4.Relationship of statistics and data management in clinical trials.
Feng CHEN ; Hua-long SUN ; Tong SHEN ; Hao YU
Acta Pharmaceutica Sinica 2015;50(11):1420-1424
A perfect clinical trial must nave a solid study design, strict conduction, complete quality control, non-interference of statistical result, and acceptable risk-benefit ratio. To reach the target, the quality control (QC) should be performed from the study design to conduction, from the analysis to conclusion. We discuss the relationship between data management and biostatistics from the statistical point of view, and emphasize the importance of the statistical concept and methods in the improvement of data quality in clinical data management.
Biostatistics
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Clinical Trials as Topic
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statistics & numerical data
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Data Collection
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standards
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Quality Control
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Research Design
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standards
6.Relationship of statistics and data management in clinical trials.
Feng CHEN ; Hualong SUN ; Tong SHEN ; Hao YU
Acta Pharmaceutica Sinica 2015;50(11):1420-4
A perfect clinical trial must nave a solid study design, strict conduction, complete quality control, non-interference of statistical result, and acceptable risk-benefit ratio. To reach the target, the quality control (QC) should be performed from the study design to conduction, from the analysis to conclusion. We discuss the relationship between data management and biostatistics from the statistical point of view, and emphasize the importance of the statistical concept and methods in the improvement of data quality in clinical data management.
7.Compatibility of human umbilical vein endothelial cells and surface-modified PHBHHx film in vitro
Lei ZHANG ; Shuling BAI ; Feng PAN ; Hao TONG ; Erlin ZHANG ; Feng SHEN
Acta Anatomica Sinica 2009;40(6):958-962
Objective To evaluate the growing condition of human umbilical vein endothelial cells (HUVECs), which were cultured on the membrane of different component, such as Chinese medicine, before or after the alkali treatment of 3-hydroxybutyrate-co-3-hydroxyhexanoate copolyesters (PHBHHx) and the biocompatibility between PHBHHx flim and endothelial cell. Methods The HUVECs were harvested by Baudine method,and identified by immunohistochemical method.Then the HUVECs of third passage were inoculated on the material surface and cultured for 8 hours,12 hours and 24 hours. After that, the morphology of HUVECs on different surfaces were observed by scanning electron microscopy, the distribution condition on different membranes were compared by cell-labeling immunofluorescence, and the cell viabilities of all groups were detected by MTT method. Results The HUVECs were successfully separated,and immunohistochemistry staining of FLK-1 and factor Ⅷ was positive.The result of HUVECs culture showed that cells on the material surface growed well, and proliferated significantly. The MTT analysis showed that the PHBHHx film of surface modification and adding some certain proportion of Chinese medicine could promote the growth and proliferation of HUVECs in vitro,and the cells were thriving, full shape, distribution on the surface by scanning electron microscopy and fluorescence microscopy.Conclusion The PHBHHx film of surface modification and containing certain proportion of Chinese medicine coating had good compatibility of HUVECs, which was favourable to cell growth, adherence and proliferation in vitro.
8.Status quo of research on HGFc-Met signaling pathway in cancers.
Hui-ling SU ; Feng-ling LIU ; Tong HAO
Chinese Journal of Oncology 2013;35(5):321-324
Antibodies, Monoclonal
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therapeutic use
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Antineoplastic Agents
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therapeutic use
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Drug Resistance, Neoplasm
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Humans
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Mutation
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Neoplasms
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metabolism
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therapy
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Polymorphism, Single Nucleotide
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Proto-Oncogene Proteins c-met
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antagonists & inhibitors
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genetics
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metabolism
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Signal Transduction
9.Dynamic susceptibility contrast enhanced MRI in differential diagnosis of glioblastoma, solitary cerebral metastasis and cerebral lymphoma
Hao LU ; Quanzhi FENG ; Qiansheng CHENG ; Yan DING ; Daibin LI ; Yuge LI ; Bihui HAN ; Tong HAN
Chinese Journal of Medical Imaging Technology 2017;33(8):1185-1189
Objective To investigate the value of the dynamic susceptibility contrast enhanced MRI (DSC-MRI) in differential diagnosis of glioblastoma,solitary cerebral metastatic tumors and cerebral lymphoma.Methods Seventeen patients with glioblastoma,15 cases with solitary cerebral metastatic tumor and 17 cases with cerebral lymphoma were analyzed retrospectively.All patients underwent conventional MR imaging,contrast enhancement and DSC-MRI preoperatively.Pseudo color pictures of cerebral blood volume (CBV) and the time signal intensity curve were obtained from the raw data of DSC MRI.The relative CBV (rCBV)were measured from regions of enhanced solid parts of the tumors,peritumoral region and contralateral normal white matter regions respectively.The percentage of signal intensity recovery (PSR) of enhanced solid parts of the tumors were measured.ROC curve analysis was performed to determine optimum indicator in differential diagnosis of three types of tumors,and the sensitivity and specificity were calculated.Results Three types of tumors all showed enhancement of solid area with obvious peritumoral edema.Besides the no difference between glioblastoma and metastasis in rCBV of solid parts of the tumors,there were statistically significant differences in comparisons of two types of tumors (all P<0.05).Besides the no difference between single brain metastases and lymphoma in rCBV of peritumoral regions,there were statistically significant differences in comparisons of two types of tumors (all P<0.05).The PSR of the solid parts of the tumors had no difference between glioblastoma and single brain metastases,while there were statistically significant differences in comparisons of two types of tumors (all P<0.05).ROC curve analysis showed sensitivity and specificity of the PSR values of solid parts of the tumors in differentiating lymphoma and non lymphoma were 100 %and 81.3 %.The rCBV of peritumoral regions was the optimum indicator for differentiating glioblastoma and solitary brain metastasis,the sensitivity and specificity were respectively 94.1% and 86.7%.Conclusion The combination of rCBV and PSR can improve the efficiency for diagnosing the three types of brain tumors.
10.Comparison analysis on remedy condition of acute chemical intoxication in emergency departments and occupational departments of general hospitals.
An LI ; Xiao-hong WANG ; Feng-tong HAO
Chinese Journal of Industrial Hygiene and Occupational Diseases 2013;31(3):212-214
OBJECTIVETo investigate the current situation of treatment for acute chemical poisoning in the emergency departments and occupational disease departments of some general hospitals and to provide a basis for improving the ability of general hospital to deal with acute chemical poisoning.
METHODSFour hospitals from Shandong Province, Beijing City, and Shanxi Province, China were selected in the study. They included two first-class hospitals located in the downtown, where the patients with acute chemical poisoning from urban and suburban areas were admitted to the occupational disease departments, and two second-class hospitals located in the suburban area or county, where the patients with acute chemical poisoning from the suburban area were admitted to the emergency departments. A questionnaire survey was conducted in 141 medical workers (51 persons in the emergence department group and 90 persons in the occupational disease department group) that were engaged in the treatment of acute chemical poisoning in the four hospitals; 1999 medical records were analyzed. Individual in-depth interviews, questionnaire investigation, and field observation were used to compare the emergency department group and occupational disease department group in terms of the ability to deal with acute chemical poisoning and the training on treatment for acute chemical poisoning.
RESULTSThe emergency department group had significantly higher proportion of pesticide poisoning cases than the occupational disease department group (P<0.01). Thirty-seven of the patients in occupational disease department group died, with a fatality rate of 2.7%, and 14 of the patients in emergence department group died,with a fatality rate of 2.2%, so there was no significant difference between the two groups in this regard (P>0.05). There were significantly more cases treated without emergency plan in the emergency department group than in the occupational disease department group ( 37.3% vs. 10.0%, P <0.0 1). The occupational disease department group had significantly higher score of knowledge about the treatment for acute chemical poisoning than the emergence department group (7.2±1.3 vs. 5.2±0.9, P<0.01 ). There were significantly lower proportions of medical staff who had received training on the knowledge about acute chemical poisoning and on the emergency disposal of acute chemical poisoning in the emergency department group than in the occupational disease department group (P<0.05).
CONCLUSIONThere is a lack of the knowledge about treatment for acute chemical poisoning and protective measures during treatment among the medical staff in general hospitals, and related training and emergency plan are needed.
Acute Disease ; Adult ; China ; Emergency Service, Hospital ; statistics & numerical data ; Female ; Hospital Departments ; statistics & numerical data ; Hospitals, General ; Humans ; Male ; Poisoning ; therapy