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OBJECTIVE： To provide references for improving the standard operating procedures of drug management in clinical trials and drug management in clinical trials. METHODS： According to Good Clinical Practice （GCP）， Data On-site Verification Points of Drugs Clinical Trial， Qualification Examination Rules of Drug Clinical Trial Institution， based on the quality control project carried out in our hospital since July 2016， the matters needing attention in the non-standard operation and key process of drug management in clinical trial were summarized， and the improvement measures were discussed. RESULTS & CONCLUSIONS： Non-standard drug management is a high-incidence link of non-standard operation in the trial process. Among them， the acceptance， distribution and use of drugs are the three links with the highest incidence of non-standard operation of drug management in the trial process. Therefore， when formulating the relevant management system， each institution should pay attention to it according to its own situation； such as， when accepting drugs in clinical trials， attention should be paid to checking the intact degree of drug packaging； drugs transported in cold chain should also be checked for temperature records and rejected in case of over-temperature； the copies of the waybill should be kept in file with the original to avoid fading of the thermosensitive paper； whether the relevant characteristics of the control drugs and placebos meet the requirements. Institutions can standardize the key links of drug management in the trial process， the time of project establishment， project start-up， quality control and supervision， formulate and constantly improve the relevant drug management system and standard operating procedures （SOP）. For example， when starting a project， attention should be paid to the participation of drug administrators in the training and signature of start-up meeting， whether the design of the form is complete， standardized and operable. It is necessary for clinical trial institutions to pay attention to the standardization and precision of drug management and the key links in clinical trials.
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Objective@#To study the functional effects of killer cell lectin-like receptor subfamily G member 1 (KLRG1) expression on natural killer cells (NK cell) in chronic hepatitis B virus infection (HBV).@*Methods@#Peripheral blood mononuclear cells (PBMC) were extracted from 120 patients with chronic hepatitis B virus infection and 19 healthy persons. The frequency of NK cells and KLRG1+ NK cells in peripheral blood was detected by flow cytometry. Interferon-γ levels secreted by NK cells were detected in peripheral blood. Statistical analysis of experimental data was performed using GraphPad Prism 6.03 software.@*Results@#The frequency of NK cells in HBV-infected group (16.92% ± 7.9%) was not significantly different from that in healthy controls (10.57% ± 6.5%). The frequency of KLRG1+NK cells in HBV-infected group was significantly higher (49.43% ± 21.2%) than that to healthy control group (31.60% ± 17.9%), (t = 7.347 6, P < 0.001). IFN-γ secretion of KLRG1 + NK cells in HBV-infected patients (2.59% ± 1.0%) were significantly lower than healthy controls (5.96% ± 2.4%), (P = 0.009).@*Conclusion@#HBV infection can increase the expression of KLRG1 in NK cells and further reduce the secretion of IFN-γ in NK cells, which may be an important cause for chronic HBV infection.
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Objective To study the effects of phycocyanin on the expressions of matrix metalloproteinase 2 and 9(MMP-2 and MMP-9) after focal cerebral ischemic reperfusion in rats.Methods A rat middle cerebral artery occlusion/reperfusion(MCAO/R) model was built up using the intraluminal filament method and treated by phycocyanin.The brain water content(BWC) was calculated with dry-wet method and the Evans blue(EB) of the brain was measured with the method of colorimetry.The expressions of MMP-2 and MMP-9 were determined by immunohistochemical assay.Results The BWC and EB of the brain increased after cerebral ischemic reperfusion and peaked at reperfusion 2d,and decreased after applying phycocyanin.In control group,the upregulation of MMP-2 began at ischemic reperfusion 24h,reached a maximum at 3～7d,then subsided gradually,but was still in high level at 14d.In phycocyanin group,the expressing time-phase pattern of MMP-2 was similar to and significantly lower than that in control group at same time.In control group,the upregulation of MMP-9 began at ischemic reperfusion 6h,increased at 12h and reached a maximum at 2d,then subsided gradually at 3d to sham group level at 14d.In the phycocyanin group,the expression of MMP-9 was significantly lower than that in control group,and the time-phase pattern of MMP-9 was similar to that in control group.Conclusions Phycocyanin might play an neuroprotective effect by down regulating the expressions of MMP-2 and MMP-9 to reduce brain edema after cerebral ischemic reperfusion.
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OBJECTIVE To determine the category of gene cassettes in type 1 integrons of multi-resistant Acinetobacter baumannii from Shenyang.METHODS Fifty clinical isolates were collected from the First Affiliated Hospital of China Medical University and K-B test was used to determine the susceptibility and the results were read based on Clinical and Laboratory Standards Institute(CLSI) of the USA.PCR was used to detect the existance of integron,and DNA sequencing was also required.RESULTS There are thirty-two isolates positive for integron.Sequencing analysis showed the integrons carried two different known genes(arr-3 and aacA4).CONCLUSIONS The results show the potential risk of integron dissemination among different strains of A.baumannii.
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Objective To evaluate the CT features and diagnostic value of non-invasive fungal sinusitis.Methods Sixty-six patients with non-invasive fungal sinusitis confirmed by surgery from Jan.2000 to Jul.2006 in our hospital were included in this study.CT features of non-invasive fungal sinusitis were analysed retrospectively.Results The features of non-invasive fungal sinusitis on CT were single sinus or bilateral sinuses filled with soft tissue,the density of lesions was unhomogeneous and the patch,mass or ribbon calcifications were seen inside the lesions.Localized bone destruction was seen in part of cases.Conclusion The mainly CT feature of non-invasive fungal sinusitis is having calcification inside the lesions,that is the basis of diagnosis.