This paper introduced the medical device classification in China and USA. Through the comparison between the two systems, several problems in Chinese classification system were exposed. To the end, some suggestions were proposed referred to the classification system of USA.
China ; Device Approval ; standards ; Equipment and Supplies ; classification ; United States

By the routine electron microscopy the ultrastructure of the epididymis of 10 rats is studied.Except the principal cells,there is no significant difference in the ultrastructure of the other cell types of the epididymal epithelium between segments.The principal cell shows the ultrastructural characteristics of secretion and absorption.However,the ultrastructural characteristics of the principal cells in the proximal epididymvs show more tendency to absorbent and that in the distal epididymis show more tendency to secretory.Further-more it is observed that some halo cells are surrounded by small cells which possess long processes.Some or a few number of clear cells in the caudal epididymis contain some crystaloid inclusions in their basal cytoplasm.The presence of the fenestrated capillary in the peritubular tissue is also found.The meaning of the ultrastructures mentioned above is discussed.

This article reviews the long-term outcome data and guidelines up to date, and systemically reviews the effect of ω-3 long-chain polyunsaturated fatty acid consumption, the major effective component in deep-sea fish oil, on metabolic syndrome, including improvements in abdominal obesity, insulin resistance, dyslipidemia, and hypertension, etc. Its adverse effects are also commented.

Objective To assess the efficiency and safety of the ureteroscope pneumatic lithotripsy (UBSL) and extracorporeal shock-wave lithotripsy (ESWL) for urinary tract calculi,and to guide the clinical practice.Methods Through searching the electronic bibliographic databases,including CNKI,VIPand WANFANG database,and searching published articles by hand to assemble the random clinical trial of ureteroscope pneumatic lithotripsy and extracorporeal shock-wave lithotripsy for urinary tract calculi.The retrieval articles were all Chinese,and the time was from January 1990 to September 2012.The retrieval results were systematically evaluated.Results Three randomized clinical trials involving 124 patients were analyzed.The results of meta-analysis demonstrated:the clearance rote at one time,the rote of efficiency,the rote of operation one more time all had statistically significant difference between two methods.The incidence of renal pain,and the incidence of hematourine had no significant difference between two methods.Conclusions Ureteroscope pneumatic lithotripsy and extracorporeal shock-wave lithotripsy for urinary tract calculi can improve the clearance rote and efficiency rote as well as decrease the rate of operation one more time.However,it can not reduce the rate of complication of the operation.

Animals ; Cells, Cultured ; Environmental Monitoring ; methods ; Humans ; Models, Animal ; Models, Biological ; Population Surveillance ; methods

Objective To assess whether lysyl oxidase like-2 (LOXL2) has a predictive or prognostic value in pulmonary fibrosis mice,and identify the relationship between LOXL2 and transforming growth factor (TGF)-β 1.Methods Male C57BL/6 mice (n=50) were randomly divided into the experimental group (n=40) and controls (n=10).Each mouse in the experimental group was induced by injecting bleomycin into trachea and mice were sacrificed on day 3,7,14 and 28,respectively.The concentrations of LOXL2,TGF-β 1 of the serum and lung homogenates were measured by enzyme-linked immunosorbent assay.One-factor analysis of variance (ANOVA) and nonparametric rank sum test was used for the comparisons between the two groups.Associations between these factors were analyzed by Spearman's test.Results ① The levels of serum and lung homogenates LOXL2 in the experimental group were obviously increased as compared to those in the controls [serum:(56±48) vs (25±23),P＜0.05;lung homogenates:(61±32) vs (22±16),P＜0.05].And in the experimental group,a positive correlation was found between the level of LOXL2 and the radiological index,the pathological score of inflammation and fibrosis.(Serum:r=0.435,0.533,0.335,P＜0.05;lung homogenates:0.675,0.736,0.526,P＜0.05).② The levels of lung homogenates TGF-β 1 in the experimental group were obviously increased as compared to those in the controls [(302±197) vs (64±16),P＜0.05].A positive correlation was found between the level of lung homogenates LOXL2 and the level of lung homogenates TGF-β1 (r=0.520,P＜0.05).Conclusion LOXL2 participates in the pathological process of bleomycin induced pulmonary fibrosis in mice.It predicts pulmonary fibrosis in the preclinical stage and is associated with increased risk for disease progression.The elevated levels of LOXL2 and TGF-β 1 may have some relationship.They both are involved in the disease progression of pulmonary fibrosis.

Objective: To develop an uncertainty evaluation method for the determination of Pb, Cd, As, Hg and Cu in Glycyrrhiza by ICP-MS.Methods: The contents of Pb, Cd, As, Hg and Cu in Glycyrrhiza were determined by ICP-MS.The determination process was analyzed to identify the source of uncertainty and the combined uncertainty was calculated.Results: The expanded uncertainty of Pb, Cd, As, Hg and Cu in Glycyrrhiza was 0.114 2, 0.046 2, 0.069 6, 0.029 2 and 1.061 8 mg·kg-1, respectively.Conclusion: The more reliable measurement results can be obtained when the measure is optimized by magnitude analysis of all standard uncertainty.The method is applicable in the uncertainty evaluation of the determination of heavy metals in Glycyrrhiza.It provides important reference for such uncertainty evaluation.

Benign familial hematuria,also called thin basement membrane nephropathy,is caused by a heterozygous mutation in the COL4A3 or COL4A4 gene.The prognosis of the patients with benign familial hematuria,who present isolated hematuria without associated with proteinuria and normal renal function,is good in childhood.However,the prognosis of part of the patients with benign familial hematuria,who appear proteinuria,hypertension,chronic renal failure and end-stage kidney disease,is poor in adulthood.Therefore,the patients with benign familial hematuria should be carried on the long-term follow-up,and may be reviewed every 1-2 years for hypertension,proteinuria,and renal impairment.Treatment for benign familial hematuria should include an angiotensin converting enzyme inhibitor to delay the onset of renal failure.

An ECG Data Processing System is designed to provide online help for cardiac disease diagnosis. Except for the object-oriented programming technology, this processing system adopts advanced techniques in signal processing area such as Wavelet Transform 、Neural Networks and Genetic Algorithm .

In recent years,the studies have shown that the incidence of type 1 diabetes(T1D)is closely related to the infection of human enteroviruses,particularly Coxsackie B Viruses(CVB).On one hand.the researches show that vires infection can induce T1D,and it is associated with the viral amount.the viral strain,and the host microenvironment.On the other hand,the studies confirm that viral infection also can inhibit the incidence of T1D.In terms of the factors,which is related to the vires infection-inducing.T1D.and the possible mechanism of the virus infection-inhibiting-T1D,the article aims to explore the relationship between CVB infection and the incidence of T1D based on referring to foreign literatures in recent years.