Objective: Soy products may cause excessive intestinal gas because of soybean oligosaccharides . The effect of recombinant ?-galactosidase on eliminating mouse flatus was observed. Methods:The mouse model of flatulence was set up by ig raffinose and stachyose and the flatulence was investigated by measuring intestinal flatulent volume. Oligosaccharides were examined by TLC test and soybean protein was examined by SDS-PAGE. Results: Raffinose and stachyose can result in mouse flatus and recombinant ?-galactosidase can eliminate it without any effect on soybean protein. Conclusion: Recombinant ?-galactosidase can eliminate flatus, and be used as food additive.

BACKGROUND:Most of the traumatic brain injury and stroke survivors have foot drop and varus deformity, that need to be treated with ankle-foot orthosis. OBJECTIVE:To investigate the advantages and effect of early application of front-ankle-foot orthosis on the walking function of the patients with hemiplegia after stroke. METHODS:The clinical data of 54 patients with hemiplegia after stroke treated in the Changshu No. 2 People’s Hospital from June 2008 to October 2009 were retrospectively analyzed. The patients treated with front-ankle-foot orthosis were the front group (n=28), and the patients treated with rear-ankle-foot orthosis were the rear group (n=26). Al the patients received 10 m maximum walking speed test, and the recovery of walking function of the patients in two groups were observed daily. RESUTLS AND CONCLUSION:There were no patients exited and dead in the observation period. The activities of daily living Barthel index in the front-ankle-foot orthoses group (60.0±12.9) was significantly higher than that in the rear-ankle-foot orthoses group (59.1±10.9), and there was no significant difference in the activities of daily living Barthel index between two groups (P>0.05). For the 10 m maximum walking speed test, the walking speed of (39.6±11.6) m/min in the front-ankle-foot orthosis group was significantly faster than that of (33.0±12.4) m/min in the rear-ankle-foot orthosis group (P<0.05). Front-ankle-foot orthosis is more appropriate for patients with hemiplegia after stroke to improve the walking speed.

Objective To study the effect of inflammatory markers on the level of reactive oxygen species (ROS) and mitochondrial DNA (mtDNA) copy numbers in granulosa cells of patients without polycystic ovary syndrome (PCOS). Methods Fifty patients without PCOS treated with in vitro fertilization and embryo transfer (IVF-ET) were selected in this study. The granulosa cells were extracted and cultured in vitro. Cells were randomly divided into treatment group and control group. The 5 nmol/L interleukin (IL)-1, IL-6 and tumor necrosis factor (TNF)-αwere given to treatment group, and same amount of inflammatory diluted solution was added to control group. The levels of ROS and copy numbers of mtDNA were compared between two groups. Results The ROS levels and mtDNA copy number of granulosa cells were significantly higher in IL-1, IL-6 and TNF-αtreatment groups than those of control group (P<0.05). Conclusion Inflammatory markers of IL-1, IL-6 and TNF-αincrease the level of ROS and damage mtDNA in granulosa cells.

Objective To prepare an influenza A(H1N1) split-virus vaccine and observe its safe-ty and effectiveness. Methods According to the process for preparing seasonal flu split-virus vaccine two batches of vaccine were prepared with the flu A (H1N1) vaccine virus strain recommended by WHO. The pilot products were tested against the requirements of flu split-virus vaccine. Results The quality of the pi-lot vaccine has been tested by National Control Laboratory and conformed to the requirements. Nine hundred and sixty volunteers received one dose of vaccine containing either 15 μg or 30 μg of hemagglutinin. The re-suits indicated the both seroconversion rate and protection rate were higher the 70%. The GMT of HIAb of the volunteers who received 1 dose of 15 μg increased significantly by 15, 39, 37 and 25 times compared to those before vaccination in the age groups of 3-11, 12-17, 18-59 and ≥60, respectively. And 26, 72, 68 and 36 times rise were found in the postvaccinated volunteers of 30 μg group. The total adverse reaction rates of 15 μg and 30 μg dose group were 29.38% and 43.75%, respectively. The grade 2 adverse reaction rates of 15 μg and 30 μg dose group were 6.25% and 15.42%, and the grade 3 adverse reaction rates of 15 μg and 30 μg dose group were 0.83% and 1.46%, respectively. No serious adverse reactions were found. Conclusion The influenza A (H1N1) split-virus vaccine prepared according to the requirements of season-al flu vaccine is safe and effective.

Objective To examine the anticancer effect of a novel histone deacetylase inhibitor (HDACi), JZ004, on colon cancer cells HCT-8 and HT-29, and to investigate the molecular mechanisms of proliferation inhibition and apoptosis induction of cancer cells treated by JZ 004.Methods Colon cancer cells were treated with a series of concentrations of JZ004 .MTT assay was used to detect the proliferation of cancer cells .The cell cycle distribution and apoptosis were deter-mined by flow cytometry .Rhodamine 123 and DCFH-DA were applied to detect the mitochondrial membrane potential (ΔΨm) and reactive oxygen species ( ROS) production.The protein expressions of acetyl-histone H3, p21, cyclin-dependent kinase(CDK)4, Bcl-2, Mcl-1 and Bax were assayed by Western blotting .Results JZ004 was found to inhibit proliferation and induce apoptosis of colon cancer cells in a time-and dose-dependent manner , accompanied by a dose-dependent hyperacetylation of histone H3.JZ004 induced the cancer cell arrest in G 0/G1 phase by increasing the expres-sion level of p21 while CDK4 was downregulated .JZ004 also increased cellular ROS production and reduced ΔΨm by regu-lating the expressions of Bcl-2 family proteins .Conclusion As a novel HDACi , JZ004 effectively inhibits proliferation and increases ROS production to induce apoptosis of colon cancer cells .The results indicate that JZ004 is a potential compound to be developed as an anti-colon cancer agent for clinic application .

Objective:To evaluate the efficacy and safety of regional citrate and heparin anticoagulation in continuous renal replacement therapy (CRRT) in critically ill patients by Meta-analysis.Methods:Randomized controlled trials (RCT) comparing the efficacy and safety of regional citrate and heparin anticoagulation in English or Chinese were retrieved from Medline, Embase, Cochrane library, Web of Science, CNKI, Wanfang Database by electronic and manual search before December 2019. The primary outcomes were mortality and circuit life span, and the secondary outcomes were complications such as bleeding, heparin-induced thrombocytopenia (HIT), metabolic alkalosis, and hypocalcemia. Meta-analysis of the literature was conducted using the methods recommended by the Cochrane Collaboration's software RevMan 5.3 and funnel plot was used to analyze whether there was publication bias in each study.Results:Sixteen RCTs with 1 229 patients were included. Meta-analysis showed that there was no significant difference in mortality between the regional citrate and heparin anticoagulation in CRRT [relative risk ( RR) = 0.95, 95% confidence interval (95% CI) was 0.83-1.09, P = 0.47]. The circuit life span in the regional citrate group was 15.37 hours (95% CI was 10.09-20.65, P < 0.000 01) longer than that in the heparin group. Bleeding risk ( RR = 0.29, 95% CI was 0.19-0.44, P < 0.000 01) and HIT ( RR = 0.35, 95% CI was 0.16-0.74, P = 0.006) were lower in the regional citrate group than those in the heparin group, whereas the regional citrate anticoagulation could cause hypocalcemia ( RR = 4.67, 95% CI was 1.88-11.60, P = 0.000 9). There was no significant difference in the incidence of metabolic alkalosis between the two groups ( RR = 0.76, 95% CI was 0.42-1.37, P = 0.36). The funnel plot showed that there were no significant publication bias in the included studies. Conclusion:Regional citrate anticoagulation could significantly prolong circuit life span and decrease the risk of bleeding, and should be preferentially selected for the CRRT anticoagulation in critically ill patients.

Objective To compare and study the two kinds of quality control methodologies related to intelligent quality management system ( iQM) and traditional quality control , and the quality control performance of iQM equivalent to traditional quality control were evaluated , ensuring the accuracy of the results of blood gas testing.Methods Beijing Chaoyang Hospital of Capital Medical University , Beijing Tiantan Hospital of Capital Medical University , Shanghai Longhua Hospital of Shanghai University of Chinese Medicine, and Sichuan Provincial People′s Hospital, these 4 medical institutions were selected to implement this study.During the period from June 2016 to December 2016, in the routine detection of total 3 712 specimen, the iQM and traditional quality control modes were used simultaneously to calculate the mean values of all blood gas parameters quality controls , SD, CV (%) and Sigma values, to evaluate the quality control performance and difference of the two quality control modes .Results During the process of testing blood gas samples from 3 712 specimen in 4 hospitals, iQM process control solution ( PCS) A, B, C ran 1 089, 7 678 and 154 quality control samples respectively , and 732 external quality control samples were run by traditional quality control mode .Considering the most sensitive parameters of blood gas testing pO 2, iQM PCS A, B, C′s Sigma value are higher than 8, however, the traditional quality control′s Sigma value are less than 6; For parameters pCO2, pO2and Na+, there exists significant difference between two quality control methods (P＝0.004 8,P＝0.000 1,P＝0.004 4,P＜0.01), other parameters pH, K+, Ca ++, Glu, Lac and Hct, there exists no significant difference between two quality control methods (P＝0.250 6, P＝0.062 3,P＝0.034 0,P＝0.346 9,P＝0.186 3,P＝0.823 1,P＞0.01).Totally 22 errors detected by iQM, includes 14 micro-clots and 8 interferences samples, which were not detected by traditional quality control .Conclusions The error in blood gas analysis mainly comes from the pre-analytical phase.iQM enhanced specimen inspection capabilities and make up for the inability of traditional quality control to monitor the quality of specimens , enabling full-scale, real-time, and dynamic monitoring of each specimen , powerful error detection capabilities , and automatic error correction capabilities . Besides, automatic documentation saves staff much time.The system can effectively ensure the accuracy of blood gas test results, meet the quality requirements of related laws and regulations and related industry standards , and also can meet the clinical intended use , providing new ideas for POCT quality management and improvement.

【Objective】 To evaluate the clinical efficacy and safety of one kind of human prothrombin complex concentrate in treatment of patients with hemophilia B. 【Methods】 The clinical data of 36 patients with hemophilia B treated with human prothrombin complex concentrate produced by Shenzhen Weiguang Biological Products Co. Ltd. from May 2018 to April 2019 were retrospectively analyzed, and its clinical efficacy and safety were analyzed. 【Results】 A total of 35 subjects entered the full analysis set (FAS)and safety set (SS), 33 subjects entered the per protocol Set (PPS). Thirty minutes after the first infusion of FAS subjects, the activity of coagulation factor Ⅸ increased from (3.93±0.975) IU/dL to (25.61±9.337) IU/dL, and the infusion efficiency was (96.43±22.007)%. The increased value of coagulation factor Ⅱ activity was (73.25±14.874) IU/dL. The activity of coagulation factor Ⅶ was (42.79±16.847) IU/dL. The increased value of coagulation factor Ⅹ activity was (65.29±17.042) IU/dL. The increased value of coagulation factor Ⅸ activity was (21.68±9.434%) IU/dL. Twenty-four hours after the first infusion of FAS subjects, the improvement of bleeding symptoms and signs was excellent in 21 cases (60%), improved in 14 cases (40.0%), and the effective rate was 100%. The incidence of adverse reactions was 2.9%(1/35), and there was no antibody to human coagulation factor Ⅸ and new virus infection. 【Conclusion】 Infusion of human prothrombin complex concentrate produced by Shenzhen Weiguang Biological Products Co. Ltd. in the treatment of hemophilia B has significant clinical efficacy and good safety.

【Objective】 To evaluate the efficacy and safety of human coagulation factor Ⅷ developed by Shenzhen Weiguang Biological products Co, Ltd in the treatment of patients with hemophilia A. 【Methods】 A prospective, multi-center, open, single-group clinical study was conducted. A total of 65 subjects with hemophilia A were enrolled, and human coagulation factor Ⅷ(FⅧ) was injected according to the patients’ bleeding severity. The improvement score of bleeding symptoms and signs after the first infusion of the first bleeding event and the transfusion efficiency of FⅧ activity at 10 min and 1 hour after infusion were taken as the main efficacy indexes. The improvement scores of bleeding symptoms and signs after the first infusion and the increase of FⅧ activity at 10 min and 1 hour after infusion were the secondary efficacy indexes. 【Results】 The 65 subjects were enrolled in safety analysis set (SS) and full analysis set (FAS), and 58 of them were enrolled in protocol analysis set (PPS). Ten minutes and one hour after the first infusion, the level of factor Ⅷ activity in the subjects increased significantly, and the FⅧ activity increased by 100% or more in more than 79% of the subjects. The average infusion efficiency of FⅧ activity in all subjects was more than 100%. In 70% of the subjects, the pain was relieved rapidly and /or the bleeding symptoms were significantly improved 8 hours after each bleeding infusion, and the improvement rate of bleeding symptoms and signs reached 100% 72 hours after infusion. 【Conclusion】 After infusion of human coagulation factor Ⅷ, the activity level of factor Ⅷ in patients with hemophilia A significantly increased. The infusion efficiency can reach a optimal level, and the bleeding symptoms can be significantly improved.