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OBJECTIVE@#To modify the monitoring process and means of adverse events diagnostic reagents,improve the quantity and quality of adverse events reported ,and reduce the workload of regulatory authorities,eventually ensure the safety and effectiveness of diagnostic reagents.@*METHODS@#The pre-filtering risk assessment system based on BP neural network was used to evaluate the adverse events of diagnostic reagents.According to the evaluation results,the administrative supervision departments took corresponding countermeasures.@*RESULTS@#The BP neural network learned the historical data,and the risk evaluation results of the adverse events were basically consistent with the expert group.@*CONCLUSIONS@#BP neural network can be used to evaluate the risk of adverse events and achieve risk signal aggregation of adverse events.
Subject(s)
Indicators and Reagents , Neural Networks, Computer , Risk AssessmentABSTRACT
OBJECTIVE@#To improve the monitoring mode of diagnostic medical devices adverse events.@*METHODS@#By discussing the objective laws of the characteristics, performances and causes of diagnostic medical devices adverse events, the key points of monitoring work were clarified.@*RESULTS@#The whole-process cloud monitoring mode for adverse events of diagnostic medical devices was constructed based on risk management, and the working procedures for the four core links i.e. collection and report, investigation, analysis and evaluation, and controlling were formulated.@*CONCLUSIONS@#The whole-process cloud monitoring mode contributes to improve the monitoring level and efficiency of diagnostic medical devices adverse events in China, so as to strengthen risk control capability and ensure the public can use medical devices safely.
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China , Equipment and Supplies , Reagent Kits, Diagnostic , Risk ManagementABSTRACT
Objective To investigate the association between serum 25(OH)D3 and high sensitive C -reac-tive protein (hs-CRP),tumor necrosis factor -alpha (TNF-α),interleukin-6 (IL-6) inflammatory markers in non-obese patients with type 2 diabetes mellitus (T2DM).Methods From June 2015 to September 2015,in this cross-sectional study,120 non-obese patients with T2DM(female in 58 cases,male in 62 cases) in Taiyuan Central Hospital were selected as T2DM group,and 120 non-obese patients with T2DM and 96 healthy subjects ( control group) were recruited.The serum concentrations of glucose,HbA1c,insulin,25( OH) D3 and inflammatory markers including TNF-α,IL-6 and hs-CRP were measured.A homeostatic model of insulin resistance (HOMA-IR) was also evaluated.The clinical and biochemical characteristics of T 2DM were observed in the group of vitamin D deficien-cy group,vitamin D insufficiency group and vitamin D normal group.And the relativities were analyzed between it with hs-CRP,TNF-α,IL-6,HOMA-IR,INF,FBG,BMI,WHR,and so on.The relativities were observed between 25(OH)D3 with all the factors.Results The mean serum concentration of 25(OH)D3 in the non -obese T2DM group was (10.65 ±3.55)ng/mL,which was significantly lower than (18.44 ±5.21)ng/mL in the normal control group (t＝-6.84,P ＝0.012).The levels of serum TNF -αand IL -6 in the T2DM group were (15.51 ± 4.87)ng/L and (18.12 ±4.13) ng/L,respectively,which were significantly higher than those in the control group [(8.99 ±2.54)ng/L,(8.89 ±2.07)ng/L](t＝7.95,10.04,P＝0.017,0.007).The proportions of deficiency,insufficiency and normal of vitamin D in T2DM patients were 60.83%,31.67%and 7.50%,respectively .The levels of TNF-αand IL-6 in the serum 25(OH) D3 deficiency group were significantly higher than those in the normal 25(OH)D3 group [(17.93 ±4.94)ng/L vs.(10.30 ±4.52)ng/L,F＝6.897,P＝0.026;(20.14 ±4.99)ng/L vs. (16.39 ±5.06)ng/L,F＝10.589,P＝0.017].There was a significant correlation between serum 25(OH)D3 and HOMA-IR(r＝-0.041;P＝0.030),TNF-α(r＝-0.229;P＝0.040) and IL -6 levels (r＝-0.299;P＝0.032),but there was no significant correlation with inflammatory factor hs -CRP and fasting blood glucose. Conclusion Vitamin D deficiency is common in patients with T2DM,and systemic chronic inflammation may also play an important role in the pathogenesis of T 2DM.This study shows that vitamin D may play an important role in the pathogenesis of insulin resistance and chronic systemic inflammatory response,an important pathogenesis of T2DM.
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<p><b>OBJECTIVES</b>To increase the number and quality of adverse events reported in medical devices, dealing with adverse events that have occurred in time, preventing the occurrence of adverse events, and ensuring the safety of device use.</p><p><b>METHODS</b>Based on risk management methods, through a comprehensive analysis of risk of adverse events, scientifically assessing the risk level and completing the classification of adverse events. Administrative supervision departments take corresponding supervision measures according to the classification results.</p><p><b>RESULTS</b>Building a classification monitoring model of medical device adverse events based on risk management.</p><p><b>CONCLUSIONS</b>The classification of adverse events will help the administrative supervision department to focus on the work, reduce the workload, and improve the efficiency of supervision.</p>
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Equipment and Supplies , Classification , Risk ManagementABSTRACT
OBJECTIVES@#To solve the problem that medical device adverse event monitoring entities perform their duties inadequately, to provide reference for perfecting the post-market surveillance system.@*METHODS@#Through theoretical and empirical research, the paper explored the ways to improve the performance of monitoring the adverse events of medical devices.@*RESULTS@#The survey found that the number of adverse event monitoring reports was few and the quality of report was poor. The root causes included lack of motivation of monitoring entities, the imperfect monitoring system, and the monitoring capability failure, etc.@*CONCLUSIONS@#The methods such as strengthening the main body responsibility consciousness, establishing evaluation system and accountability system, building social work network, are beneficial to the adverse events monitoring.
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Equipment Safety , Equipment and Supplies , Product Surveillance, Postmarketing , Surveys and QuestionnairesABSTRACT
OBJECTIVE:To provide reference for improving the quality of pharmaceutical talents training.METHODS:The requirements and equipment status of pharmaceutical talents in China,the status quo of its pharmacy and the status quo of pharmaceutical higher education were analyzed.The pathway of pharmaceutical talents training under the cooperative vision of "medicine,education and research" was explored.RESULTS:Through the integration of industry,our school had constructed a platform of collaborative education of "politics,production,medicine,teaching and research";paid attention to quality,the cultivation path was constructed by establishing "management,teachers,practice and evaluation" guarantee mechanism from the implementation of two-level management,strengthening the construction of teaching staff,strengthening the construction of practical conditions and strengthening the quality evaluation system.CONCLUSIONS:Our college constructs a replicable innovation model for pharmacy talents training.The quality of pharmaceutical talents training is constantly improving,which provides the necessary guarantee for the implementation of "healthy China" strategy.
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AIM:To investigate the mechanisms by which bilirubin inhibits acute lung injury(ALI).METHODS: 30 female Wistar rats were divided into normal group,ALI group and bilirubin treatment group.ALI was induced by intravenous injection of LPS.The contents of OH-,H2O2 and O——?-2 in the lung as well as the expression of caspase-3 in the lungs were investigated.RESULTS:(1) The contents of OH-,H2O2 and O——?-2 in the lung homogenate and the expression of caspase-3 in the lungs in ALI group increased compared with those in normal group(P