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.Evaluation on Transverse Process Fractures of the Lumbar Spine
Journal of Practical Radiology 2000;0(02):-
Objective To evaluate the relationship between transverse process fractures of lumbar spine and blunt abdominal trauma.Methods 169 cases of blunt abdominal trauma were reviewed.Number and type of lumbar transverse process fractures associated intra-abdominal injuries were recorded.Results 148 fractures in 81 cases showed transverse process fractures on CT (single fractures in 43,multiple fractures in 38).Of them,the fractures were at right-sided in 28 patients,left-sided in 33 and bilateral in 20.Transverse process fractures of L 1 vertebra were most common(n=60).Transverse process fractures were associated with abdominal trauma in 15 cases (18%), both was statistically significant (?
4.The serum levels and roles of regulated upon activation normal T cell expressed and secreted and monocyte chemoattractant protein-1 in human immunodeficiency virus-1 infected patients
Liang CHEN ; Nan-Ping WU ; Hang-Ping YAO ;
Chinese Journal of Infectious Diseases 2007;0(12):-
Objective To study the roles of regulated upon activation normal T cell expressed and secreted(RANTES) and monocyte cbemoattractant protein-1 (MCP-1) in human immunodeficien- cy virus-1(HIV 1) infected patients.Methods RANTES and MCP-1 in HIV-1 infected patients, including treated and untreated groups,and healthy control group were determined by enzyme-linked immunosorbent assay(ELISA).The recombinant plasmids,hMCP-pcDNA3.1,bRANTES- peDNA3.1 and hMCP/bRANTES-pcDNA3.1,were constructed and transfected into CHO cells to overexpress the corresponding recombinant proteins,whose chemoattract function was then studied. Results The level of RANTES was (164.3?21.3) pg/mL in healthy control group,(1 224.1?62.0) pg/mL in untreated group and (475.3?36.2) pg/mL in treated group.The level of MCP-1 was (90.6?28.5) pg/mL in healthy control group,(335.0?30.3) pg/mL in untreated group and (807.2?62.6) pg/mL in treated group.In HIV-1 infected patients,the levels of RANTES and MCP-1 were significantly increased.After highly active antiretroviral therapy (HAART),the level of RANTES declined,but MCP-1 increased further.Western blot assay revealed that the three recombinant proteins could be recognized by monoclonal antibodies respectively.All of them could chemoattract human peripheral blood mononuclear cells(PBMCs).And the chemoattractant potency of MCP/RANTES fusion protein was stronger.When the recombinant proteins were used with con- centrations as 50,200,400 and 800 pg/mL,respectively,the number of PBMCs chemoattracted by MCP/RANTES fusion protein was 52?10~4/mL,102?10~4/mL,132?10~4/mL and 184?10~4/mL; the number of PBMCs chemoattracted by RANTES was 27?10~4/mL,51?10~4/mL,65?10~4/mL and 96?10~4/mL;the number of PBMCs chemoattracted by MCP-1 was 18?10~4/mL,44?10~4/mL, 54?10~4/mL and 74?10~4/mL.Conclusion RANTES and MCP-1 may both be involved in the HIV infection process and host immunological reaction against HIV.
6.Function and structure analysis of premembrane and envelope proteins of Zika virus
Chang LU ; Na LI ; Pu XUE ; Nan LI ; Ping CHEN
Chinese Journal of Zoonoses 2017;33(1):81-84
The premembrane and envelope proteins (prM-E),which contains the mainly protective antigen related with virulence and tropism,are the primary structural protein of flavivirus.However,prM-E in ZIKV is rarely understood.We have analyzed the structure and biological effects of prM-E in ZIKV by bionformatics methods.The prM-E proteins virus-like particles of dengue virus was introduced in the present.Then,the prM-E proteins virus like particles of ZIKV was prospected.
7.Comparative study of continuous ambulatory peritoneal dialysis and hemodialysis on polycystic kidney disease patients
Jingyuan XIE ; Nan CHEN ; Hong REN ; Xiaonong CHEN ; Wen ZHANG ; Jing XU ; Ping ZHU
Chinese Journal of Nephrology 2009;25(2):101-105
Objective To compare the efficacy of continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD) on polycystic kidney disease (PKD) patients with end-stage renal disease (ESRD). Methods Retrospective analysis was made on 29 patients with PKD who carded out dialysis therapy for over 3 months in our department from January 2001 to December 2007. They were divided into the CAPD group (10 cases, 34.5%) and HD group (19 cases, 65.5%). Ten cases of non-PKD CAPD patients were randomly selected as the control, who matched the CAPD group in terms of age and gender. The patient information was recorded, such as general data, initial dialysis data, comphcations, survival time, quit of dialysis or death, etc. Kaplan-Meier method and Log-rank test were adopted to analyze the survival rate. Results The survival rates of 1-, 3- and 5-year for the CAPD group were 90%, 75% and 25% respectively, while for the HD group were 94.4%, 67.6%, and 48.3%, and for the control were 83.3%, 44.4% and 22.2% respectively, with no significant differences among 3 groups (P>0.05). group and the control were quite similar. The incidence of peritonitis for the CAPD group (0.62 times/patient year) was similar to that for the control (0.30 times/patient year)(P>0.05). The duration of the lust peritonitis[(23.5±4.0) months vs (20.0±15.8) months] and the catheter exit-site infection (0 time vs 1 time) for two groups were similar as well (P>0.05). One patient had hernia in CAPD group and no patient in control group had hernia. The incidence of peritoneal dialysate leakage was similar between these two groups. In the HD group, two patients (10.5%) had cerebral hemorrhage resulting in death, and 10 patients (52.6%) had cystic hemorrhage, 5 out of whom underwent operation due to repeated cystic hemorrhage and 2 cases received unilateral nephrectomy because of severe hemorrhage. No patient in CAPD group had cerebral hemorrhage but 1 patient (10%) had cystic hemorrhage and recovered after conservative treatment. The hemorrhage complication incidence of CAPD group was significantly lower than that of HD group (P<0.05). Conclusions The prognosis and complication incidence in PKD and non-PKD patients treated with CAPD are similar. The prognosis of PKD patients treated with CAPD or HD is also similar, and the risk of hemorrhage complications of PKD patients treated with CAPD may be decreased compared with those treated with HD. PKD patients can choose HD or PD as the initial therapy of ESRD unless existence of hernia or intolerance. PKD is not the contraindication of PD.
8.Study on the Scientific Research and its Corresponding Strategy for 34 third-grade class A hospitals of Fujian Province between the year 2001 and 2010
Ronghui JIANG ; Nan REN ; Xiaonan WU ; Qiuli CHEN ; Ping LIN ; Xuezhen CHEN ; Liuli DENG
Chinese Journal of Medical Science Research Management 2014;27(1):21-26
Third-grade class A hospitals undertake three tasks-medical service,scientific research and teaching.scientific research is the motivation for third-grade class A hospitals' continuous development and also an important symbol of their medical and academic level.On the purpose of evaluating overall scientific level of such hospitals this thesis analyze the scientific projects and the outcomes of 34 hospitals by using the method of literature research and questionnaire,extracting advantages for scientific research,seeking their problems and coming up with corresponding strategy.have analyzed the achievements we acquired as well as the problems still existing.According to the reality of Fujian Province,some suggestions are coming up with so as to improve the scientific research.
9.Prospective efficacy comparison between the two-cuff swan neck catheter and the Tenckhoff catheter in peritoneal dialysis patients
Jingyuan XIE ; Ping ZHU ; Pingyan SHEN ; Hong REN ; Xiaomin HUANG ; Xiao LI ; Xiaonong CHEN ; Nan CHEN
Chinese Journal of Nephrology 2008;24(10):685-689
Objective To compare the efficacy between the two-cuff swan neck catheter and the Tenckhoff catheter in continuous ambulatory peritoneal dialysis (CAPD) patients prospectively. Methods One hundred and ten patients with end-stage renal disease (ESRD) were selected as candidates, who received catheter implantation and CAPD therapy for the first time. Patients were divided into group A (swan neck catheter group) and group B (Tenckhoff catheter group), 55 patients for each group. Catheters of beth groups had a straight end and were implanted by routine surgical procedure. One-year follow-up was performed and information was recorded such as complications, survival time, quit of dialysis, death, etc. Survival analysis was carried out by Kaplan-Meier method and Log-Rank tests. Results At the end of follow-up, 17 patients died, 3 received renal transplantation, 8 were transferred to hemodialysis, 3 went to other hospitals, and 79 patients (71.8%) remained in our department for CAPD. Twenty-six patients of both groups had peritonitis with a total of 35 occurrences. The total incidence of peritonitis was 0.32 times/patient year, with the detailed figure of 0.35 times/patient year for group A and 0.29 times/patient year for group B respectively (P0.05). The time interval between the catheter implanting and the onset of peritonitis was (30±29) weeks and (29±24) weeks for group A and group B respectively (P0.05). The risk of developing peritonitis in both groups was 26.97% within 1 year. Tunnel infection occurred in 2 patients and exit-site infections in 9 patients of two groups. The incidence of tunnel plus exit-site infections was 0.1 times/patient year. Incidence of tunnel infection and the exit-site infection for group A was lower than that of group B (0 vs 0.036 times/patient year and 0.06 times/patient year vs 0.11 times/patient year respectively). However, the difference was not significant (P0.05). Mechanical complications of catheter (catheter migration, omcntum wrapping, leakage of peritoneal dialysates, slip out of outer cuff), incidence of inguinal hernia and bellyache between two groups were not significantly different (P0.05). There were 4 cases of catheter drawing in each group. Both two groups had the same 12-month technical survival rate as 92.73%. Of 17 dead cases, 7 were in group A and 10 in group B (P0.05). The main death causes were cardiocerebral events (47.1%) and infections (23.5%). The 12-month survival rate was 86.34% for group A and 80.68% for group B (P0.05). Conclusions There are no significant differences of infection, mechanical complications, technical survival rate and patients' survival rate between two groups. The efficacy of swan-neck catheter is similar to Tenckhoff catheter in CAPD patients.
10.Comparison of P63 Protein Expression in Non-small Cell Lung Cancer between Xuanwei and Other Regions
Jun LIU ; Gaofeng LI ; Nan CHEN ; Jun PENG ; Xinlong CHEN ; Ping WANG ; Xin MAO ; Xiangu NING
Journal of Kunming Medical University 2014;(1):37-41
Objective The purpose of the study was to compare the P63 expression in non-small cell lung cancer (NSCLC) between Xuanwei and other regions, and to investigate the relationship of P63 expression and biological behavior. Methods Immunohistochemical method was used. Results The results indicated that the expression of P63 in lung squamous cell carcinoma was extraordinarily high. P63 was related to the TNM staging system,tissue differentiation degree and lymph node metastasis,but not related to gender. In NSCLC,there was no significant difference of the P63 positive expression rate in the same pathological types, staging, tissue differentiation degree, lymph node metastasis and gender between Xuanwei and other regions. It indicated that the expression of P63 was not the reason why it was high incidence of lung cancer in Xuanwei region.