3.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
5.Effect of extended nursing intervention in family nursing of discharged patients with intubation of T-tubes
Modern Clinical Nursing 2014;(10):47-50
ObjectiveTo explore the effects of extended nursing intervention (ENI) in nursing ability of discharged patients with intubation of T-tubes.Methods Eighty-two patients with biliary diseases discharged with intubation of T-tubes were equally divided into two groups.The patients in the experiment group were treated with ENI and those in the control group were treated with conventional nursing.Each group received routine nursing and health education before discharge.All patients were followed up by a self-designed written questionnaire.Data regarding patients’ compliance behavior,knowledge of the diseases and satisfaction were collected and analyzed.Result Significant differences were observed between the two groups,the patients in the experiment group exhibiting better compliance behavior,their knowledge of their diseases improved and the rate of satisfaction higher (P<0.05). Conclusion ENI may be effective for the discharged patients with intubation of T-tubes to improve their compliance behavior, enhance their knowledge of their diseases and raise the rate of satisfaction.
6.Effect of tetraethylammonium on the apoptosis of pancreatic ? cell
Tao YU ; Qunli CHEN ; Ping HU
Chinese Journal of Diabetes 1995;0(04):-
Objective To examine the effect of tetraethylammonium (TEA, K~+ channel blocker) on pancreatic ?-cell apoptosis and explore the mechanism. Methods Mouse ? cells (NIT cells) were exposed to streptozotocin(STZ) to induce apoptosis, and TEA of different concentrations were applied along with STZ to prevent efflux of intracellular K~+. Cells were stained with annexin V, PI and rhodamine 123. Flow cytometer (FCM) was used to determine the percent of apoptotic or viable cells and the change of mitochondrial membrane potential. Culture media was collected to quantify the content of NO and ROS produced by NIT-cells. Cells were collected for detecting the activity of super oxide dismutase (SOD) in cells lysates. Results STZ induced apoptosis of NIT cells significantly (P
7.Etiology Study of Hand-foot-mouth Disease in Liuzhou city from 2013 to 2016
Junchi YU ; Ping HUANG ; Liujun CHEN
International Journal of Laboratory Medicine 2017;38(17):2377-2379
Objective To analyze the etiological and epidemiological characteristics of hand-foot-mouth disease(HFMD) in Liuzhou city from 2013 to 2016,and to provide scientific evidence for preventive policy making.Methods Specimens of HFMD cases were collected from the hospitals and county CDC from 2013 to 2016.The nucleic acids which are enterovirus viruses71(EV71),coxasckie virus A16(CoxA16) and other enterovirus(EV) was detected by Real time PCR technique.Results A total of 3 503 suspected HFMD cases were found,and 2 720 cases were identified.The main pathogen of HFMD in Liuzhou city was change every year from 2013 to 2016,in addition to EV71 and CoxA16,there was a higher proportion of EV.HFMD was a seasonal disease,most cases occurred from March to September.The children under 5 years old,especially 1-3 years old were the main patients,and male patients was higher than female.Severe and death HFMD was EV71,but death HFMD had no CoxA16.Conclusion EV was the main pathogen of mild HFMD in Liuzhou city from 2013 to 2016,but the pathogenic spectrum was changing every yeas.EV71 was the main pathogen of severe and death HFMD.
8.Study on Hydrolysis of chitosan by Lysozyme
Sunying ZHOU ; Ping YU ; Sheng CHEN
Chinese Journal of Marine Drugs 2000;0(06):-
The effects of reaction temperature, pH, substrate and enzyme concentration, deacetylation degree of chitosan on the hydrolytic velocity of chitosan by Lysozyme were investigated. The results showed that the specificity of catalyst obey the dynamics of michae-lis-Menten. The optimum temperature and pH were 50℃ and 6. 0 respectively, the reaction velocity was reduced while the deacetylation degree of chitosan was raised. The mean molecular weight of low molecular chitosan has been determined by high performance liquid chro-matography method, the mean molecular weight was 8328.
9.Design and Implement of Data Collection and Management System for Water Meters, Electric Meters and Oxygen Gauges in Hospital
Ping HUANG ; Jinxiong CHEN ; Haizhu YU
Chinese Medical Equipment Journal 2003;0(11):-
Objective To research and develop a data collection and management system for water meters, electric meters and oxygen gauges within the hospital intranet and perform an interface to the reckon of No.1 Military Project to make sure the accruracy of reckon entry. Methods Terminal equipment is water meters, electric meters and oxygen gauges with RS485 long-distance transmission interface. All the long-distance transmission meters for each independent reckon unit are connected to a single or a group of Comport-Network transformers. The data collected by data collection software will then periodically transmit and save the equipment data in a single or multiple special datatables built on No.1 Military database platform. Results This technology has been applied to the newly built in -patient building. Conclusion The interface designed to integrate decentralized equipment and data into the hospital's local area network using Comport- Network will have extensive application and promising marketing prospect.
10.The relationship between accompanying infection and immunologic function changes in type 2 diabetes melli-tus patients
Bing YU ; Ping YU ; Li LI ; Qiang CHEN ; Chunli WU
Chinese Journal of Primary Medicine and Pharmacy 2016;23(5):690-694
Objective To investigate the relationship between accompanying infection and the change of immunologic function in type 2 diabetes mellitus ( T2DM) patients.Methods One hundred and fifteen T2DM patients with infection and 95 T2DM patients with no infection were selected,and 102 subjects with no history of dia-betes were selected as no diabetetes with infection group.The venous blood of all groups were sampled after an over-night fast of 12h.Glycosylated hemoglobin a1c(HbA1c) level was tested by glycosylated hemoglobin automatic analy-zer.The levels of T cell subsets including CD3 ,CD4 ,CD8 ,NK cell and B cell ratio were tested by flow cytometry,Ig and complement level was tested by immune nephelometry.Results The level of body mass indices(BMI) in T2DM patients with infection group[(27.39 ±9.18) kg/m2 ] and with no infection group[(26.15 ±7.39) kg/m2 ] were higher than no diabetes with infection group (24.21 ±5.37)kg/m2 (t =2.548,4.702,all P <0.05).The levels of IgG,IgA,IgM,C3 ,C4 in T2DM with infection group were (11.83 ±3.92)mg/mL,(3.02 ±0.96)mg/mL,(3.38 ± 0.82)mg/mL,(1.70 ±0.38)mg/mL,(0.52 ±0.18)mg/mL,which in T2DM with non infection group were (12.46 ± 2.47)mg/mL,(2.63 ±1.37)mg/mL,(2.91 ±1.79)mg/mL,(1.58 ±0.43)mg/mL,(0.46 ±0.31)mg/mL,which in no diabetetes with infection group were (13.26 ±3.74)mg/mL,(2.06 ±1.86)mg/mL,(2.49 ±1.01)mg/mL, (1.19 ±0.82)mg/mL,(0.30 ±0.05)mg/mL.In T2DM with non infection group and T2DM with infection group, humoral immunity index including the level of IgG was lower and IgA,IgM,C3 ,C4 levels were higher than no dia-betetes with infection group,the differences were statistically significant(t =7.052,23.059,12.617,18.326,8.730, all P <0.05).The levels of CD4 ,CD8 ,NK,CD4 /CD8 ,CD3 were (37.68 ±8.39)%,(31.58 ±6.98)%,(10.76 ± 6.49)%,(1.19 ±0.75),(62.83 ±5.28)% in T2DM with infection group,which in T2DM with non infection group were (39.23 ±10.28)%,(27.61 ±5.65)%,(14.89 ±7.12)%,(1.39 ±1.01),(64.19 ±6.46)%,which in no diabetes with infection group were (42.91 ±5.67)%,(25.17 ±7.25)%,(16.39 ±6.24)%,(1.86 ±0.82), (73.65 ±9.10)%.Cellular immunity index containing CD4 ,CD8 ,NK,CD4 /CD8 ,CD3 levels decreased more signifi-cantly than no diabetic group,T2DMI group compared with T2DM group,the levels of IgG,CD4 ,CD8 ,NK,B cell ratio, CD4 /CD8 ,CD3 decreased obviously,while the levels of IgA,IgM,C3 declined greatly,there were significant differences (t =11.038,8.237,18.549,25.871,2.436,all P <0.05).Conclusion Patients with T2DM have humoral and cellular immunity abnormalities,T2DM patients with infection is closely related with the imbalance of immunologic function.