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

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.

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.

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.

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.

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.

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.

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.

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.

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.