This paper introduces the premarket registration procedures and the post market regulatory requirements in India. According to Indian medical device act and related medical regulations on medical device, this is a preliminary discussion on the registration management system to provide referance for foreign medical device to enter India market.
Equipment and Supplies ; economics ; standards ; India

The concept and classification of Korean medical device were introduced. The phases for Korea to import medical device include selecting Korean certification holder, hospital admittance, device marketing and supervision after marketing. China and other countries can find references to export medical devices into Korea.

Objective To explore the effects of intra-jugular vein dual lumen catheter lock heparin in different concentrations on the coagulation function,hemorrhagic tendency and catheter thrombosis risk in hemodialysis patients,and to investigate the reasonable lock heparin cuncentration. Method Ninety end stage renal disease (ESRD)patients receiving regular hemodialysis were enrolled and randomly assigned into 3 groups(n=30):Group A(pure heparin lock solution,6250 U/m1),GrouP B(medium heparin lock solution,1040 U/ml)and Group C(low hepafin lock solution,625 U/ml).The coagulation indexes were determined in short term.Complications such as bleeding,thrombosis,infection and thrombocytopenia were monitored.Results Prothrombin time(PT),actiwtted partial thromboplastin time(APTT)and thrombin time (TT)were significantly prolonged in Group A(P＜0.01);only APTT was signifieanlly prolonged in Group B:however,no significant changes were observed in Group C.Hemorrhage risk was much higher in Group A than that in Group B and C (26.7%vs 10%and 0.P＜0.05).Catheter thrombosis incidence was significantly higher in Group C than that in Group A and B(23.3%vs 0and 10%,P＜0.05).Only 1 suspected catheter related infection was found in Group C,and 2cases of moderated thrombocytopenia in Group A. Concltrsion Moderate concentration of lock heparin solution has the best balance of hemorrhagic and thrombotic risk,and should be recommended to most of regular hemodialysis patients.

Animals ; Autophagy ; Bone Marrow Cells ; cytology ; Cell Differentiation ; Cells, Cultured ; Mesenchymal Stromal Cells ; cytology ; Neurons ; cytology ; Rats ; Rats, Sprague-Dawley

The sequences of ITS, matK, rbcL and psbA-trnH of 9 Gynostemma species or variety including 38 samples were compared and analyzed by molecular phylogeny method. Hemsleya macrosperma was designated as outgroup. The MP and NJ phylogenetic tree of Gynostemma was built based on ITS sequence, the results of PAUP phylogenetic analysis showed the following results: (1) The eight individuals of G. pentaphyllum var. pentaphyllum were not supported as monophyletic in the strict consensus trees and NJ trees. (2) It is suspected whether G. longipes and G. laxum should be classified as the independent species. (3)The classification of subgenus units of Gynostemma plants is supported.
Gynostemma ; classification ; genetics ; Molecular Sequence Data ; Phylogeny ; Plant Proteins ; genetics ; Sequence Analysis, DNA

Objective: To explore the association of hypertriglyceridemic waist phenotype ( HTGW ) with impaired fasting glucose ( IFG ) and diabetes, so as to provide reference for the early prevention and control of diabetes. Methods: The survey was conducted among 35 to 75-year-old residents in 8 project sites in Jiangsu Province from 2015 to 2019. The information about demography and lifestyle was collected by the general information questionnaire and the primary screening questionnaire from the National Center for Cardiovascular Diseases; waist circumference, height, weight, triglyceride, high-density lipoprotein cholesterol, total cholesterol and fasting plasma glucose were measured. The multinomial logistic regression model was employed to analyze the association of HTGW with IFG and diabetes. Results: A total of 118 383 subjects were included, among whom 21 851 cases of HTGW, 27 245 cases of IFG and 22 899 cases of diabetes were identified, with the prevalence of 18.46%, 23.01% and 19.34%. The multinomial logistic regression analysis showed HTGW was statistically associated with IFG ( OR=1.414, 95%CI: 1.343-1.489 ) and diabetes ( OR=2.216, 95%CI: 2.098-2.341 ). Conclusion HTGW is associated with IFG and diabetes, which make it possible to be an indicator for screening and assessment of glucose abnormality in middle-aged and elderly population.

OBJECTIVETo analyze the risk factors of cognitive impairment after off-pump coronary artery bypass grafting (OPCABG).

METHODSA total of 102 patients [male: 82, age: (65.7 ± 7.1) years] undergoing OPCABG in our hospital between January 2009 and December 2010 were divided into postoperative cognitive dysfunction (POCD) group and non-POCD group by the MMSE questionnaire survey conducted at 7 days pre- and post-operation respectively.

RESULTSThe incidence of POCD was 48.0% (49/102). Multivariate logistic stepwise regression analysis showed: advanced age (OR = 1.32, 95%CI: 1.10 - 1.46, P = 0.002), smoking (OR = 1.26, 95%CI: 1.18 - 1.32, P = 0.001), hypertension (OR = 1.66, 95%CI: 1.36 - 1.78, P = 0.023), diabetes (OR = 1.62, 95%CI: 1.02 - 2.84, P = 0.032), stroke (OR = 3.32, 95%CI: 1.68 - 6.49, P < 0.001), mitral regurgitation (OR = 1.48, 95%CI: 1.26 - 1.89, P < 0.001), and time of wall clamp (OR = 4.84, 95%CI: 1.08 - 7.28, P < 0.001) were independent risk factors of POCD.

CONCLUSIONAdvanced age, smoking, hypertension, diabetes, stroke, mitral regurgitation, and prolonged time of wall clamp are major risk factors for POCD in patients undergoing OPCABG.

Aged ; Cognition Disorders ; etiology ; Coronary Artery Bypass, Off-Pump ; adverse effects ; Female ; Humans ; Male ; Middle Aged ; Postoperative Complications ; etiology ; Risk Factors ; Treatment Outcome

OBJECTIVETo explore the role of cyclin dependent kinase 5 (CDK5) in 2, 5-hexanedione (HD)-induced neuropathy.

METHODSThirty male Wistar rats weighted 200 approximately 240 g were divided randomly into three groups, i.e. control group, 200 mg/kg HD group and 400 mg/kg HD group (n = 10 for each group). HD was administered to rats by intraperitoneal injection at dosage of 200 or 400 mg/kg for 8 weeks (five times per week) to establish the intoxicated rats model. The relative contents of CDK5, p35 and p25 were determined in cerebrum, spinal cord and sciatic nerve of rats by Western Blotting.

RESULTSCompared with that of the control group rats, p35 contents were significantly decreased (P < 0.01) in the cytosolic fractions of cerebrum and spinal cord in both the 200 and 400 mg/kg HD intoxicated rats, while in the membrane fractions of spinal cord and sciatic nerve, p35 contents were increased significantly (P < 0.01). The changes of p25 showed the same pattern with p35. P25 contents were significantly reduced (P < 0.05) in the cytosolic (cerebrum and spinal cord) and membrane (cerebrum) fractions of both HD-treated rats and were elevated (P < 0.01) in the membrane fraction of spinal cord and cytosolic fraction of sciatic nerve. The relative amounts of CDK5 were significantly decreased (P < 0.01) in the cytosolic and membrane fractions of cerebrum in both the 200 and 400 mg/kg HD intoxicated rats. Except for membrane fraction of sciatic nerve, the significant increased (P < 0.01) of CDK5 were observed in the spinal cord and sciatic nerve of both the 200 and 400 mg/kg HD treated rats.

CONCLUSIONHD can induce significant changes of CDK5 and its activators p35, p25 in nerve tissues, which may be related to the neuropathy induced by HD.

Animals ; Cyclin-Dependent Kinase 5 ; metabolism ; Disease Models, Animal ; Hexanones ; poisoning ; Male ; Nerve Tissue ; metabolism ; Nervous System Diseases ; chemically induced ; Phosphotransferases ; metabolism ; Rats ; Rats, Wistar

OBJECTIVETo examine the association between CLOCK gene T3111C polymorphism with attention deficit hyperactivity disorder (ADHD) and ADHD related sleep disturbances in children.

METHODSOne hundred and sixty-six unrelated children with ADHD diagnosed according to DSM-IV criteria and a control group of 150 normal children were enrolled in this study. Parents filled out the Sleep Disturbance Scale for Children (SDSC). Genotype and allele frequencies of T3111C of the CLOCK gene were examined by PCR-restriction fragment length polymorphisms (PCR-RFLP).

RESULTSThere were significant differences in the genotype and allele frequencies of T3111C of the CLOCK gene between the ADHD and control groups (P<0.05). C allele frequency in the ADHD group was significantly higher than in the control group (χ2=7.254, P=0.007, OR=1.740, 95%CI=1.160-2.612). The ADHD children with sleep disturbances were found to have higher C allele frequency than those without sleep disturbances (χ2=13.052, P<0.001, OR=2.766, 95%CI=1.573-4.865).

CONCLUSIONSThere is an association between CLOCK gene T3111C polymorphism and both ADHD and related sleep disturbances in children. The individuals with C allele are susceptible to ADHD as well as ADHD related sleep disturbances.

Adolescent ; Attention Deficit Disorder with Hyperactivity ; complications ; genetics ; CLOCK Proteins ; genetics ; Child ; Child, Preschool ; Female ; Humans ; Male ; Polymorphism, Genetic ; Sleep Wake Disorders ; etiology ; genetics

Objective To determinate the prognostic value of etiology in patients with chronic systolic heart failure (CSHF).Methods Data of in-hospital patients with CSHF were investigated between 2000 and 2010 from 12 hospitals in Hubei province.All patients were followed up through telephone calls.Univariate and multivariate Cox proportional hazards analyses were then used to explore the differences in the all-cause mortality,heart failure (HF) mortality and sudden cardiac death (SCD) among patients caused by different etiologies.Kaplan-Meier curve were then constructed and Univariate and multivariate Cox regression analyses were used to select demographic and clinical variables in predicting the all-cause mortality,HF mortality and SCD in CSHF patients.Multivariate logistic models and ROC curve were developed with or without the cinfirmed etiology to assess the incremental additive information related to different etiologies.Results (1)Over the median 3 (2-4) years follow-up program,6453 (38.69％) patients died,including 5505 (33.00％) due to HF prognosis and 717 (4.30％) died of SCD.All-cause mortality rates accounted for 34.50％,54.30％,41.48％ and 15.76％,with HF mortality rates as 30.11％,44.95％,36.25％ and 13.10％.SCDs accounted 8.46％,8.45％,9.84％ and 1.05％ in patients with CHD,DCM,HHD and RHD,respectively.(2) Compared with RHD patients,the adjusted HRs for all-cause mortality were 1.554 (1.240 to 1.947;P＜0.001),1.405(1.119 to 1.764;P=0.003) and 1.315(1.147 to 1.467;P=0.005) while the adjusted HRs and 95％CIs for HF mortality were 1.458( 1.213-1.751 ;P＜0.001 ),1.763( 1.448-2.147;P＜0.001 ) and 1.281 ( 1.067-1.537; P=0.008),in patients with CHD,DCM and HHD,respectively.There were no significant differences in CHD (HR 3.345; 95％ CI,1.291 to 8.666; P=0.013 ) or HHD (HR 2.062; 95％CI,0.794 to 5.352; P=0.137 ),while only DCM ( HR 4.764; 95％CI,1.799 to 12.618;P=0.002) remained significant in SCD despite of the multivariate adjustment.(3) Etiology increased the sensitivity and specificity of predicting models for all-cause mortality(AUC 0.839,95％CI,0.832to 0.845 vs.0.776,95％CI,0.768 to 0.784) and HF mortality(AUC 0.814,95％CI,0.806 to 0.822 vs.0.796,95％CI,0.788 to 0.804) but not with SCD (AUC 0.777,95％CI,0.749 to 0.809 vs.0.747,95％CI,0.727 to 0.766).Conclusion CSHF due to CHD,DCM and HHD carried a worse prognosis than that of RHD.Different etiologies provided significant incremental prognostic information beyond readily available clinical variables for all-cause mortality and HF mortality.