Based on the analysis of risk management to Chinese medical device situation and deficiencies, provide some guidance for the application of risk management to medical device.
Equipment and Supplies ; adverse effects ; standards ; Risk Management

Modern perinatal and neonatal medical advances make the survival rate of extremely low birth weight infants(ELBWI) higher,but its neurodevelopmental impairment,growth stasis and health status are poor.The survival rate of our county is lower than that of developed countries.In China,there are a few reports on neurodevelopment injury of ELBWI.This review will summarize prevention and prognosis on neurodevelopmental of ELBWI.

Objective To assess the relationship between Mycoplasma pneumonia (MP) and sex,age and season,and to provide a basis for the epidemiology of MP.Methods The serum samples were tested for Mycoplasma pneumonia antibody IgM (MP-IgM) by enzyme-linked immunosorbent assay for 782 children with respiratory tract infection.Results Among the 782 children with respiratory tract infection,221 (28.3％,221/782) were MP-IgM positive,and no difference was seen between male and female (P＞ 0.05).The incidence was in all ages,but it in 3-5 years old was the highest (50.0％,78/156),and ＜ 1 year old was the lowest (9.6％,19/198),there was significant difference compared with the others (P＜ 0.05).The total MP-IgM positive rate in children less than 6 years old was 32.4％ (193/595),which was higher than that in children over 6-14 years old [15.0％ (28/187)] (P ＜ 0.05).MP was epidemic in all year round,but the positive rate of MP-IgM was highest in spring (42.6％,107/251),the positive rate in summer,autumn and winter was 27.4％(57/208),10.8％(19/176) and 25.9％(38/147),respectively,and there was significant difference (P ＜ 0.05).Conclusions MP infections in children demonstrate a definite seasonality,and the positive rate may differ by age.The higher rate of MP infection is higher in the children less than 6 years old without sexual difference.MP is epidemic in spring.

Objective To explore the level of hypoxia-inducible factor-1α( HIF-1α) and vascular endotheli-al growth factor( VEGF) in serum and tissue of patients with metrocarcinoma.Methods 48 patients diagnosed with cervical cancer were analyzed retrospectively.Patients were treated with paclitaxel combination chemotherapy,HIF-1αand VEGF levels in serum of patients were detected by ELISA method before and after the treatment.HIF-1αand VEGF levels in cervical tissue of patients were observed by immunehistochemical staining methods.Western blot method was used to detect the change of HIF-1αand VEGF expression levels in cervical tissues of patients.And the levels of HIF-1αand VEGF in patients with lymphatic metastasis and lymph node metastases were compared. Results Lymph node metastasis did not occur in patients with uterine cancer serum HIF-1αand VEGF were (16.71 ±34.75)ng/L,(255.77 ±87.99)ng/L,respectively,and those after treatment were (98.33 ±32.17)ng/L, (153.67 ±65.45)ng/L,the differences were statistically significant(t=9.416,5.001,P=0.003,0.007) before and after treatment;The serum of patients with lymph node metastasis of uterine cancer in HIF-1αand VEGF increased, and cervical cancer patients after treatment,cervical tissue HIF-1αand VEGF;The metastasis were statistically signif-icant differences occurred(t=3.055,16.196,P=0.038,0.000);HIF-1αand VEGF decreased after treatment,the expression levels were significantly decreased compared with before treatment ( t=5.899,P=0.004;t=9.649,P=0.001);patients with lymph node metastasis after treatment,the expression levels of HIF-1αdecreased compared with before treatmen ( t =5.233, P =0.004), but there was no significant changes in the expression of VEGF. Conclusion The mechanism of taxol anti-uterine cancer may be related with inhibition the expression of HIF-1αand VEGF protein,and thereby inhibiting tumor angiogenesis and cancer metastasis.

Somatostatin is a regulatory peptide,widely distributed in the brain,pancreas and gastrointestinal tract.Clinically,somatostatin and its analogues have been widely used in the treatment of diseases such as acute pancreatitis.Based on studies on the mechanism,such as inhibiting of inflammatory reaction,reducing endotoxin level,inhibiting oxidative damage,enhancing immune function,protecting cells and reducing ischemiareperfusion injury,it may play a certain role in sepsis,especially in the comorbidity or secondary to pancreatic and gastrointestinal damage.Somatostatin is relatively safe in clinical application.

Objective To investigate the clinical pathway in the health education for prevention of postpartum urinary retention and effect evaluation. Methods 150 cases who completed delivery in our hospital were set as the observation group, they received health education of clinical pathways. 150 pregnant women who completed delivery in our hospital in the past were named as the control group, they were given traditional health education. The incidence rate of urinary retention was compared between the two groups. Results 7 cases, accounting for 4.67% of urinary retention occurred in the observation group, 24 patients, accounted for 16.00% of urinary retention occurred in the control group, the incidence of urinary retention in the experimental group was significantly lower than the control group. Conclusions Application of clinical pathway in the health education for prevention of postpartum urinary retention has good clinical value, can largely reduce the incidence of urinary retention.

Cytokine induced killer (CIK)cells are immune effector cells generated from mononuclear cells induced by many cytokines.CIK cells have several advantages, such as rapid proliferation, broad spectrum killing activity, high tumoricidal activity and non-major histocompatibility complex restriction.Recently, cord blood derived CIK cells have attracted extensive concerns because of its faster proliferation, higher tumoricidal activity and lower incidence of GVHD compared with adult peripheral blood derived CIK cells. This paper will review the biological characteristics, clinical application and research advances of cord blood derived CIK cells.

The role of dopamine D3 receptors playing in drug dependence has attracted a lot of attention.Pharmacological experiments suggest that dopamine D3 receptors be involved in mechanism of drug addiction and affect the movement and behavior of rodents. Dopamine D3 receptor gene is considered as a candidate gene related to dopaminergic system dysfunction including schizophrenic disorders and essential tremor.

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OBJECTIVE: To explore the effects of Shenfu injection on myocardial ATPase activities and sodium/calcium metabolism in viral myocarditis model mice.METHODS: The experimental mice were randomly divided into 4 groups: control group,infected group,high dose Shenfu injection group and low dose Shenfu injection group.The myocardial ATPase activities and concentrations of sodium/calcium were determined at different time poins,and the pathologic changes were investigated as well.RESULTS: As compared to control group,the activities of Na+,K+-ATPase and Ca2+-ATPase of the infected group decreasd significantly(P