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

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.

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.

Pain is a common symptom in patients with terminal cancer and is the main factor that affects their quality of life. Morphine is commonly used for the treatment of acute and chronic pain, but the long-time application of morphine results in morphine tolerance and hyperalgesia, which restrict the clinical applications of the anesthetic. In this review, pertinent studies on morphine over recent years were summarized and analyzed, and the mechanism of morphine tolerance and hyperalgesia were discussed, specifically on the function of calcitonin gene-related peptide (CGRP) in clinical practice. The authors analyzed the relationship between the plastic changes in the nervous system and chronic morphine application in terms of CGRP up-regulation based on its molecular biology charac-teristics and distribution, the relationship between CGRP and chronic application of morphine, and between CGRP and hyperalgesia. The effect of CGRP up-regulation on the nociceptive system and the relationship between CGRP up-regulation and the formation of hy-peralgesia were also analyzed. We discussed the sensitized effect of CGRP up-regulation on the nociceptive system, which promotes morphine tolerance and hyperalgesia. This study provides a framework for treating morphine tolerance and can be used as a guide for further research on the topic.

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.

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.

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.

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.