OBJECTIVE:To promote the management of clinical trial drugs and to guarantee the quality of clinical trials. METHODS:According to the management regulatory requirements,in Good Clinical Practice(GCP)and Drug Clinical Trial In-stitution Qualification Review Inspection Standard for clinical trial drug the problems including hardware facilities,personnel and re-cording documents such as receiving,storing,dispensing and recycling for surplus drugs were reviewed,meanwhile,countermea-sures and relative suggestions were put forward. RESULTS & CONCLUSIONS:The hardware facilities and personnel meet the re-quirements of GCP,but many recording documents such as receiving,storing,dispensing and surplus drug recycling are incom-plete and should be improved in our hospital. Therefore,the improvement of the process of experimental drug flow management and the complement of record of the documents are established. And suggestions about the establishment of electronic drug manage-ment system,pharmacists to take an active part in the whole process of drug clinical trials intervention,the establishment of full-time pharmacist to manage the clinical trial drugs in the clinical trial institution pharmacy are put forward.

OBJECTIVE: To establish GC-MS method for the determination of the Menthol in inclusion complex of compound essential oil-? -cyclodextrin. METHODS: Menthol was determined with ion fragment peak ( M/Z=71) . The chromatographic column was DM-5 fused silica capillary column ( 0. 25mm? 30m) ; the internal standard was naphthol and the temperature programming was 80～ 180℃ . RESULTS: The calibration curves of Menthol were linear in the ranges of 1. 344～ 10. 752? g? mL-1( r=0. 999 8) and the average recovery was 97. 52% , RSD=1. 56% . CONCLUSION: The method is rapid, accurate and reproducible, and suitable for the quality control of the same kind of the preparation.

OBJECTIVE To investigate the application of blood test in the prognosis of nasal NK/T-cell lymphoma.METHODS The clinicopathologic and follow-up data of 62 patients with nasal NK/T-cell lymphoma proven by pathological examination were collected.The blood lactic dehydrogenase(LDH),globulin(GLB),albumin(ALB),hemoglobin(Hb),and white blood cell(WBC) were examined in these patients.The correlation between these factors and prognosis were analyzed with univariate analysis and multivariate analysis.RESULTS Of the 62 patients,47 were males and 15 were females.Their median age was 42 years.Ninety two percent of the patients were in Ann Arbor I/Ⅱ stage,and 76 % had international prognostic index(IPI) of 0 or 1.Before treatment,92 % of the patients had ECOG performance status(PS) score of 0-1,26 % had anemia,53 % presented B symptoms.The median overall survival time was 27 months(95 % CI:10-45months).In univariate analysis,gender,age,PS score,LDH,IPI,B symptoms,Hb and WBC were statistically significantly correlated to the prognosis.In multivariate analysis,Hb1 were statistically significant unfavorable prognostic factors.CONCLUSION Hb together with B symptoms and PS score may be independent prognostic factors for nasal NK/T cell lymphoma.

OBJECTIVE:To study the effects of clozapine on blood glucose and insulin levels in schizophrenic patients. METHODS:This is a self-controlled study in which the levels of blood glucose and insulin in clozapine group(n=63) were compared before and after treatment,and which were compared with the levels in the control group(n=64).Insular cellular antibody(ICA) and insulin autoantibody(IAA) were detected in patients with high level of blood glucose.RESULTS:After treatment for 8 weeks,the blood glucose level was increased in clozapine group as compared with the same group before treatment and the control group,showing significant differences(P

OBJECTIVE:To evaluate the distribution and drugs resistance of pathogenic bacteria causing nosocomial infection over 2 years in our hospital.METHODS:A total of 4 653 strains of pathogens were analyzed statistically by retrospective study.RESULTS:Among 4 653 strains of pathogens,709 were fungi(15.2%),1 078 were Gram-positive cocci(23.2%)and 2 866 were Gram-negative bacilli(61.6%).Over the 2 years,the detection rates of extended spectrum ?-lactamase-producing Escherichia coli and Klebsiella spp.were 36.5% and 27.9%,respectively.The average resistance rate of Gram-positive cocci to penicillin,oxacillin,cefazolin,erythromycin,Co-trimoxazole and ciprofloxacin over the 2 years were 84.5%.The average resistance rate of Gram-negative bacilli to ampicillin was 96.0% and to cefotaxime,cefepime,gentamycin,Co-trimoxazole,ciprofloxacin and aztreonam were 52.7% in 2 years.CONCLUSION:Over the 2 years,Gram-negative bacilliin strains causing hospital nosocomial infections increased,Gram-positive cocci strains remain stable,but fungous infection showed a decline tendency.In view of the increasing drug resistance,rational use of antimicrobial agents should be stressed in the clinic.

Objective To investigate the effect of apolipoprotein E (ApoE) gene polymorphism on lipid metabolism of renal transplant recipients before and after transplantation. Methods ApoE gene polymorphism was detected by Polymerase chain reaction restriction fragment length polymorphism and serum lipid levels were measured by biochemical method. Results Serum lipid levels in the recipients were increased significantly at 3rd month after renal transplantation, and were ulteriorly elevated at 6 th month and the first year. The patients with higher total serum cholesterol (TC) and triglyceride (TG) levels were only accounted for 2.9 % and 7.6 % respectively before renal transplantation, but for 28.6 % and 46.7 % respectively at 3rd month after renal transplantation ( P

Objective To investigate the expression and significance of glucogen synthase kinase-3β (GSK-3β) in the pathogenesis of chronic allograft nephropathy (CAN) in rats.Methods Kidneys of Fisher (F344) rats as donors were orthotopically transplanted into Lewis (LEW) rats as recipients.The renal function and histopathological changes were observed at 4,8,12,16,and 24week post-transplantation.Phosphorylated GSK-3β (p-GSK-3β) protein and mRNA expression was determined by using immunohistological assays and RT-PCR respectively.Results Our data showed that 24-h urinary protein excretion in CAN rats was increased significantly at week 16 as compared with F344/LEW controls.Allografts showed markedly increased mononuclear cells infiltration and presented with severe interstitial fibrosis and tubular atrophy at 16 and 24 week post-transplantation.p-GSK-3β expression (protein/mRNA) was down-regulated in rat kidneys with CAN,and the decrease became more significant over time after transplantation.p-GSK-3β expression was correlated significantly with 24-h urinary protein excretion,serum creatinine levels,tubulointerstitial mononuclear cells infiltration,smooth muscle cells migration in vascular wall,and interstitial fibrosis.Conclusion It was concluded that GSK-3β down-regulation was the key event that may be involved in mononuclear cells infiltration and vascular SMCs migration at early stage,and interstitial fibrosis and allograft nephroangiosclerosis at later stage of CAN pathogenesis in rats.

Objective To investigate the role and mechanism of phosphate myosin light chain (pMLC) in the rat kidney of chronic allograft nephropathy (CAN) model. Methods The left donor kidneys from Fisher (F344) rats were orthotopically transplanted into Lewis recipients. Meanwhile, the F344 rats and LEW rats with resection of the right kidney served as control groups. Animals were harvested respectively at the 4th, 8th and 12th week after transplantation. The creatinine clearance rate (CCr) was calculated by urine creatinine of 24-h urine. Blood samples were collected from rats for determination of serum creatinine. The expression of pMLC was detected by using Western blotting and immunohistochernistry, and that of integrin-linked kinase (ILK) by using immunohistochemistry. Results Mononuclear cells infiltration of allografts was markedly aggravated as compared to the controls. Allografts got severe interstitial fibrosis and tubular atrophy at 12th week after transplantation. The expression of pMILC and ILK was up-regulated in the kidney of CAN rats after transplantation, and increased more significantly as the time went on. The expression of pMILC was significantly correlated with 24-h urine protein excretion (r= 0. 273, P＜0. 05), serum creatinine levels (r = 0. 434, P＜0. 01 ), the number of tubulointerstitial infiltrated mononuclear cells (r = 0. 525, P＜0. 01 ), the number of smooth muscle cells (SMC) in vascular wall (r= 0. 676, P＜0. 01 ) and the extent of interstitial fibrosis (r= 0. 570, P＜0. 01 ).There was a significantly positive correlation between ILK and pMLC in CAN rats at the 4th week after transplantation (r= 0. 778, P＜0. 01 ). Conclusion pMLC might play an key role in CAN, and the over-expression of ILK might be involve in the pathogenesis of CAN.

OBJECTIVE: To investigate the significance of expressions of p53 and p21 in nasal NK/T-cell lymphoma (NKTL) and their relationship with cell proliferation and apoptosis. METHOD: Sixty-two cases of NKTL were examined for p53, p21 and Ki67 proteins by means of tissue microarray technique, TUNEL and immunohistochemistry. The proliferation index (PI) was determined by expression of Ki67 proteins. RESULT: The positive expression rates of p53 and p21 proteins in NKTL were 79.03% and 58.06% respectively. The positive expression rates of p53 in Ann Arbor stage I, II, III and IV NKTL were 69.57%, 75%, 86.67% and 100% respectively, while those of p21 were 47.83%, 56.25%, 60% and 87.50%. With the progression of tumor, the positive expression rates of p53 and p21 proteins gradually increased. And there were significant differences between them (P<0.05). The positive expression rates of p53 in NKTL with large, medium and small size tumor cells were 92.86%, 78.95% and 53.33% respectively, while those of p21 were 67.86%, 57.89% and 40.00%. With the expanding of tumor cells, the positive expression rates of p53 and p21 proteins gradually increased. And there were significant differences between them (P<0.05). The expression of p53 was positively correlated with the expression of p21 (P<0.05). The intensity of p53 and p21 expression, the Ann Arbor stage and the size of tumor cell all were positively correlated with PI (Spearman correlation analysis, P<0.05), while no correlation with AI (P>0.05). CONCLUSION The expressions of p53, p21 and Ki67 proteins are closely related with the pathogenesis and progression of NKTL. Combined detection of p53, p21 and Ki67 is a good marker to judge the biological behavior of NKTL, such as the proliferation and the invasiveness of the tumor.
Adolescent ; Adult ; Aged ; Apoptosis ; Cell Proliferation ; Cyclin-Dependent Kinase Inhibitor p21 ; metabolism ; Female ; Humans ; Ki-67 Antigen ; metabolism ; Lymphoma, Extranodal NK-T-Cell ; pathology ; Male ; Middle Aged ; Tumor Suppressor Protein p53 ; metabolism ; Young Adult

OBJECTIVE: To investigate the clinicopathological features and prognostic factors of nasal NK/T-cell lymphoma. METHOD: The clinicopathological data, treatment modality and survival status were analyzed. RESULT: The overall five year survival rate of: 62 patients was 63.5%. In univariate analysis, the prognosis of the patients was correlated with the age, perforation, B symptom, stage, Hb concentration, LDH level, size of tumor cell, number of involvement sites, angioinvasion and treatment modality (P < 0.05 or P <0.01). In multivariate analysis, the Hb concentration, the size of the tumor cell and the treatment modality were the independent prognostic factors. CONCLUSION The Hb concentration, the size of the tumor cell and the treatment modality play key role in the prognosis of nasal NK/T-cell lymphoma.
Adolescent ; Adult ; Aged ; Female ; Humans ; Lymphoma, Extranodal NK-T-Cell ; diagnosis ; pathology ; Male ; Middle Aged ; Neoplasm Staging ; Nose Neoplasms ; diagnosis ; pathology ; Prognosis ; Survival Rate ; Young Adult