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

Objective To investigate the expression and significance of Maspin and IKKα in nasosinusoidal mucosa of rats with fungal rhinosinusitis (FRS).Methods A total of 40 SD rats were used to establish the FRS model, and randomly divided into nasal obstruction group, FRS group, immunosuppressive group and invasive FRS group, 10 rats in each group.Another 10 normal rats were used as control group.Mice in the control group were fed with normal diet.In the nasal obstruction group, the mice had only hemostatic cotton stuffed in the nasal cavity and injection of 0.9% NaCl in the abdominal and nasal cavities.In the FRS group, the mice were injected Aspergillus fumigatus spore suspension into the nasal cavity and 0.9% NaCl i.p.The mice of the immunosuppressive group were given cyclophosphamide i.p.and 0.9% NaCl injection into the nasal cavity.The invasive FRS group was injected with cyclophosphamide i.p.and Aspergillus fumigatus spore suspension into the nasal cavity.The serum levels of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) were measured by enzyme-linked immunosorbent assay (ELISA).The expression of Maspin and IKKα in nasosinusoidal mucosa was detected by immunohistochemical staining.The expression of Maspin mRNA and IKKα mRNA in the nasosinusoidal mucosa was detected by fluorescence quantitative PCR.Results The serum levels of IL-6 and TNF-α in different groups were significantly different (P< 0.05).The level of IL-6 in the FRS group was (69.3 ± 10.9) ng/L, significantly higher than those in the control group, nasal obstruction group, immunosuppressive group and invasive FRS group [(45.2 ± 7.1)ng/L, (46.4 ± 6.7) ng/L, (21.3 ± 4.5) ng/L, and (20.9 ± 4.3 ng/L)] (P < 0.05).The level of TNF-α in the FRS group was (30.4 ± 4.8) ng/L, significantly higher than those in the control group, nasal obstruction group, immunosuppressive group and invasive FRS group [(14.8 ± 2.7) ng/L, (13.9 ± 1.4) ng/L, (7.9 ± 0.6) ng/L, and (7.8 ± 0.4 ng/L)] (P < 0.05).The levels of IL-6 and TNF-α in the control group were significantly higher than those in the immunosuppressive group and invasive FRS group (P< 0.05).There was no significant difference between the immunosuppressive group and the invasive group (P> 0.05).Theresult of immunohistochemical staining showed that the protein expression of Maspin in the FRS group and invasive FRS group was significantly lower than that in the control group, nasal obstruction group and immunosuppressive group, while the expression of IKKα protein was significantly higher than that of control group, nasal obstruction group and immunosuppressive group (P< 0.05).The protein expression of Maspin in the invasive FRS group was significantly lower than that in the FRS group, by contrast, the expression of IKKα protein was significantly higher (P< 0.05).The PCRresult revealed that the expression levels of Maspin and IKKα mRNA were (0.217 ± 0.013) and (0.193 ± 0.012), significantly lower than that in the control, obstruction and immunosuppressive groups [(0.309 ± 0.021), (0.302 ± 0.017), and (0.293 ± 0.02)] (P< 0.05), while the expressions level of IKKα mRNA were significantly higher [(0.319 ± 0.043), (0.384 ± 0.048) vs (0.169 ± 0.015), (0.171 ± 0.018), and (0.175 ± 0.019)] (P< 0.05).Conclusions Down-regulation of Maspin expression after IKKα activation is the main cause of the onset of FRS, which may also be one of the mechanisms of invasive FRS.

?AlM:To compare the effect of iris location guided sub-bowman keratomileusis ( SBK ) and iris location guided thin - flap laser in situ keratomileusis ( LASlK ) for extremely high myopia treatment.
?METHODS:lris location guided SBK was performed in 64 eyes of 32 patients with extremely high myopia and 42 eyes of 84 patients were received iris location guided thin-flap LASlK. All the patients’ spherical refraction was-9. 00D ~ - 11. 00D and the age was 22 ~ 35 years. Uncorrected visual acuity ( UCVA) , refraction, split-lamp examination, topography examination, central corneal stroma thickness, thickness of central corneal flap, thickness of peripheral corneal flap and complication was examined in these patients and follow-up was 6mo.
?RESULTS:At 6mo after surgery, 93. 8% of the patients received iris location guided SBK and 92. 9% received iris location guided thin-flap LASlK achieved a UCVA better than 20/20. There was no significant difference between two groups. Refraction between ±0. 5D was 89. 1% of SBK group and 84. 5% of LASlK group. There was no significant difference. Corneal rear surface height of SBK was 0. 046±0. 012μm and LASlK was 0. 056±0. 015μm. Thickness of corneal stroma after surgery was 328. 6±14. 7μm in SBK group, while it was 301. 2±21. 6μm in LASlK group and there was significant difference ( t =3. 127, P=0. 001). BUT was 11. 38±4. 02s and 17. 81±4. 89s in SBK and LASlK group respectively, with no statistical difference. There was no serious complication in two groups.?CONCLUTlON:Both iris location guided SBK and thin-flap LASlK are effective for extremely high myopia, but SBK is safer and more predictive than thin-flap LASlK.

Objective To investigate the effects of loop electrosurgical excision procedure(LEEP) on preg- nancy and delivery outcome in patients with CIN3.Methods Fifty-eight patients with CIN3 who were considering future pregnancies underwent LEEP from January 2003 to December 2006,and their following reproductive perfor- mances and delivery outcomes were observed.Results The mean time of the follow-up survey was 21 months(range from 6～42 months).There were 34 cases getting intrauterine pregnancies and 4 cases getting ectopic pregnancies. Among the 34 cases of intrauterine pregnancies,4 terminated by induced abortion and 1 by delayed abortion in early stage.21 cases delivered termed baby vaginally and 7 underwent cesarean section.No cervical dystocia had been re- ported.No disease recurrence had been found until the end of follow-up survey.Conclusion Loop electrosurgical ex- cision procedure is a safe and effective treatment for patients with CIN3.It will not effect the pregnancy and delivery outcome after LEEP.

ObjectiveTo explore the species distribution and constituent ratio of diatoms in main sections of urban district rivers where drowning occurs frequently in Chengdu.MethodsTotal 39 water samples from the sampling points of 5 rivers(Jinjiang, Jinniu, Qingyang, Wuhou and Chenghua districts)in Octo-ber 2014 were collected. The diatoms smear were made and the species distribution and constituent ratio of diatoms from the water samples were analyzed using biological microscope and acquisition system of digital microscope.ResultsTotal 21 species of diatoms were detected in main sections of urban district rivers in Chengdu. Significant differences in the dominant diatom species and proportions of the different rivers were observed, and there were different species existed in all sampling points of the upstream, midstream and downstream of the rivers.ConclusionThe database of species map, species distribution and constituent ratio of diatoms in main sections of urban district rivers in Chengdu are preliminarily es-tablished, which has special meaning for the analysis and evaluation of falling location inference using diatoms test in case investigation.

AIM:To examine the efficacy and safety of cryotherapy in the management of Fusarium corneal ulcer.
METHODS: Retrospective contract analysis of the clinical data of 41 patients ( 41 eyes ) who infected with Fusarium corneal ulcer. All of them underwent focal lesion keratectomy combined with amniotic membrane transplantation between January 2010 and May 2013. The cryotherapy treatment group of 22 cases (22 eyes), non-cryotherapy group of 19 cases ( 19 eyes ) . All the cases were followed up for 3 ~12mo. We analyzed the healing of corneal ulcer, corneal neovascularization, postoperative visual acuity, complications and ulcer recurrences.
RESULTS: There were no significant difference for the two groups at the cure rate and the recovery rate, the corneal neovascularization and postoperative visual acuity (P>0. 05). The total effective rate and corneal healing time in cryotherapy group was significantly higher than that in non - cryotherapy group ( P < 0. 05 ). The postoperative visual acuity of two group were higher than that of preoperatively ( P < 0. 05 ). There was no complication occurred in cryotherapy group while there was 1 patient of secondary glaucoma in non-cryotherapy group.
CONCLUSION: Cryotherapy is an effective and safe method for the treatment of Fusarium corneal ulcer.

Rough set is a mathematical approach to study imprecise, uncertain or incomplete information or knowledge. The data mining technology based on the rough set theory can be trained through the training data set. The technology is applied to such fields as the prognosis of the pain in the chest, emergence diagnosis in ICU, distinguishing and diagnosis of lung tumor and rheumatoid disease, diagnosis of galactophore disease, diagnosis of premature birth, classification and diagnosis of liver disease and acute appendicitis. The technology has a brilliant future in medical data mining.

Objective To study programmed death-1 (PD-1) and T-cell immunoglobulin mucin3 (Tim-3) co-expression on peripheral blood mononuclear cells (PBMC) and hepatitis B virus (HBV)-specific CD8+ T cells in patients with chronic HBV infection and its correlation with liver inflammatory activities.Methods One hundred and sixty subjects with chronic HBV infection who visited the outpatient and inpatient Department of Infectious Diseases in the Third Affiliated Hospital of Sun Yatsen University were enrolled,including 63 cases of mild or moderate CHB (MCHB),31 of severe CHB (SCHB),55 of acute-on-chronic liver failure (ACLF) and 11 inactive HBsAg carriers.Twenty healthy subjects were enrolled as controls.Real-time quantitative polymerase chain reaction (qRT-PCR) was used to detect HBV DNA,enzyme-linked immunosorbent assay (ELISA) to measure HBV serological markers,and flow cytometry to detect human leukocyte antigen (HLA)-A2 and determine the expression of PD-1 and Tim-3 on PBMC and HBV-specific CD8+ T cells.Cell counts of Tim-3+,PD-1+,and Tim-3+/PD1+ PBMC and HBV-specific CD8+ T cells were compared among different groups,and their correlation with commonly used inflammatory activity indicators were studied.Analysis of variance and Kruskal-Wallis test were used for measurement data with gaussian distribution and skewed distribution,respectively.Spearman correlation analysis was used to assess the association between Tim-3/PD-1 expression and inflammatory activity indicators.Results The frequency of Tim-3+/PD-1+ PBMC was 0.25 ％ in ACLF group (P=0.0049),0.24 ％ in SCHB group (P-0.0025) and 0.13％ in MCHB group (P=0.0006),which were significantly higher than that in control group (0.03％),and the frequency of Tim-3 /PD-1-PBMC in the three groups were significantly lower than that in control group (P =0.0000),but the differences between HBsAg carriers (0.10％) and controls (0.03％) were not statistically significant (P=0.28).Among 160 subjects,78 were HLA-A2 positive.The frequency of Tim-3+/PD-1+ HBV-specific CD8+ T cells was 68.72％±17.21％ in ACLF group,and 59.66％± 19.25％ in SCHB group,which were significantly higher than that in HBsAg carrier group (33.93％ ± 10.80％,P=0.0000,P=0.0054).The frequency of Tim-3 /PD-1-HBV-specific CD8+ T cells in ACLF group was 2.80％,which was significantly lower than that in HBsAg carrier group (27.24％,P=0.0004).The frequency of Tim3+/PD-1+ HBV-specific CD8+ T cells was positively correlated with alanine aminotransferase (r=0.26,P=0.022),aspartate aminotransferase (r=0.28,P=0.012) and total bilirubin levels (r=0.36,P=0.001); and inversely correlated with albumin level (r=-0.35,P=0.002) in serum.Furthermore,it was positively correlated with international normalized ratio (INR,r=0.34,P =0.045) and model for end-stage liver disease score (r=0.43,P=0.027) in ACLF group.Conclusions Co-expressions of Tim-3 and PD-1 on PBMC and HBV-specific CD8+ T cells are significantly upregulated in patients with CHB,and correlated with liver inflammatory activities.These findings indicate that Tim-3 and PD-1 co-expression may involve in disease activity and liver failure in CHB.

Objective To explore the atopic condition of children with stable asthma and their parents by detecting total IgE concentration in serum and collecting history. Methods Fifteen children with asthma in remission stage and 24 parents and 40 normal children were involved in this study. The concentrations of serum total IgE were measured with UniCAP Pharmacia system. The history including eczema and allergic rhinitis and asthma of children and parents were collected. Skin test with 10 kinds of inhalant allergens were taken in children with asthma. Results Of 15 children with asthma, 13 cases (86.7%)had eczema in infant stage and allergic rhinitis, 13 parents(86.7%)had allergic rhinitis or asthma. There was significant difference in the stable asthmatic children compared with parents and normal control group increased amounts of serum total lg IgE(F=68.42 P=0). There was significant difference in serum total lg IgE in patients group(2.43?0.73)kU/L compared with that in normal control group(0.72?0.54)kU/L (q=14.176 P0.05). Twelve children were positive in skin test, which were mainly dermatophagoides pteronyssinus and dermatophagoides farinae.Conclusions There is obvious congregate phenomena of atopy in the family of asthmatic children. The continuous high IgE concentration was associated with immune pathological mechanisms of atopic diseases.

Objective To explore the changes of interleukin-13(IL-13) and total immunoglobulin E(IgE) levels in children with stable asthma.Methods Eighty-eight cases of children with asthma in remission stage aged 6-14 years old and 40 normal children were involved in this study.The concentrations of serum IL-13 and total IgE were measured with enzyme linked immunosorbent assay(ELISA) method and UniCAP pharmacia system.Results Clinical evaluation and lung function were improved in asthmatic children.Serum IL-13 level of asthmatic children in remission stage was higher than that of control group(U=3.93 P0.05).Conclusions There exists continuous allergic inflammation for children with asthma in remission stage.The high concentrations of serum IL-13 and IgE are associated with immune pathological mechanisms of asthma.