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OBJECTIVE@#Common findings are to be found from 144 different type of medical device manufacturers' audit reports which are from Jan. 2017 to Jun. 2019. Advise is to be provided for medical device manufacturers on continual improvement.@*METHODS@#Classify and analyze the on-site audit findings from different type of medical device manufacturers.@*RESULTS@#The frequency of findings from chapter production management, buildings and facilities, quality control are comparatively high.@*CONCLUSIONS@#The key to improve the quality management system is to cultivate the staff sense of continual improvement of quality system, improve the staff ability of finding and solving problems, encourage staff participation in quality system, fit the quality system on product realization.
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Industry , Quality Control , Time FactorsABSTRACT
Objective The pathogenesis of T2DM has not been elucidated.This study aimed to explore the association of FXR gene polymorphisms with the risk of T2DM in Eastern China population. Methods We collected 467 cases in the Health Examination Center of our hospital from January 2011 to December 2012.Ligase detection reaction was performed to test the genotypes in 240 T2DM patients and 227 controls.Unconditioned logistic regression analysis was used to explore the association of FXR gene polymorphisms with the risk of T2DM in different genetic models, after adjusting for age, sex, smoking and drinking status. Results Compared with AA genotype, GG significantly increased the risk of T2DM (P=0.017), while GA+GG approached marginal significance in association with T2DM (P=0.049) in rs1030454.For rs10860598, GA reduced the incidence of T2DM (P=0.025) compared with AA genotype, while GA+GG had marginal significance with T2DM (P=0.049).For rs11110411, CT or CT+CC could reduce the risk of T2DM compared with TT with P value of 0.016 and 0.024 respectively.Compared with AA, GA or GA+GG in rs17030270 was negative with the risk of T2DM with P value of 0.018 and 0.032 respectively. Conclusion FXR gene polymorphisms are associated with the risk of T2DM in northern Chinese Han population and the variation of FXR gene may play a role in the pathogenesis of T2DM.
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Objective Though paraquat (PQ) is highly toxic, there is still no effective treatment for PQ poisoning .The aim of the article was to study the protective effect and mechanism of the p 38 mitogen-activated protein kinase ( MAPK) inhibitor SB203580 on PQ-induced acute lung injury in rats . Methods 72 SD rats were randomly divided into three groups ( n=24 ): normal saline (NS) group, PQ poisoning group and p38 inhibitor SB203580 intervention (PQ+SB) group.The arterial blood gas analysis, lung wet and dry ratio (W/D),the expression of tumor necrosis factor-α(TNF-α), the superoxide dismutase (SOD) level and the pathological changes of lung tissues were recorded at different time points after drug intervention . Results On the 1st , 3rd, 5th days after drug intervention in PQ group, the alveolo-arterial oxygen partial pressure difference (PA-aO2) [(45.67 ±4.17), (68.78 ±6.63), (80.23 ±7.12 ) mmHg ], the lung tissue TNF-αexpression (14.63 ±3.10], [18.24 ±2.98], [16.22 ±2.79] pg/mg) and W/D ([4.931 ±0.034], [5.020 ±0.064], [5.079 ±0.016]) in-creased gradually to a peak on the 3rd day, while the SOD level de-creased respectively on the 1st , 3rd, 5th days after drug intervention ([175.26 ±7.98], [167.57 ±8.05], [160.24 ±6.78] U/ug) (P<0.05).Compared with PQ group, PQ+SB group got a decrease in the PA-aO2([80.23 ±7.12] vs [44.17 ±4.16]), the lung tissue TNF-αexpression ([16.22 ±2.79] vs [9.48 ±2.72]) and W/D ([4.805 ±0.070] vs [5.079 ±0.016]) (P<0.05), while the pulmonary SOD level increased in comparison with PQ group ([125.89 ±6.65] vs [160.24 ±6.78]) (P<0.05). Conclusion The p38MAPK inhibitor SB203580 plays a certain protective role in PQ-induced acute lung injury by reducing inflammation and improving antioxidant capacity .
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Objective To observe the effects of penehydidine hydrochloride (PHC) on t acute lung injury ( ALI) . To investigate into the expression of TLR4 on peripheral monocytes, kinetics of inflammatory and anti- inflammatory mediators. To explore the mechanism of TLR4 in ALI. Method A total of 45 patients with ALI were randomly divided into PHC treatment group(experimental group, n =21) and routine treatment group (control group, n = 24) . Patients of both groups were given with the routine treatment,and patients in experimental group were given with PHC in addition (1 mg,im,ql2h) . Therapeutic effects, average length of hospital stay, ICU stay,PaO_2 and PaO_2/FiO_2 > as well as the expression of TLR4 and some cytokines were observed for 48 hours. Results Patients of both groups got better gradually after treatment. The PaO_2 and PaO_2/FiO_2 of patients of both groups progressively increased. At 6 hours, 12 hours, 24 hours and 48 hours after treatment, the PaO_2 and PaO_2/FiO_2significantly increased than 0 hour ( P < 0.05). The improvement in experimental group was obviously better than that in control group at 6 hours, 24 hours and 48 hours after treatment (P < 0.05). There were no differences in average length of hospital stay between the two groups. The ICU stay was significantly shorter in the experimental group ( P < 0.01) . The expressions of TLR4 were higher in patients of both groups than in healthy ones (P <0.01) . TLR4 decreased significantly at 24 hours and 48 hours, while it was lower in experimental group than that in the control group (P < 0.05). The higher level of TLR4in the early stage implied worse prognosis. Most of them deteriorated to ARDS stage. At 24 hours, the incidence of ARDS in experimental group was 23.8 % , and 29.17% in control group. Two patients in control group didn' t become ARDS till 48 hours. Serum IL-1, IL-8 and TNF-α level reduced atr 24 hours in both groups. The reduction of IL-8 and TNF-α in experimental group was more obvious than in control group ( P < 0.05). IL-13 increased gradually from 0 hour to 24 hours, then descended a little at 48 hours. There was no difference in IL-13 some difference between the two groups ( P > 0.05) . Conclusions PHC can improve the arterial oxygen pressure, down-regulate TLR4, restrain inflammatory factors in its signal transduction downstream. This inhibitory action is not accomplished by increase in anti-inflammatory factors,but by down-regulating TLR4. PHC can prevent the development of ALI, and can be considered to act as an effective medicine for the treatment of ALI. TLR4 plays an important role in ALT process, and it is suggested that TLR4 can be used as a prognostic factor.
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Objective Using real-time fluorescence quantitative PCR to detect the gene expression of MMP-2,T1MP-1 in the rats' lung intoxicated by paraquat, and to discuss the effect of the MMP-2,T1MP-1 in the acute lung injury and pulmonary fibrosis afltr paraquat intoxication. Method Eighty Sprague-Dawley rats were randomly divided into control group and the intoxication group. The rats of the control group were given equivalent volume of normal saline, and the rats of the intoxication group were given a intraperitoneal injection of paraquat(18 mg/kg) . At 1,3,5,7,14 and 28 days after intoxication, the pathological changes were observed under the light microscope and the expression of MMP-2, TTMP-1 mRNA in the rats lung were detected by using real-time fluorescence quantitative PCR. Results Compared with the control group, in the early days after intoxication, the lung tissue of the intoxication group showed obvious inflammation, pulmonary edema and bleeding. Five daye after intoxication, pulmonary fibrosis could be ideatified and the fibrosis became obvious. At 28 days later the expression of MMP-2 mRNA was remarkably increased in lung tissue from the day of intoxication, and reached the peak 7 days later, It was control group, that in and then gradually, declined however, higher than that in control group (P < 0.01). The expression of TIMP-1 mRNA in lung tissue was also higher than the control group on the day 1, then increased gradually, reached the peak on day 14,7.28 times more than the control group, decreased from the fourteenth day,higher than the control group on day 28 (P < 0.01) . Conclusions MMP-2,TIMP-1 played a very important role in the acute lung injury induced by paraquat, meanwhile the development of pulmonary fibrosis had great relations on their disproportion.
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Objective:To investigate the relation between the AT 1 receptor gene polymorphism and some biochemical indices of essential hypertension patients. Methods:Sixty-four patients of mild-moderate essential hypertension were not given any anti-hypertension drugs for 5 half lives,then used the PCR-RFLP to detect the AT 1 receptor gene type and measured the basic blood pressure at the same time. After that, fasting serum glucose , serum total cholesterol(TC) , triglyceride(TG) , high-density lipoprotein cholesterol(HDL-C) , low-density lipoprotein cholesterol(LDL-C) , blood urea nitrogen(BUN) , creatinine(Cr) were measured in all subjects. Results:①The frequency of AC gene type in these essential hypertension patients and the C1166 allete of AT 1 receptor gene was 23.4% and 11.7%. ②There was a remarkable difference on TG between two gene groups. ③There were obvious difference on Cr and UA between two gene groups .④There were no obvious difference on Glu, TC ,HDL-C ,LDL-C ,BUN between AC and AA gene type. Conclusion:①The concentration of TG of AC gene type is lower than that of AA , there may be relativity between two gene type. ② A1166/C gene polymorphism may be associated with renal function. AA gene type may have poorer renal function. ③A1166/C gene polymorphism may be not relative with Glu,TCH ,HDL-C ,LDL-C ,BUN.
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Objective:To determine the half lethal dose(LD50) of paraquat in rats and to establish a relatively safe and stable pathological animals model of pulmonary fibrosis.Methods: Ninety-six SD rats totally in half genders.Fifty SD rats in half genders were randomly divided into 5 groups,each had 10 rats.Feed the rats with different doses of liquor of paraquat intraperitoneally one time and definite the half lethal dose of one and two weeks.After that,prepare another forty-six SD rats,also in half genders,as intonication group,twenty-eight rats were treated with the liquor of paraquat in dosage of 18 mg/kg intraperitoneally.As control group,sixteen rats were treated with equivalent volume of normal saline.Observe the toxic symptom daily and rats were sacrificed on day 1,3,5,7,14,21,28,35 and 42 respectively for the histological examination.Results: The half lethal doses of intraperitoneal paraquat of 1 and 2 weeks were 18.27 and 17.29,with 95% confidence intervals of 16.61-20.09 and 15.99-18.67,respectively.After intraperitoneal paraquat injection at the dose of 18 mg/kg,typical toxic symptoms were observed at different times in the rats.The whole process of acute lung injury and fibrosis induced by paraquat intoxication could be seen with the naked eyes or under the light microscope.Conclusion: Paraquat has a strong toxicity to rats.A proper dose of paraquat solution can not only reduce the number of experimental rats,but also induce typical pulmonary fibrosis in rats.
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Objective: To evaluate the effect and safety of continuous veno-venous hemofiltration(CVVH) in the treatment of multiple organ failure(MOF) in senile patients.Methods: Sixteen patients with multiple organ failure,aged over 80 years,were divided into a survival group,who lived more than 20 days,and a non-survival group,less than 20 days after CVVH,and observed for such clinical indexes as of renal function,K+and blood gas analysis,APACHEⅡ scores and complications.Results: After CVVH,eleven of the patients survived for over 20 days,with 1 case up to 3 years.CVVH effected a significant improvement in BUN,Scr,K+and blood gas as well as a marked reduction in complications.APACHE Ⅱ scores decreased significantly after CVVH in the survival group though not in the non-survival group,as compared with those before CVVH,which were significantly lower in the former than in the latter.Conclusion: CVVH is a safe,effective and well-tolerated method for the treatment of MOF in senile patients.Patients with higher APACHEⅡscores have a poor prognosis.
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0.05).The data of nitrogenous retention rate,net nitrogenous utililizing rate and cumulative nitrogen balance showed that there was significant difference in Group G comparing with Group N and Group V respectively( P
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Objective: To investigate the value of double source CT(DSCT)in the diagnosis of myocardial bridge(MB)and analyze the correlation of MB-associated coronary atherosclerotic plaque with age.Methods: A total of 417 patients suspected of coronary artery disease(CAD)were divided into a young group(n=137,30-44 yrs),a middle-aged group(n=197,45-59 yrs) and an old group(n=83,60-84 yrs),subjected to DSCT coronary angiography,and analyzed for the differences in the incidence of MB and coronary atherosclerosis.Results: Altogether 76 cases(18.2%) were diagnosed as MB,10(13.2%) in the young,36(47.4%) in the middle-aged and 30(39.5%) in the old group.Of the MB patients,41(53.9%) were complicated with coronary atherosclerotic plaque,2(20.0%) in the young,17(47.2%) in the middle-aged 22(73.3%) in the old group.There were significant statistical differences in the incidence and the nature of coronary atherosclerotic plaque among the 3 groups(P
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Objective:Studies suggested that some growth factors and their receptors play important roles in the treatment and prognosis of lung cancer.In this study we investigated the expression of epidermal growth factor receptor(EGFR),vascular endothelial growth factor(VEGF),and Ki-67 simultaneously in the tissues of aged patients with non-small cell lung cancer(NSCLC). Methods:The expression levels of EGFR,VEGF,and Ki-67 in 64 cases of aged patients with NSCLC were detected by immunohistochemistry staining.Results:The positive expression of EGFR,VEGF and Ki-67 in the tissue of lung cancer was 59.4%,57.8% and 92.2%,respectively.It is different significantly while compared with control group of benign tissues.The expression levels of EGFR and VEGF are correlated significantly with the pathologic type,differential degree,TNM stage and lymphatic metastasis.The expression level of Ki-67 is related to differential degree and TNM stage of lung cancer.Conclusion:The method of immunohistochemistry to detect multiple biological markers simultaneously is simple and feasible.It can supply important information for the staging and prognoses of patients with NSCLC,and more than that,it can also provide the theoretic basis for the individualized molecular targeting therapy of NSCLC.
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OBJECTIVE: To evaluate the role of MHC II expression in posttrauma immune disturbances and infections. METHODS: In experimental study, peritoneal macrophages were harvested from traumatized mice and treated with GM-CSF, Ia molecules were determined by flow cytometry. In 24 trauma patients, monocyte HLA-DR expression was measured by APAAP technique. RESULTS: Marked inhibition of MHC II molecule expression was found in both traumatized mice and patients. In traumatic patients with infection, the inhibition was more severe. Treatment with GM-CSF in mice partially restored the Ia expression. CONCLUSIONS: Inhibition of MHC II molecules plays an important role in postrauma immune disturbances. There is a close relationship between HLA-DR inhibition and clinical infections.
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Objective: To investigate the effect of enteral nutrition on proliferation of colon mucusa in long fasting patients. Methods: Ten patients fasted over two weeks were selected.All patients had no any histories of chemotherapy, radiotherapy and immunosuppressive therapy.They received enteral nutrition for tow weeks. Before and two weeks after enteral nutrition,specimens were obtained between sigmoid and descending colon by colonofibroscope.All specimens of colon mucosa were determined by FCM for proliferation index (PI),S phase factor (SPF)and aptosis(Apto). Results: PI,SPF and Apto were ( 4.010 ?1.290)%,(1.904?2.679)% and (1.913?2.021)% in patients fasted over two weeks respectively, and (7.337?2.679)%,(5.367?3.211)% and (1.208?1.488)% after enteral nutrition for two weeks. Conclusions: Enteral nutrition could improve the proliferation of colon mucosa in long fasting patients.
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Objective To monitor the systemic gene expression profile in a murine model of li-popolysaccharide (LPS)-induced acute lung injury by the recently modified long serial analysis of gene expression (SAGE) so as to discuss the molecular mechanism of acute lung injury. Methods Acute lung injury was induced by intra-tracheal injection of LPS (25 mg/kg). Control mice were given normal saline in same volume. Animals were killed at 24 hours after the administration of LPS and lungs were harvested en bloc for SAGE study. Results A total of 24 670 tags representing 12 168 transcripts in the control mice and 26 378 tags representing 13 397 transcripts in the mice with lung injury were identified respectively. There were 11 transcripts increased more than 10 folds, 107 transcripts 5-10 folds and 2 121 transcripts 2-5 folds in the LPS-treated mice. But seven transcripts decreased to 1/10, 87 transcripts to 1/10-1/5 and 1 571 transcripts to 1/5-1/2. The most overexpressed genes in the lung injury mice mainly included serum amyloid A 3, metallothionein 2, lipocalin 2, cyclin-dependent kinase inhibitor 1A, lactate dehydrogenase 1 , melatonin receptor, SI00 calcium-binding protein A9 and natriuretic pep-tide precursor. Mitogen activated protein kinase 3, serum albumin, complement component 1 inhibitor, and ATP synthase were underexpressed in the lung injury mice. Conclusion The changes of various genes as well as some unreported genes have been confirmed in the LPS-induced acute lung injury. Further studies of these unreported genes are beneficial to better understanding the mechanism of acute lung injury and may provide useful markers for clinical diagnosis.