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This study introduced the current testing content and standards of ECG medical electronic instruments, combined with actual clinical needs, and discussed the comprehensive verification and evaluation protocol for ECG medical electronic instruments. The protocol mainly includes hardware performance testing, automatic diagnostic function testing and clinical application evaluation. The protocol emphasizes the clinical practicality and importance of the comprehensive verification and evaluation program, and provides a reference for the institutions involved in the program.
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Electrocardiography , Electronics, Medical , Reference StandardsABSTRACT
This study established a rapid ECG screening system through the application of wearable ECG equipment. The closed-loop and self-service process of ECG inspection, data collection, transmission and printing have been realized. The new rapid ECG screening system docking with HIS system in the hospital, forming a new intelligent mode of rapid ECG screening. This paper introduces the design of the intelligent mode of ECG rapid screening from the aspects of hardware, software, wearable ECG examination equipment, and briefly describes its implementation path and technical scheme. With the rapid ECG screening system, human power can be saved, the timeliness of ECG examination can be enhanced. The level of ECG diagnosis in the basic units can be improved through building a multiple medical centers which is rely on the cloud platform.
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Humans , Electrocardiography , Equipment Design , Research , Software , Wearable Electronic DevicesABSTRACT
It is significant to establish scene ECG database which improves the automatic diagnostic function of electrocardiograph under different application scenarios. We built the ECG database in different scene according to the hospital level (grade 3, grade 2, grade 1) and clinical environment (intensive care and acute wards, outpatient clinics and general wards). Sample size was obtained according to the incidence of various ECG diagnoses. The database covers ECG signal, ECG waveform, ECG characteristic values, ECG diagnostic results by experts and clinical information of patients etc. It not only provides important reference for electrocardiograph manufacturers to evaluate and test the parameters of automatic diagnosis under different clinical scene, but also provides valuable scientific research and teaching resources for medical workers.
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Humans , Databases, Factual , ElectrocardiographyABSTRACT
OBJECTIVE@#To train convolutional networks using multi-lead ECG data and classify new data accurately to provide reliable information for clinical diagnosis.@*METHODS@#The data were pre-processed with a bandpass filter, and signal framing was adopted to adjust the data of different lengths to the same size to facilitate network training and prediction. The dataset was expanded by increasing the sample size to improve the detection rate of abnormal samples. A depth-wise separable convolution structure was used for more specific feature extraction for different channels of twelve-lead ECG data. We trained the two classifiers for each label using the improved DenseNet to classify different labels.@*RESULTS@#The propose model showed an accuracy of 80.13% for distinguishing between normal and abnormal ECG with a sensitivity of 80.38%, a specificity of 79.91% and a F1 score of 79.35%.@*CONCLUSIONS@#The model proposed herein can rapidly and effectively classify the ECG data. The running time of a single dataset on GPU is 33.59 ms, which allows real-time prediction to meet the clinical requirements.
Subject(s)
Humans , Algorithms , Arrhythmias, Cardiac , Diagnosis , Databases as Topic , Electrocardiography , Classification , Methods , Neural Networks, Computer , Sensitivity and SpecificityABSTRACT
Objective: To compare the anti-inflammatory effect of Fraxini Cortex pieces between integrated production process and traditional processing method. Methods: The model of rat paw swelling induced by carrageenan was used to study the anti-inflammatory and swelling reliving effects of water extracts of Cortex Fraxini with different methods. The main chemical components of the 2 kinds of Cortex Fraxini herbal pieces were determined by high performance liquid phase. Results: Compared with the blank group, the water extracts of the 2 kinds of Cortex Fraxini could reduce the swelling of the rats and improve the various indicators of inflammation. However, the anti-inflammatory and swelling reliving effects of the integrated processing of Cortex Fraxini were more significant. The contents of 4 main active ingredients of esculine, fraxin, aesculetin and fraxetin in the integrated processing of Cortex Fraxini were higher than that of the traditionally processed Cortex Fraxini. The total amount of 4 kinds of coumarins in the integrated Cortex Fraxini was about 1.5 times that of the traditionally processed water extract of Cortex Fraxini. Conclusion: The integrated processing and traditional processing of Cortex Fraxini have similar effects on anti-inflammatory effects, and have the superiority of reducing the loss of active ingredients, which is worthy of popularization and application.
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Objective:To design and develop a formula of solid lipid nanoparticles containing the total saponins of Paris Polyphylla using a quality by design ( QbD) method. Methods:The target product profile of solid lipid nanoparticles was determined according to the properties of dosage form and administration. The risk assessment was carried out according to the theoretical knowledge and experi-ence to define the critical variables influencing the properties of solid lipid nanoparticles. Firstly, Plackett-Burman test was used to screen out the key variables significantly affecting the pharmacological properties of solid lipid nanoparticles, and then the Box-Behnken effect surface method was use to further optimize the selected variables. The physicochemical properties of solid lipid nanoparticles con-taining the total saponins of Paris Polyphylla were studied, such as the particle size distribution, polydispersity index ( PdI) , zeta po-tential, morphology and in vitro drug release behavior. Results: The optimum formula and preparation process were as follows: the concentration of glycerol monostearate was 5. 5％, the concentration of soybean phospholipid was 8. 0％, the number of homogenization was 6 times, the concentration of drug was 5. 0％, the surfactant was Tween 80, the mass pressure was 600 bar and the homogeneous temperature was 65℃. The mean particle size, PdI and zeta potential of the optimized solid lipid nanoparticles was (116. 5 ± 32. 1) nm, (0. 198 ± 0. 018) and ( -23. 6. 5 ± 0. 9) mV, respectively. Transmission electron microscopy showed that the solid lipid nanop-articles were spherical. The results of in vitro release showed a sustained release property, and the cumulative release was 63. 5％ in 24 h. Conclusion:It is feasible to design and develop solid lipid nanoparticles containing the total saponins of Paris Polyphylla by using the QbD method, which can ensure the product quality to meet the requirements.
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Objective: To prepare the total saponins from Paris Polyphylla self-microemulsifying drug delivery system (SMEDDSs) and its solid fied granule, and investigate the in vitro release.Methods: The solubility of the total saponins from Paris Polyphylla in different excipients was investigated.The pseudo-ternary phase diagram composed of different oil phase, emulsifier and co-emulsifier was used to define the self-emulsifying area.The optimal formula of the total saponins from Paris Polyphylla SMEDDSs was prepared into granule.The appearance, morphology, particle size distribution, PdI and zeta potential of the microemulsion and the granule were determined by a dilution method.The drug release profile of the total saponins from Paris Polyphylla SMEDDSs and SMEDDSs granule were compared.Results: The optimal formula of SMEDDSs was as follows: propylene glycol monocaprylate as the oil phase, Tween-80 as the emulsifier and propylene glycol as the co-emulsifier with the optimum ratio of 7.0∶1.5∶1.5.After diluted by water,the total saponins from Paris PolyphyllaSMEDDSs and the granule formed a clear and transparent microemulsion solution with small homogeneous spheres as seen under a transmission electron microscope.The average particle size of the total saponins from Paris Polyphylla SMEDDSs and the granule was (58.6±16.4) nm and (68.1±12.1) nm with PdI of (0.183±0.04) and (0.209±0.05), respectively, and the zeta potential was (-20.2±1.9) mV and (-18.9±1.5) mV, respectively.The results of transmission electron microscopy showed the microemulsion was round, regular and spherical distribution.The in vitro release profile indicated that the accumulated release of the total saponins from Paris Polyphylla SMEDDSs and SMEDDSs granule was more than 85% in 45 min.Conclusion: The self-microemulsifying granule can significantly improve the in vitro dissolution rate of the total saponins from Paris Polyphylla, and the preparation process is simple and feasible.
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<p><b>OBJECTIVE</b>To explore the association between urinary microalbumin-to-creatinine ratio (ACR) and brachial-ankle pulse wave velocity (baPWV) in hypertensive patients.</p><p><b>METHODS</b>A total of 877 primary hypertension patients were enrolled in this trial from September 2009 to December 2012, and were randomly recruited and patients were divided into normal ACR group (ACR < 30 mg/g, n = 723), micro-albuminuria group (30 mg/g ≤ ACR < 300 mg/g, n = 136) and macro-albuminuria group (ACR ≥ 300 mg/g, n = 18). baPWV was measure by automatic pulse wave velocity measuring system.</p><p><b>RESULTS</b>The baPWV values in patients of micro-albuminuria group and macro-albuminuria group were significantly higher than in the normal ACR group (all P < 0.05). The baPWV value of macro-albuminuria group was significantly higher than in the micro-albuminuria group (P < 0.05). Linear correlation analysis revealed that ACR was positively correlated with baPWV (r = 0.413, P < 0.01). Multiple linear regression analysis showed that ACR independently correlated with baPWV in patients with primary hypertension (β = 0.29, R(2) = 0.112, P < 0.01) after adjusting for age, sex, body mass index, systolic blood pressure, diastolic blood pressure, blood glucose, total cholesterol, low density lipoprotein, high density lipoprotein and triglyceride. Using ACR < 30 mg/g and ACR ≥ 30 mg/g as dichotomous variable, binary logistic regression analysis showed that ACR ≥ 30 mg/g was also a risk factor of the ascending baPWV in primary hypertension patients (OR: 1.73, 95% CI: 1.62-2.98) after adjusting the traditional cardiovascular risk factors.</p><p><b>CONCLUSION</b>ACR is positively correlated to baPWV in primary hypertension patients, and the ascending baPWV is a risk factor of early renal dysfunction in primary hypertension patients.</p>
Subject(s)
Humans , Albuminuria , Ankle , Ankle Brachial Index , Blood Flow Velocity , Blood Pressure , Body Mass Index , Cardiovascular Diseases , Creatinine , Urine , Essential Hypertension , Hypertension , Urine , Pulsatile Flow , Pulse Wave Analysis , Regression Analysis , Risk FactorsABSTRACT
Objective To assess the value of exercise treadmill testing (bruce protocol) in diagnosing early atherosclerotic lesions of the lower limb. Methods Between March and September 2008, 173 outpatients with high risks of peripheral arterial disease (PAD) were enrolled randomly from the cardiology clinic of Chinese PLA General Hospital. The patients were subjected to exercise treadmill testing (Bruce protocol) and ankle-brachial index (ABI) determination, as well as lower limb artery ultrasonography within one week. Using ultrasonic findings as diagnostic criteria, the diagnostic sensitivity, specificity, positive likelihood ratio and negative likelihood ratio of exercise treadmill testing for early atherosclerotic lesions of the lower limb were analyzed, and the diagnostic value of exercise treadmill testing was assessed using the ROC curve. Results After exercise, ABI decrement (R value) increased in subjects with high risks for PAD with atherosclerotic lesions of the lower limb aggravating. Using the presence of large atherosclerotic plaques (area > 20 mm2 ), atherosclerotic plaques and atherosclerotic lesions in lower limb arteries as positive diagnostic criteria, the area under curve of ROC was 0. 80 (95% CI: 0.72-0.88), 0.78 (95% CI: 0.71-0.85) and 0. 60 (95% CI: 0.44-0.76), respectively. Using the presence of large atherosclerotic plaques in lower extremities as positive diagnosis, R value was 0.80, with a sensitivity of 54. 0%, a specificity of 96. 7%, a LR+ of 16. 4, and a LR- of 0. 58, meanwhile, R value was 0. 85, with a sensitivity of 70.0%, a specificity of 91.9%, a LR + of 8.64, and a LR- of 0.33. Conclusions Exercise treadmill testing (Bruce protocol) in combination with ABI determination is a safe, accurate, objective tool for detecting early atherosclerotic lesions of the lower limb. Immediately after exercise, 0.85 is the cut-off R value appropriate for diagnosing large atherosclerotic plaques of the lower limb (area > 20 mm2).
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Objective To explore the mechanism of preventive effect of Chinese medicine with Replenishing kidney and invigorating Qi on osteoarthritis. Methods 72 male Long-eared white rabbits aged 4 months were randomly divided into six groups, A group (blank control group), B group (model group), C group (traditional Chinese medicine high-dose prevention group), D group (Chinese herbal medicine with medium-dose prevention group), E group (Chinese herbal medicine with low-dose prevention group), F group (glucose-amino acid hydrochloride capsules prevention group).All the animals apart from A group were established osteoarthritis model by immobilizing knee joint with plaster cast for 6 weeks. In the same time of immobilization, traditional Chinese medicine and glucose-amino acid hydrochloride capsules were given to C, D, E and F group for 4 weeks. Physiological saline was given to B group. After 6 weeks of modeling, synovial fluid was extracted and the changes of TNF-α in it were analyzed by ELISA. Results Articular cartilage degeneration of B group was most obviously compared with C, D, E and F group. There was a significant difference of TNF-α level in comparison of A and B group (P＜0.05), B and C, D, E and F group (P＜0.05), and among C, D and E group. Conclusion Chinese medicine with replenishing kidney and invigorating Qi can prevent osteoarthritis by reducing TNF-α level in synovial fluid, enhancing cartilage cell metabolism, and slowing down cartilage degradation.
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Objective To investigate the clinical characteristics of the results of coronary artery CT angiography and coronary artery angiography in 36 patients with probable positive results of treadmill exercise test(TET).Methods Thirty-six patients due to chest pain received 1ET and coronary artery CT angiography and coronary artery angiography in 2 weeks after admission.The coronary plaques were categorized as noncalcified and calcified plaque on CTA images.Results In 36 patients with probable positive results of TET.23 patients were confirmed as coronary artery disease by coronary artery angiography,and the other 13patients had normal coronary artery.Of 23 coronary artery disease patients,9 patients were presented as onevessel disease,5 patients were presented as two-vessel disease,and 9 patients were presented as three-vessel disease,29 non-calcified plaques and 23 calcified plaques were demeted On CTA.Conclusion TET was useful in confirming the diagnosis of coronary artery disease.The characteristics of the coronary artery plaque is correlated with probable positive results of TET.