OBJECTIVE:To promote the supervision and management of clinical trial by institution. METHODS:The structure and function of clinical trial management system(CTMS)developed by our hospital and other enterprise together were analyzed to evaluate the application and operation result of CTMS. RESULTS & CONCLUSIONS:CTMS of our hospital is made up of foun-dation,efficiency and strategy. It is equipped with role allocation,information exchange and report,information warning,drug tracking,clinical trial process control,quality control of electronic record,electronic signature and integration and connection with other system,etc. Relevant operation procedure is established to promote standardization and institutionalization of CTMS. Due to the application of CTMS,the cooperation among departments become smoother,and management level have been enhanced in dai-ly management,pharmacy management,subjects and document administration. It also simplifies the work of researcher and reduc-es the human error by the autogeneration of trial records and tables with the system. Consequently,the monitor coveraged through-out all the trial process.

OBJECTIVE:To ensure the stability of electronic data capture(EDC)system in drug clinical trials and to improve the quality of drug clinical trials. METHODS:The quality control system for EDC system was established and introduced from the formulation of quality control process,establishment of data standard,trial project management,daily management,trial project design,system operation,system function,etc. RESULTS & CONCLUSIONS:Data standard have been achieved through estab-lishing EDC quality control system by our hospital based on attributable,legible,contemporaneous,original and accurate principle. The management of trial project and daily management are conducted through data registration,staff training,the formulation of da-ta management plan,fault emergency treatment,database backup;multiple verification of support data,data lock and export,trial report autogeneration and other functions have been realized by formulating related standard operation instruction,program file,op-eration manual and quality record. Those aspects improve facticity,accuracy and integrality of data in clinical trials,and lay a foun-dation for further data mining.

Objective To observe the clinical effect of plasma exchange(PE) combined with continuous veno-venous hemodialysis filtration(CVVHDF) in children with acute liver failure.Methods Thirty-nine cases with acute liver failure admitted to pediatric intensive care unit of Shengjing Hospital Affiliated to China Medical University from August 2008 to January 2014 were treated with PE combined with CVVHDF.CVVHDF was performed after PE immediately,each PE + CVVHDF lasted 24 ～ 72 hours.Prothrombin time,blood ammonia,alanine transaminase,aspartate transaminase,serum total bilirubin,conjugated bilirubin were detected before and after PE + CVVHDF treatment.Glasgow Coma Scale were assessed before and after PE +CVVHDF in the thirty-five cases with hepatic encephalopathy.Results After the treatment of PE + CVVHDF,20 children were clinical recover,7 died,12 abandoned the treatment and the results of follow-up were death.PE + CVVHDF was effective in the treatment by decreasing serum total bilirubin,conjugated bilirubin,alanine transaminase,aspartate transaminase [(128.8 ± 82.6) μmol/L vs (73.2 ± 92.4) μmol/L; (90.2 ±71.5) μmol/L vs (55.1 ± 42.6) μmol/L; (3 024.1 ± 2 457.0) U/L vs (1 256.8 ± 757.8) U/L; (3 420.6 ±2 216.3) U/L v s (579.4 ± 338.6) U/L] (P ＜ 0.05),increasing Glasgow Coma Scale (9.5 ± 3.1 vs 12.1 ±2.9) (P ＜0.01),shortening prothrombin time[(40.4 ± 23.0) s vs (22.8 ±9.4) s] (P ＜0.01),in association with the improvement of hemorrhage tendency.Conclusion PE + CVVHDF significantly improves clinical symptoms and biochemical abnormalities in children with acute liver failure.Security of PE + CVVHDF is good and with no obvious adverse reactions.

To obtain active protein of pIL-18 expression in Lactococcus lactis, and to observe its biological activity, the total RNA was extracted as template from peripheral blood mononuclear cells. Porcine interleukin 18 (pIL-18) was amplified by RT-PCR. The resulting fragment was cloned into pAMJ399 L. lactis vector, and then transformed to L. lactis MG1363 cells by electroporation. Expression of pIL-18 protein was detected by SDS-PAGE and Western-blotting. Bioactivity of the product was tested by pig spleen lymphocyte proliferation test and cytopathogenic effect inhibition assay. The result of Western blotting and bioactivity test shows that the molecular weight of pIL-18 protein was 19 kDa. The react line was observed in both supernatant and precipitated of the recombinant bacteria pAMJ399-pIL18/MG1363. The expressed pIL-18 can promote the proliferation of pig spleen lymphocyte, and significantly inhibit virus multiplication. As conclusion, porcine interleukin-18 was successfully expressed in L. lactis, and the product was biologically active.
Animals ; Blotting, Western ; Electrophoresis, Polyacrylamide Gel ; Electroporation ; Genetic Vectors ; Interleukin-18 ; biosynthesis ; Lactococcus lactis ; metabolism ; Reverse Transcriptase Polymerase Chain Reaction ; Swine

The coding sequence for the mature peptide of porcine lactoferrin (Plf) was synthesized according to the codon usage of lactobacillus, to establish optimized porcine lactoferrin Lactobacillus expression system. The gene was ligated into the Xho I/BamH I site of Lactobacillus expression vector pPG612.1 and the recombinant plasmid pPG612.1-plf was transformed individually into Lactobacillus casei ATCC393, Lactobacillus pentosus KLDS1.0413, Lactobacillus plantarum KLDS1.0344 or Lactobacillus paracasei KLDS1.0652 by electroporation. After induction with xylose, expression of the recombinant proteins was detected by Western blotting and confocal laser scanning microscopy. Secretion of recombinant Plf proteins from four recombinant species was determined quantitatively by ELISA. The antibacterial activities of recombinant proteins were measured by agar diffusion method. The result shows that Plf was correctly expressed in four species of recombinant lactobacillus, with molecular weight of about 73 kDa. The expression levels in recombinant Lactobacillus casei, Lactobacillus pentosus, Lactobacillus plantarum, Lactobacillus paracasei were 9.6 μg/mL, 10.8 μg/mL, 12.5 μg/mL and 9.9 μg/mL, respectively. Antimicrobial activity experiment shows that the recombinant proteins were active against E. coli, Staphylococcus aureus, Salmonella typhimurium, Listeria, Pasteurella. The recombinant Plf expressed by recombinant Lactobacillus plantarum showed the best antibacterial activity among all recombinant lactobacillus species. These data represent a basis for the development and application of porcine lactoferrin from recombinant lactobacillus.
Animals ; Anti-Bacterial Agents ; biosynthesis ; Lactobacillus ; metabolism ; Lactoferrin ; biosynthesis ; Recombinant Proteins ; biosynthesis ; Swine

Objective To elucidate the association of the susceptibility for rheumatoid arthritis ( RA )and peptidylarginine deiminase 4(PADI4) genetic single nucleotide polymorphism (SNP) in Han population in Hebei province.Methods This hospital-based ease-control study included 105 untreated RA patients and 96 healthy controls.The genotypes and allele frequencies of padi4_92 gene polymorphisms were analyzed by PCR-RFLP method,and the analysis of linkage disequilibrium and haplotype construction were performed for padi4_92,padi4_94 and padi4_104 SNPs.The Peason Chi-square test and Woolf statistic method were used to analyze the odds ration (OR) and 95％ confidence interval (95％CI).Results Significant differences in the frequency of PADI4 alleles and genotypes between the cases and controls were observed.The combined effect of padi4_92,padi4_94 and padi4_104 SNPs was analyzed by SHEsis snd Genehunter software,and got three haplotypes,CCC,GTT and GCC.There was significant difference in haplotypes distribution of 3 SNPs of padi4 between the two groups.This analysis of haplotypes revealed that haplotype of PADI4 was a risk factor for RA The ORs for these three haplotypes for RA susceptibility were 0.634 (95％CI=0.425-0.946),1.306 (95％CI=0.864-1.975),4.286 (95％CI=1.274-14.424),respectively.Conclnsion The SNPs of PADI4 may contribute to genetic susceptibility to RA in Han population in Hebei Province.

Objective To analyze the diagnosis and prognosis value of abdominal CT scans in patients with acute pancreatitis complications.Methods 151 cases with acute pancreatitis were selected.The relationship between abdominal CT performances and the common complications and death in patients was analyzed.The prognosis of patients with different Balthazar CT severity index (CTSI) grade was compared.Results The complication rate of patients with CT signs of fatty liver, pleural effusion, liver gap effusion, adrenal gland involvement (AGI), penirenal space involvement (PSI) and gastric bare area involvement (GBAI) was significantly higher than that of patients with negative CT findings above (P<0.05).With CTSI grading increasing, the patient''s fasting time, heating time, hospital stay, recovery time of blood amylase were extended, and the incidence of pseudo cyst, transit surgery, organ failure and death was gradually increasing (P<0.05).Conclusion Severe fatty liver, AGI, GBAI, PSI and liver gap effusion are risk factors for acute complications and death in patients with pancreatitis.

Objective To investigate the clinical features,pathogenic distribution of children with in-fective endocarditis(IE)during the past 10 years.Methods Medical records of 30 children with IE admitted to Shengjing Hospital of China Medical University from October 2006 to October 2016 were retrospectively analyzed,including the clinical data and pathogenic characteristics.Results Among the 30 cases of IE,there were 18 males and 12 females,age ranged from 2 months to 13 years old.Fever was found as initial symp-toms in 21 cases(70.0%),respiratory symptoms in 4 cases(13.3%),neurological symptoms in 4 cases (13.3%),edema in 2 cases(6.7%),murmur in 1 case,precordial discomfort in 1 case,and peripheral blood cell reduction in 1 case. The most common underlying factor was congenital heart disease(17 cases, 56.7%).Surgery was performed in 6 children due to congenital heart disease before endocarditis.Vegetations were detected on echocardiography in all cases(100%).Blood cultures were positive in 50.0%,Staphylococ-cus aureus was the most common organism,accounting for 6 cases (40.0%).Other notable pathogens in-cluded Streptococcus pneumoniae(4 cases,26.7%),Enterococcus faecalis(2 cases,13.3%),Streptococcus suis(1 case),Streptococcus anginosus(1 case) and Staphylococcus epidermidis(1 case).C-reactive protein was raised in 25 cases(83.3%)at the time of admission.C-reactive protein was higher than 100 mg/L in 8 cases.Conclusion Early clinical manifestations of IE are atypical.Fever is the most common symptom. Congenital heart disease is the major risk factor of IE,Gram-positive cocci is the most common organism. Antibiotic treatment is not effective,then surgical treatment may be considered.

Objective:To understand the thyroid function of the physical examination population in Tangshan area, and analyze the effects of thyroid function on blood lipids, fasting blood glucose (FPG), and serum 25 hydroxyvitamin D [25(OH)D].Methods:A population from the Tangshan area who underwent physical examinations at the Kailuan General Hospital from June 2020 to June 2021 was selected as the study subjects and the levels of their thyroid serological indicators [thyroid stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), triiodothyronine (TT3), and thyroid hormone (TT4)] were tested. According to thyroid function, they were divided into normal group, hyperthyroidism group, hypothyroidism group, subclinical hyperthyroidism group, and subclinical hypothyroidism group. We compared the blood lipid indicators [triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)], FPG, and 25(OH)D levels in different subgroups, and the Pearson correlation analysis was used to investigate the correlation between TSH levels and blood lipids, FPG, and 25(OH)D levels.Results:In this study, 2 884 subjects were selected from the physical examination population in Tangshan area. The proportion of people with abnormal thyroid function was 12.03%(347/2 884), among which the proportion of subclinical thyroid function abnormal population in the total thyroid function abnormal population was 80.69%(280/347). As men age, the proportion of thyroid dysfunction in the age groups of 21-<30 years old, 30-<40 years old, 40-<50 years old, and ≥50 years old was 5.06%(4/79), 7.52%(33/439), 8.91%(53/595), and 9.95%(66/663), respectively. The proportion of thyroid dysfunction in the above age group of women was 14.02%(15/107), 15.06%(61/405), 15.47%(67/433), and 29.45%(48/163). The serum TG, TC, LDL-C, and 25(OH)D levels in the hyperthyroidism group were lower than those in the normal group, while HDL-C and FPG levels were higher than those in the normal group, with statistically significant differences (all P<0.05). The serum TG and TC in the hypothyroidism group were higher than those in the normal group, while FPG and 25(OH)D were lower than those in the normal group, with statistically significant differences (all P<0.05). TSH levels were positively correlated with TC and LDL-C, while negatively correlated with FPG and 25(OH)D (all P<0.05). Conclusions:Subclinical thyroid dysfunction is the main cause of thyroid dysfunction in the Tangshan area, and TSH levels are correlated with blood lipids, fasting blood glucose, and serum 25(OH)D levels.

Objective To evaluate the efficacy of selective laser trabeculoplasty (SLT) as treatments of secondary glaucoma after intravitreal silicone oil injection. Methods Forty-five cases(45 eyes) of silicone oil glaucoma (SOG) from June 2014 to April 2016 were enrolled and divided into two groups according random digits table. The SLT treatment group had 21 cases (21 eyes), and drug treatment group had 23 cases(23 eyes).Intraocular pressure(IOP)changes were recorded 1 d, 1 week, 3 weeks, 1 month, 2 months, 3 months,4 months,5 months and 6 months after treatment.Results The decrease of IOP in SLT group was (11.47 ± 2.23), (11.27 ± 2.59), (10.43 ± 2.55), (11.93 ± 2.71), (13.75 ± 2.57),(13.93 ± 2.65),(10.45 ± 2.53)and(12.73 ±2.86)mmHg(1 mmHg=0.133 kPa).IOP of the control group decreased respectively (7.53 ± 3.29), (9.57 ± 3.49), (8.78 ± 4.21), (8.74 ± 3.86), (6.12 ± 4.41),(7.84 ± 3.26),(8.84 ± 4.25),(8.24 ± 3.56)mmHg.There was significant difference between the two groups 1 week, 1 month, 2 months, 3 months,4 months,5 months and 6 months after treatment (t = 4.17, 1.38, 2.89, 6.32, 3.89, 5.32, 5.19, P < 0.05 or < 0.01). Conclusions SLT is a safe and effective option for the treatment of patients with SOG.