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.

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.

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.

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 analyze the relationship between HBsAg level and HBV DNA level as well as illness severity in patients with HBV-related acute-on-chronic liver failure (ACLF).Methods One hundred and nineteen patients with chronic hepatitis B (CHB group) and 98 patients with ACLF(ACLF group) were enrolled.HBsAg and HBeAg were assayed with Roche electrochemical luminescence method.HBV DNA was quantified using a real-time polymerase chain reaction (PCR) assay.HBsAg and HBV DNA levels were compared between two groups and between HBeAg-positive and HBeAg-negative patients in ACLF group respectively,also the correlationbetween HBsAg and HBV DNA was studied.Results The proportions of HBeAg-negative patients were 68.4％(67/98) and 42.9％(51/119) in ACLF group and CHB group respectively,and there was significant difference between two groups (P ＜0.01).There was no significant difference in HBV DNA between two groups (P ＞ 0.05).HBV DNA in HBeAg-positive patients was higher than that in HBeAg-negative patients in two groups(P ＜ 0.05).There was no significant difference in HBsAg between HBeAg-positive patients and HBeAg-negative patients in ACLF group (P ＞ 0.05 ),but they were higher than that in HBeAg-positive patients in CHB group (P＜ 0.05).HBsAg was correlated to ALT,AST in HBeAg-positive patients (P ＜ 0.05).No significant correlation was found among HBsAg and HBV DNA as well as biochemical changes (P＞ 0.05).There was no significant difference in the ratio of different HBsAg levels among the patients of different HBV DNA in ACLF group (P＞ 0.05).Conclusion The level of HBsAg does not directly correlate with serum HBV DNA level,and has no directly correlation with the severity of the disease in patients with HBV-related ACLF.

BACKGROUND: The proliferation and differentiation of mesenchymal stem cells (MSCs) lack of regulatory functions. Following combining with suitable vectors, MSCs cannot highly effectively proliferate and differentiate, which are keys to prevent MSCs entering the clinic. It is of great importance to effectively regulate the differentiation of stem cells into osteoblasts using pulse electromagnetic field.OBJECTIVE: To investigate the differentiation of mouse MSCs into osteoblasts in vitro following stimulation of pulse electromagnetic field.DESIGN, TIME AND SETTING: The cytological in vitro controlled study was conducted at the Laboratory of Department of Orthopaedics, Puai Hospital of Tongji Medical College, Huazhong University of Science and Technology from May 2004 to October 2007.MATEIRALS: Totally 20 BALB/C mice were supplied by the Experimental Animal Center of Tongji Medical College. Pulse electromagnetic field deviser was designed and made by the Department of Electric Machine, Naval University of Engineering.METHODS: Mouse bilateral femur was sterilely isolated. BMSCs were harvested by the Percoll density gradient centrifugation,and purified and proliferated by the adherent method. Cells at the third passage (2×10~7/L) were incubated in a 6-well plate, and then divided into 4 groups. Cells in the blank control group were incubated in the complete medium. Cells in the pulse electromagnetic field underwent pulse electromagnetic field radiation of 50 Hz, sinusoidal wave, and 1 mT, twice a day, once 30 minutes, with an interval of 12 hours, totally 10 days. Cells in the osteogenic induction group were incubated in the complete medium, supplemented with dexamethasone, sodium glycerophosphate and VitC. Cells in the pulse electromagnetic field + osteogenic induction group were subjected to the same pulse electromagnetic field radiation and then incubated in the complete medium.MAIN OUTCOME MEASURES: The differentiation of BMSCs was measured.RESULTS: Results of alkaline phosphatase staining showed that cells were negative in the blank control group, but weakly positive in the pulse electromagnetic field group, positive in the osteogenic induction group, and strongly positive in the pulse electromagnetic field + osteogenic induction group 10 days following intervention. Compared with the blank control group,absorbance value of type I collagen immunohistochemistry was significantly greater in the osteogenic induction group, pulse electromagnetic field + osteogenic induction group (P < 0.05, P < 0.01).CONCLUSION: Pulsed electromagnetism fields of 50 Hz, waves of sine, with the intensity of 1 mT could promote alkaline phosphatase and type I collagen expression and enhance the differentiation of mouse BMSCs into osteoblasts in vitro.