Objective:Recently,selenium was used for the treatment of Graves disease. However,there has been no reports that selenium affected the immune function of Graves disease at the cellular level so far. It is reported the effect of sodium selenite on Treg cells in peripheral blood mononuclear cells in patients with Graves disease in the present study. Methods:AFS were used to detect the level of serum selenium;PBMC( Peripheral blood mononuclear cells) were extracted,then,cultured with sodium selenite. Foxp3 mRNA expression was tested by Real-time fluorescence PCR,and ELISA was used to detect the secretion of IL-35. Results:The serum sodium selenite levels of GD group are significantly lower than the HC group;The expression of Foxp3 mRNA and secretion of IL-35 are both increased. Conclusion:It shows sodium selenite could improve the state of immune disorders by recovering the function of Treg cells.

The immune nutrients play an important role in nutritional support,immune regulation and maintenance of intestinal barrier function.In recent years,with the deepening study,the effect of immune nutrients in the comprehensive cancer treatment has constantly being recognized.Many studies have shown that glutamine (Gln),arginine (Arg) and polyunsaturated fatty acids (PUFA) have effect on the tumor itself and the combination cancer chemotherapy.

The bioactivity of a working reference standard was determined by replicate bioassays with calibration against a primary reference standard. In this study the number of bioassay replicates needed for calibration first was calculated theoretically, and if the mean value of the experimental bioassay replicates fell within the predefined bioactivity level the bioactivity of the working reference was defined as 100%. Our results showed that when the total intermediate precision of the bioassay method was at 11.66% and the predefined bioactivity level was set at 95%-105% with a confidence level of 95%, 21 bioassay replicates should be carried out for calibration. The average value of the 22 experimental bioassay replicates was 101.96%, so the bioactivity of the working reference standard was consistent with that of the primary reference standard at 100%. The results suggest that a strategy of first calculating the number of bioassay replicates needed for calibration and then determining whether the resulting experimental mean value is within the predefined bioactivity level will be of value to the biopharmaceutical industry.

Objective To investigate the expressions of transferrin receptor (TfR) mRNA, ferritin(Fn) mRNA and iron regulatory proteinl (IRP-1) mRNA in the placentas complicated with fetal iron deficiency(ID). Methods Depending on the cord SF,the subjects were divided to fetal ID group and fetal iron sufficient( IS) group. TfR mRNA, Fn mRNA and IRP - 1 mRNA in placentas were measured by RT - PCR. Results 1. The expression of TfR mRNA in ID group was 1.10 ? 0. 26, it was significantly higher than that in IS group (t=0.028 P0.05) ;4. TfR mRNA and Fn mRNA correlated with fetal IS respectively. Conclusion Fetal ID induces highly expressed TfR mRNA and lower level of Fn mRNA to furthest satisfy the iron need for fetus.

Objective To investigate the bone metabolism of children with leukemia and its relationship to tumor necrosis factor-?(TNF-?)pre-and post-treatment.Methods Serum bone gla protein(BGP),the excretion rate of urianry deoxypyridinoline(DPD)and TNF-? were measured in 35 children with leucocythemia pre-and post-treatment and 30 normal children(control group).Results The results showed that BGP,the excretion rate of DPD and TNF-? in children with leucocythemia before treatment were significantly higher than those in control group.However,the excretion rate of DPD decreased after chemotherapy but still significantly higher than that of control group(P0.05).Conclusions In children with leukemia,there are bone absorption and bone dissolution before chemotherapy,while there is osteogenesis dysfunction and bone absorption after chemotherapy.TNF-? can be used as a parametre for evaluating treatment effect and monitoring relapse.

OBJECTIVE: To analyze the trend in quality control of anti-HER2 monoclonal antibody. METHODS: The biological activity of anti-HER2 monoclonal antibody (mAb) was monitored by the proliferation inhibition with CellTiter 96® AQueous Assay kit using BT474 cells as target, and the potency of anti-HER2 mAbs was calculated by comparison with the reference standard using the method of parallel analysis. Cation exchange chromatography method was used to detect the purity by calculating the area percentage of the main peak according to the area normalization method. Ultraviolet spectrophotometry was used to detect the protein content. And pH was detected by potential method. The warning limit (x±2s) and action limit (x±3s) were defined according to the determination results of several batches of anti-HERmAb by National Institutes for Food and Drug Control (NIFDC) and the quality control laboratory of manufacturer, based on which the trend graph was plotted, and the consistent and periodic trend of anti-HER2 mAb were analyzed. RESULTS: The potencies of 74 batches of anti-HER2 antibodies from a certain enterprise during 2012 to 2014 were analyzed. The products and reference standard both showed a dose-response effect in biological activity, presenting parallel straight lines on semilog coordinate paper. The potencies determined by NIFDC and the manufacturer were (1.04±0.11)×104 and (0.94±0.08)×104U·mg-1, respectively. And the protein contents were (442.15±13.59) and (442.07±6.60) mg·vial-1. The main peak areas of IEC-HPLC were (76.29±1.36)% and (73.76±1.17)%, while the pHs were (6.16±0.11) and (6.22±0.08), respectively. The consistent and periodic trend analysis of the above-mentioned results showed that the total trend was relatively steady. CONCLUSION: This is the first time to conduct trend analysis of critical quality attributes (CQA) of anti-HER2 monoclonal antibody. These results reveal the quality changes of the products, which would help a lot in evaluating the batch consistency and production stability, and also provide reference for trend analysis of critical quality attributes for other monoclonal antibodies.

ObjectiveTo investigate the efficacy of combined therapy of mild hypothermia and hibernation to treat severe brain injury. Methods24 patients with severe brain injury were randomly divided into combined therapy group and normothermia group. Glasgow Coma Scale scores of all the patients were in the range of 3 to 8. No later than 10 hours after their injury, hypothermia patients were given half dosage of No.1 hibernation cocktail and had been cooled by cooling blankets to 32℃-34℃ (rectal temperature) for 5 days, then to 35℃ for 24 hours, and slowly increased to their normal level. 3 days and 7 days after their admission, intracranial pressure,creatine phosphate kinase,partial pressure of arterial O2 and CO2, platelet and Na+,K+ were measured.7 days after their admission, Glasgow Outcome Scale scores of each patient and mortality of each group were measured. ResultsThe mortality of combined therapy group(25.0%) was significantly lower than that of normothermia group (66.6%,P<0.05). The decreased values of intracranial pressure, creatine phosphate kinase and platelet number of combined therapy group were all significantly higher than that of normothermia group respectively (P<0.05). There were no significant difference in mean artery pressure, blood electrolyte, and partial pressure of arterial O2 and CO2 between these two groups(P>0.05). ConclusionThe combined therapy of mild hypothermia and hibernation can effectively reduce the mortality of patients with severe brain injury as it is much easier, less invasive and with less complications.

Objective To investigate the cardiac protection effect of venous fructose-1,6-diphosphate in pa-tients with primary bone malignant tumors. Methods 178 patients received 9 times of chemotherapy were randomly divided into non-cardiac protective therapy group (A group)and cardiac protective therapy group(B group). The car-diac toxicity was reflected by abnormal electrocardiographic changes. The abnormal electrocardiographic changes were compared in two groups. Results Abnormal electrocardiographic changes were significantly decreased in B group eompared with A group (30 vs 81 ,P <.05). Conclusion The cardiac protective medicine fructose-1,6-diphosphate efficiently decreased the cardiac toxicity in patients with primary bone malignant tumors treating with chemotherapy.

Objective To explore the relationship between brachial ankle pulse wave velocity (BaPWV) change and carotid artery plaque formation in middle-aged and elderly patients with essential hypertension(EH).Methods A cross sectional study was conducted in 409 patients who were admitted in Hypertension Department in our hospital from January to September 2013.Their age ranged from 35 to 75 years,with mean aged(53.2±15.0) years.Parallel carotid artery ultrasound and BaPWV examination were performed in all patients.According to whether carotid plaques were present,patients were divided into two groups:carotid plaque group and control group.And carotid plaque group was sub-grouped into normal BaPWV group (BaPWV ＜ 1400cm/s) and increased BaPWV group(BaPWV≥1400 cm/s) according to BaPWV levels.The detection rate of carotid plaque was compared between normal BaPWV group and increased BaPWV group.The correlation between BaPWV and carotid plaques was analyzed by multivariate logistic regression analysis.Results Compared with the control group,carotid plaque group showed the prevalence of carotid plaques was increased along with the increases of age(t=11.0,P=11.0),systolic blood pressure (t=3.87,P=3.87),diastolic blood pressure(t=3.70,P=0.00),pulse pressure(t=6.13,P 6.13),total cholesterol levels(t=2.57,P=0.01).The detection rate of carotid plaque was higher in increased BaPWV group than in normal BaPWV group [62.6％(159/254) vs.43.2％(67/155),x2=14.61,P=0.00].After adjusting for age,blood pressure and other cardiovascular risk factors,the multivariate logistic regression analysis showed that increased BaPWV was an independent risk factor for carotid plaques(OR=2.06,P=0.05),and age,smoking,systolic pressure,diastolic pressure,pulse pressure,total cholesterol,low-density lipoprotein cholesterol,triglyceride levels were positively correlated with carotid plaques.Conclusions BaPWV is one of the independent impact factors for carotid plaques,which plays an important role in early diagnosis and screening for subclinical vascular lesions.

OBJECTIVE:To explore the effects of PDCA(plan,do,check,action)cycle theory in the ADR monitoring of our hospital. METHODS:The problems of ADR monitoring in our hospital in 2012 were analyzed and intervened by PDCA cycle. The effects of PDCA cycle were evaluated 1 year later. RESULTS:After implementation of PDCA cycle,we had improved the manage-ment system,brought ADR monitoring into the appraisal of clinical pharmacists,established the networking platform of ADR report-ing,strengthened the training of physicians and nurses,the publicty of ADR information and ADR monitoring of important medi-cine. The number of ADR reports increased by 18.37% in 2013,the proportion of new and serious ADR reports obviously in-creased(increasing from 22.28% to 38.42%);in terms of ADR reporting source,the ADR reporting in wards obviously increased (increasing from 8.16% to 43.84%). The proportion of ADR induced by antibiotics or TCM preparation decreased significantly(re-spetively decreasing from 54.52% to 43.84% and 23.03% to 13.30%);in term of ADR clinical manifestations,the proportion of skin and its appendants involved decreased significantly (decreasing from 53.64% to 39.41%). CONCLUSIONS:The application of PDCA cycle obviously improves the management of ADR monitoring in our hospital.