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Objective:To investigate the etiological characteristics of nasal bacterial infection in patients with nasal lymphoma. Methods:The results of bacterial culture of nasal secretions from 39 healthy people and 86 patients with nasal lymphoma in the Affiliated Hospital of Qingdao University from January 2019 to June 2022 were retrospectively analyzed, and the differences in nasal bacteria distribution between nasal lymphoma and healthy people were analyzed and compared. Results:Corynebacterium（38.90%） was the most common bacteria in the nasal cavity of healthy people, followed by coagulase-negative Staphylococcus（31.95%）, Staphylococcus epidermidis（15.28%） and Staphylococcus aureus（6.95%）. The most common bacteria in nasal lymphoma patients was Staphylococcus aureus（30.37%）, followed by Corynebacterium（9.63%）, Staphylococcus epidermidis（7.41%） and coagulase negative Staphylococcus（6.67%）. A total of 81 nasal lymphoma patients were detected with bacteria, positive rate is as high as 94.19%（81/86）. Conclusion:Staphylococcus aureus is the main pathogenic bacteria in nasal secretion of patients with nasal lymphoma, which provides guiding significance for the clinical prevention and treatment of nasal lymphoma complicated with infection or not.
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Humanos , Estudos Retrospectivos , Coagulase , Cavidade Nasal , Bactérias , Staphylococcus aureus , Rinite/complicações , Infecções EstafilocócicasRESUMO
Orally inhaled drug products (OIDPs) play a great role in the pharmacological treatment of chronic obstructive pulmonary disease (COPD) and asthma. There is an unmet clinical need for OIDPs. Pharmacodynamics-Bioequivalence studies (PD-BE) are recommended by several national guidelines as important research methods for bioequivalence study of OIDPs. It can effectively bridge the gap between in vitro studies and PK-BE studies in evaluating the efficacy and safety consistency of generic drugs with the original drugs. There are two research methods for PD-BE, using a diastolic model or an excitation model. The different methods use different metrics to evaluate efficacy. The more commonly used metrics include Forced Expiratory Volume in the First Second (FEV1), Specific Airway Conductance (sGaw), Peripheral Airway Resistance (R5-20), and stimulant concentration/dose (PC20/PD20). PD-BE studies using FEV1 as an efficacy metric is also recommended by the FDA (Food and Drug Administration), EMA (European Medicines Agency) and NMPA (National Medical Products Administration) guidelines and is widely accepted by investigators. In such PD-BE studies, the trial protocols for different OIDPs drugs are relatively consistent in terms of trial design, trial data processing, and equivalence evaluation criteria, while there are detailed differences in terms of target population, single/multiple dosing, dose administration, and collection site design. This paper reviews the progress of PD-BE studies in the bioequivalence evaluation of OIDPs by combining national guidelines and PD-BE-related studies of OIDPs published in the last five years, with a view to providing important theoretical information for PD-BE studies of OIDPs.
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Orally inhaled drug products (OIDPs) have a pivotal position and great clinical demand in the treatment of asthma and chronic obstructive pulmonary disease. The development of local generic drugs which are bioequivalent to branded drugs in efficacy and safety while with less price will not only help to solve the problem of drug accessibility, but also greatly reduce the public health burden.OIDPs are complex combinations of formulation and device, and have special drug delivery route and characteristic of local release. Thus, generic drugs of OIDPs are difficult to develop and get registration. Until now, Food and Drug Administration (FDA), European Medicines Association (EMA), Health Canada (HC) and National Medical Products Administration (NMPA) all consider that pharmacokinetics (PK) method can be used to evaluate systemic exposure (safety) in human bioequivalence (BE) study of OIDPs, but there is no consensus on its role in the evaluation of pulmonary deposition (efficacy). The possible reason lies in that the efficacy of OIDPs is determined by both the amount and the region of drug pulmonary deposition. Nevertheless, PK study is still more sensitive and economical in assessing potential differences among products, when compared with pharmacodynamics or clinical endpoint study. Here we mainly compared the domestic and international guidelines and evaluation methods of OIDPs BE study, and introduced the experimental design of PK study and its application and progress in lung deposition study.
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Objective@#To discusses the feasibility of establishing the allergic rhinitis (AR) model in Kunming mice.@*Methods@#Kunming mice (n=20) and BALB/c mice (n=20) were sensitized and motivated by ovalbumin (OVA) and aluminium hydroxide. The symptoms rating scale (symptoms score>5 as successful model) was used to evaluate AR symptoms of two kinds of mice after the AR model were set up. The differences of OVA serum specific IgE (OVA-sIgE) and the levels of interleukin 4 (IL-4) in Kunming mice model group and Kunming mice blank group were evaluated, the symptom scores, OVA serum specific IgE (OVA-sIgE) and the levels of interleukin 4 (IL-4) of successful model of Kunming mice and BALB/c mice were compared, and the difference between two kinds of animal models. SPSS 22.0 statistical software was used for statistical analysis was analysed. SPSS 22.0 statistical software was used for statistical analysis.@*Results@#During the experiment, 2 mice died in BALB/c mouse model group, and no mouse died in Kunming mouse model group. Kunming model group gained a certain incease of weight. The clinical symptom scores, OVA - sIgE levels, serum IL - 4 levels of Kunming mouse model group were significantly higher than those of blank control group. The difference was statistically significant [(6.100±0.568) vs (2.700±0.823), (29.083±10.470) ng/ml vs (3.908±1.984) ng/ml, (219.250±30.821) pg/ml vs (140.056±27.684) pg/ml, all P<0.05]. Compared with BALB/c mice model group, the symptom score and serum level of IL-4 of Kunming mice model group had no statistically significant differences (6.100±0.568) vs (6.313±0.704), (219.250±30.821) pg/ml vs (253.294±53.953) pg/ml, all P>0.05), and the difference of serum level of OVA-sIgE was statistically significant ((29.083±10.470) ng/ml vs (76.277±25.724) ng/ml, P<0.05).@*Conclusions@#Kunming mice are able to obtain a clinically significant AR model through OVA modeling, with a significant increase in serum OVA-SIgE and IL-4. Kunming mice AR model shows good tolerance, and could reduce the losses in animal experiment.
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Objective To observe the expression of cysteine-rich protein 61 (Cyr61) in transforming growth factor-β1 (TGF-β1)-activated renal fibroblasts (NRK-49F),and to explore its effect and mechanism.Methods (1) NRK-49F cells were activated by TGF-β1 with different concentrations (0.0,0.5,1.0,2.0,5.0 μg/L).Western blotting was used to detect the expression of Cyr61 protein,and CCK-8 assay was used to test the proliferative activity of NRK-49F cells.(2) NRK-49F cells with low expression and over expression of Cyr61 were established by plasmid transfection.The cells were divided into control group (null vector transfection),over-expression group and lowexpression group.The proliferation was discovered by CCK-8 assay after 24,48 and 72 h.Further,5.0 μg/L TGF-β1 activated these three groups.The proliferation was also discovered by CCK-8 assay and the cell cycle was analyzed by flow cytometry.The mRNA expressions of fibrosis markers (Collα1,Col3αl,MMP9,MMP13) and factors of cell senescence signal pathway (p53,p21,Rb,p16) were ascertained by real time PCR,and the protein expressions of Col3 and MMP9 were detected by Western blotting.Results (1) Compared with 0.0 μg/L TGF-β1 group,the proliferation of NRK-49F cells was enhanced in 0.5,1.0,2.0 and 5.0 μg/L TGF-β1 groups (all P ＜ 0.05),while the expression of Cyr61 protein was decreased in 1.0 μg/L group and increased in 5.0 μg/L group (all P ＜0.05).(2) The proliferation of over-expression group was lower than that of control group after 24,48and 72 h (all P＜ 0.05),which was in a time-dependent manner.(3) Compared with control group activated by TGF-β1,the over-expression group expressed less fibrosis factors (Col1α1 and Col3α1)and more anti-fibrosis factors (MMP9 and MMP13) with decreased proliferation (all P ＜ 0.05).Simultaneously,the proportion of cells bogged down in G1 phases,as well as the expressions of p53,p21 and Rb mRNA increased (all P ＜ 0.05).The above effects of low-expression group were just opposite to over-expression group.Moreover,there was no significant difference in the expression of p16 gene among the three groups (P ＞ 0.05).Conclusions Cyr61 can curb the proliferation and fibrotic phenotypes of fibroblasts,thereafter slowing down the process of renal fibrosis.The p53/p21/Rb interrelated cell senescence signal pathway may be involved in the anti-fibrosis process.
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Objective To observe the expression of cysteine-rich protein 61 (Cyr61) in transforming growth factor-β1 (TGF-β1)-activated renal fibroblasts (NRK-49F),and to explore its effect and mechanism.Methods (1) NRK-49F cells were activated by TGF-β1 with different concentrations (0.0,0.5,1.0,2.0,5.0 μg/L).Western blotting was used to detect the expression of Cyr61 protein,and CCK-8 assay was used to test the proliferative activity of NRK-49F cells.(2) NRK-49F cells with low expression and over expression of Cyr61 were established by plasmid transfection.The cells were divided into control group (null vector transfection),over-expression group and lowexpression group.The proliferation was discovered by CCK-8 assay after 24,48 and 72 h.Further,5.0 μg/L TGF-β1 activated these three groups.The proliferation was also discovered by CCK-8 assay and the cell cycle was analyzed by flow cytometry.The mRNA expressions of fibrosis markers (Collα1,Col3αl,MMP9,MMP13) and factors of cell senescence signal pathway (p53,p21,Rb,p16) were ascertained by real time PCR,and the protein expressions of Col3 and MMP9 were detected by Western blotting.Results (1) Compared with 0.0 μg/L TGF-β1 group,the proliferation of NRK-49F cells was enhanced in 0.5,1.0,2.0 and 5.0 μg/L TGF-β1 groups (all P ＜ 0.05),while the expression of Cyr61 protein was decreased in 1.0 μg/L group and increased in 5.0 μg/L group (all P ＜0.05).(2) The proliferation of over-expression group was lower than that of control group after 24,48and 72 h (all P＜ 0.05),which was in a time-dependent manner.(3) Compared with control group activated by TGF-β1,the over-expression group expressed less fibrosis factors (Col1α1 and Col3α1)and more anti-fibrosis factors (MMP9 and MMP13) with decreased proliferation (all P ＜ 0.05).Simultaneously,the proportion of cells bogged down in G1 phases,as well as the expressions of p53,p21 and Rb mRNA increased (all P ＜ 0.05).The above effects of low-expression group were just opposite to over-expression group.Moreover,there was no significant difference in the expression of p16 gene among the three groups (P ＞ 0.05).Conclusions Cyr61 can curb the proliferation and fibrotic phenotypes of fibroblasts,thereafter slowing down the process of renal fibrosis.The p53/p21/Rb interrelated cell senescence signal pathway may be involved in the anti-fibrosis process.
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Objective To observe and study the influence state of ulinastatin for multi system function state of patients with acute abdomen during the the perioperative period.Methods 60 patients with acute abdomen treated with operation in our hospital during the time of October 2015 to July 2016 were selected as the research object, and they were randomly divided into control group ( conventional perioperative treatment group ) 30 cases and observation group(conventional treatment and ulinastatin group)30 cases,then the liver function,renal function,gastrointestinal function and immune function related indexes of two groups before the operation and at second,fifth and seventh day after the operation were detected and compared.Results The liver function,renal function,gastrointestinal function and immune function related indexes of two groups before the operation were compared ,,while the liver function,renal function,gastrointestinal function and immune function related indexes of observation group at second,fifth and seventh day after the operation were all significantly better than those of control group(P<0.05),those detection results of two groups after the operation all had significant differences.Conclusion The ulinastatin can effectively protect multi system function state of patients with acute abdomen during the the perioperative period,so its application value in these surgical patients is higher.
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Objective To explore the effects of Chinese herbal compound, Tengmei decoction, on type II collagen-induced arthritis ( CIA) in rats, and to examine the changes of arthritis index ( AI) , limb swelling, joint tissue inflammatory infiltration, and the effects on immune-inflammatory factors.Methods Sprague-Dawley rat models of arthritis were successfully established by intradermal injection of type II collagen and Freund’ s complete adjuvant.The model rats were randomly divided into model group, positive drug group, and high-and low-dose Chinese medicine groups, 6 rats in each group.The intervention and treatment period was 12 weeks.To measure weekly the anteroposterior and transverse diameters of the rear ankles and wrists, the transverse diameter of the claw foot palm pad, the thickness and the highest point width of hind limb plantar joint swelling, and to evaluate the integrated scores of joints and limbs swelling using a vernier caliper.Results ①Compared with the normal group, the total arthritis scores and hind limbs AI scores of the model group were significantly increased ( P <0.05 or P <0.01 ) .The left forelimb AI scores were significantly increased during 10 -12 weeks ( P <0.05 ) .The anteroposterior and transverse diameters of the left hind limb, the thickness of the highest point measurement of the left hind foot pad metatarsal were significantly increased ( P<0.05 or P<0.01) in different time periods between 1-12 weeks.Compared with the model group, the total scores and the left hind limb joints AI scores of the high-and low-dose drug groups were decreased after 6 weeks (P<0.05).②Compared with the normal control group, levels of mRNA transcription and protein expression of IL-6 and TNF-αwere significantly up-regulated ( P<0.01 ) in the model group.Compared with the model group, the levels of mRNA transcription and the expression of IL-6 and TNF-αproteins were significantly down-regulated in the positive group and Chinese medicine groups ( P <0.01 ) .③ Histological examination showed that the low-dose TCM significantly improved the CIA synovial hyperplasia and inflammatory cell infiltration.Conclusions The molecular mechanism of Chinese herbal compound Tengmei decotion in improving joint pathological injury of CIA rat models may be related to its inhibitory effect on the high expression of immune-inflammatory factors in the synovial tissue of CIA rats.
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0.05). But according to the data, IL-8 in Qingqinye low dosage group was lower than model group, positive medicine group, Qingqinye high dosage group and Qingqinye middle dosage group. TNF-? in Qingqinye group was lower than model group and positive medicine group, especially in Qingqinye middle dosage group. Pathological section with articular cavity and surrounding tissues were better in positive medicine group and Qingqinye group. Conclusion Qingqinye has a certain effect for repairing joint immune pathological injury in hyperuricemia model rats.
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0.05). Positive medicine group, Qingqinye high dosage group, Qingqinye low dosage group and Qingqinye middle dosage group reduced blood ADA activity and better than model group (P
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Objective To understand the effect of diabetes on the nerve cells injury in hippocampal region by observing the nerve cells changes in this region of ischemia after focal cerebral ischemia reperfusion for rats with diabetes.Methods Sixty healthy male Wister rats were randomly divided into four groups:the control group,sham operation group,normal cerebral ischemia-reperfusion(NIR)group,and diabetic cerebral ischemia-reperfusion(DIR)group.The model of local cerebral ischemia and reperfusion was established by the thread-embolism and cerclage of rats with STZ-induced diabetes.Hematoxylin-eosin(HE)-stained neurons in hippocampal CA1 region were observed by selecting 8 un-overlapped fields under light microscope(?400);the total number of the normal pyramidal neurons with whole cellular organ structure were counted within 100 ?m length in CA1 region.The numbers of positive neurons were presented as mean with standard errors(?s).Significant differences between groups were analyzed by t-test.Results Neuronal loss or apoptotic cells were not found in the control group or sham operation group after observing under light microscope.There were neuronal losses in both NIR and DIR groups,neuronal loss of DIR group being more serious than that of NIR group(P
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Objective Myocardial blush grade (MBG) as a new angiographic parameter was used to describe the effectiveness of myocardial reperfusion in patients treated with thrombolysis for acute myocardial infarction (AMI) Methods Eighty nine patients received a small dose alteplase 50mg within 12 hours of acute infarction Coronary angiography was performed at 90 min after the initiation of thrombolytic therapy to evaluate infarct related artery (IRA) patency and myocardial reperfusion Cardiac events during a 6 month period were recorded Results There were 87 6% and 12 4% patients with and without successful clinical recanalization after thrombolysis respectively Coronary angiography showed that 82 6% patients with TIMI flow 2 or 3, 88 8% patients with MBG 2 or 3, and 40 4% patients with TIMI flow 3 and MBG 3 Mortality at follow up was 10 1% Multivariate analysis showed that the MBG and Killip grade at admission were major significant predictors of 6 month mortality Conclusion The primary objective of reperfusion therapies is not only restoration of blood flow in the epicardial coronary artery, but also complete reperfusion of the infarcted myocardium