Key trial activities include: development of the trial protocol;development of standard operating procedures;development of support systems and tools;generation and approval of trial information documents;selection of trial sites and the selection of properly qualified,trained,and experienced investigators and study personnel;ethics committee review and approval of the protocol;review and approval by applicable regulatory authorities;enrollment of subjects into the study: recruitment,eligibility,and informed consent;the investigational product(s): quality,handling,and accounting;trial data acquisition: conducting the trial;trial data acquisition: conducting the trial; safety management and reporting;monitoring the trial;managing trial data;quality assurance of the trial performance and data;reporting the trial.

Cochlear Implantation ; Cochlear Implants ; Humans ; Tinnitus

Adult ; Coal Mining ; Cognition Disorders ; etiology ; Explosions ; Follow-Up Studies ; Humans ; Surveys and Questionnaires ; Survivors ; Young Adult

Objective To analyse the antibiotics susceptibility result of Neisseria gonorrhoeae(N.g) isolates.Method 95 strains of N.g were performed the in-vitro susceptibility test.MICs of penicillin, tetracycline, ciprofloxacin, levofloxacin, ceftriaxone, cefotaxime, cefepime, and spectinomycin were determined by agar dilution.Results Almost all of the N.g strains were susceptible to the first-line antibiotics used for treating the infection. The resistance rate to ciprofloxacin, tetracycline and penicillin were 100%, 78.9% and 68.4% respectively.Conclusion Although N.g is susceptible to first-line antibiotics used for treating the infections at the clinics, the situation of resistance to penicillin, tetracycline and ciprofloxacin is very serious.

Objective:To evaluate the diagnostic values of single and combined detection of serum CA199, complement 3 (C3),complement 4 (C4),total cholesterol (TC),triglyceride (TG),and lipid metabolism levels in the patients with pancreatic cancer, and to explore their correlations with TNM stage and pathological stage of pancreatic cancer.Methods:Total 185 subjects were enrolled into the study by three groups:pancreatic cancer patients group (Pc group,n=77),non-digestive system cancer patients group (Ndc group,n=58)and healthy control group (Hc group,n=50).The levels of serum CA199,C3,C4,and high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein A (ApoA), apolipoprotein B (ApoB), apolipoprotein E (ApoE),and lipoprotein a (Lpa)levels were detected.Results:① The serum level of CA199, C3,C4,and ApoE of the patients in Pc group were higher than those in Ndc and Hc groups (P<0.01).No statistical difference was observed in the serum CA199 between Ndc and Hc groups (P>0.05).The levels of C3, C4,and ApoE in Pc group and Ndc group was higher than those in Hc group (P<0.01),and the levels of the biomarkers in Pc group were also higher than those in Ndc group (P<0.01).The levels of HDL-C,ApoA and Lp (a)of the patients in Pc group were significantly lower than those in Ndc and Hc groups (P<0.05).② The area under ROC curve (AUC)of serum CA199,C3,C4,ApoE,HDL-C,and ApoA were 0.916,0.841, 0.788,0.785,0.834,and 0.810,respectively.Furthermore,multiple factor analysis showed that the combined detection of CA199,C3,and HDL-C (AUC=0.968)improved the diagnosis compared with detecting CA199 alone (P<0.05).③ The CA199 level of the patients inⅢ-Ⅳ stage of TNM stage was higher than that in the patients inⅠ-Ⅱ stage (P<0.01).For the pathological stage,the ApoA level in low differentiation group was higher than that in moderate and high differentiation group (P<0.05).There was no statistical difference in other biomarkers between the different TNM stages and pathological stages.Conclusion:The levels of CA199,C3,C4 and ApoE of pancreatic cancer patients are significantly increased, while the levels of HDL-C, ApoA, and Lp (a ) are significantly reduced.Combined detection of CA199,C3,and HDL-C can improve the early diagnosis of pancreatic cancer compared with the single assessment of each biomarker.

MicroRNA(miRNA) is a class of non-coding RNA that plays an important role in gene expression and controlling. In recent years,the role of miRNA in the development of the disease has aroused great interest. Abnormal osteoclastogenesis and persistent inflammatory response induced by wear particles or osteoblast differentiation and maturation is the main cause of aseptic loosening in joint replacements. New researches shows that persistent inflammatory response, osteoclastogenesis and osteoblast differentiation are closely associated with miRNA, suggesting that there are certain relations between miRNA and aseptic loosening of prostheses. Additionally, the alteration of the expression levels of some miRNA may be curative for aseptic loosening. With the findings of the new miRNA targets, the important role of miRNA is further confirmed.
Animals ; Arthroplasty, Replacement ; Cell Differentiation ; Humans ; Joint Diseases ; genetics ; metabolism ; surgery ; MicroRNAs ; genetics ; metabolism ; Osteoblasts ; cytology ; metabolism ; Prostheses and Implants

Aged ; Female ; Humans ; Immunophenotyping ; Leukemia, Large Granular Lymphocytic ; classification ; immunology

Objective To explore the possibility of using 131I as a targeted therapy method for malignant glioma by infecting U87 and U251 cells with conditionally replicative adenovirus Ad-Tp-E1a-Gp-NIS.Methods Human telomerase reverse transcriptase (hTERT) promoter and glial fibrillary acidic protein (GFAP) promoter were cloned and their transcriptional activities were detected by luciferase assay.The conditionally replicative adenovirus Ad-Tp-E1 a-Gp-NIS was constructed,purified,and transfected into U87 and U251 glioma cells.For these transfected cells,the selective replication ability was evaluated by plaque forming assay,and protein expression was detected by Western blot assay.125I-iodide uptake and exflux,the clonoy formation of 131I-iodide treated cells were also measured.Results Transcriptions activity of the GFAP and hTERT promoters was 59.75％-62.10％ (F =11.89,P ＜ 0.01) in U87 cells and 37.31％-49.00％ (F =5.87,P ＜ 0.05) in U251 cells.The Ad-Tp-E1a-Gp-NIS could be selectively replicated and the hNIS gene was successfully expressed in the hTERT-positive and GFAP-positive glioma cells which showed two protein bands with relative molecular mass of 120 × 103 and 49 × 103 in Western blot assay.After infection with Ad-Tp-E1a-Gp-NIS,the cell ability of 125I uptake was increased by 78.80 (F =2 914.58,P ＜0.01) and 92.48 (F =2 275.91,P ＜0.01) times in U87 and U251 cells,respectively.The GFAP-negative MRC-5 cells could not take in 125I.The in vitro clonogenic assay indicated that,after 131I treatment,more than 90％ of the transfected cells were killed,while only about 65％ (t =11.73-78.33,P ＜ 0.01) of control cells were killed.Conclusions The Ad-Tp-E1a-Gp-NIS has a good ability in selective replication and the enhancement of antitumor therapy effect by increasing tumor-specific iodide uptake in malignant glioma cells.

Objective To observe the effects of low frequency transcranial magnetic stimulation (LF-TMS) on the electroencephalogram (EEG),expression of NPY in hippocampus in pilocarpine (PLO)-induced epileptic rats. Methods Forty male Sprague-Dawley rats (240-260 g) were used to establish a model of epilepsy by in- tradominal injection of pilocarpine,and then randomized into 2 groups:a control group and an intervention group. The control group was treated by sham LF-TMS,while the intervention group was treated by LF-TMS once daily for 7 days.Ⅰgroup simply celiac inject pilocarpine.Ⅱgroup celiac inject PLO after LF-TMS.The EEG was recorded in both groups and the checked pathology.Pathological item include HE staining,NPY immunohisto chemical staining. Results The latency for seizure attack was significantly lengthened,while the frequency of seizure attack and times of major seizure attack were significantly decreased in the intervention group.The HE staining revealed significant de- generation and necrosis of neurons in the hippocampus,especially in the CA3 region,in rats in the control group. The pathologic changes were significantly less severe in the intervention,Immunohistochemical staining showed a sig- nificantly higher expression of NPY in the hippocampus as compared with the intervention group. Conclusion U- sing the PLO-induced epilepsy model,LF-TMS could not only postpone the generation of kindling but also inhibit the progress of epilepsy.The increased NPY expression in the hippocampusin the intervention group implied a close rela- tionship between NPY and epilepsy attack.

OBJECTIVE:To provide reference for prescriptions audit before payment in hospital pharmacy. METHODS:The management measures of prescriptions audit and intervention before payment in our hospital were introduced. 1 200 outpatient pre-scriptions within 1 year before and after management were subjected to a statistical analysis. The effects of prescriptions audit be-fore payment were evaluated through analyzing and comparing qualification rate of prescription and unqualified prescriptions. RE-SULTS:Our hospital adopted a series of measure to realize prescriptions audit and intervention before payment by clinical pharma-cists,such as using information audit system,formulating audit standard,educating pharmacists,establishing audit job system, prescriptions review and feedback system,setting up communication system,etc. Of the total audited 189 665 prescriptions, 14 581(7.69%)failed to audit and 606 prescriptions hadn’t been revised after 1 year management,with effective intervention rate of 95.84%. Compared with before management,the prescription qualification rate increased from 88.83% to 98.67% after manage-ment(P<0.01). The quantity of overdose,inconformity with medical insurance,overload and other conditions reduced to 0. CON-CLUSIONS:It is feasible for pharmacists to audit and intervent prescriptions before payment in hospital pharmacy to improve pre-scription qualification and promote rational drug use in the clinic.