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.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.
5.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
6.Value of clinical parameters in predicting the initiation of renal replacement therapy in acute kidney injury patients with cardiorenal syndrome
Yongjun CUI ; Meiyan WAN ; Ping XIA ; Shujian ZHANG ; Yan XU
Chinese Journal of Nephrology 2015;31(7):481-486
Objective To investigate the value of clinical parameters in predicting the initiation of renal replacement therapy(RRT) in acute kidney injury (AKI) patients with cardiorenal syndrome (CRS).Methods A total of 75 AKI patients hospitalized with CRS were enrolled.All patients received pharmacologic therapy on the beginning 3 days.The patients whose heart function improved were divided into control group (n=39),and the patients whose heart function worsened were divided into RRT group (n=36).Clinical and laboratory data on the first day and the fourth day were collected and analyzed.The factors on the first day were labeled asⅠ ,and those on the fourth day were labeled asⅡ. The ratio of some parameters calculated were labeled asⅡ/Ⅰ .Area under curve (AUC) of receiver operating characteristic curve (ROC) of these factors was used to evaluate the sensitivity and specificity in predicting the initiation of RRT.Results The patients in RRT group had significantly higher levels of BNP-Ⅱ,BNP Ⅱ / Ⅰ and creatinine Ⅱ / Ⅰ (P < 0.01),and lower levels of 24 hours urine volume-Ⅰ and 24 hours urine volume-Ⅱ (P < 0.01).From ROC curve analysis,the AUC of 24 hours urine volume-Ⅰ,24 hours urine volume-Ⅱ,creatinine Ⅱ / Ⅰ,BNP-Ⅱ levels and BNP Ⅱ/Ⅰ to predict RRT were 0.736,0.875,0.747,0.779 and 0.894 respectively.When the cutoff values of 24 hours urine volume-Ⅰ,24 hours urine volume-Ⅱ,BNP-Ⅱ levels,BNP Ⅱ / Ⅰ and creatinine Ⅱ / Ⅰ were 905 ml (sensitivity 75%,specificity 94.9%),1450 ml (sensitivity 75%,specificity 100%),3360 ng/L (sensitivity 72.2%,specificity 100%),1.37 (sensitivity 75%,specificity 100%) and 1.25 (sensitivity 72.2%,specificity 94.4%) respectively,the value of the parameters to predict RRT was high.Conclusions The 24 hours urine volume,BNP levels after treatment and the dynamic changes of BNP levels and creatinine levels can be used as predictors of the initiation of RRT in the AKI patients with CRS.
7.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
9.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.
10.The characteristics of Chinese agrammatic aphasics' comprehension and production of general and wh-questions
Da-Yan HE ; Shan-Ping MAO ; Xu-Ming FANG ;
Chinese Journal of Physical Medicine and Rehabilitation 2003;0(04):-
Objective To investigate question comprehension and production among agrammatic aphasics, and to explore the mechanisms of any dysfunction in questioning.Methods Twenty aphasics were recruited in this study.According to the Chinese Agrammatism Battery,10 were classified as agrammatic (the agrammatic group) and 10 as non-agrammatic (the non-agrammatic group).Ten normal subjects served as a control group.All the subjects were tested in terms of their comprehension and production of questions using a set of general and what-where-who- why questions (wh-questions).Results No significant difference was found between the two experimental groups with regard to the correct comprehension and production of both general and wh-questions.However,there was a sig- nificant difference in correctness between comprehension and production.The performance of the agrammatic aphasics was worse than that of the non-agramatics and the normal subjects.Conclusion The impaired question comprehen- sion and production of Chinese agrammatic aphasics has its own characteristies which can form a basis for rehabilita- tion planning and outcome prediction.