1.How to Protect the Vulnerable Groups in Drug Clinical Trials
Chinese Medical Ethics 2017;30(5):572-575
Objective:To find a better way to protect the security and interests of vulnerable groups by exploring the problem of protecting the vulnerable groups in drug clinical trial from the perspectives of ethics committees,organization and researchers.Methods:According to the relevant literature and the actual situation of the hospital,this paper analyzed the security issues of vulnerable groups comprehensively.Results:Only the ethics committees,organization and researchers work together,can it protect the security and interests of vulnerable groups to the greatest extents.Conclusion:Further research on the security of vulnerable groups not only promotes the development of human health,but also plays a decisive role in improving the protection of subjects in drug clinical trial.
2.Recombinant adenovirus-mediated hypoxia inducible factor 1alpha mutant promotes proliferation of adipose-derived mesenchymal stem cells
Xin ZHANG ; Lin ZHOU ; Xiaolei ZHANG
Chinese Journal of Tissue Engineering Research 2016;20(23):3386-3393
BACKGROUND:To improve the survival rate of transplanted tissue, most scholars focus on cel therapy, particularly cel-assisted fat grafting.
OBJECTIVE:To analyze the effect of recombinant adenovirus-mediated hypoxia inducible factor 1alpha (HIF1α) mutant on survival rate of transplanted fat particles through transfection of adipose-derived mesenchymal stem cels.
METHODS:Recombinant adenovirus-mediatedtriple-mutantHIF1αwas inserted into an adenovirus pAdEasy-1 system, folowed by viral packaging and titer determination. Human adipose-derived mesenchymal stem cels were cultured, passaged and identified, and subsequently transfected with three kinds of viruses and blank vector (experimental group with transfection of the triple mutantof HIF1α;positive control group; negative control group; blank control group). Transfection efficiency was determined using enhanced green fluorescent protein labeling. Additionaly, MTT assay was used to detect cel proliferation.
RESULTS AND CONCLUSION:The recombinant adenovirus was successfuly constructed and packaged in line with transfection requirements. Moreover, adipose-derived mesenchymal stem cels were successfuly identified by adipogenic, osteogenic and chondrogenic induction and could be used asseed cels for subsequent experiments. RT-PCR results showed that HIF1α mRNA expression in the experimental group and positive control group was significantly higher than that in the other two groups (P< 0.05). Western blot analysis showed that the relative absorbance value in the experimental group was significantly higher than that in the other three groups (P< 0.05). A significant increase in the cel proliferation was found in the experimental group, significantly different from the other three groups (P<0.05). Therefore, our findings indicate that transfection of adenovirus-mediated triple-mutant HIF1α not only can sustain the expression of target protein in transfected adipose-derived mesenchymal stem cels under normoxic conditions, but also can promote the proliferation of transfected adipose-derived mesenchymal stem cels.
3.Nosocomial Infection in Hangzhou Community Health Centers 2007
Xin ZHOU ; Ting DING ; Bing LIN
Chinese Journal of Nosocomiology 2006;0(12):-
OBJECTIVE To investigate the status of nosocomial infection in community health services and offer a scientific basis for nosocomial infection control.METHODS Totally 5738 outpatients were investigated retrospectively for nosocomial infection in community.RESULTS The most frequently nosocomial infection sites were lower respiratory tract,and next upper respiratory tract and urinary tract(2131,1045 and 934,respectively).The major reasons of causing the nosocomial infection were irrational usage of antibacterial drugs(39.0%),invasive procedures(31.0%) and using glucocorticoids(10.0%).Most of the pathogenic bacteria of the nosocomial infection were Gram-negative and the next were Gram-positive and fungi.74.4% of the pathogens were resistant to most of antibioties.CONCLUSIONS Alzeimer′s disease patients in the community health centers are popular and susceptible to infection.
4.Analysis of bacterial spectrum in diabetes ulcer
Xin ZHOU ; Song LIN ; Hengshu ZHANG
Journal of Endocrine Surgery 2012;6(6):384-387
Objective To evaluate the features of bacterial spectrum and drug resistance in diabetic ulcer.Methods Excretion specimen of diabetic ulcer from 130 patients admitted into our hospital from Mar.2010 to Sep.2011 were collected for bacterial culture and drug sensitivity test.28 antibiotics were chosen from 35commonly used antibiotics to test antibiotic sensitivity to decide whether the antibiotic was sensitive (S),intermediate sensitive (I),or resistant (R).Results 19 strains were isolated from 130 cases.Staphylococcus aureus with 14.62 % (19 cases)rated the first,followed by escherichia coli with 13.85% (18 cases),proteus mirabilis with 13.08% (17 cases),staphylococcus epidermidis with 12.31% (16 cases),enterococcus faecalis with 12.31% (16 cases),acinetobacter baumannii with 10.77% (14 cases).Antibiotics with high sensitivity to Gram-positive bacteria were tigecycline and vancomycin while with high sensitivity to Gram-negative bacteria were imipenem and amikacin.Conclusions Bacteria of diabetic ulcer are commonly resistant to antibiotics.It is of great importance for clinical rational drug use to know the distribution and resistance of commonly encountered bacteria.
5.Interaction among peroxisome proliferators-activated receptor alpha, cytochrome P450 oxysterol 7α-hydroxylase and estrogen receptor and its association with intrahepatic cholestasis in pregnant rats
Qingyun SHI ; Yugeng LIN ; Xin ZHOU ; Yingqi LIN ; Shi YAN
Chinese Journal of Obstetrics and Gynecology 2010;45(6):440-444
Objective To investigate the relationship between interaction of peroxisome proliferators-activated receptor alpha (PPARα), cytochrome P450 oxysterol 7α-hydroxylase (CYP7B1) and estrogen receptor (ER) and intrahepatic cholestasis in pregnant rats. Methods Eighty clean SD pregnant rats were selected and divided into four groups randomly with 20 in each. Since the 13th day of pregnancy,rats in the control group was injected subcutaneously with refined vegetable oil 2.0 ml · kg-1 · d -1 , those in the low-dose, moderate-dose and high-dose groups received 17-α-ethynylestradiol (EE) 1.0 mg · kg-1 · d-1,1.25 mg · kg-1 · d-1 and 1.5 mg · kg-1 · d-1, respectively. All rats were sacrificed at the 21at day of pregnancy and maternal hepatic tissues were collected. The serum levels of alanine aminotransferase(ALT), aspartate transaminase (AST), total bile acid (TBA) and bilirubin (BIL) were determined by enzyme linked immunosorbent assay (ELISA). The mRNA expressions of PPARα, CYP7B1, Erα and Erβ in maternal rat livers were examined by real-time PCR. Results (1) Biochemical indicators: the serum levels of ALT,AST, TBA and BIL were significantly lower in the control group than in the rest 3 groups,respectively [ control group: (41.1 ± 2.8 ) U/L, (44.4 ± 3.6) U/L, (26.4 ± 5.6 ) μmol/L and( 2.8 ± 0.2)U/L;low-dose group: (48.2 ±3.4) U/L,(47.9 ±3.7) U/L,(36.4 ±4.2) μmol/L and (4.2 ±0.2) U/L;moderate-dose group: (70.4 ± 5.3 ) U/L, (68.4 ± 5.6) U/L, (64.3 ± 3.8 ) μmol/L and ( 6.2 ± 1.2)U/L; high-dose group: (72.4 ±7.6) U/L, (70.2 ±3.8) U/L, (72.4 ±7.8) μmol/L and (8.2 ±2.2)U/L, P<0.05], and those in the moderate or high-dose groups were higher than in the low-dose group (P<0.05). (2) mRNA expression of Erα and Erβ: the mRNA expression of Erα in pregnant rat livers increased in a dose-dependent manner, which were all significantly higher than that in the control group,respectively ( low-dose group: 0.76 ± 0.02 ); moderate -dose group: ( 0.99 ± 0.04; high-dose group:1.21 ±0.01 ;control group:0.65 ±0.01, P <0.05), but no difference was found among the 4 groups in the mRNA expression of Erβ ( P > 0.05 ). (3) mRNA expression of CYP7B1 and PPARα: the mRNA expression of CYP7B1 in pregnant rat livers increased from the low-dose group to the high-dose group, and were all higher than that of the control group ( low-dose group: 0.93 ± 0.01; moderate-dose group: 0.99 ±0.06; high-dose group: 1.22 ± 0.04; control group: 0.75 ± 0.02, P < 0.05 ). However, the mRNA expression of PPARα decreased from the low-dose group to the high-dose group, and were all lower than that of the control group (low-dose group: 0.83 ± 0.05; moderate-dose group: 0.71 ± 0.02; high-dose group:0.64 ± 0.03; control group: 1.35 ± 0. 05; P < 0.05 ) . Conclusions The down regulated mRNA expression of PPARα, caused by higher dose of estrogen, may increase the expression of CYP7B1 due to the ineffectiveness of the inhibition of PPARα on CYP7B1, which may further stimulate the Erα activity and then induce intrahepatic cholestasis. Abnormal expression of PPARα, CYP7B1 and ER may play a role in the pathogenesis of estrogen-induced intrahepatic cholestasis.
6.Expressions of estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2 and relationships of these expressions with clinical pathology in breast cancer patients aged 70 years old and over
Ping ZHANG ; Li DING ; Xin NIE ; Lin LI ; Meizhen ZHOU
Chinese Journal of Geriatrics 2010;29(8):644-647
Objective To investigate the expressions of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER-2) and relationships of these expressions with the clinicopathology in breast cancer patients aged 70 years old and over. Methods The expressions of ER, PR and HER-2 were detected by immunohistochemical staining from 124 elderly breast cancer patients, and the relationships of these expressions with pathological classification, tumor size, lymph node metastasis and TNM stage were analyzed. Results Among 124 patients, the positive expression rate of ER and PR was 75.0% (93/124) and 71.0% (88/124),respectively. They were not associated with pathological classification, tumor size, lymph node metastasis or TNM stage (all P>0. 05). The positive expression rate of Her-2(+++) and Her-2 (++) was 11.3% (14/124) and 24.2% (30/124), respectively. And the expression of Her-2 was significantly associated with tumor size, lymph node metastasis and TNM stage (P<0. 05) but not with pathological classification (P>0. 05). Conclusions The positive expressions of ER and PR are not correlated with the clinicopathology in elderly breast cancer patients. Her-2 overexpression is positively associated with tumor size, lymph node metastasis and TNM stage.
8.Effect of double gene transduction mediated by lentiviral vectors on characteristics of human embryonic stem cells
Liuhong CAI ; Canquan ZHOU ; Bin ZHANG ; Xin TAO ; Hui LIN
Chinese Journal of Pathophysiology 2009;25(11):2197-2203
AIM: To study the effect of double gene transduction mediated by lentiviral vectors on the characteristics of human embryonic stem cells (hESCs). METHODS: Using the backbone from inducibal dual and excisable transgene vector (iDuet101) , lentiviral vectors overexpressing cytotoxic T lymphocyte - associated molecule - 4 immuno-globulin (iDuet101 - CTLA4Ig) , indoleamine 2, 3 dioxygenase (iDuet101 - IDO) , and ubiquitin - C promoter - lueifer-ase - ires - puromycin ( ULIP) were constructed and packaged according to the standard recombinant techniques. Human embryonic stem cells (hESCs) were first transduced with iDuet101, iDuet101 - CTLA4Ig or iDuet101 - IDO, then, after the selection, were transduced again with ULIP. The expression and function of the exogenous genes were detected. Immu-nohistochemistry, RT - PCR and flow cytometry were applied for detection of embryoid bodies ( EB) formation in vitro and in vivo teratoma formation. RESULTS: Double - transduced hESCs showed typical shape of cell clones and positive staining of tumor rejection antigen -1 - 60 ( Tra -1 - 60 ) and octomer transcription factor - 4 ( OCT - 4 ). The formation of EB was observed, in which a - fetoprotein (AFP), paired box gene 6 ( Pax6) and Musashi 1 ( MSI1) were positively expressed. The cells formed teratomas, and the luciferase signals existed until 28 days after xeno - transplantation. CONCLUSION : Double transduction of non - transcriptional factors mediated by lentiviral vectors does not affect the cell growth rate and their differentiation ability.