1.Key activities involved in conduct of clinical trials
Ai-Jian LI ; Ning-Ning XIONG ; Xiu-Qin WANG ;
Chinese Journal of Clinical Pharmacology and Therapeutics 2000;0(03):-
Key trial activities include: development of the trial protocol;development of standard operating procedures;development of support systems and tools;generation and approval of trial information documents;selection of trial sites and the selection of properly qualified,trained,and experienced investigators and study personnel;ethics committee review and approval of the protocol;review and approval by applicable regulatory authorities;enrollment of subjects into the study: recruitment,eligibility,and informed consent;the investigational product(s): quality,handling,and accounting;trial data acquisition: conducting the trial;trial data acquisition: conducting the trial; safety management and reporting;monitoring the trial;managing trial data;quality assurance of the trial performance and data;reporting the trial.
2.Protective effects of zinc sulfate on the reperfusion injury following pancreaticoduodenal transplantation in rats
Chunhui YUAN ; Dianrong XIU ; Lijun LI ; Li NING ; Guohong YUAN ; Tonglin ZHANG
Chinese Journal of General Surgery 2000;0(11):-
Objective To study the protective effects of the heat shock protein 70(HSP70)induced by zinc sulfate on reperfusion injury following pancreaticoduodenal transplantation in rats.Methods The homologous male Wistar rat model of heterotopic total pancreaticoduodenal transplantation was used.The ZnSO4 treated rats received the intravenous injection of Zn2+5 mins before and after operation at a dose of 5 mg/kg(Zn-1 group),10 mg/kg(Zn-2 group) and 15 mg/kg(Zn-3 group),and the control group with the same volume of saline.The tissue concentration of HSP70 was determined using Western-Blot.In addition,blood sugar(BG) and serum concentration of amylase and lipase were examined 24h after transplantation,and the activity of myeloperoxidase(MPO) in the pancrease graft was measured at the same time.Histological observation was performed.Results Light microscopic studies showed that histomorphological changes of pancreas in Zn-2 group and Zn-1 group were much less than those in control group and Zn-3 group.The value of BG and serum lipase and MPO in Zn-2 group
3.Impact of directly sequenced core and non-structrural protein 5B regions on hepatitis C virus genotyping
Wei LI ; Huibin NING ; Yi KANG ; Xiu JIN ; Junping LIU ; Jia SHANG
Chinese Journal of Infectious Diseases 2015;(6):343-345
Objective To explore the sensitivity and accuracy of directly sequenced core and non-structrural protein (NS)5B regions for hepatitis C virus (HCV)genotyping.Methods Fifty-one serum samples from chronic hepatitis C patients were collected in the study.Reverse transcription-polymerase chain reaction was used to amplify core and NS5B regions.Genotypes or subtypes were determined by the phylogenetic analysis of directly sequenced core and NS5B regions.Results Among the 51 samples,49 (96.1 %)were successfully typed by phylogenetic analysis of directly sequenced core region.There were overall five genotypes determined in the area,including 1b (61 .2%,30/49 ),2a (20.4%,10/49 ),2b (2.0%,1/49),3a (4.1 %,2/49 )and 6a (12.2%,6/49 ).The positive rate of HCV genotying was 88.2% (45/51 )on the basis of NS5B region.HCV genotypes 1b,2a,2b,3a and 6a were found in 62.2% (28/45),20.0% (9/45 ),2.2% (1/45 ),4.4% (2/45 )and 11 .1 % (5/45 )of the patients, respectively.Conclusion The HCV genotyping based on core regions,compared with that based on NS5B,shows the advantages of primer design,amplification efficiency and accuracy,suggesting that it has the priority to be used in the epidemiological and clinical study of HCV genotyping.
4.The Preparation of the Recombinant Fusion Protein Human Retinal Pigment Epithelium-derived Factor and the Analysis of Its Angiogenesis Activity
Ya-Ni WANG ; Xian-Ning LIU ; Juan-Li ZHU ; Na AN ; Xiu-Ping ZHU ;
China Biotechnology 2006;0(12):-
Objective:The recombinant human retinal pigment epithelium-derived factor(PEDF)protein to be obtained and the angiogenesis of the rPEDF to be identified.Methods: PEDF gene gene was amplified by PCR and cloned into pET32a,rPEDF protein was expressed in E.coli BL21 and confirmed by SDS-PAGE and Western blot.The rPEDF was purified by Ni-NTA on denature condition.The concentration of the rPEDF was determined by Bradford method.The angiogenesis of the rPEDF was determined by chick chorioallantoic membrane(CAM) method.Results: The expression plasmid pET32a-PEDF was constructed successfully.The rPEDF was expressed with stable efficiency in E.coli BL21.The results of the CAM experiment showed that the rPEDF had notable angiogenesis effect in the concentration 0.4、0.04 ng/ml,but had no effect in 4 ng/ml.Conclusion:The PEDF gene was cloned and expressed efficiently,the angiogenesis of the rPEDF to be identified and the activity was worked in certain range.The results can facilitate studying its function and spreading its application.
5.The prevention and nursing of contrast-induced nephropathy within peri-operation period of cardiac resynchronization therapy
Chinese Journal of Modern Nursing 2010;16(14):1658-1660
Objective To explore the prevention and nursing strategies of contrast-induced nephropathy (CIN) in patients with congestive heart failure (CHF) within peri-operation period of cardiac resynchronization therapy (CRT). Methods Thirty inpatients with CHF from June 2007 to September 2009 were studied. All 30 patients received hydration therapy within peri-operation period and different contrast agents were administrated based on renal function of patients. The prevention and nursing measures, such as strictly limited the dosage of contrast agents were adopted. Results The heart function was significantly improved in all patients. There were no changes in renal function of 24 patients. However, 6 patients occurred the symptom of serum creatine increasing and 2 of whom was diagnosis as CIN and 1 patient degenerated into end stage renal function which relied on dialysis. Conclusions The comprehensive prevention and nursing measures including carefully evaluating renal function, taking the therapies of hydration and alkalization therapy can effectively prevent CIN for CHF patients receiving CRT.
6.Comparison of two different health education methods on alleviating preoperative anxiety of coronary intervention in patients with coronary heart disease
Ye LI ; Qing-Xiu NING ; Jing HAO
Chinese Journal of Modern Nursing 2012;18(5):543-545
Objective To explore appropriate health education method for patients receive coronary intervention operation to alleviate patients' anxiety and provide some scientific evidence for clinical to launch high quality nursing education.Methods According to the different days,totals of 420 patients with first coronary intervention operation were selected and randomly divided into control group (210 cases )and experimental group (210 cases).Control group received individual pattern health education,while experimental group received group patten health education.All patients were investigated with self-anxiety scale(SAS) before and after health education,then the incidence of anxiety and SAS score between two groups were compared.Results Before health education,64.8% patients of control group and 65.7% patients of experimental group existed anxiety,and the difference was statistically significant (x2=0.04,P >0.05 ).After education,the anxiety incidence of two groups lower than before education,experimental group ( 17.1% ) was lower than control group( 27.6% ),and the difference was statistically significant( x2=6.63,P <0.05 ).Before education,the SAS score of control group was ( 53.85 ± 3.78 ) and experimental group was ( 53.57 ± 4.89 ),and the difference was no statistically significant ( P > 0.05 ).After education,the SAS score of control group and experimental group was (45.65 ±0.94),(42.18 ± 1.29),respectively,lower than before education,and the difference was statistically significant ( t=6.24,7.76,respectively; P < 0.05 ).Also,the SAS score of experimental group lower than that of control group the difference was statistically significant ( t=7.39,P <0.05 ).Conclusions Health education for patients with coronary intervention can alleviate their pre-operation anxiety,and group patten health education is better than individual pattern health education in reducing anxiety patients number and alleviate patients' anxiety.
7.Effect of knowledge, attitude, belief, and practice model towards student nurses' hand hygiene
Ye LI ; Qing-Xiu NING ; Ming-Mei DU
Chinese Journal of Modern Nursing 2012;18(10):1197-1199
Objective To elevate student nurses' hand hygiene compliance through knowledge,attitude,belief,and practice(KAP) model.Methods 82 student nurses were selected and received KAP hand hygiene training.The knowledge,practical compliance and qualification of hand hygiene were observed before and after training.Results Hand hygiene and washing hand indication awareness rate were 92.68% and 97.56% after training,which were higher than those before training (46.34% and 64.63%,respectively),and the difference was significant (x2 =36.03,25.04,respectively; P < 0.01 ) ; Other awareness rates of hand hygiene after training were significantly improved than those before training ( P < 0.01 ).The total compliance rate of hand hygiene of student nurses after training ( 82.97% ) was significantly higher than that before training (50.92%) (x2 =316.08,P<0.01 ).The qualified hand hygiene ratio was elevated from 58.54% to 92.68 %( x2 =25.92,P < 0.01 ).Conclusions KAP model was effective towards student nurses' hand hygiene compliance and worthy for application.
8.Changes in Hydrogen Sulfide in Rats with Hepatic Cirrhosis in Different Stages
ZHANG NING ; ZHENG YONG ; CHEN WEI-GANG ; LI RUI ; SONG LI-XIU ; XU LI-HONG ; XU KE-SHU
Journal of Huazhong University of Science and Technology (Medical Sciences) 2017;37(5):705-710
This study aimed to observe changes in the hydrogen sulfide (H2S) system in the blood and liver tissue of rats with hepatic cirrhosis at different stages by studying the effect of H2S on the course of hyperdynamic circulation in rats with hepatic cirrhosis.H2S concentration in the blood from the portal vein and inferior vena cava of hepatic cirrhosis rat model induced with carbon tetrachloride was detected on the 15th,30th,and 52nd day.The expression of cystathionine β-synthase (CBS) and cystathionine γ-lyase (CSE) protein,and CBS and CSE mRNA in the liver was detected by immunohistochemistry and reverse transcriptase polymerase chain reaction (RT-PCR),respectively.The results indicated that H2S concentration in the blood from the portal vein and inferior vena cava of rats with hepatic cirrhosis was significantly lower than that in the control group.H2S was gradually decreased with the development of the disease and significantly lower in the blood from portal vein than in the blood of inferior vena cava at the mid-stage and the late stage groups.The expression levels of CBS and CSE protein,and CBS and CSE mRNA in the livers with hepatic cirrhosis at different stages were all higher than those in the control group,and the expression gradually increased with the development of the disease.The expression of CBS was lower than CSE in the same stages.The results indicated that the CSE mRNA was expressed predominantly in the cirrhosis groups as compared with CBS rnRNA.Among experimental rats,the H2S system has an important effect on the occurrence and development of hyperdynamic circulation in rats with hepatic cirrhosis.This finding adds to the literature by demonstrating that H2S protects vascular remodelling in the liver,and that CSE is indispensable in this process.
9.Antiviral effects of the combination of glycyrrhizin and ribavirin against influenza A H1N1 virus infection in vivo.
Xiu-xiu CHEN ; Hong-xia ZHOU ; Wen-bao QI ; Zhang-yong NING ; Yong-jiang MA ; Yao-lan LI ; Guo-cai WANG ; Jian-xin CHEN
Acta Pharmaceutica Sinica 2015;50(8):966-972
Ribavirin is a broad-spectrum antiviral agent and glycyrrhizin has activities of anti-inflammation, immunoregulation and anti-viral infections. To enhance antiviral efficacy and weaken side-effects of ribavirin, antiviral effects of the combination of glycyrrhizin and ribavirin were studied in the present study. Firstly, a mouse model of viral pneumonia was established by inoculation of influenza H1N1 virus. Protective effects of glycyrrhizin and ribavirin used alone or in combination against H1N1 virus infection in mice were evaluated based on the survival rate, lung index and virus titer in lungs of mice. Results showed that the combination of glycyrrhizin and ribavirin significantly inhibited the lung consolidation with a 36% inhibition ratio on the lung swell of infected mice. The combination of the two drugs exhibited synergetic effects on survival of infected mice. The combination of 50 mg · kg(-1) · d(-1) glycyrrhizin and 40 mg · kg(-1) · d(-1) ribavirin resulted a 100% protection for infected mice with a synergetic value of 36, which was significantly higher than the control group and each drug alone. This combination also resulted a significant drop of lung virus titer (P < 0.01), as well as inhibition on the production of proinflammatory cytokines IL-6 (P < 0.01), TNF-α (P < 0.01) and IL-1β (P < 0.05) induced by virus infection compared to the control. The treatment of ribavirin plus glycyrrhizin was more effective in influenza A infection in mice than either compound used alone, which suggested a potential clinical value of the combination of the two agents.
Animals
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Antiviral Agents
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pharmacology
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Disease Models, Animal
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Drug Synergism
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Drug Therapy, Combination
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Glycyrrhizic Acid
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pharmacology
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Inflammation
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immunology
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Influenza A Virus, H1N1 Subtype
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drug effects
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Interleukin-1beta
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immunology
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Interleukin-6
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immunology
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Lung
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immunology
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virology
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Mice
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Orthomyxoviridae Infections
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drug therapy
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Pneumonia, Viral
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drug therapy
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Ribavirin
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pharmacology
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Tumor Necrosis Factor-alpha
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immunology
10.Inhibitory effect of phenylhexyl isothiocyanate on notch signaling of multiple myeloma cells in vitro.
Xiu-Li HONG ; Ze-Chuan ZHANG ; Jiang-Ning ZHAO ; Quan-Yi LU
Journal of Experimental Hematology 2011;19(4):940-943
In order to investigate the mechanisms of phenylhexyl isothiocyanate (PHI) inhibiting the proliferation of multiple myeloma cell RPMI8226 in vitro, the RPMI8226 cells were co-cultured with PHI of various concentrations. The inhibition of proliferation was measured by MTT test and the cell apoptosis was assayed by DAPI staining. The changes of Notch1, Jagged2, BCL-2 and p-Akt proteins in the PHI-treated cells were detected by Western blot. The results showed that PHI inhibited RPMI8226 cell proliferation in certain concentration range and induced their apoptosis. The inhibiting effect caused by PHI showed a concentration-and time-dependent manner. The PHI decreased expressions of Notch1 and Jagged2 proteins in a concentration-and time-dependent manners, the levels of BCL-2 and p-Akt declined at the same time. It is concluded that PHI can inhibit proliferation of RPMI8226 cells, and induce their apoptosis. The cell apoptosis is associated with the inhibition of Notch signaling and downstream targets BCL-2 and p-Akt proteins of RPMI8226 cells, PHI may be a new Notch signaling inhibitor and a promising therapeutic drug for multiple myeloma.
Cell Line, Tumor
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Humans
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Intercellular Signaling Peptides and Proteins
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metabolism
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Isothiocyanates
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pharmacology
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Jagged-2 Protein
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Membrane Proteins
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metabolism
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Multiple Myeloma
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metabolism
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Proto-Oncogene Proteins c-akt
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metabolism
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Proto-Oncogene Proteins c-bcl-2
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metabolism
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Receptor, Notch1
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metabolism
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Signal Transduction
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drug effects