2.Key issues on the clinical trial data management.
Ping-yan CHEN ; Yu XU ; Nan DAI
Acta Pharmaceutica Sinica 2015;50(11):1485-1487
This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.
Clinical Trials as Topic
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Data Collection
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standards
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Information Storage and Retrieval
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standards
3.Study on Removal of Nitrogen Oxides in Tobacco Smoke Main Stream
Shaomin LIU ; Ping XU ; Xiangyang YAN
Journal of Environment and Health 1993;0(03):-
ve To explore the effective methods for removing the nitrogen oxides in tobacco smoke main stream. Methods Porphyrin and ferriporphyrin were added into cigarette filter with doses of 2.0, 4.0 and 8.0 ?g per cigarette. The effectiveness of removal of nitrogen oxides in tobacco smoke main stream by porphyrin and ferripor-phyrin were determined by muriatic acid naphthaline-ethylene diamine spectrophotometry. Results The contents of nitrogen oxides in tobacco smoke main stream decreased with the increases of the contents of porphyrin and ferripor-phyrin added into the cigarette filters (porphyrin: r= -0.9943, P
4.Expression of thyroid transcription factor-1 in hepatocellular carcinoma
yan-ying, SHEN ; yan-ping, XU ; xiao-lu, YIN
Journal of Shanghai Jiaotong University(Medical Science) 2006;0(02):-
Objective To investigate the value of thyroid transcription factor-1(TTF-1) in the diagnosis and biological behavior assessment of hepatocellular carcinoma (HCC). Methods Thirty liver specimens obtained from benign lesions were analysed, among which 25 were hepatic cirrhosis and inflammatory diseases, and the other 5 were adenomas. And there were 176 specimens of liver tumors, among which 142 were HCC (well differentiated, n=12; moderately differentiated, n=57; poorly differentiated, n=73), 17 were intrahepatic cholangiocellular carcinoma (ICC) and the other 17 were liver metastatic carcinoma (MC). The expression of TTF-1 was examined immunohistochemically in the above tissues, and the difference in expression of TTF-1 among different tissues was examined by Fisher's exact test, Kruskal-Wallis test and Spearman rank correlation analysis. Results TTF-1 was significantly expressed in the cytoplasms of all the hepatocytes besides tumors and liver benign lesions. The expression rate of TTF-1 in HCC was 78.9% (112/142), however, TTF-1 was negatively expressed in ICC and MC(P
5.Advances in the Isolation Methods of Fungal Polyketide Synthase Genes
Shao-Hua YAN ; Liang GUO ; Yan-Ping LI ; Yang XU ;
China Biotechnology 2006;0(07):-
Fungal polyketide synthases are responsible for the biosynthesis of secondary metabolites such as pigments, mycotoxins, and they are very important in pharmacology , food science and agriculture. The recent advances in the methods for the isolation and manipulation of multiple classes of polyketide synthase genes from fungi were introduced. It is useful for discovery of novel fungal polyketide synthase gene clusters. These methods can also be useful for revealing the genetic potential of fungi to produce multiple types of bioactive polyketide.
7.Effects of zinc finger protein A20 on the inflammatory reaction in rats with peritoneal dialysis-related acute peritonitis
Xunliang ZOU ; Juzhen YAN ; Gang XU ; Ping WU
Chongqing Medicine 2013;(31):3788-3791
Objective To explore the effects of zinc finger protein A20(A20) on the expression of CD40 and the phosphorylation of IκBαas well as the local inflammatory reaction of abdominal cavity in Sprague Dawley (SD) rats with peritoneal dialysis-related a-cute peritonitis induced by lipopolysaccharide (LPS ) .Methods 24 male SD rats were equally randomized to four groups (n= 6 , each) .Control group:injected with 4 .25% dextrose peritoneal dialysate(PDF) via abdominal cavity (90 mL/kg);LPS group :injec-ted with LPS(1 mg/kg) via abdominal cavity 4 hour later followed by PDF injection ;transfection A20 plasmid group and empty plasmid group:after transfer pGEM-T easy-A20 or pGEM-T easy plasmid via intraperitoneally using an ultrasound-microbubble-mediated system for 3 days ,then injected with LPS and PDF via abdominal cavity .The rats were killed 4 hours after PDF injection . Peritoneum tissue was stained using Masson and HE .Leucocytes count in abdominal dropsy was performed .The proteins expres-sion of A20 ,p-IκBα,IκBα,and CD40 in peritoneum tissue were analyzed by western blot ;the expression of CD40 mRNA in peritone-um tissue were determined by RT-PCR;IL-6 level in abdominal dropsy was determined by ELISA .Results LPS could induce the protein expression of A20 in rats peritoneum tissue .Compared with LPS group and empty plasmid group ,the degree of edema ,in-flammatory cells infiltration ,and the ratio of p-IκBα/IκBα,mRNA and protein expression of CD40 in rats peritoneum as well as leu-cocyte counts and IL-6 level of abdominal dropsy were also significantly decreased in transfection A20 plasmid group(P<0 .05);meanwhile ,compared with control group ,that of the ratio of p-IκBα/IκBαand IL-6 level in transfection A20 plasmid group were no significant difference(P>0 .05) ,but the mRNA and protein expression of CD40 were significantly higher than that of control group (P<0 .05) .Conclusion Over expression of A20 in SD rats peritoneum tissue could down-regulate the inflammatory reaction in peritonitis induced by LPS ,which might be involved in modulating the expression of associated functional protein during LPS signal pathw ay .
8.Study on Preparation and Identification of Immobilized Metal Ion Affinity Adsorption Gel
Ping LIU ; Shuangquan ZHANG ; Xiaomei YAN ; Jinshu XU
Progress in Biochemistry and Biophysics 2001;28(2):267-269
Sepharose 6B was activated by epichlorohydrin in the strong base condition, and then reacted with solution of iminodiacetic sodium. The arms of IDA were conjuncted to the activated Sepharose 6B. Then the products were reacted with the solution of NiSO4. The arms of IDA were chelated with Ni2+,and the chelating resin―Ni2+-IDA could be prepared. The physicochemical indexes and performance in purifying protein of the expressing product were assayed with atomic absorption method and purifying aimed protein-human B lymphocyte stimulator(hBLyS) from the expressing products in E.coli. The results indicated that the performance of made gel is very good, and its price is less than 1/10 of that of commodity gel.
9.Effect of midazolam on inflammatory mediators in patients with moderate and severe brain injury
Ping XU ; Ruiqiang ZHENG ; Xiaofeng OU ; Min ZHANG ; Peixia YAN
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2017;24(2):162-165,197
Objective To investigate the effect of midazolam on inflammatory response in patients with moderate and severe craniocerebral injury and its protective effect on the brain and mechanism.Methods A prospective study was conducted.One hundred and twenty patients with moderate and severe craniocerebral injury admitted to the Intensive Care Unit (ICU) of Jiangsu Subei Peoples' Hospital from April 2013 to July 2016 were enrolled,and they were divided into a conventional treatment group (58 cases) and a midazolam group (62 cases) according to the random number table method.Both groups were given conventional western medicine treatment,and in cases with surgical indications,operations were performed;in midazolam group,additionally intravenous injection of midazolam 2-3 mg was given firstly,and then continuous intravenous infusion of the drug 0.05-0.10 mg· kg-1· h-1 was applied by a pump,and in operative patients,the above management was given 3 hours after operation.The mean arterial pressure (MAP),heart rate (HR),Riker sedation agitation score (SAS) and electroencephalogram bispectral index (BIS) were measured before and after treatment for 24,48 and 72 hours,respectively.The levels of interleukin-6 (IL-6) and soluble nerve chemotactic protein (sFkn) in plasm and cerebrospinal fluid (CSF) were measured by double antibody sandwich enzyme linked immunosorbent assay (ELISA) at each time point;the incidence of epilepsy and 28-day mortality were recorded.Results Before and after treatment,the MAP and HR in the two groups of patients were stable,the difference being not statistically significant (both P > 0.05).Compared with those before treatment,after treatment the SAS score and BIS in two groups of patients were gradually decreased,and at 72 hours reached the lowest levels (SAS score:conventional treatment group was 3.8 ± 1.0 vs.5.7 ± 2.0,midazolam group was 3.6 ± 0.9 vs.5.8 ± 1.7;BIS:conventional treatment group was 69± 12 vs.82± 12,midazolam group was 72± 15 vs.82± 12,all P < 0.05),but there were no significant differences between the two groups (all P > 0.05),suggesting that the two groups had achieved the desired goal of sedation.ELISA results showed:compared with those before treatment,after treatment for 24 hours,the CSF IL-6,sFkn and plasm sFkn levels were temporarily increased in short term,and then showed a tendency of gradually decreasing,and the plasm IL-6 presented persistently descending in the conventional treatment group,while in the midazolam group,since 24 hours after treatment,each index showed a trend of decrease and continued to 72 hours.After treatment at each time point,the CSF and plasm levels of IL-6 and sFkn were significantly lower in midazolam group than those of the conventional treatment group,and reached to the minimal levels at 72 hours [CSF:IL-6 (ng/L) was 251.6 ± 145.7 vs.347.3 ± 146.4,sFkn (ng/L):289.7 ± 79.3 vs.423.6 ± 132.8;plasm:IL-6 (ng/L) was 54.4± 27.3 vs.85.6 ± 41.8,SFkn (ng/L):919.9±426.3 vs.1 199.4 ± 414.8,all P < 0.05].The incidence of epilepsy in the midazolam group was obviously lower than that in the conventional treatment group [1.61% (1/62) vs.10.34% (6/58),P < 0.05],but there was no significant difference between midazolam group and the conventional treatment group in the 28-day mortality [11.29% (7/62) vs.10.34% (6/58),P > 0.05].Conclusion Midazolam can reduce the incidence of epilepsy in patients with moderate and severe traumatic brain injury,and its brain protective effect may be related to the decrease of CSF and plasm IL-6 and sFkn levels.
10.Pre-radiation neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, prognostic nutritional index, and CA19-9 as prognostic factors in pancreatic cancer patients treat-ed with radiotherapy
Jianhui LIU ; Yan LUO ; Xiao CHEN ; Xiangsheng XU ; Ping ZHOU
Chinese Journal of Clinical Oncology 2017;44(6):289-293
Objective:To investigate the prognostic value of neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), and prognostic nutritional index (PNI) before radiation in pancreatic cancer patients underwent radiation therapy. Methods:Clinical data of 61 patients with pathologically confirmed pancreatic cancer were retrospectirely analyzed. Query index values for each patient were clinically tested through electronic medical records. Overall survival (OS) data were collected through electronic medical records or telephone follow-up. Survival curves were compared using Kaplan-Meier methodology and log-rank test. Cox regression methodolo-gy was used for univariate analysis. Results:Using log-rank test and univariate regression analysis, we found that patients with lower NLR, PLR, CA19-9, increased PNI, and lower TNM-staging lived longer than those with increased NLR, PLR, CA19-9, lower PNI, and high-er TNM-staging, and that the difference was statistically significant. Through multivariate analysis, we found that NLR (P=0.029, OR 2.344, 95%CI:1.090-5.041) and PNI (P=0.026, OR 0.477, 95%CI:0.248-0.917) were independent predictors of OS in patients with pan-creatic cancer. Conclusion:NLR, PLR, and PNI are simple, effective, and reliable indicators for evaluating the prognosis of pancreatic cancer.