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.
6.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.
7.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.
8.Investigation of virus inactivation methods used in the production of urinary trypsin inhibitor(UTI)
Xipeng ZHOU ; Ping MA ; Fang YAN ; Jinbo XU
Chinese Journal of Biochemical Pharmaceutics 2009;30(6):407-409
Purpose To test the virus inactivation effect of water bath method at 60 ℃ for 10 hours and alcohol treatment for 3 hours which was used in the production of urinary trypsin inhibitor(UTI).Methods Sindbis virus,Pseudorabies virus(PRV) and poliovirus1(PV1) were used as indicated viruses in this test.After being added separately into the UTI raw material in 10% proportion,the viruses were treated with water bath at 60 ℃ for 10 hours and alcohol for 3 hours and then the samples of UTI were taken to inoculate the cell line for assay of cytopathic effect.Results The water bath at 60 ℃ for 10 hours could inactive Sindbis,PRV and PV1 in more than(6.503±0.102)LgTCID_(50),(6.42±0.158) LgTCID_(50) and(6.587±0.061)LgTCID_(50) respectively,and alcohol treatment for 3 hours could inactive Sindbis,PRV and PV1 in more than(5.88±0.204)LgTCID_(50),(6.378±0.268)LgTCID_(50) and(5.963±0.118) LgTCID_(50) respectively.No cytopathic effect was found in the cell line which was inoculated with treated samples after blind passage for three generations.Conclusion The water bath method at 60 ℃ for 10 hours and alcohol treatment for 3 hours which were used in the production of UTI had good effects on virus inactivation and the inactivation efficiency on Sindbis,PRV and PV1 was more than 6 LgTCID_(50)/mL.
9.Association of DAZL A260G and A386G polymorphisms with oligozoospermia- or azoospermia-induced male infertility: A meta-analysis.
Xiao-yan CHEN ; Ping CHEN ; Chang XU ; Xin-hua ZHANG
National Journal of Andrology 2015;21(4):345-356
OBJECTIVETo investigate the association of A260G and A386G polymorphisms of the DAZL gene with male infertility caused by oligozoospermia or azoospermia.
METHODSWe searched the PubMed, Science Direct, Wiley Online Library, CNKI, VIP, and CDDB databases up to November 30, 2013 for case-control studies evaluating the relationship of SNP260 and SNP386 polymorphisms of the DAZL gene with male infertility, and meanwhile conducted manual sourcing of the references in the identified studies and relevant articles. Two reviewers independently screened the title, abstract and keywords of each article retrieved. The StataSE12. 0 software was used for meta-analysis and other statistical analyses.
RESULTSTotally, 13 case-control studies were included (10 about A260G and 11 about A386G), involving 2 715 infertile patients (2 500 with oligozoospermia or azoospermia) and 1 835 normozoospermic men. DAZL A260G showed no statistical significance in the allele, dominant, recessive, co-dominant, or super-dominant gene model (P >0. 05). DAZL A386G exhibited a strong correlation with oligozoospermia or azoospermia in Asians in the allele gene model (OR = 0. 15, 95% CI 0.07 -0.34, P <0.05), dominant gene model (OR =0. 16, 95% CI 0.07 - 0. 35, P <0.05), co-dominant gene model (AA/AG) (OR = 0. 15, 95% CI 0. 06 - 0. 33, P < 0. 05), and super-dominant gene model (OR = 0. 15 (95% CI 0.06 - 0.33, P <0.05) , and so did it in Chinese in the four gene models ( OR = 0. 11, 95% CI 0.04 - 0. 28, P <0.05; OR =0. 11, 95% CI 0.04 - 0.28, P<0.05; OR = 0.09, 95% CI 0.03 - 0.26, P<0.05; OR = 0.09, 95% CI 0.03 - 0.26, P< 0.05).
CONCLUSIONOur study manifested that the DAZL polymorphism A386G, but not A260G, was correlated with reduced sper- matogenesis or sperm count specifically in Chinese males. More high-quality trials are required for a deeper insight into the exact relationship of DAZL A260G and A386G polymorphisms with oligozoospermia- or azoospermia-induced male infertility.
Alleles ; Asian Continental Ancestry Group ; Azoospermia ; genetics ; Case-Control Studies ; Humans ; Infertility, Male ; genetics ; Male ; Oligospermia ; genetics ; Polymorphism, Genetic ; RNA-Binding Proteins ; genetics ; Spermatozoa
10.Chronic pain and cognitive-behavioral treatment.
Chinese Journal of Stomatology 2006;41(9):572-574