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

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.

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.

Endogenous NO and CO have been identified in the recent years as signaling molecules and act as the messengers in the body . Both of them have identical characteristics in the mechanism of production and action. Many evidences indicated that NO and CO play important roles in physiological and pathophysiological processes in the prostate. This review highlights the current ideas on localization and function of them in the prostate. We also discussed the relationship between the gaseous messengers and the prostatic diseases.

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.

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.

Objective:To investigate the application of three-dimensional visualization technology in preoperative assessment of hilar cholangiocarcinoma. Methods:Thirty-eight patients with hilar cholangiocarcinoma who underwent surgery from March 2014 to April 2016 were enrolled in the retrospective study. Among the cases, an observational group of 18 patients had preoperative three-dimensional visualization surgical planning, while a control group of 20 patients did not have the visualization surgical plan. The preoperative diagnostic results were analyzed with the actual intraoperative findings. Related surgicall indicators between the two groups were compared. Results:No significant difference in the accuracy rates of longitudinal and vertical infiltration of cholangiocarcinoma between was observed the observational group and control group. While the vascular and ductal branching pattern of all patients are consistent with intraoperative findings, the coincidence rate was higher in the observational group than that in the control group (100%vs. 70%, P<0.05). The estimated liver volumes were also exactly consistent with the actual liver volume (r=0.986, P<0.001). In comparison with the control group, the average intraoperative blood loss and operative time of the observational group were significantly lower. However, the potential curative resection between the two groups exhibited no significant difference. Conclusion:Three-dimensional visualization technology can accurately complete the preoperative evaluation of hilarcholangiocarcinoma.

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.