This paper focuses on issues needed to be clear towards the product quality supervision of medical devices in use. The life circle of medical devices, the supervision regarding its boundary, target, emphasis, basis and standards have been analyzed in turn. A clear and creative idea is also provided for theoretical exploration of the supervision on medical devices in use.
Materials Management, Hospital ; Quality Assurance, Health Care

Abnormalities, Multiple ; diagnosis ; diagnostic imaging ; Aorta, Thoracic ; abnormalities ; diagnostic imaging ; Aortic Aneurysm, Thoracic ; congenital ; diagnosis ; diagnostic imaging ; Aortic Diseases ; congenital ; diagnosis ; diagnostic imaging ; Child ; Diagnosis, Differential ; Humans ; Male ; Radiography ; Rare Diseases ; X-Rays

Coccidioides ; Coccidioidomycosis ; pathology ; Humans ; Infant ; Male

Objective To observe the effect of atorvastatin on mixed dyslipidemia in type 2 diabetic patients. Methods 39 patients of type 2 diabetic with mixed dyslipidemia were taken with atorvastatin for 6 months,and the change of total cholesterel(TC),triglyceride(TG),low-debsity-lipoprotein-cholesteral(LDL-C),high-debsity-lipopro- tein-cholesteral(HDL-C)were observed.The incidence of side-effect was recorded.Results TC,TG,LDL-C were obviously reduced and their extent of reduction were 26.17 %,54.97 %,38.92 %.HDL-C was obviously increased and it's extent of increase was 14.81%(P

Objective To develop a multiplex sequence-specific PCR assay for simultaneous screening of 5 types of JAK2 mutations and investigate its clinical application value. Methods Multiplex sequence-specific PCR assay for simultaneous screening of JAK2 V617F, K539L (include 2 types of gene mutations), N542-E543del and E543-D544del mutations were developed. 115 patients with myeloproliferative diseases (MPD) including 61 polycythemia vera (PV) cases, 43 essential thrombocythemia (ET) cases and 11 primary myelofibrosis (MF) cases were analyzed. Results The assay can screen the 5 types of JAK2 mutations efficiently. The detection sensitivity is 1% for JAK2 V617F mutation and 0.1% for the other mutations. JAK2 V617F mutation and JAK2 exon12 mutation were detected in 56 and 3 of the 61 PV samples, respectively. 27 of the 43 ET samples and 6 of the 11 MF samples were JAK2 V617F positive, but no JAK2 exon12 mutation was found in both groups. The 3 cases carrying JAK2 exon12 mutation had the clinical feature of erythrocytosis and erythropoietin-independent erythroid colony formation but without apparent leukocytosis, thrombocytosis and splenectasis. Conclusion The assay can simultaneously screen 5 types of JAK2 mutations with high sensitivity and thus lead to an increased detection rate.

·AIM: To investigate the preparation of endostatin protein and its biologic activity on vascular endothelial cell.· METHODS: pBlast-hEndostatin and pBlast-Mcs were identified by digesting with Nhe Ⅰ and Sal Ⅰ, by PCR reaction, by sequencing, and by Alignments of PCR products with gene bank using NCBIBLAST software. The identified pBlast-hEndostatin as well as pBlast-Mcs were then purified with QIAGEN Endofree plasmid maxi kit.The purified plasmids transfected human fibroblasts. The expression of endostatin was detected by RT-PCR, Westem-Blot and immunohistochemistry. The endostatin prorein produced by transfected fibroblasts was purified by ultrafiltration and affinity chromatography. The inhibitory action of endostatin on human umbilical vein endothelium was measured by MTT assay.· RESULTS: pBlast-hEndostatin was found to contain human endostatin gene. Endostatin protein was produced by transfected fibroblasts. The inhibitory ratio of 2.5,5,10,20,40,80mg/L endostatin on human umbilical vein endothelium for 48h were 8.5%,13.1%,27.7%,38.1%,56.7%,63.8% respectively. IC50 value was 34.5mg/L.No inhibition action was found on fibroblasts.·CONCLUSIONS: Endostatin protein can be produced by the transfected fibroblasts. The produced endostatin has inhibitory action on human umbilical vein endothelium and has no inhibition action on fibroblasts.

Objective To investigate whether the left ventricular delayed contraction site determined by tissue Doppler imaging might be an optimal left ventricular lead position for improved outcomes of cardiac resynchronization therapy (CRT) in patients with non-ischemic cardiomyopathy. Methods Thirty-three patients subjected to CRT were selected, and all were performed conventional ultrasound cardiography and tissue Doppler examinations before operation. The left ventricular delayed contraction site was determined according to the interval between the onset of QRS and the peak systolic velocity. Retrograde coronary venography was performed during operation, and the left ventricular lead site was selected according to the left ventricular delayed contraction site determined by tissue Doppler examination before operation. The coronary sinus lead site was determined under the guidance of X ray of dorsaventral, lateral, right anterior oblique and left anterior oblique positions. Patients were divided into group A(n=20, the left ventricular lead site was in line with the delayed contraction site) and group B (n=13, the left ventricular lead site was not in line with the delayed contraction site). Results There was no significant difference in age, NYHA grading, left ventricular end-systolic volume(LVESV), left ventricular ejection fraction(LVEF), pulmonary arterial systolic pressure, QRS width and Ts-SD between the two groups before operation(P> 0.05). Six months after CRT, there was no significant difference in NYHA grading, LVESV and mitral regurgitation(MR) grading between the two groups(P>0.05), while the increase in LVEF and decrease in LVESV of group A were more significant than those of group B (P<0.01). Conclusion In patients with non-ischemic cardiomyopathy, CRT significantly improves left ventricular performance, and the more favourable outcomes are achieved in those pace at the delayed contraction site. Tissue Doppler imaging may help to guide the implant of left ventricular lead.

No abstract available.
Asian Continental Ancestry Group* ; Ectodermal Dysplasia 1, Anhidrotic* ; Humans

Objective of this study was to investigate the transcriptional regulation of BHLHB2 gene by the PML-RARα fusion protein in APL cells and reveal the pathogenesis of APL. RT-PCR was performed to detect the expression change of BHLHB2 before and after the induction of PML-RARα in PR9 cells, and its expression level after the treatment of ATRA in PR9 and APL patient derived NB4 cells. Chromatin immunoprecipitation (ChIP)-based PCR was used to analyze whether the BHLHB2 promoter could be bound by PML-RARα in vivo. A large-scale gene expression profile dataset was used to observe the expression pattern of BHLHB2 in AML. The results showed that the expression level of BHLHB2 was significantly reduced with the induction of PML-RARα and ATRA could reverse this inhibition in both PR9 and NB4 cells and increase the expression of BHLHB2. However, the expression of BHLHB2 could not be induced by ATRA in U937 cells which do not express PML-RARα. Mechanism study revealed that PML-RARα could bound to the promoter of BHLHB2 in vivo to regulate the the expression of BHLHB2. It was found that the expression of BHLHB2 was relatively lower in APL as compared with other subtypes of AML and normal bone marrow cells. It is concluded that BHLHB2 is the target of PML-RARα, and the expression of BHLHB2 is inhibited by PML-RARα through binding to its promoter in APL.
Basic Helix-Loop-Helix Transcription Factors ; genetics ; Gene Expression Regulation, Leukemic ; Homeodomain Proteins ; genetics ; Humans ; Leukemia, Promyelocytic, Acute ; genetics ; pathology ; Oncogene Proteins, Fusion ; genetics ; Promoter Regions, Genetic ; Transcription Factors ; genetics ; Tumor Cells, Cultured ; U937 Cells

OBJECTIVETo compare the clinical results of early and delayed intramedullary nailing and locked plating for the treatment of multi-segments tibial fractures of type AO/ASIF-42C2.

METHODSBetween January 2010 and January 2013,45 patients with multi-segments closed tibial fractures of AO/ASIF-42C2 were treated by early primary intramedullary nailing and locked plating in 20 cases as early group and delayed in 25 cases as delayed group. In early group,20 cases included 13 males and 7 females with an average age of (37.9±14.3) years old ranging from 20 to 56 years;according to soft tissue injury Tscherne classification, 8 fractures were frade I,12 were grade II. In delayed group, 25 cases included 17 males and 8 females with an average age of (38.7±17.2) years old ranging from 24 to 55 years,4 fractures were grade I ,19 were grade II ,2 were grade III. The operative time, blood loss, hospital stay,fracture healing time and complications were recorded. At final follow-up, the Johner-Wruhs score were used to evaluate functional efficacy, and the posterior-anterior and lateral X-ray to evaluate fracture reduction and alignment.

RESULTSAll the patients were followed up for (12.5±2.5) months in early group and (13.2±2.8) months in delayed group (P>0.05). No wounds infections were happened. At the last follow-up, the mean range of knee joint was 10°-0°-120°. According to Johner-Wruhs scoring,there were 15 cases in excellent,3 in good,fair in 2 in early group; 21 in excellent,2 in good,2 in fair. The average operative time,blood loss had no significant differences between two groups (P>0.05), but hospital stay in early group was significantly shorter than those in delayed group(P<0.05). Average fracture healing time of early group and delayed group were (5.3±2.6) months and (6.0±2.9) months, respectively (P>0.05).

CONCLUSIONFor multi-segments tibial fractures of type AO/ASIF-42C2 with preoperative minor soft tissue injuries lighter of Tscherne grade I or II, early primary intramedullary nailing and locked plating does not significantly increase the postoperative incidence of soft tissue complications for patients. The early and delayed primary intramedullary nailing and locked plating for treatment of AO/ASIF-42C2 proximal third tibial fractures can get similar curative effect.

Adult ; Bone Plates ; Female ; Fracture Fixation, Intramedullary ; methods ; Humans ; Male ; Middle Aged ; Tibial Fractures ; surgery