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

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

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.

As an emergent attack,dyspnea can be caused by a variety of diseases,therefore,it is difficult and important as to the differential diagnosis in clinical practice.In the past,Physicians identified the cause of dyspnea primarily based on the clinical symptoms,signs and laboratory tests.However,dyspnea often misdiagnosed because the similarity and overlapping of clinical manifestations among many different diseases and lack of specificity for those conventional lab tests.Until recently,B-type natriuretic peptide (BNP) has emerged as a highly sensitive and specific index to identify heart failure,and has made it reality that rapid and accurate differential diagnosis of dyspnea in the lab.In the last couple of years,the differential diagnosis of dyspnea has been remarkably improved because of the increasing new test reagents,advanced devices and better assay techniques.The present article will review the laboratory differential diagnosis of dyspnea between cardiovascular and pulmonary diseases.

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.

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.

Since recent years, the incidence of precocious puberty has been rising. However, questions regarding its treatment and other conditions remain. This article reviews recent published papers with long-term outcome data and guidelines, and systemical introduction to identification of precocious puberty, different treatment options, therapeutic goals, and indications for different types of diseases, as well as adverse effects of drugs.

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.

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.

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 .