The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system still existed some deficiencies which resulting in confusion when filling the forms, especially those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.
China ; Consumer Product Safety ; Equipment and Supplies ; Safety Management

DNA topoisomerase is a basic enzyme in eucaryon and prokaryotic cells, which distributes in cell nucleus generally. DNA topoisomerase plays important roles in the process of duplication, transcription, translation, recombination and chromosome monomer isolation to control, keep and modify the DNA topology. It is reported that DNA topoisomerase has a high expression level, which related with the mechanism of many antitumor drugs.

OBJECTIVE:To establish a method for the content determination of chlorogenic acid,protocatechuic acid and total phenolics in Chaenomeles sinensis,compare the content of total phenolics and 2 phenolic acids from different areas. METHODS:Wavelength switching HPLC method was conducted to determine the chlorogenic acid and protocatechuic acid. The column was Shim-pack CLC-ODS(M)with the mobile phase of acetonitrile-0.1% phoephoric acid(15∶85,V/V),the detection wavelength was 259 nm(for protocatechuic acid)and 325 nm(for chlorogenic acid)and the switching time was 14 min. With the index of proto-catechuic acid,Folin-Ciocalteau colorimetric method was conducted to determine the total phenolics. RESULTS:The 2 methods of quantitative analysis showed that the precision,repeatability,recoveries and standard curves were all validated by methodology. The mass fraction of total phenolics was 0.87%-3.77% with the average of 2.16%;the chlorogenic acid was 0.053%-0.387% with the average of 0.192% and the protocatechuic acid was 0.024%-0.541% with the average of 0.087%. The order of total phenolics content in C. sinensis from different areas was Yunnan>Anhui Xuancheng>Sichuan>Hubei and the order of total amount of chlo-rogenic acid and protocatechuic acid from different areas was the same as the total phenolics. There were differences among the con-tents of C. sinensis from different areas,however,the positive correlation was found between the content of total phenolics and the total amount of chlorogenic acid and protocatechuic acid with the pearson correlation coefficient of 0.719(P<0.01).CONCLU-SIONS:The established method is simple,accurate and reproducible and can be used for the content determination of chlorogenic acid,protocatechuic acid and total phenolics in chaenomelis fructus.

Objective:To explore the effect of group psychotherapy on damage of theory of mind (TOM) in patients with early-onset schizophrenia.Methods:Totally 60 patients with early-onset schizophrenia were included and divided into the intervention group (n ＝ 30) and the health education group (n ＝ 30).The patients in the intervention group were offered 10 twice a week 2-hour sessions of group psychotherapy,and those in the control were offered group health education twice a week.All participants completed baseline measures and post-intervention measures with the Eye Emotion Recognition and Theory of mind Picture-sequencing Task (TOM-PST).Results:Totally 23 patients in the intervention group and 29 patients in the health education group finished the post-intervention measures.After 5-week intervention,subscores of sad and fear and total score of emotion recognition,total score of TOM-PST,understanding first order error belief,second order error belief,third order error belief,sense of reality,detecting fraud compared to baseline had statistically significant difference in intervention group.In health education group,subscores of joy emotion recognition,understanding first order error belief,third order error belief,total score of TOM-PST compared to baseline had statstically significant difference.The patients with group psychotherapy got higher scores of total score of TOM-PST and understanding second order error belief and third order error belief than the health education group after 5-week intervention (P ＜ 0.05).Conclusion:This study suggests the group psychotherapy could partially improve theory of mind with early-onset schizophrenia,and promote the recovery of social cognition.

Objective:To explore the correlation among childhood trauma, obsessive-compulsive symptoms, and implicit and explicit memory in patients with obsessive-compulsive disorder(OCD).Methods:Fifty-two OCD patients were enrolled, and the childhood trauma was investigated by using the childhood trauma questionnaire short-form(CTQ-SF). The degree of obsessive-compulsive symptoms was assessed by using the Yale-Brown obsessive symptoms scale (Y-BOCS). In addition, the abilities of implicit memory and explicit memory were tested by vocabulary perception speed tasks and vocabulary recognition tasks.According to the scores of CTQ-SF, the patients were divided into abuse group( n=26) and neglect group( n=26). SPSS 22.0 software was used for t-test and Pearson correlation analysis. Results:Results of obsessive-compulsive symptoms, implicit memory, and explicit memory showed no differences between the abuse group and the neglect group( t=-1.959-1.839, P>0.05). The scores of obsessions symptoms(12.52±4.61) were positively correlated with the total scores of CTQ-SF (40.10±10.20)( r=0.331, P<0.05). On the subscale, the scores of obsessions were positively correlated with the scores of physical abuse(7.89±3.02), sexual abuse(6.47±2.28)( r=0.373, P<0.01, r=0.356, P<0.05). There was a negative correlation between the scores of physical abuse and the accuracy of explicit memory(68.75±13.33)( r=-0.281, P<0.05). The scores of physical neglect(8.98±2.67) was positively correlated with implicit memory response time(4 285.94±2 067.42)( r=0.314, P<0.05). Conclusion:Obsessions in patients with OCD are related to traumatic childhood experiences, especially physical abuse and sexual abuse.Physical trauma may influence the level of implicit and explicit memory in patients with OCD.

Objective To study the influence of NS4B on host defense system. Methods After cell line stably expressed NS4B was established, cell expression profiling caused by NS4B was studied using DNA microarray, and the results of microarray were verified via IFNGR1 fluorescence intensity analysis. Results The data showed that HCV-NS4B could suppress host defense system-associated gene ex-pression, in particular, IFN-γsignal transduction-related genes. Conclusion NS4B could play a role in persistence and resistance to IFN therapy in HCV infection.

OBJECTIVE:To provide reference for the application of position number in the pharmacy drug management. METHODS:Three-dimensional coding method was used for coding the position number. The mentioned method was combined with hospital information management system (HIS) for the out of storage,deployment and inventory. Memory field assumptions method was used to compare the size of field memorized by pharmacist in inpatient pharmacy before and after management of posi-tion number. Sampling controlled trial was conducted to compare the drugs deployment time and walking distance of pharmacists in inpatient pharmacy and drug storehouse before and after coding management of position number. RESULTS:After management of coding management in inpatient pharmacy,the memory required field was decreased from 1 028 to 25,deployment time of pharma-cists was decreased from(36.57±0.82)min to(24.20±0.33)min,and the walking distance was decreased from(79.17±0.29)m to(38.59±0.56)m. After management of coding management in drug storehouse,deployment time of pharmacists was decreased from(61.86±0.44)min to(47.18±0.63)min,and the walking distance was decreased from(129.53±0.58)m to(68.97±0.32) m. CONCLUSIONS:The drug coding management of position number can improve the deployment efficiency and reduce the brain and physical quantity of pharmacists.

Objective:To investigate the expression of Caveolin-1,GPR30 and Vimentin at tumor tissues of human papillary thyroid carcinoma( PTC) patients and analyze their associations for the possible clinical implication.Methods: Immunohistochemistry was used to analyze the expression of Caveolin-1, GPR30 and Vimentin in 76 PTC and 44 normal samples.The correlations of Caveolin-1, GPR30 and Vimentin expression with one another, and with several clinicopathological indicators were statistically analyzed.Results:In PTCs,the positive expression rates of Caveolin-1,GPR30 and Vimentin were 9.21%(7/76),80.26%(61/76) and 76.32%(58/76),respectively.Caveolin-1,GPR30 and Vimentin expression had significant correlations with TNM stages(P=0.005,P<0.001,and P<0.001,respectively) and with cervical lymph node metastasis(P≤0.001 for all).Meanwhile,Caveolin-1 ex-pression had a negative correlation with GPR30(rs=-0.528,P<0.001) and Vimentin(rs=-0.572,P<0.001).GPR30 and Vimentin expression were positively correlated ( rs=0.812, P<0.001 ).Caveolin-1 under-expression was accompanied by GPR30 or Vimentin over-expression had stronger correlation with LNM ( P=0.020 for Caveolin-1/GPR30 and P=0.001 Caveolin-1/Vimentin ) than did each alone;concomitant high expression of GPR30 and Vimentin had stronger correlation with LNM( P=0.005 for GPR30/Vimentin) than did each alone.And lower expression of Caveolin-1 accompanied by higher expression of GPR30 and Vimentin was significantly as-sociated with LNM as compared with cases not showing such expressing(P<0.001).Conclusion:These results demonstrated that the evaluation of Caveolin-1 ,GPR30 and Vimentin expression may be play an important role in the development and metastasis of PTC,and their biological function may relate with each other.

Objective To observe any effect of low-frequency transcranial magnetic stimulation (rTMS) on the sleep and mood of elderly insomniacs.Methods Thirty-four elderly insomniacs were divided randomly into an experiment group (n =18) and a control group (n =16).The experiment group received rTMS of the right dorsolateral prefrontal cortex,while the control group was given alternating magnetic field stimulation at the same site.Before and after 4 weeks of the treatments,all of the subjects were assessed using the Pittsburgh sleep quality index (PSQI),the Hamilton anxiety scale (HAMA) and the Hamilton depression scale (HAMD).They were also assessed with those instruments omitting the sleep items in order to reduce the possible impact of any sleep changes on the HAMA and HAMD scores.Results Before the treatment there were no significant differences in the groups' average PSQI,HAMA and HAMD scores.After 4 weeks all the measurements in both groups had decreased significantly,with the experimental group's averages significantly lower than those of the control group.Conclusions rTMS treatment is more effective than alternating magnetic field treatment for the elderly with insomnia,significantly improving their sleep and mood.

Alterations of the lactoferrin gene are associated with an increased incidence of tumor,however,the exact mechanisms involved in the anti-tumor activity of lactoferrin are still unclear.Several studies suggest that lactoferrin can affect the initiation and development of tumors via different mechanisms such as damaging cell membranes,inducing apoptosis,blocking cell cycle,regulating cellular immune response and inhibiting angiogenesis in different cancer cell lines.Further study about the mechanism can provide new ideas for clinical prevention and treatment of tumors.