Splenic radiofrequency ablation (RFA) is a safe, effective and minimally-invasive approach for the management of hypersplenism due to portal hypertension. After RFA, the remnant volume of the spleen will be decreased, the hypersplenism can be corrected, and the hepatic artery blood flow can be significantly increased with resultant marked improvement of liver function; in addition, hypertrophy and regeneration of the liver can be induced. However, many factors can affect the therapeutic results of RFA,therefore, further studies are necessary to clarify the underlying mechanisms.

Each WHO CC forms part of an inter-institutional collaborative network set up by WHO in support of its pro-gramme at the country,inter-country,regional,interregional and global levels.WHO Collaborating Centre for Diagnostics and Laboratory Support provide quality assurance programs for diagnostic technologies and diagnostic products on infectious disease for WHO and other international organization and act as a source of technical information for WHO,staff of national regulatory authorities and manufacturers.To promote the development of global health.It is very important for our country to establish the cooperation center of this function,to enhance the ability of our country’s in vitro diagnostic products in-spection,and to promote the development of the in vitro diagnostics industry.

This paper analyses overall situation of the national quality inspection for medical devices in recent 13 years. The statistics cover the inspected varieties, sampling quantity and quality status. The achievements and suggestions are provided, which are helpful for future work.
Equipment and Supplies ; standards ; Humans

Objective To investigate the effects of mTOR/S6K1 signaling pathway on the development of insulin resistantce. Methods 20 male C57BL/6 mice were divided into normal diet group (NC) and high fat diet group (HF).HF mice were fed with high fat diet for 14 weeks and insulin resistance was confirmed in all mice. We observed the morphology of pancreatic islet by HE staining. Serum insulin concentration was also evaluated by ELISA. Northern blot, Western blot and immunofluorescence were performed to detect mTOR and S6K1 mRNA and protein expression in skeletal muscle. Results As compared with NC group,HF group showed that the body weight and fasting serum insulin level were increased by 21.99%(P＜0.05) and 181.82%(P＜0.01) respectively;the area of pancreatic islet was significantly increased;glucose tolerance was impaired;expressions of mTOR mRNA (125.61±10.43 vs 100.00, P＜0.05) and protein (137.41±7.86 vs 100.00, P＜0.01) were significantly increased. And we also found an significant increase in total S6K1 mRNA (154.98±16.26 vs 100.00, P＜0.01) and protein (137.36±3.08 vs 100.00,P＜0.01) as well as pS6K1 protein (390.15±69.62 vs 50.59±16.65,P＜0.01)expression in HF group as compared with NC group.Conclusions mTOR/S6K1 signaling pathway plays an important role in the development of higt fat diet induced insulin resistance.

Objective To observe the extent of bone coagulation and the thermal field distribution created in ablating the swine vertebral bodies in vitro with multi-polar radiofrequency and to discuss the correlation between the electrode position in the vertebral body and the safety of the spinal cord as well as the soft tissue injury around the vertebral body. Methods Thirty fresh adult porcine vertebrae, were randomly and equally divided into two groups. The depth of the electrode needle was 10 mm or 20 mm. When the ablation process reached to a stable state, the temperature at the scheduled spots was estimated. Twenty minutes after ablation, the vertebral body was cut along the electrode needle plane and also along the plane perpendicular to the electrode needle to observe the extent of bone coagulation. Results The temperature at the scheduled spots reached to a stable state in 3.5 minutes. The more close to the electrode the spot was,the more quickly the temperature rose. No soft tissue injury around the vertebral body was observed in both groups and no spinal cord injury occurred when the electrode needle was 10 mm or 20 mm deep in the vertebral body. Conclusion In treating vertebral metastases, the radiofrequency ablation is safe and reliable if the posterior wall of the vertebral body remains intact.

Objective To study the relationship between IGF-1, IGFBP-3 and prostatic volume (PV) by examining the levels of insulin and insulin-like growth fator-1 (IGF-1) and insulin-like growth factor binding protein-3 ( IGFBP-3 ) and other indicators in patients with impaired glucose regulation and benign prostate hypertrophy. Methods According to 75 g oral glucose tolerance test (OGTT) results, 109 BPH patients aged over 50 years were divided into three groups: normal glucose tolerance (NGT) group (n = 56), impaired fasting glucose (IFG) group (n = 14), impaired glucose tolerance (IGT group, n = 39). The biochemical indicators and postatic hyperplasia related factors and IGF-1, GFBP-3 were measured. Results There were no statistical differences between the three groups in terms of blood lipids, homocysteine, urinary inhibition C, fasting insulin (FINS), glycosylated hemoglobin, IGF-1 and IGFBP-3 (P > 0.05). There were no significant differences between the groups in terms of PV, prostate specific antigen, the quality of life score and the international prostate symptom score (P > 0.05). Fasting plasma glucose and insulin resistance index (HOMA IR) were higher in IFG group than NGT group (P′ < 0.017) and IGT group (P′ < 0.017). 2-hour plasma glucose and 2-hour insulin were higher in IGT group than NGT group (P′ < 0.017) and IFG group (P′ < 0.017). PV was positively correlated with FINS but not correlated with IGF-1, IGFBP- 3 by multiple multiple step wise regression analysis. Conclusion Oyperinsulinemia is a risk factor in the development of BPH with IGR, and IGF-1 and IGFBP-3 are not associated with BPH risk. Further investigation is needed to elucidate the role of the IGF-1 and IGFBP-3 in BPH.

ObjectiveTo investigate the technical success rate and outcome of transjugular intrahepatic portosystemic shunt (TIPS) in preventing esophageal variceal rebleeding in patients with portal vein thrombosis (PVT) after splenectomy. MethodsA retrospective analysis was performed for the clinical data of 46 patients with PVT after splenectomy who were admitted to Shandong Provincial Hospital from December 2009 to January 2017 and underwent TIPS to prevent esophageal variceal rebleeding. According to the success or failure of TIPS, the patients were divided into TIPS success group with 38 patients and TIPS failure group with 8 patients. The two groups were compared in terms of postoperative variceal rebleeding, stent dysfunction, hepatic encephalopathy (HE), and survival. The paired t-test was used for comparison of continuous data between two groups, and the chi-square test was used for comparison of categorical data between two groups. The Kaplan-Meier curve was used to analyze variceal rebleeding-free rate, stent patency rate, HE-free rate, and survival rate, and the log-rank test was used for comparison of cumulative rebleeding-free rate and cumulative survival rate. ResultsThe technical success rate of TIPS was 82.6%. There were significant differences in 6-, 12-, and 24-month cumulative rebleeding-free rates between the TIPS success group and the TIPS failure group (94.3%/89.8%/89.8% vs 85.7%/85.7%/28.6%, χ2=4.563, P=0.033). In the TIPS success group, the 6-, 12-, and 24-month cumulative stent patency rates were 79.3%, 74.3%, and 69.0%, respectively, and the 6-, 12-, and 24-month cumulative HE-free rates after TIPS were 72.1%, 55.5%, and 55.5%, respectively. There were significant differences in 6-, 12-, and 24-month cumulative survival rates between the TIPS success group and the TIPS failure group (94.0%/94.0%/86.2% vs 714%/71.4%/71.4%, χ2=4.988, P=0.026). ConclusionTIPS is a safe and feasible method for preventing esophageal variceal rebleeding in patients with PVT after splenectomy, and TIPS combined with a percutaneous transhepatic approach may promote technical success.

Objective: To investigate the epidemiological characteristics of clusters of hand, foot and mouth disease (HFMD) in kindergartens and schools in Jinshan District, Shanghai Municipality from 2016 to 2021, so as to provide insights into improving the prevention and control measurements of HFMD in Jinshan District. Methods: Data of HFMD cases in Jinshan District from 2016 to 2021 were collected through Chinese Disease Prevention and Control Information System, and data pertaining to HFMD clusters in kindergartens and schools were also collected. The scale, temporal distribution, regional distribution and distribution of cluster places were descriptively analyzed. Results: Totally 338 HFMD clusters involving 974 cases were identified in kindergartens and schools in Jinshan District from 2016 to 2021, with an average attack rate of 9.89%. The number of cases in each cluster ranged from 2 to 12 cases, with a median number of 2 (interquartile range, 1) cases, and there were 223 clusters involving 2 cases, accounting for 65.98%. The duration of clusters ranged from 1 to 16 days, with a median duration of 4 (interquartile range, 3) days. HFMD peaked from April to June (136 clusters, 40.24%) and from September to December (176 clusters, 52.07%). All the 11 streets and towns (high-tech zones) were reported HFMD clusters, and the three largest number of clusters were reported in Zhujing Town (72 clusters, 21.30%), Shanyang Town (63 clusters, 18.64%) and Tinglin Town (40 clusters, 11.83%). There were 268 HFMD clusters in kindergartens (79.29%) and 70 in schools (20.71%), and the prevalence of HFMD clusters was higher in kindergartens than in schools (35.51% vs. 17.03%; χ2=31.507, P<0.001). Conclusions HFMD clusters in kindergartens and schools showed seasonal characteristics from 2016 to 2021 in Jinshan District, which predominantly occurred in Zhujing Town, Shanyang Town and Tinglin Town, and kindergartens were the main places.

Medical device test is a very important step of medical device registration processes and is also a procedure to confirm whether the medical devices comply with applicable standards. The standardization system is imperfect yet in China due to the complexity of medical devices and the specialty of medical device industry. In this circumstance, the medical device standard is not only the important criteria for the medical devices registration, but also an important practical procedure of the medical device registration. This paper reviews the existing questions and also gives some comments and suggestions on the medical device standardization system from the view point of medical device test.
China ; Device Approval ; legislation & jurisprudence ; Equipment Safety ; standards ; Equipment and Supplies ; standards ; Legislation, Medical ; Prostheses and Implants ; standards

BACKGROUND:In order to optimize the biological activity of hydroxyapatite, previous experiments have used plasma spraying technique to prepare a piezoelectric ceramic coating on the surface of hydroxyapatite, but the cytotoxicity of this new material is not clear.
OBJECTIVE: To evaluate the cytotoxicity of hydroxyapatite/barium titanate biological piezoelectric ceramic coatingin vitro.
METHODS: The 3rd generation beagle bone marrow mesenchymal stem cels were seeded on
hydroxyapatite/barium titanate piezoelectric ceramic specimens and hydroxyapatite specimens, respectively.
After 5 days, the celladhesion was detected by scanning electron microscopy. The 3rd generation bone marrow
mesenchymal stem cels were also co-cultured with hydroxyapatite/barium titanate piezoelectric ceramic specimen extract, hydroxyapatite specimen extract, low-glucose Dulbecco’s modified Eagle’s medium containing 5%
dimethylsulfoxide and 15% fetal bovine serum, and low-glucose Dulbecco’s modified Eagle’s medium containing 15%
fetal bovine serum, respectively. The cytotoxicity was tested by cellCounting Kit-8 assay at days 1, 3, 5 after co-culture. RESULTS AND CONCLUSION:Bone marrow mesenchymal stem cels on the surface of hydroxyapatite/barium titanate piezoelectric ceramic specimens and hydroxyapatite specimens grew proliferatively and presented with multi-layer
growth. The connection between cels and pseudopodia was very close, which indicates that the two kinds of materials both have good cytocompatibility. cellCounting Kit-8 assay showed that the cels cultured in the extracts of
hydroxyapatite/barium titanate biological piezoelectric ceramic and hydroxyapatite specimens proliferated more than 80%, and the toxicity was grade 1 that meant no cytotoxicity.