%, respectively. The functional sensitivity was 2.48 μIU/mL, and its reportable results were ranged from 2.48 to 4 240 μIU/mL. The recovery rates of different PRL calibrators (42.2, 424, 4 240 μIU/mL) added to human sera were ranged from 96.25% to 102.93%. There was no interference from bilirubin＜20 mg/dL, hemoglobin＜200 mg/dL, triglyceride＜3 000 mg/dL and biotin＜20 ng/mL. Also, the light-initiated chemiluminescent assay for PRL (PRL-LICA) correlated well with Beckman Unicel Dxi 800 Access 2. @*Conclusions@#LICA showed effective performance for detecting PRL in human serum, and it could meet the basic requirements of clinical diagnosis.
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OBJECTIVE@#Providing a risk assessment method for the implementation of radiotherapy to identify possible risks in the implementation of the treatment process, and proposing measures to reduce or prevent these risks.@*METHODS@#A multidisciplinary expert evaluation team was developed and the radiotherapy treatment process flow was drawn. Through the expert team, the failure mode analysis is carried out in each step of the flow chart. The results were summarized and the (risk priority ordinal) score was obtained, and the quantitative evaluation results of the whole process risk were obtained.@*RESULTS@#One hundred and six failure modes were obtained, risk assessment of (20%) high risk failure model are 22 and severity (≥ 8) high risk failure model are 27. The reasons for the failures were man-made errors or hardware and software failures.@*CONCLUSIONS@#Failure mode and effect analysis can be used to evaluate the risk assessment of radiotherapy, and it provides a new solution for risk control in radiotherapy field.
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Healthcare Failure Mode and Effect Analysis , Risk AssessmentABSTRACT
Objective To discuss the relationship between the expression of secretory Phospholipase A2-Ⅱ A(sPLA2-ⅡA) and the pathogenesis psoriasis vulgaris patients lesions.Methods Using Psoriasis Area Severity Index(PASI),50 psoriasis vulgaris were divided into three groups:mild (n =16),moderate (n =18) and severe group (n =16),and compared to the non-psoriasis control group (n=52).The serum level of sPLA2-ⅡA in psoriasis vulgaris patients and the normal control group were detected using ELISA methods.Using RT-PCR,mRNA expression levels of sPLA2-ⅡA and subtypes were detected.Using western blot,the expression levels of Akt and p-Akt were detected.Results The serum level of sPLA2-ⅡA in the psoriasis lesion's group was significantly higher than that in the healthy control (t=13.62,P＜0.01).The mRNA expression of sPLA2-ⅡA in the lesion of psoriasis was significantly higher than that in health control (t=113.41,P＜0.01).In the other subtypes,the mRNA expression of sPLA2 had no distinctive.Among the three groups (mild group,moderate group and severe group),the difference in serum level and mRNA expression of sPLA2-ⅡA were statistically significant (F =28.12,69.62,P＜0.01).There was statistical significance among three groups (t=3.14,5.14,6.38,all P＜0.01;t=4.77,10.42,10.58,all P＜0.01).The expression of Akt/p-Akt in the psoriasis lesion's group were higher than that in health control (t=17.79,19.04,P＜0.01).Conclusion The expression of sPLA2-ⅡA would be associated with order of severity in lesions of psoriasis vulgaris.The pathway was relate to expression of Akt and p-Akt.
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Objective To analyze the history and present situation of international medical device with visualization softwareto provide references for medical device development in China.Methods CiteSpace visualization software was used to explore international literatures related to medical device from the aspects of yearly quantity,research direction,research organization,quoted literature and etc from 2005 to 2014.Results Medical device drew increasing attention from corresponding researchers,whose development depended on international cooperation.Medical device related closely to engineering and medicine,and had to paid attention to informatization and clinical requirements.Conclusion CiteSpace software is of great value for the study on medical device.
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OBJECTIVE To explore the difference of vestibular damage between sudden deafness and vestibular neuritis.METHODS Patients in otolaryngology head and neck surgery eenterin PLA general hospital from February 25 in 2016 to July 20 in 2016 were included in this research.Among these patients,55 cases were diagnosed as sudden deafness group,including 39 cases With vertigo.And other 46 cases were diagnosed as vestibular neuritis.Vestibular bithermal caloric test,head impulse test(head impulse test,HIT),cervical vestibular evoked myogenic potentials(cervical vestibular evoked myogenic potential,cVEMP),ocular vestibular evoked myogenic potentials(ocular vestibular evoked myogenic potential,oVEMP) were performed to evaluate their vestibular function and were compared.RESULTS The abnormal rate of vestibular bithermal caloric test in sudden deafness group 25.45％,and 97.82％ in vestibular neuritis group.There was significant difference between two groups(x2=54.01,P＜0.001).HIT:the abnormal ratein sudden deafness groupwas 9.09％ and 32.61％ in vestibular neuritis group,there was significant difference between two groups(x2=8.72,P=0.003).VEMP:the abnormal rate of cVEMP in sudden deafness group was 69.10％ and 43.47％ in vestibular neuritis group,there was significant difference between two groups(x2=6.72,P=0.010).But the abnormal rate of oVEMP in sudden deafness group was 54.55％ and 63.04％ in vestibular neuritis group,and there was not statistically significant difference between two groups(x2=0.745,P=0.388).CONCLUSION The vestibular damage of sudden deafness with vertigo was more likely involved with saccule and inferior vestibular nerve,more close to the nerve terminal,and the injury was in a low frequency range;but the vestibular damage in vestibular neuritis was wider,and the injury involved a full band,the damaged part may be higher.
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This paper studied the selection of training tasks of medical equipment preventive maintenance,to provide theoretical basis for standardized training design.Eight tasks of medical equipment PM process were quantitatively analyzed in multi factors based on the AHp and MFM,and the CDF decision trees model was compared with the selection standard.The studied identified the selection standards and criteria of the tasks,as well as reliable theoretical references for building the standardized training system.
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Based on specified demands on medical devices maintenance for clinical engineers and Browser/Server architecture technology, a medical device maintenance information platform was developed, which implemented the following modules such as repair, preventive maintenance, accessories management, training, document, system management and regional cooperation. The characteristics of this system were summarized and application in increase of repair efficiency, improvement of preventive maintenance and cost control was introduced. The application of this platform increases medical device maintenance service level.
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Equipment and Supplies , Maintenance , Medical Informatics Applications , SoftwareABSTRACT
ObjectiveTo evaluate the accuracy of measurement of left ventricular(LV) volume and function in coronary heart disease(CHD) by real-time three-dimensional echocardiography(RT-3DE) using cardiac magnetic resonance imaging (CMRI).Methods LV end diastolic volume(EDV),LV end systolic volume(ESV) and LV ejection fraction(EF) were measured with RT-3DE in patients with CHD ( n =37) and in the control ( n =30).The results measured by RT 3DE were compared with those of CMRI.The diagnostic value of RT-3DE was evaluated using receiver operating characteristic(ROC) curve.Results Compared with that measured by CMRI,EDV,ESV and EF by RT 3DE( P ＞0.05) were almost similar as that in the control.Area under ROC curve of in EDV and ESV were 0.912 and 0.944 in the control.However,EDV determined by RT-3DE was smaller than that by CMRI( P ＜0.05) in CHD group.A difference (10.95 ± 31.26 ml) was existed in EDV between the two methods.ESV measured by RT-3DE was smaller than that calculated by CMRI( P ＞0.05) with a mean differance of (3.17 ± 16.42)ml in CHD group.EF by RT-3DE( P ＞0.05)was almost as same as that by CMRI in CHD group,with a mean difference of (1.54 ± 11.85)％.The area under ROC curve of EDV and ESV were 0.834 and 0.873 in CHD group and their diagnostic performance was moderate.ConclusionsMeasurment of LV volume and function by RT 3DE in control was more acurrate than that in CHD.In the cases of LV remodeling in patients with CHD,RT-3DE would underestimate the LV volume.
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<p><b>OBJECTIVES</b>To analyze medical device recall information of FDA U.S. and to address the safety issue of medical device.</p><p><b>METHOD</b>For each report, the recall class, product name, product class and recall reason were recorded and classified for analysis.</p><p><b>RESULTS</b>3093 reports were identified; the recalling reasons of the three classes were significantly different. It is found that the main recall reason for medical material is package problems (39%) and design defectiveness (19%), for medical tools are design defectiveness (27%) and package problems (26%), and for medical equipment are design defectiveness (45%) and system failures (39%). The number of software recalled is 109. The main recall reason for high risk equipment is design defectiveness, and the I class level of high risk equipment recalled was decline in 2006 compared to that in 2005.</p><p><b>CONCLUSION</b>Monitoring and application of medical device recall information should be strengthened, and the objective law of medical device safety issue should be summed up, in order to provide reference for supervision of medical device.</p>
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Equipment Safety , Medical Device Recalls , Product Surveillance, Postmarketing , United States , United States Food and Drug AdministrationABSTRACT
Objective To develop a new method for describe features of inflow of left ventricle(LV) from color Doppler image by color singular value,and evaluat the value of color singular value in assessment of diastolic dysfunction. Methods Patients with diastolic dysfunction of LV including myocardial infarction (n = 37), angina( n = 35), cardiomyopathy( n = 45) and hypertension ( n =46) were selected and 30 healthy cases as control. CV and AV from color singular value of LV inflow was displayed and calculated automatically by an analyzing system developed in our laboratory. Results Compared with that of control (CV:2.40 0.22 and AV: -0.25 0.05), the absolute value of CV(1.67-1.90 in average)and AV( - 0. 11～-0. 20 in average) from color singular value were decreased significantly( P <0. 001) in groupsof myocardial infarction, angina, cardiomyopathy and hypertension. Conclusions Singular value can be applied to detect color differences in LV inflow from color Doppler signals. Changes of singular value within the diastolic inflow under pathological conditions may reflect the diastolic dysfunction of LV.
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To understand the mechanical properties of aortic artery of atheroselerosis (AS), the aortic artery of rat with AS was studied by mechanical test. Wistar rats were used for establishing the model. The mechanical measurements of opening angle in zero-stress state and the vessel loading test were conducted on the isolated aortic arteries of AS rats. Data on the stress-strain of aortic artery were obtained. Determination of percentage of collagen content was made with the use of electron microscope. The relationship between mechanical measurements and collagen concentration was evaluated. The opening angle in the group of AS was significantly smaller than that in control (87.74 degrees +/-9.67 degrees vs. 196.03 degrees +/- 27.76 degrees, P < 0.001). Significant decrease of material constants (alpha0, alpha1, alpha2, b0, b1, b2) in both long axis and radial axis was observed in AS group(campared with control, P < 0.05-0.001). Close relationship between the mechanical constants and the percentage of elastin and collagen content was observed (r = -0.7523 to -0.8423, P < 0.001). In conclusion, mechanical remodeling in aortic artery of AS might be related with histological remodeling.
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Animals , Female , Male , Rats , Aorta, Abdominal , Metabolism , Pathology , Atherosclerosis , Metabolism , Pathology , Biomechanical Phenomena , Collagen , Elastin , Random Allocation , Rats, Wistar , Stress, MechanicalABSTRACT
Objective To explore the differences of systolic segmental motion of left ventricle (LV) in patients with dilated cardiomyopathy (DCM) using illustration of the bull eye (IBE) from real-time three-dimensional echoeardiography(RT-3DE). Methods Quantitative analysis of LV segmental function was made in 43 patients with DCM by IBE. Percentage of compensated segments(PCS) was determined according to the segmental distribution by different color from IBE. Maximal exeursion(Emax),minimal excursion(Emin), average excursion (EA), standard difference of excursion(SD) and dispersion of excursion(Edis) were calculated. Results PCS in patients with DCM was 27.22%. Significant differences between DCM group and control group in Emax, Emin, EA,SD and Edis were observed( P <0. 001 ). Significant difference in segmental motion of LV was existed in patients with DCM and its distribution of motion seems tendency of irregularity. Conclnsions PCS and Edis from IBE might provide a convenient and macroscopic modality in selection of treatment and evaluation of prognosis in patients with DCM.
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ERP system is introduced. Combined with the deficiencies of management of medical consumable materials in supply chain and high-value materials, the application of ERP to workflow, fundamental material, operation and high-value material management are explored. It indicates that although with some deficiencies, this ERP system optimizes business process and then improves work efficiency of management of medical consumable materials greatly.
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Objective To evaluate the effect of -477C/T single nucleotide polymorphism (SNP) in promoter region of ABCA1 gene on plasma levels of high density lipoprotein cholesterol (HDL-C) and coronary artery disease (CAD). Methods -477C/T genotypes in promoter region of ABCA1 gene were assessed in 96 CAD patients and 100 healthy individuals with polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP), and distribution of the -477C/T genotypes was compared between CAD group and healthy group, and also between patients with different CAD clinical manifestations. The clinical indexes associated with CAD were also compared among the three genotypes. Results The distributive frequency of CC, CT, or TT genotype of CAD group and healthy group was different from one another, and the proportion of the TT genotype or the T allele was obviously higher in CAD group than in healthy group (P