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

Traditionally it has been widely accepted that our genes together with adult lifestyle factors determine our risk of developing noncommunicable diseases such as type 2 diabetes mellitus ,cardiovascular disease and obesity in lat-er life.Currently, there is substantial evidence that the early life environment plays a key role in determining our suscepti -ble to such diseases in later life .As an increased focus on the understanding of central insulin resistance , central nerve sys-tem plays an extremely important role in regulating the peripheral glucose homeostasis .Substantial studies have indicated that it may be regulated by epigenetic mechanisms .Epigenetics can be defined as the study of heritable changes in gene ex-pression that do not involve alterations in the DNA sequence .Epigenetic processes play a central role in regulating tissue specific gene expression and hence alterations in these processes can induce long -term changes in gene expression and me-tabolism which persist throughout the lifecourse .This review will focus on the epigenetic machanisms of central neuroregula-tion between early life environment and glucose metabolism in adulthood .

For the preparation of implementing IEC 60601-1 Ed. 3.1 in advance, this paper analyzes the main difference between IEC 60601-1 Ed. 3.1 and GB 9706.1-2007, and discusses the possible influence to medical device designing and testing.
Equipment Design ; standards ; Equipment and Supplies ; standards

Objective To summarize the characteristics of liver injury due to brucellosis to provide reference for clinical diagnosis and treatment of brucellosis.Methods A total of 359 patients with brucellosis at the First affiliated Hospital of Xinjiang Medical University during 2010-2016 were enrolled, among them 113 (31.5%) developed liver injury.Alanine aminotransferase (ALT), aspartate transaminase (AST), γ-glutamyl transferase (γ-GT), serum albumin (Alb), alkaline phosphatase (ALP) and total bilirubin (TBil) were obtained before and after treatment.Ultrasound of upper abdomen was performed to observe the morphological changes of liver and spleen at admission.The routine blood test, erythrocyte sedimentation rate, C-reactive protein and other laboratory examinations were also performed.The data of patients before and after therapy were analyzed by t test.Results A total of 113 patients were included in this study.Eighty-eight (77.9%) were male.The mean age was (43.2±15.8) years old, among whom 81(71.7%) cases were between 31 and 60 years old.Seventy-one cases (62.8%) was in acute phase, and 42(37.2%) in chronic phase.The Han, Uighurs and Kazak nationalities accounted for 41.6%(47 patients),31.0%(35 patients) and 18.6%(21 cases), respectively.At admission, ALT level was (98.54±59.32) U/L before treatment, and decreased to (38.18±17.13) U/L after treatment, with statistically significant difference (t=6.627, P<0.05).AST levels before and after treatment were (93.17±59.19) U/L and (30.67±12.56) U/L, respectively, with significant difference (t=8.042, P<0.05).γ-GT levels before and after treatment were (162.27±48.19) U/L and (69.53±32.17) U/L, respectively, with statistically significant difference (t=8.271, P<0.05).Alb was (32.31±5.29) g/L before therapy, and increased to (38.00±4.27) g/L after therapy, with statistically significant difference (t=4.429, P<0.05).Conclusions Liver injury is common in patients with brucellosis.Elevation of transaminase is usually mild to moderate, accompanied by reduced ALB.For brucellosis patients with liver injury, antimicrobial treatment combined with liver protecting drugs could improve liver function effectively, and even within the normal range.

Child ; Humans ; Middle Ear Ventilation ; Otitis Media ; Otitis Media with Effusion ; surgery ; Recurrence

OBJECTIVE: To investigate the pharmacokinetics of levofloxacin in rats brain tissues and blood. METHODS: Brain tissues and blood were sampled by microdialysis simultaneously. The concentrations of levofloxacin in both blood and brain tissues were measured by high performance liquid chromatography. The concentration-time data was analyzed by WinNonlin software. RESULTS: The maximum concentrations of free levofloxacin in blood and brain tissues were reached at 10 min and 20 min, respectively, then both continuously decreased. The concentration of free levofloxacin in blood was higher than that in brain tissues in the first 4h, then returned to similar level. The area under the curve (AUC) of free levofloxacin was (21.17±7.83) μg · h · mL-1 in blood and (7.00±2.65) μg · h · mL-1 in brain tissues. CONCLUSION: Microdialysis with reversed phase high performance liquid chromatography established in this study can be used to determine the pharmacokinetics of levofloxacin in brain tissues and blood.

This paper discussed some specific issues in the preparation of medical device standards. On the basis of GB/T 1.1-2009, some preliminary suggestions were accordingly proposed.
Equipment and Supplies ; standards ; Quality Control

Conclude some specific problems in drafting the industry standards of medical devices which are adopted to international standards. Provide relevant suggestion and recommendation in accordance to GB/T 1.1-2009 and GB/T 20000.2-2009, some preliminary suggestions were accordingly proposed.
Device Approval ; standards ; International Cooperation

Objective To explore effects of endoscopic subtotal thyroidectomy on nodular goiter and its clinical significance.Methods From Jun.2004 to Dec.2009,72 patients with nodular goiter underwent endoscopic subtotal thyroidectomy in Southwest Hospital.Of the 72 cases,22 cases had left-side nodule,31 cases had right-side nodule and 19 cases had bilateral nodules.Single thyroid nodule occurred in 41 cases and multiple nodules in 31 cases.The total number of nodules was 113.The average nodule size was 2.8 cm(ranging from 0.4 to 6.3 cm).Results Of the 72 cases,19 patients underwent bilateral subtotal thyroidectomy and the mean operative time was 97 min(ranging from 80 to 150 min).53 patients underwent unilateral subtotal thyroidectomy and the mean operative time was 65 min(ranging from 25 to 120 min).The mean intraoperative blood loss was 45 ml (ranging from 5 to 120 ml).Of the 72 cases,68 cases were given cervical plexus block regional anesthesia and among them 66 cases(97%)acquired good anesthesia.Temporary hoarse voice occurred in 2 cases and postoperative bleeding occurred in the subcutaneous tunnel of breast in 2 cases.Patients were followed up from 3 to 5years and the cosmetic result was satisfactory.The postoperative review half year later showed that unilateral nodule recurred in 1 case and the recurrence rate was 1.4%.Conclusions Endoscopic subtotal thyroidectomy through anterior chest wall or breast approach under local anesthesia is a safe and effective treatment in nodular goiter.In the process of dissecting thyroid,blunt maneuver and proper use of ultrasonic knife instead of clamping thyroid nodules directly are recommended in order to reduce intraoperative blood loss and enhance safe practice.

Objective Maternal dietary modifications determine the susceptibility to metabolic diseases in adult life.However, whether maternal high-fat diet can induce early-onset aberrant glucose and lipid metabolism in offspring mice is less understood .Materials and Methods We examined the effects of feeding the pregnant mice with either a high fat diet or nornal chow diet throughout pregnancy and lactation on the glucose and lipid metabolism in their offsprings . Some glucose and lipid metabolism biomarkers and hepatic histology were analyzed .Results At weaning, for males of dams fed high-fat diet , they had heavier body weight , the blood glucose levels were significantly higher at 30 min ( P<0.001) and 60 min (P<0.01) after intraperitoneal glucose administration , and the AUC was also significantly larger (P=0.0016) and HOMA-IR was higher(P<0.05).For females of dams fed high-fat diet, they had higher blood glucose levels at 30 min ( P<0.01 ) after intraperitoneal glucose administration .No significant differences were observed of AUC and HOMA-IR.Both males and females of dams fed high-fat diet had elevated total cholesterol levels ( P<0.0001 and P=0.0004, respectively).Triglyceride levels showed no significant differences between the two groups of males and females . The offsprings of high-fat diet group indicated hepatic steatosis and there were no differences between males and females . Conclusions Maternal high fat diet during pregnancy and lactation can induce early -onset aberrant glucose and lipid me-tabolism in offspring mice , and the male offsprings are more prone to metabolic changes , such as obesity , glucose intoler-ance and insulin resistance .