Objective To evaluate the quality status of recombinant human interferon α1b injection and find out some quality problems.Methods Totally 31 batches of recombinant human interferon α1b for injection and 11 batches of recombinant human interferon α1b injection from two enterprises were examined according to Chinese Pharmacopoeia Volume Ⅲ (2010),and the quality status of recombinant human interferon α1b injection was evaluated by statistical analysis of the results.Results All 42 batches of samples were qualified.The production process of each enterprise was steady.Conclusion At present the quality of recombinant human interferon αlb injection is generally good.The current standards are feasible,but the specified standard of osmolality needs to be improved.

In order to investigate the hygienic characteristic of anti-immersion trousers, ten male soldiers dressed in the trousers or in camouflage trousers were subjected to exercise test and sedentary test respectively at room temperature of 17?2℃. In the test, eleven parameters such as core temperature, skin temperature, heat flow and so on were observed. The results indicated that in sedentary tests, the low limb heat flow of the subjects dressed in anti-immersion trousers was larger than that dressed in camouflage trousers; the heat insulation value of anti-immersion trousers was smaller than that of camouflage trousers; and for the other parameters, there was no evident difference between the two group. It suggested that when used on land, hygiene characteristic and effect on body heat balance of the anti-immersion trousers were similar to those of camouflage trousers.

Objective To investigate the supply of iodized salt in non-excessive iodine counties and iodine-free salt in excessive iodine counties at household level in Jiangsu Province so as to provide a basis for the prevention and control of iodine deficiency disorders(IDD).Methods According to the National Iodine Deficiency Disorders Monitoring Program(Trial),county(city,district) was taken as a elementary sampling unit in Jiangsu Province.Townships(towns) and administrative villages were selected by systematic sampling and random sampling in every county and households were chosen by random sampling to collect their edible salt samples.The salt iodine content in non-and excessive iodine regions was detected by direct titration method and semi-quantitative method,respectively.Results All 30 840 salt samples were collected from 106 non-excessive iodine counties,and qualified iodized salt was 30 303 copies,iodine-free salt 199 copies.Weighted by the population of counties,the rate of iodine-free salt was 0.71％,the coverage rate of iodized salt accounted for 99.29％,out of which,98.93％ was qualified and the consuming rate of qualified iodized salt was 98.23％.All 1296 salt samples were collected in 5 counties with excessive water iodine content and the coverage rate of iodine-free salt was 98.99％ (1283/1295).Conclusions The national targets for preliminary elimination of IDD have been achieved in regions of nonexcessive and excessive iodine of Jiangsu Province.But it still should be strengthen the management work of iodinefree salt in excessive iodine counties and iodine saft in non-excessive iodine counties.

Objective To determine the cardiac and renal arteriole pathological changes in autopied elderly hypertensive patients with left vcntricular hypertrophy (LVH).Methods Autopsy samples from 25 essential hypertension (EH) patients with LVH aged over 60 years and age-matched 8 controls were analyzed.LVH was further divided into three degrees from Ⅰ to Ⅲ according to left ventricular free wall thickness in EH patients.Quantitative measurements of arteriolar morphometric parameters in heart and kidney were performed under light microscope with computer image analysis post HE and Maeson staining.The lesion index and plasma albumen infiltration of arteriole were evaluated by the semiquantitative method.Results The inner diameter (ID) and lamina] cross-sectional area (LCSA) were significantly decreased while wall thickness (WT),wall cross-sectional area (WCSA),ratio of WCSA to LCSA (WCSA/LCSA) and ratio of WT to ID (WT/ID) were significantly increased in EH patients in proportion to LVH degree.Both cardiac and renal arterioles WCSA/LCSA and WT/ID were significantly decreased with increasing outer diameters (OD).Under the same OD rang,the pathological changes were more significant in the renal arterioles compared to those in the cardiac arterioles (P＜0.05).The arterio]ar lesion index and the plasma albumen infiltration index of cardiac and renal arterioles in EH group were significantly higher than those in the control group (P＜0.01) and the arteriolar lesion index and the plasma albumen infiltration of arteriole in the renal tissue were significantly higher than those in the cardiac tissue (P＜0.01).Conclusion Concentric remodeling occurs in the cardiac and renal arterioles of EH patients in proportion to LVH degree and renal arterioles lesions were significantly severer than that of cardiac arterioles in EH patients with LVH.

Objective To quantitatively analyze total hepatitis B virus (HBV) DNA (HBV tDNA),covalently closed circular DNA (cccDNA) and HBsAg in patients with chronic hepatitis B (CHB),HBV-related liver cirrhosis (LC) and hepatocellular carcinoma (HCC),and to analyze the characteristics.Methods HBV tDNA and HBV cccDNA in the serum and liver biopsy samples were measured in 21 CHB,23 LC and 25 HCC patients by real-time polymerase chain reaction (PCR) assay. HBsAg titer was measured by chemiluminescence. Normally distributed variables among multiple groups were analyzed by ANOVA and t-test.Correlation between two variables was tested using Pearson correlation analysis.Skewed distribution was tested using Rank sum test.Results In CHB,LC and HCC patients,the serum HBV tDNA levels were (5.38±2.08),(4.96± 1.65) and (4.18 ± 0.91) lg copy/mL,respectively; the intrahepatic HBV tDNA levels in three groups were (7.18±1.91),(6.51±1.87) and (5.87± 1.47) lg copy/ug,respectively; the intrahepatic HBV cccDNA levels were (3.53±2.03),(2.63±2.13) and (0.58± 1.40) lg copy/μg,respectively; the serum HBsAg levels were (3.30±0.65),(3.12±0.52) and (2.60± 1.03) lg IU/mL,respectively.In CHB patients,the serum HBV tDNA,intrahepatic HBV tDNA,HBV cccDNA and HBsAg levels were all significantly higher than those of HCC patients (t=2.446,P=0.013; t=2.562,P=0.014;t=5.799,P＜0.01 ; t=2.709,P=0.003,respectively).However,only intrahepatic HBV cccDNA and HBsAg levels were statistically different between LC and HCC patients (t=-3.894,P＜0.01;t=-2.237,P=0.023,respectively).HBV cccDNA was all negative in the serum of 69 patients.The serum HBsAg level was positively correlated with serum HBV tDNA (r=0.290,P=0.016),intrahepatic HBV tDNA (r=0.372,P =0.002) and intrahepatic HBV cccDNA (r=0.378,P=0.001).Conclusions The levels of HBV tDNA,HBV cccDNA and HBsAg decrease gradually with the disease progression.The serum HBsAg level is positively correlated with serum HBV tDNA,intrahepatic HBV tDNA and intrahepatic HBV cccDNA.

Objective The present study was to differentiate the hyperdensities on CT immediately after intra-arterial thrombolysis in patients with acute isehemic stroke.Methods Twenty two patients with acute ischemic stroke were treated with intra-arterial combining with intravenous thrombolysis within 6 hours after onset.All patients underwent nonenhaneed CT scans before,immediately and 24 hours after thrombolytic therapy.The hyperdensities on CT after intra-arterial thrombolysis were analyzed retrospectively.Results Five hyperdense areas were seen in 22 patients immediately after thrombolytie therapy.According to their locations, CT values and follow-up CT scans,the hyperdensities on CT imaging were classified into two groups:contrast enhancement and hemorrhagic transformation.The former was characterized by rapid clearance of the hyperdensity lesion with maximum Hounsifild Unit＜90,on the contrary,the latter was noted by persistence of hyperdensity lesion after 24 hours CT scan with maximum Hounsifild Unit＞90.Two of the five hyperdense lesion patients were confirmed to be contrast enhancement with location in cerebral cortex,the other were hemorrhagic transformation,mostly located in basal ganglia.Hyperdensity in patients with contrast enhancement showed neurological improvement although no further medical cares were offered.Conclusions Different kind of hyperdensity on CT immediately after intra-arterial thrombolysis in patients with acute ischemic stroke can be differentiated according to its location,CT value and follow-up CT scan.When contrast enhancement occurred,no further medical care is needed.

Objective To explore the prevalence satate of children in burning coal endemic fluorosis in Zhijin county of Guizhou province, provide the scientific basis for the prevention of skeletal fluorosis.Methods One thousand six hundred and sixteen children in school under 16 years old that were sampled in cluster sampling were examined with dental fluorosis,X-ray in the type of burning coal pollution fluorosis areas of Zhijin county Guizhou province.Results Total prevalence rate of dental fluorosis was 96.42%,prevalence rate of skeletal fluorosis was 7.49%, constrictive skeletal fluorosis was main type in Zhijin county Guizhou province.Conclusion Prevalence states of dental fluorosis and skeletal fluorosis are still serious, more effectual preventive and control measure shall be used.

AIMTo investigate the mechanism of the vascular endothelial cell (VEC) injury caused by freezing/thawing.

METHODSThe frozen/thawed neutrophil (PMN) model was founded by freezing PMNs with a rate cooling instrument and then rewarming them in a water bath, the PMNs used here were separated from rat's peripheral blood using density gradients centrifugation techniques. The expression of LFA-1 on the surface of frozen/thawed PMNs was observed at 4 h,12 h and 24 h after freezing/thawing. After co-incubating untreated VECs with frozen/thawed PMNs, we detected the VEC injury and the changes in PMN-VEC adhesion.

RESULTS(1) The PMNs LFA-1 expression increased in a time-dependent manner within 24 h after the freezing/thawing of PMNs. (2) After co-incubating untreated VECs with frozen/thawed PMNs, the adhesion between frozen/thawed PMNs and VECs increased and VEC injury occurred. (3) Monoclonal antibody against LFA-1 could block the PMN-VEC adhesion and subsequently attenuated the VEC injury.

CONCLUSIONThe freezing/thawing of PMNs can elicited an increase in PMN LFA-1 expression and trigger the PMN-VEC adhesion and subsequently bring about the VEC injury.

Animals ; Cells, Cultured ; Endothelial Cells ; cytology ; Freezing ; Lymphocyte Function-Associated Antigen-1 ; metabolism ; Neutrophils ; cytology ; metabolism ; Rats ; Rats, Wistar

OBJECTIVETo evaluate the performance of BNII auto-analyzer system in detecting C3 and C4.

METHODSCLSI protocols (EP15-A, EP6-A, EP9-A2) and other relevant literatures were use to or evaluate the precision, accuracy, linearity of C3 and C4 detection by the auto-analyzer system, and the results were compared with the recognized standards.

RESULTSThe relative bias of C3 and C4 was less than one third of the CLIA'88 standard and the precision met the clinical requirement. The results tested by DADE BNII system were not compatible with those by Roche Modular System. C3 showed good linearity in the tests (R2>0.975, P<0.05) with a linearity range of 0.18-5.1 g/L. The linearity of C4 was not available because of lack of high-level samples.

CONCLUSIONThe performances of DADE BNII System basically meet the recognized standards in clinical detection of C3 and C4, but the method comparison needs further validation.

Autoanalysis ; methods ; Blood Chemical Analysis ; instrumentation ; methods ; Complement C3 ; analysis ; Complement C4 ; analysis ; Humans ; Nephelometry and Turbidimetry ; instrumentation ; methods ; Proteins ; analysis ; Sensitivity and Specificity

Objective To establish a method performance verification project and experimental method for the clinical chemiluminescence immunoassay.Methods Referring to CLSI evaluation protocols and pertinent literature,and by combining our actual works,we designed a verification procedure and experimental method.By Using these above,the precision,accuracy,analytical sensitivity,analytical measurement range,clinical reportable range and biotic interval of AFP on the Bayer Centaur 240 chemiluminescence immunoassay system were verificated.Results would be compared with the declaration of the manufacturer or desirable specifications derived from biologic variation.Results The results showed that the between-day inaccuracy on AFP levels at 77.4 ng/ml and 168.0 ng/ml was 5.70% and 4.84% respectively,these were consistent with manufacturer's inaccuracy claimed.The relative bias between the results measured for calibrator at four levels and target value was less 5.0%,and the relative bias between the results measured for EQA control sample at five levels and target value was-3.4% to 11.9%.Lower limit of detection was 1.04 ng/ml,lower slightly manufacturer's analytical sensitivity claimed.Biologic limit of detection was 2.65 ng/ml-3.53 ng/ml,functional sensitivity was 3.53 ng/ml.Analytical measurement range was 3.53-912.00 ng/ml,within manufacturer's liner range claimed.Clinical reportable range was 3.53-182 400.00 ng/ml.Reference interval was 0.6-7.7 ng/ml,within manufacturer' s claimed.Conclusions The main performances of the detection system are accorded with the declaration of the manufacturer.The performance verification procedure and experimental method of our research ars simple and practical,which has important significations for building medical laboratory and laboratory accreditation, improving quality of the chemiluminescence immunoassay.