1.Establishment and Application of Electronic Data Capture System in Drug Clinical Trials of Our Hospital
Jia ZHAO ; Chunmei JIANG ; Yuan GUO ; Mingming LI ; Wen WEN ; Lijie LANG ; Guoxin LI
China Pharmacy 2016;(4):452-454
OBJECTIVE:To ensure the stability of electronic data capture(EDC)system in drug clinical trials and to improve the quality of drug clinical trials. METHODS:The quality control system for EDC system was established and introduced from the formulation of quality control process,establishment of data standard,trial project management,daily management,trial project design,system operation,system function,etc. RESULTS & CONCLUSIONS:Data standard have been achieved through estab-lishing EDC quality control system by our hospital based on attributable,legible,contemporaneous,original and accurate principle. The management of trial project and daily management are conducted through data registration,staff training,the formulation of da-ta management plan,fault emergency treatment,database backup;multiple verification of support data,data lock and export,trial report autogeneration and other functions have been realized by formulating related standard operation instruction,program file,op-eration manual and quality record. Those aspects improve facticity,accuracy and integrality of data in clinical trials,and lay a foun-dation for further data mining.
2.Structure,Function and Operation Practice of Clinical Trial Management System in Our Hospital
Jia ZHAO ; Chunmei JIANG ; Mingming LI ; Yuan GUO ; Wen WEN ; Lijie LANG ; Guoxin LI
China Pharmacy 2015;(34):4759-4761,4762
OBJECTIVE:To promote the supervision and management of clinical trial by institution. METHODS:The structure and function of clinical trial management system(CTMS)developed by our hospital and other enterprise together were analyzed to evaluate the application and operation result of CTMS. RESULTS & CONCLUSIONS:CTMS of our hospital is made up of foun-dation,efficiency and strategy. It is equipped with role allocation,information exchange and report,information warning,drug tracking,clinical trial process control,quality control of electronic record,electronic signature and integration and connection with other system,etc. Relevant operation procedure is established to promote standardization and institutionalization of CTMS. Due to the application of CTMS,the cooperation among departments become smoother,and management level have been enhanced in dai-ly management,pharmacy management,subjects and document administration. It also simplifies the work of researcher and reduc-es the human error by the autogeneration of trial records and tables with the system. Consequently,the monitor coveraged through-out all the trial process.
3.The correlation, between expression of stanniocalcin-1 gene and level of hydrogen peroxide in tissue during cutaneous scand repair in mice.
Hong-xu YUAN ; Yong-fang JIA ; Jiang-jiang ZHANG ; Kun-ying WANG ; Wei-guo LI ; Jia-wen LI
Chinese Journal of Applied Physiology 2011;27(3):298-337
Animals
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Burns
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physiopathology
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Female
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Glycoproteins
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genetics
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metabolism
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Hydrogen Peroxide
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metabolism
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Male
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Mice
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RNA, Messenger
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genetics
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metabolism
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Skin
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injuries
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metabolism
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Wound Healing
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physiology
4.Application of the microprobe dredging operation in the treatment of the meibomian gland dysfunction (MGD)
Qing-Qiang, WANG ; Xin-Guo, JIA ; Wen-Bo, ZHANG ; Qing, FU ; Qiang, MA
International Eye Science 2014;(7):1269-1271
AlM: To evaluate the function of the microprobe dredging technology in the treatment of meibomian gland dysfunction ( MGD ) and to provide fast, efficient, economical and practical method of treatment for meibomian gland dysfunction ( MGD) .
METHODS:The 100μm diameter stainless steel wire was made as the microprobe with the total length of 3cm, which the needle was about 5mm and hand shank was about 2. 5cm. Selected 140 cases with dry eyes of meibomian gland dysfunction ( MGD ) , patients were divided into two groups and made them have comparability. Observation group ( n = 70 ) used microprobe to dredge meibomian gland pipe accompanied with drugs, hot compress and meibomian gland massage treatment. The control group (n=70) was given conventional drugs, hot compress and meibomian massage treatment. To compare the tear break-up time ( BUT) , efficient rate and the cure rate of the two groups after treatment of 1d, 1wk, 2wk, 1 mo, 2mo and 3mo.
RESULTS: BUT were significantly prolonged in observation group and control group after treatment, and the observation group improved more obviously; the efficient rate and cure rate of the observation group were significantly higher than that of the control group after 1d, 1wk, 2wk, 1mo, 2mo and 3mo treatment.
CONCLUSlON: Using microprobe to unclog the meibomian gland tube can provide the fast and efficient, economical and practical treatment for meibomian gland dysfunction ( MGD ) , which can be promoted in the clinical practice.
5.The clinical diagnostic value of high-frequency ultrasound in diagnosis of thyroid benign and malignant tumors
Ying, LIU ; Yi, XU ; Wen, CHENG ; Cun-li, GUO ; Jie-bing, LI ; Jia-wei, TIAN
Chinese Journal of Endemiology 2011;30(3):339-341
Objective To detect and analyze thyroid tumor by two-dimensional sonogram and Doppler parameter, and evaluate the value of high-frequency ultrasound in diagnosing thyroid benign and malignant tumors. Methods The ultrasonic images of 104 thyroid tumor from 80 patients with typical features were collected. Thyroid tumor was classified into benign and malignant nodules, based on the shape, border, or the rear wall echo, echo attenuation loss, internal echo, and microcalcifications in two-dimensional sonogram and systolic blood peak velocity (Vmax) and resistant index (RI) in Doppler examination. The expected results of high frequency ultrasound were compared with pathological results on consistency and error rate. Results Prediction of benign tumor by high frequency ultrasound was 66, and pathology 61, consistency rate of the two was 92.4%. Prediction of malignant lesions was 38, and pathological examination 32, consistency rate of the two was 84.2%. The total coincidence rate was 89.4%(93/104) and the error rate was 11.6%( 11/104). Conclusions The typical features of thyroid tumor on high-frequency ultrasound are helpful in diagnosis of benign or malignant nodules, which is valuable in guiding clinical treatment.
6.Detection and clinical significance of T cell subgroups and NK cell activity in refractory lymphoma patients
Xiaobo WU ; Qiaohua ZHANG ; Shuling HOU ; Junning SUN ; Li JIA ; Wen SU ; Runlian GUO
Journal of Leukemia & Lymphoma 2011;20(3):162-164
Objective To investigate the correlation of T cell subgroups and natural killer (NK) cell's activity level of peripheral blood of the patients with refractory lymphoma. Methods Flow cytometry was applied to detect T cell subgroups' level and NK cell's activity of peripheral blood in 60 early cure lymphoma patients with chemotherapy before and 20 normal controls , after chemotherapy follow-up they were divided into 30 cases of difficult cure group and 30 cases of effective group. Results Compared with the normal controls, CD+4, CD+4/CD+8 and NK cell in lymphoma patients with chemotherapy before decreased (30.17±8.63 vs 46.52±1.39, t =12.218, P <0.05; 0.86±0.45 vs 1.64±0.05, t =11.225, P <0.05; 12.39±7.08 vs 19.29±0.84,t =6.365, P<0.05), while CD+3 and CD+8 cell increased (76.14±10.71 vs 70.48±1.44, t =-3.439, P<0.05;40.28±14.03 vs 28.35±0.73, t =-5.625, P <0.05). Compared with effective group, CD+4 CD+4/CD+8 and NK cell in difficult response group with chemotherapy before decreased (27.70±7.81 vs 33.13±8.82, t =2.163, P =0.036;0.67±0.27 vs 1.10±0.52, t =3.272, P =0.003; 9.87±6.60 vs 15.40±6.58, t =2.771, P =0.008), while CD+3 and CD+8 cell increased (79.67±8.18 vs 71.91±12.00, t =-2.540, P =0.015; 44.70±13.99 vs 34.98±12.41, t =-2.416,P =0.020). Conclusion The detection of T cell subgroups' level and NK cell' s activity in early lymphoma patients before chemotherapy may play a role to diagnose and predict the outcome of refractory lymphoma patients.
7.Mental resilience tested with the Resilience Scale for Chinese Adolescents (RSCA)in Chinese children:A meta-analysis
Yi WEN ; Qin LIU ; Fan ZHANG ; Ke HUANG ; Jia LU ; Xue GUO ; Hong WANG
Chinese Mental Health Journal 2015;(11):826-832
Objective:To synthesize the mental resilience of Chinese children tested with the Resilience Scale for Chinese Adolescents (RSCA)to evaluate its status as well as the research status. Methods:Four Chinese elec-tronic databases including China Biology Medicine disc (CBM),VIP Database,China National Knowledge Infra-structure (CNKI)and WangFang Database were searched from database established to December 2014. Literatures that reported the mental resilience status of Chinese children tested with RSCA were included. A statistical formula was used to synthesize means and standard deviations to get a total score;the standard mean difference (SMD)and 95% confidence interval (95%CI)of scores measured with RSCA scale were used to conduct meta-analyses usingthe software of Review Manager 5. 2 for comparison between different subgroups. Results:Thirty-nine studies with 16 493 children were included for the final analysis. Quantitative synthesis results showed that the average total score of Chinese children was (3. 3 0. 6 ). The status of psychological resilience was at a good level. The average psychological resilience scores of girls,not left-behind children,urban children,Han children and not-only-child were higher than those of boys [SMD (95%CI):-0. 09 (-0. 14--0. 05 )],left-behind children [SMD (95%CI):-0. 37(-0. 56--0. 19)],rural children [SMD (95%CI):0. 26(0. 13 -0. 38)],minority children [SMD (95%CI):0. 12(0. 04-0. 21)]and only-children [SMD (95%CI):0. 30(0. 16-0. 44)]respectively. Conclusion:The mental resilience of Chinese children is modest with internal diversity.
8.Change on composition of immune cells in spleen of miRNA-126 knockdown mice
Liangyu LEI ; Yan HU ; Mengmeng GUO ; Jia LU ; Wen ZHENG ; Hualin XU ; Chao CHEN ; Lin XU
Chinese Journal of Immunology 2016;32(4):460-464
Objective:To detect the change of composition of immune cells in the spleen of miR-126 knockdown(miR-126KD) mice and preliminarily explore its significance .Methods: The expression level of miR-126 in spleens of miR-126KD mice was deter-mined by Realtime PCR.And the total number of splenocytes was calculated.The pathologic morphology change of the spleen was observed by HE staining.And the changes on proportion of DCs ,macrophages cells ,γδ T cells and NK T cells,CD3+T cells and its subgroup ,as well as CD19+B cells in spleens of miR-126KD mice were analyzed by Flow cytometry and calculated respectively.The level of phosphorylated AKt and NF-κB was analyzed by Western blot assay.Results:Compared with those of WT mice ,the expression level of miR-126 decreased obviously ( P<0.05 ) and the total number of cells increased obviously in spleen of miR-126 KD mice ( P<0.05).Moreover,the pathologic morphology of miR-126KD mice was significantly changed.The proportion and number of NK T cells in the inherent cells were significantly increased ( P<0.05 ) , but the proportion of Mφcells were significantly decreased ( P<0.05 ) . Meanwhile,the proportion and number of CD3+T cells and CD4+T cells in the adaptive immune cells were significantly increased (P<0.05),while the total number of CD19+B cells were significantly decreased (P<0.05).Last,the level of phosphorylation Akt and NF-κB increased obviously in spleen of miRNA-126 knockdown mice.Conclusion: Change obviously on the composition of immune cells subsets in the spleen of miRNA-126 knockdown mice ,which it may be related to the altered level of phosphorylated AKt and NF-κB and provides a preliminary experimental basis for the further exploring the roles of miR -126 in immune response.
9.Effect of Mild Hypothermia Therapy on Neonatal Bilirubin Encephalopathy:Evaluated with 18F-fluorodeoxyglu-cose Positron Emission Tomography/CT and Amplitude Integrated Electroencephalogram
Yun YAN ; Qingping LI ; Wenbin DONG ; Wen JIA ; Lin GUO ; Xuesong ZHAI ; Lan KANG
Chinese Journal of Rehabilitation Theory and Practice 2017;23(6):690-695
Objective To investigate the clinical effect of mild hypothermia on neonatal bilirubin encephalopathy, and the value of 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/CT and amplitude integrated electroencephalogram (aEEG) for diagnosis and evaluation of curative effect. Methods From May, 2013 to December, 2014, 29 newborns with bilirubin encephalopathy were divided into conventional group (n=15) and mild hypothermia group (n=14). The conventional group received conventional therapy, and the other group received mild hypothermia in addition. The aEEG and neuron-specific enolase (NSE) were measured before and after treatment, as well as the glucose metabolism rate with 18F-FDG PET/CT after treatment. Results The NSE was lower after treatment in both groups (t>9.670, P<0.001), and was lower in the mild hypothermia group than in the conventional group (F=46.146, P<0.001). After treatment, sleep-wake cycle (SWC), epileptiform activity and the degree of abnormality were obviously improved (P<0.05), and were better in the mild hypothermia group than in the conventional group (P<0.05). The cerebral glucose metabolism rate was significantly better in the mild hypo-thermia group than in the conventional group (t>2.943, P<0.01). The cerebral glucose metabolism rate was negatively correlated with aEEG and NSE (r>0.640, P<0.05). Conclusion Mild hypothermia therapy could further promote the energy metabolism of brain cells in neonatal bilirubin encephalopathy. 18F-FDG PET/CT and aEEG can be used for early diagnosis and therapeutic evaluation.
10.Analysis of influencing factors for slow blood flow phenomenon after emergency percutaneous coronary intervention in patients with acute myocardial infarction
Liang GUO ; Haishan ZHANG ; Yuan GAO ; Qigang GUAN ; Wen TIAN ; Dalin JIA ; Yingxian SUN
Chinese Journal of cardiovascular Rehabilitation Medicine 2014;23(6):601-605
Objective: To explore the influencing factors of slow blood flow phenomenon after emergency percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI). Methods: Clinical and PCI angiographic data of 488 patients, who were diagnosed as AMI and received primary PCI in our hospital from Jan 2010 to Jun 2011, were retrospectively analyzed. Patients were divided into slow blood flow group (n=51, TIMI flow ≤ grade 2) and normal flow group (n=437, TIMI flow= grade 3). Their clinical characteristics between two groups were compared. Results: Compared with normal flow group, there were significant reductions in percentages of thrombus aspiration (75.3% vs. 60.8%) and application of platelet glycoprotein IIb/IIIa receptor antagonist (81.7% vs. 68.6%) during PCI, and significant rise in total length of implanted stents [(31.8±12.2) mm vs. (35.7±12.0) mm] in slow blood flow group, P<0.05 all. Multi-factor Logistic regression analysis indicated that percentages of thrombus aspiration during PCI and total length of stents were independent influencing factors for slow blood flow (P<0.05 both). Conclusion: Percentages of thrombus aspiration and total length of stents during PCI are independent influencing factors for slow blood flow.