1.Study on the Current Situation of the Implementation of New Version Good Manufacture Practice of Drugs in Pharmaceutical Enterprises in Guizhou Province
Geyao ZHOU ; Wenjiao CHEN ; Haiyu TIAN ; Xiaoxia MENG ; Jia CHENG
China Pharmacy 2017;28(7):865-868
OBJECTIVE:To provide reference for the sustainable development of pharmaceutical enterprises in Guizhou prov-ince. METHODS:A questionnaire was conducted for 55 pharmaceutical enterprises in Guizhou province,the basic situation of en-terprises,familiarity of related directors to Good Manufacture Practice of Drugs(GMP)and relevant policy,the current situation of implementing the new version GMP were investigated and statistically analyzed,problems were found,and corresponding coun-termeasures were put forward. RESULTS & CONCLUSIONS:Totally 55 questionnaires were sent out,49 valid ones were received with effectively recovery of 85.1%. The results showed 43 enterprises(87.8%)had passed the GMP authentication;only 13 enter-prises(26.5%)directors were very familiar with the new version GMP. In terms of personnel management,the head of production management and quality management and the authorized person of quality and personnel had not yet met related requirements of the new version GMP fully;in terms of equipment and production management,production area transformation(clean areas,lounges, warehouses,water use) and air purification system design in most enterprises met related requirements of the new version GMP, 23 enterprises (46.9%) still can not conduct fully inspection to products and materials;in terms of document management,there were still some enterprises not meeting the new version GMP standards fully,enterprises'documents(health area layout,air purifi-cation layout,management procedures,operating procedures,etc.) of production site were imperfect. According to the investiga-tion,the main existing problems included lack of funds in implementing the new version GMP reform,not enough understanding or familiarity with the new version GMP,relevant personnel management not reaching the designated position,equipment and pro-duction management needing to be strengthened,document management systemic being poor,risk management being not sound, etc. It is suggested that government should give all forms of capital policy and strengthen the training of the new version GMP;en-terprises should attach great importance to the relevant personnel management,strengthen the equipment and production manage-ment,set up perfect document management system and a sound system of risk management.
2.The role of polymorphonuclear leukocyte in Staphylococcus aureus Panton-Valentine leukocidin-induced acute lung inflammation and injury
Cuiping ZHANG ; Xiaoling MA ; Wenjiao CHANG ; Xin ZHOU
Chinese Journal of Infectious Diseases 2012;30(3):131-136
ObjectiveTo explore the role of polymorpbonuclear leukocyte (PMN) in PantonValentine leucocidin (PVL)-induccd acute lung inflammation and injury. Methods Fifteen New Zealand rabbits were divided into 3 groups with five rabbits in each group.The controls were treated with pbosphate buffer solution (PBS),the rabbits with normal granulocyte in rPVL group were treated with endotracheal instillation of rPVL,the granulocytopenia rabbits in vincristine (VCR) +rPVL group were firstly treated with VCR,thcn with endotracheal instillation of rPVL.Nine hours after injection,the peripheral blood and bronchoalveolar lavage fluid (BALF) were collected for counting PMN.The lactate dehydrogenase (LDH) activity in BALF,lung permeability index (LPI),PMN apoptosis and necrosis and the release of reactive oxygen species (ROS)in BALF were measured.After the rabbits sacrificed,the lung tissue samples were collcctcd for dctcrmining wet/dry (W/D) ratio and histopathological examination.The comparison among groups was done by t test.ResultsThe PMN count in the peripheral blood was (2.69=0.34) × 10 mL in rPVL group,which was significantly lower than control group [(3.63 ± 0.38) × 105/mL] (t =4.12,P<0.05).The PMN counts in BALF in control group,rPVL group and VCR+rPVL group were (0.57±0.01 ) ×106/mL,(3.01±0.02) × 106/mL and (0.10±0.02) × 106/mL,respectively; that in rPVL group was significantly higher than those in control group (t=254.39,P<0.05).The LDH activity,LPI and W/D ratio in rPVL group were all significantly higher than control group,while those in VCR+rPVL group were not significantly different from control group.The PMN apoptosis rate and necrosis rate in VCR+rPVL groupwere (1.17±0.24)% and (1.13±0.17)%,respectively.The releases of ROS (meanfluorescence intensity) in rPVL group,control group and VCR+rPVL group were 1.56±0.39,0.41±0.03 and 0.39±0.02,respectively,and that in rPVL group was significantly higher (t=6.58,P<0.05).Histopathological examination of the lung showed the diffuse infiltration of inflammatory cells,hemorrhage and edema in rPVL group,wbile there was only thimbleful infiltration of inflammatory cells observed in surrounding bronchia and alveolar septun in VCR-rPVL group.ConclusionsrPVL can induce lung inflammation and injury in rabbits with normal granulocyte,but not in neutropenic rabbirs.Lung inflammation and injury may be the result of recruitment,aggregation and subsequent lysis and/or activation of PMN,which can damage the lung by releasing the contents of cytotoxic granules and/or reactive oxygen metabolites.
3.The role of NF-κB signaling pathway protein and cytokines in Staphylococcus aureus Panton-Valentine leukocidin-induced lung inflammation and injury
Cuiping ZHANG ; Xiaoling MA ; Wenjiao CHANG ; Xin ZHOU
Chinese Journal of Microbiology and Immunology 2012;32(1):43-47
ObjectiveTo explore the role of NF-κB signaling pathway protein and cytokines in Panton-Valentine leukocidin (PVL)-induced acute lung inflammation and injury.MethodsThirty rabbits were distributed randomly into two groups,each group had fifteen rabbits.Group rPVL were directly treated with endotracheal instillation of rPVL,normal control were treated with PBS.Then five rabbits chosen at random from each group were killed at 3,6,or 9 h postinfection.The lung was removed from the rabbits to determine histopathology studies.ELISA was performed to evaluate levels of IL-6,IL-8,IL-10 and TNF-α.NF-κB p65 protein of the lung tissue was assessed by immunohistochemistry method.ResultsIn group rPVL histopathology study showed symptoms of severe illness:diffuse infiltration of inflammatory cells,hemorrhage,edema and other manifestations of lung injury.Levels of IL-6,IL-8 and TNF-α were increased gradually,and the level of IL-10 was increased at 9 h postinfection.The expression of NF-κB p65 protein was increased gradually with the infection time.ConclusionNF-κB activation and cytokines release play an important role in PVL-related lung injury.It may be an important path to down regulate the counts of NF-κB activation.
4.The father involvement scale: development, reliability and validity
Ligang WANG ; Dongjie XIE ; Wenjiao ZHOU ; Ying YE ; Wenbin GAO
Chinese Journal of Behavioral Medicine and Brain Science 2013;22(9):853-855
Objective To develop a father involvement scale and test the reliability and validity.Methods The scale was developed based on previous studies and depth interviews with more than 20 fathers.Totally 1565 families from 3 provinces were recruited.Item analysis was conducted to identify valid items.Then the construct validity of the scale was tested by exploratory and confirmatory factor analysis (EFA & CFA).Finally the reliability and criterion validity of the scale was examined.Results The scale was consisted of 8 factors wihch were involvement attitude,activities and playing,accompany and taking care of children,attentiveness,discipline and school encouragement,economic support,protection,support mother.They explained 59.94% of the total variance.Besides,the CFA results demonstrated a satisfactory construct validity of the scale (RMSEA =0.05,NFI =0.95,NNFI =0.96,CFI =0.97).The Cronbach(')s α coefficients of the scale was 0.897,and those of its 8 were 0.828,0.788,0.764,0.781,0.671,0.754,0.528 and 0.693 respectively.Conclusion The Father Involvement Scale with 8 factors has a good reliability and validity,demonstrating it a valid tool to measure father involvement in China.
5.Characteristics of young workers' basic psychological needs and its relationship with index of well-being
Dongjie XIE ; Ligang WANG ; Wenjiao ZHOU ; Wenbin GAO
Chinese Journal of Behavioral Medicine and Brain Science 2013;(3):253-255
Objective To explore the current situation of basic psychological needs satisfaction (BPNS) and the relationship between index of well-being and BPNS among young workers in China.Methods The samples consisting of 5972 young workers were selected by stratified and random sampling according to the proportion.The Chinese vision of the Basic Needs Satisfaction in General Scale and the Index of Well-being Scale were used.Results The overall situation of BPNS of young workers (4.36 ± 0.71) was good,satisfied state of relatedness need (SSRN,4.70 ± 1.05) was the highest,satisfied state of autonomy need (SSAN,3.96 ± 1.21) and blocked state of autonomy need (BSAN,4.08 ± 1.17) were lower,blocked state of relatedness need (BSRN,3.20 ± 1.26) was the lowest; education and income had interaction on SSRN (F0.05(6.5948) =4.068,P < 0.01)while there was no difference between gender on all of the dimensions.Pearson correlation analysis showed that all the dimensions of BPNS were significantly related to the index of well-being;and linear regression analysis showed that SSAN,SSRN and BSAN could forecast the index of well-being (adjR2 =0.339),β =0.457,0.186,-0.102 respectively.Conclusion The overall situation of BPNS of young workers is good ; and adjustment of SSAN,SSRN and BSAN could improve the index of well-being of young workers.
6.Panton-valentine leukocidin induce THP-1 macrophages IL-8 and IL-6 response through nuclear TLR4/NF-κB pathway
Xin ZHOU ; Xiaoling MA ; Wenjiao CHANG ; Cuiping ZHANG ; Qiang XIE
Chinese Journal of Microbiology and Immunology 2011;31(10):875-880
Objective To investigate the influence of panton-valentine leucocidin (PVL) on expression of Toll like receptor 4(TLR4)/nuclear factor-kappa B(NF-κB) signals and IL-8,IL-6 in THP-1 macrophages,and to study the mechanism of PVL-related lung tissue damage.Methods THP-1 cells were cultured in the presence of 100 nmol/L phorbol-12-myristate 3-acetate (PMA) for 48 h to induce monocytemacrophage differentiation.rPVL-F and rPVL-S were induced and expressed from the recombinant plasmid,respectively purified with chromatographic column. After that,THP-1 macrophages were incubated with rPVL,and then ELISA was performed to test expression of IL-8 and L-6 in supernatants fluid; RT-PCR was performed to detect expression of IL-8,L-6 and TLR4 ; NF-κB was analyzed by Western blot and immunohistochemistry method.Results PVL was able to induce expression of IL-8 and IL-6 in THP-1 macrophages in time-and concentration-dependent manners.PVL could also significantly promote the activation of TLR4/NF-κB signals.Conclusion PVL can activate the expression of TLR4/NF-κB signals,and increased the high expression of inflammatory cytokines.Maybe it's the mechanism of action of PVL exerts the function of lung tissue damage.
7.Cloning, expressing and identifying of IN5 part of chlamydiaphage phiCPG1 capsid protein Vp1 protein and its inhibitory effect on the Chlamydia trachomatis
Lei ZHENG ; Yuanjun LIU ; Rui GUO ; Quan ZHOU ; Wenjiao ZHOU ; Quanzhong LIU
Chinese Journal of Clinical Infectious Diseases 2017;10(3):199-204,226
Objective To investigate the inhibitory effect of IN5 from chlamydiaphage phiCPG1 capsid protein Vp1 on Chlamydia trachomatis (Ct).Methods PCR was used to amplify IN5 gene from Vp1 DNA of phiCPG1, then the recombinant plasmid pET28a/IN5 was constructed.After transformation, the fusion protein IN5 was induced,identified and purified.Ct was incubated with the purified IN5 protein or Vp1 protein.After 48 h of incubation, the inclusion bodies were counted with iodine staining and indirect immunofluorescence.One-way ANOVA was used to compare the difference of inclusion bodies among groups.If the difference among the groups was statistically significant, the Bonferroni method was used to compare any two mean values.Finally, the inhibitory rate of IN5 protein and Vp1 protein to Ct was calculated.Results IN5 protein from chlamydiaphage phiCPG1 capsid protein Vp1 was successfully obtained.At the same concentration of 53μg/mL,the inhibitory rates of Ct growth in IN5 and in Vp1 groups were 52.42% and 78.04%, respectively.Conclusion IN5 protein has inhibitory effect on the growth of Ct,but the inhibitory rate is lower than that of Vp1, which provides a preliminary clue for searching the dominant region of Vp1 protein inhibiting the growth of Ct.
8.Curative effect of radiofrequency ablation combined with chemotherapy on middle-late stage non-small cell lung cancer
Jingxu ZHOU ; Hong LI ; Wenjiao LV ; Shutang WANG ; Xinting ZHENG ; Lizhu LIN
The Journal of Practical Medicine 2015;(11):1786-1789
Objective To observe the clinical curative effect of Ⅲb~Ⅳstage non-small cell lung cancer treated by radiofrequency ablation combined with chemotherapy. Methods Forty-eight Ⅲb~Ⅳstage non-small cell lung cancer patients were divided into the study group (RFA + chemotherapy) and 74 were in control group (chemotherapy alone) by the method of non randomized controlled. Curative effect was evaluated every two cycles during the treatment. A 6 to 36 months follow-up was conducted after the treatment. Results The objective response rate of experiment group and control group was 58.3%and 41.9%respectively (P>0.05) with no significant difference and disease control rates of experiment group and control group were 91.7% and 75.7% respectively (P<0.05). MST were 14.4 months and 8.2 months respectively (P<0.01), with statistically significant differences in experiment group and control group and clinical benefit efficient were 87 . 5% and 66 . 2% respectively ( P < 0.05). Conclusion The treatment of radiofrequency ablation combined with chemotherapy for advanced non-small cell lung cancer can significantly improve the patient′s survival and the clinical curative effect.
9.Current Situation and Thinking of Statistical Management of TCM
Yong XIAO ; Shaowu SHEN ; Wenjiao FU ; Ting ZHOU ; Shuanggui TIAN ; Na ZHAO
Chinese Journal of Information on Traditional Chinese Medicine 2017;24(2):5-8
Objective To understand the current situation of statistical management of TCM;To analyze existing problems; To provide references for policy formulation and measure implementation for statistical management of TCM. Methods Literature research, field research, comparative analysis, questionnaire surveys, expert consultation, and Fisher's exact test were used in the study. Results It was found that China’s statistical management of TCM had the problems of imperfect system, unestablished investigation system, incomplete statistical index system, and nonstandard statistical management. No statistical difference was found in the three regions of east, middle and the west. Conclusion Management and investigation system should be established in statistical management of TCM; pilot projects should be conducted before they are spread;information sharing and data mining should be strengthened.
10.The 5-HTT gene polymorphisms correlated with the clinical manifestations of depression
Wenjiao MIN ; Bo ZHOU ; Min MA ; Yunge LI ; Chuanxin LIU ; Bo ZHANG ; Xueli SUN
Chinese Journal of Behavioral Medicine and Brain Science 2016;25(9):797-802
Objective To determine the potential correlation of 5-HTT gene polymorphisms (5-HTTLPR and STin2) with clinical manifestations in depression.Methods A total of 401 depressed patients,all of Chinese Han region,were collected and genotyped by polymerase chain reactions (PCR).All patients were evaluated using a 17-item Hamilton depression rating scale (HAMD-17) and Hamilton anxiety rating scale (HAMA),and then associated analysis was applied.Results (1) The age of onset in patients with L/S genotype of 5-HTLPR polymorphism were much younger than that of patients with L/L and S/S genotype (F=3.281,P=0.039).Besides,there was also a significant difference of HAMA1 (anxious mood) scores among patients with different genotypes for 5-HTTLPR polymorphism,where the scores of those with L/S genotype were the highest (2.34±0.80,P=0.010).(2) The scores of HAMD10 (mental anxiety),HAMA1 (anxious mood),HAMA3 (fear) and mental anxiety factor were higher in patients with 12/10 genotype than patients with 12/12 and 10/10 genotype for STin2 polymorphism (2.40±0.83,2.38±0.90,1.42± 1.04,14.60±4.26 respectively;P value:0.014,0.044,0.03 and 0.006 respectively).The scores of HAMD10(mental anxiety) and mental anxiety factor were (2.11±0.77),(12.96±3.78) in the 12/12 genotype patients,and significantly lower than that in the 12/10 genotype patients (adjustedPvalue:0.018,0.006).Conclusions A positive association of the 5-HTT polymorphisms with anxious symptoms in depressed patients is revealed.These findings might provide some evidences for the clinical phenotype and optimization of depression treatment.