2.Implementation of performance metrics in clinical trial data management.
Ya-zhong DENG ; Hong-wei WANG ; Hai-jun FU
Acta Pharmaceutica Sinica 2015;50(11):1488-1492
There is no a systemic performance metrics for clinical data management. While the CDMC in China starts to develop the quality metrics for clinical data management, it is essential to think over the performance and pursue metrics implementation of clinical data management in China. This article provides the basic concept, development and implementation of the performance metric in clinical data management.
China
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Clinical Trials as Topic
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standards
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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.A case of primary cardiac lymphoma.
Yan XU ; Zhong-Wei SHI ; Wang-Fu ZANG
Chinese Journal of Cardiology 2009;37(11):1046-1046
4.Effect of Osthole on Mast Cells and Expression of STAT5 Gene and Protein in Mice with Eczema
Jian XIONG ; Zhendong ZHONG ; Rong FU ; Wei XIONG
Herald of Medicine 2015;34(12):1584-1587
Objective To explore the effect of osthole on mast cells and expression of STAT5 gene and protein in them. Methods Passive cutaneous anaphylaxis was made in mice to copy eczema model, then the allergic mast cells were separated, and the ovalbumin was used to induce allergy of mast cells. Different concentrations of osthole were used to intervene the sensitized mast cells.Then the sensitized mast cells were divided into blank control group, osthole high-dose group and low-dose group.At the end of the experiment, morphology of the mast cells was detected by immunofluorescence technology.MTT assay was used to detect the influence of drugs on mast cells proliferation. RT-PCR and Western blotting were used to detect the expression of STAT5 gene and protein. Results As compared with blank control group, the number of mast cells in the osthole groups was significantly reduced, cells and nuclei obviously shrank, even apoptosis of some cells could be observed; the inhibition rate of mast cells in osthole groups was significantly increased in concentration-dependent manner ( P<0. 01 ) . As compared with blank control group (2.16±0.57), gene expression of STAT5 was significantly decreased in osthole high-dose group (0.59±0.12) and low-dose group (0.82±0.13) (P<0.01).The protein expression of STAT5 was also significantly decreased in osthole high-dose group and low-dose group as compared with blank control group (P<0.01). Conclusion Osthole can inhibit the proliferation of sensitized mast cells, and reduce the expression of STAT5 gene and protein.
5.Quantitative detection of the expression level of transform-ing growth factor-β and its receptors in pterygium with RT- PCR
Ming, ZHONG ; Wei, SHEN ; Qing, FU ; Yuan, ZHANG
International Eye Science 2009;09(4):619-622
AIM: To quantitatively investigate transforming growth factor-β(TGF-β) and its receptors in normal bulbar conjunctival tissues and pterygium tissues. METHODS: Thirty cases of pterygium patients were randomly selected to undergo surgical resection of pterygium lesion, and the normal margin of bulbar con-junctival tissues were collected as control. Gene expres-sion was detected quantitatively by the method of quantitative real-time PCR (QRT-PCR) analysis. RESULTS: The expression level of TGF-β1 and TGF-β2 was 4.26×10-7±1.45×10-7 and 1.08×10-10±0.68×10-10 in normal bulbar conjunctival tissues, while 10.67×10-7±7.47×10-7 and 8.23×10-11±6.63×10-11 in pterygium tissues. The expression level of TGF-βRⅠand TGF-βRⅡwas 0.003015±0.0036 and 5.33×10-5±5.05×10-5in normal bulbar conjunctival tissues, while 0.000379±0.000281 and 1.002×10-5±9.04×10-6 in pterygium tissues. The expression level of TGF-β1 and TGF-β2 in pterygium was elevated (P<0.01). TGF-β1 expression level in pterygium increase 2.9±2.8 times than in normal conjunctiva. TGF-β2 expression level in pterygium increase 7.5±1.4 times than in normal conjunctiva. The expression level of TGF-βRⅠin pterygium was significantly lower (P<0.05). The expression level of TGF-βRII in pterygium was significantly lower (P<0.01). CONCLUSION: QRT-PCR is an effective method to quantitatively detect gene expression in eye. The upregulation of TGF-β1 and TGF-β2 and downregulation of their receptors expression may play an important role in the pathogenesis of pterygium, which is noteworthy further investigation in diagnosis and treatment of pterygium.real-time PCR; gene expression
6.Survey of natural foci of plague in Xiji county, Ningxia in 2007
Wei-cheng, FU ; Fu-gui, QIAO ; Liang-jun, ZHU ; Xing-hu, WANG ; Zhong-she, LI
Chinese Journal of Endemiology 2010;29(6):666-668
Objective To learn the plague's host animals and parasitic flea composition, and to investigate the natural foci of plague in Xiji county in order to provide basic information for plague prevention and control. Methods The Citellus alaschanicus density, nocturnal rodents, the body flea, the burrow track flea, the nest flea were investigated in 8 townships (town) of Xiji county from June 11 2007 to July 25 2007. Specimens of small mammalian, fleas were collected for bacteriological and serological testing. Results The average density of the main host Citellus alaschanicus was 0.85 per hectare. The nocturnal mouse capture rate was 0.80%(24/2987).The survey found 16 species of small mammals that belonging to 3 orders, 9 families and 16 species with Citellus alaschanicus the dominant species. The Citellus alaschanicus had 2.84 fleas per body. Four families and 16 species of fleas were identified in the areas. The Citellus alaschanicus and Citellophilus Tesquorum Mongolicus were the dominant species. Plague bacteriology and serology tests were negative. Conclusions The study shows that the area is suitable for the formation of natural foci of Citellus alaschanicus plague. Surveillance is an important measure for prevention and control of the plague.
7.Changes in serum PSA after brachytherapy for prostate cancer
Wei-Gang YAN ; Han-Zhong LI ; Yi ZHOU ; Fu-Quan ZHANG ;
Chinese Journal of Urology 2001;0(06):-
Objective To evaluate the serum prostate specific antigen(PSA)change after I-125 radioactive seed implantation without androgen ablation therapy for prostate cancer,Methods A total of 13 patients with prostate cancer were included.The clinical stage was T_(1c)N_0M_0 in 8 cases,and T_(2a)N_0M_0 in 5. The Gleason scores were 5 in 4 cases and 6 in 9.The mean serum PSA was 8.2 ng/ml(range,2.8-14.6 ng/ml).I-125 seed implantation(D90=140-155 Gy)was performed.Serum PSA was monitored every month for the first 3 months and every 3 months for the next 20 months.Results The range of follow-up time was 3-23 months.At 1,2,3,6,9,12,15,18 and 21 months after implantation,the median serum PSA values were 6.7,5.0,2.7,1.6,1.2,0.9,0.8,0.8 and 0.7 ng/ml;and the median percentage change in ser- um PSA were 72%,51%,29%,20%,13%,11%,9%,9% and 8%,respectively.One month after brachy- therapy,30% of the patients had fluctuation in PSA.Conclusions Compared with radical prostatectomy and androgen ablation therapy,the rate of PSA decline is slower with fluctuation at early phase.The most sig- nificant decline of PSA occurs in the first 12 months,especially in the first 3 months after I-125 seed implan- tation.
8.Therapeutic effect of the transplantation of trans-TrkC gene neural stem cells on spinal cord injury
Ri-Sheng LIANG ; Liang-Fu ZHOU ; Rong ZHANG ; Ying MAO ; Wei-Zhong YANG ;
Chinese Journal of Trauma 2003;0(12):-
Objective To investigate the therapeutic effect of trans-TrkC gene neural stem cells (NSCs)on the recovery of neural function after spinal cord injury.Methods Sixty SD rats were ran- domly divided into six groups:normal control group(A),hemisection group(B),NSCs transplantation grnup(C),NSCs transplantation with the regional application of NT-3 group(D),trans-TrkC gene NSCs transplantation group(E)and trans-TrkC genc NSCs transplantation with the regional application of NT- 3 group(F),10 rats in each group.Nine days after the set up of animal models,cell transplantation into the injured spinal cord was performed.The BBB locomotor score was calculated,and MEP(motor evoked potential)and SEP(somatesensory evoked potential)were pedormed two months after cell transplanta- tion.Results Two months after cell transplantation,the BBB locomotor score was partly recovered, and the MEP and SEP(somatosensory evoked potential)results were also markedly improved in Group F, which indicated the restoration of the upward and downward nerve conduction function of the injured spinal cord.But it seemed that the restoration of the downward nerve conduction was better than that of the up- want,and the extent of the improvement of MEP and SEP results was larger than that of motion function recovery.The onset latency,peak to peak amplitude of MEP and SEP,and the BBB score of Group F re- stored the best compared with the other groups,and the differences were statistically significant(P
9.Posterior short-segment instrumentation without fusion for treatment of thoracolumbar compression fractures
Daode LIU ; Ling ZHOU ; Rui ZHONG ; Chuanen WANG ; Zhibin FU ; Wei DAI ; Guangyou JIANG
Chinese Journal of Trauma 2013;29(8):749-752
Objective To investigate the clinical effect of posterior short-segment pedicle screw reduction and fixation without fusion in treatment of thoracolumbar mono-segmental compression fractures.Methods Thirty cases of thoracolumbar mono-segmental compression fractures admitted from January 2009 to February 2010 were assigned to single posterior pedicle screw fixation (screw group,n =15) and posterior pedicle screw fixation with posterolateral fusion (fusion group,n =15) according to random number table.Clinical results in the two groups were assessed based on Cobb' s angle,anterior vertebral body height ratio (%) and Oswestry disability index (ODI) before operation,after operation,prior to the removal of implant and at the latest follow-up.Results All the cases were followed up for average 24 months.Both operation time and blood loss were less in screw group than in fusion group [(76.58 ±12.67) min vs (116.29 ± 17.45) min,P < 0.01 ; (287.54 ± 30.76) ml vs (480.34 ± 100.54) ml,P <0.01],whereas there were no statistical differences between the two groups in aspects of Cobb' s angle and anterior vertebral body height ratio before and after operation,prior to the removal of implant as well as at the latest follow-up.Moreover,no statistical difference of ODI was noted between the two groups prior to the removal of implant and at the latest follow-up.Conclusion Posterior pedicle screw fixation without bone grafting achieves similar effects with pedicle screw fixation with bone grafting.
10.Chinese medicine for acute upper respiratory tract infection: a systematic review of randomized controlled trials.
Wenbing ZHANG ; Hongli JIANG ; Wei ZHOU ; Yunqing ZHONG ; Hongmei YANG ; Juanjuan FU ; Bing MAO
Journal of Integrative Medicine 2009;7(8):706-16
To evaluate the efficacy and safety of new drugs of traditional Chinese medicine (TCM) for acute upper respiratory tract infection (common cold).