AIM:To investigate the mechanisms by which bilirubin inhibits acute lung injury(ALI).METHODS: 30 female Wistar rats were divided into normal group,ALI group and bilirubin treatment group.ALI was induced by intravenous injection of LPS.The contents of OH-,H2O2 and O——?-2 in the lung as well as the expression of caspase-3 in the lungs were investigated.RESULTS:(1) The contents of OH-,H2O2 and O——?-2 in the lung homogenate and the expression of caspase-3 in the lungs in ALI group increased compared with those in normal group(P

OBJECTIVE:To provide reference for improving the quality of pharmaceutical talents training.METHODS:The requirements and equipment status of pharmaceutical talents in China,the status quo of its pharmacy and the status quo of pharmaceutical higher education were analyzed.The pathway of pharmaceutical talents training under the cooperative vision of "medicine,education and research" was explored.RESULTS:Through the integration of industry,our school had constructed a platform of collaborative education of "politics,production,medicine,teaching and research";paid attention to quality,the cultivation path was constructed by establishing "management,teachers,practice and evaluation" guarantee mechanism from the implementation of two-level management,strengthening the construction of teaching staff,strengthening the construction of practical conditions and strengthening the quality evaluation system.CONCLUSIONS:Our college constructs a replicable innovation model for pharmacy talents training.The quality of pharmaceutical talents training is constantly improving,which provides the necessary guarantee for the implementation of "healthy China" strategy.

Objective To investigate the association between serum 25(OH)D3 and high sensitive C -reac-tive protein (hs-CRP),tumor necrosis factor -alpha (TNF-α),interleukin-6 (IL-6) inflammatory markers in non-obese patients with type 2 diabetes mellitus (T2DM).Methods From June 2015 to September 2015,in this cross-sectional study,120 non-obese patients with T2DM(female in 58 cases,male in 62 cases) in Taiyuan Central Hospital were selected as T2DM group,and 120 non-obese patients with T2DM and 96 healthy subjects ( control group) were recruited.The serum concentrations of glucose,HbA1c,insulin,25( OH) D3 and inflammatory markers including TNF-α,IL-6 and hs-CRP were measured.A homeostatic model of insulin resistance (HOMA-IR) was also evaluated.The clinical and biochemical characteristics of T 2DM were observed in the group of vitamin D deficien-cy group,vitamin D insufficiency group and vitamin D normal group.And the relativities were analyzed between it with hs-CRP,TNF-α,IL-6,HOMA-IR,INF,FBG,BMI,WHR,and so on.The relativities were observed between 25(OH)D3 with all the factors.Results The mean serum concentration of 25(OH)D3 in the non -obese T2DM group was (10.65 ±3.55)ng/mL,which was significantly lower than (18.44 ±5.21)ng/mL in the normal control group (t＝-6.84,P ＝0.012).The levels of serum TNF -αand IL -6 in the T2DM group were (15.51 ± 4.87)ng/L and (18.12 ±4.13) ng/L,respectively,which were significantly higher than those in the control group [(8.99 ±2.54)ng/L,(8.89 ±2.07)ng/L](t＝7.95,10.04,P＝0.017,0.007).The proportions of deficiency,insufficiency and normal of vitamin D in T2DM patients were 60.83%,31.67%and 7.50%,respectively .The levels of TNF-αand IL-6 in the serum 25(OH) D3 deficiency group were significantly higher than those in the normal 25(OH)D3 group [(17.93 ±4.94)ng/L vs.(10.30 ±4.52)ng/L,F＝6.897,P＝0.026;(20.14 ±4.99)ng/L vs. (16.39 ±5.06)ng/L,F＝10.589,P＝0.017].There was a significant correlation between serum 25(OH)D3 and HOMA-IR(r＝-0.041;P＝0.030),TNF-α(r＝-0.229;P＝0.040) and IL -6 levels (r＝-0.299;P＝0.032),but there was no significant correlation with inflammatory factor hs -CRP and fasting blood glucose. Conclusion Vitamin D deficiency is common in patients with T2DM,and systemic chronic inflammation may also play an important role in the pathogenesis of T 2DM.This study shows that vitamin D may play an important role in the pathogenesis of insulin resistance and chronic systemic inflammatory response,an important pathogenesis of T2DM.

OBJECTIVE: To modify the monitoring process and means of adverse events diagnostic reagents,improve the quantity and quality of adverse events reported ,and reduce the workload of regulatory authorities,eventually ensure the safety and effectiveness of diagnostic reagents. METHODS: The pre-filtering risk assessment system based on BP neural network was used to evaluate the adverse events of diagnostic reagents.According to the evaluation results,the administrative supervision departments took corresponding countermeasures. RESULTS: The BP neural network learned the historical data,and the risk evaluation results of the adverse events were basically consistent with the expert group. CONCLUSIONS BP neural network can be used to evaluate the risk of adverse events and achieve risk signal aggregation of adverse events.
Indicators and Reagents ; adverse effects ; Neural Networks (Computer) ; Risk Assessment

BACKGROUNDTo evaluate and compare the effects and toxicity of the domestic product of nrhTNF combined with chemotherapy in the trial group and chemotherapy alone in the control group in the treatment of patients with non-small cell lung cancer (NSCLC).

METHODSNinety patients with NSCLC in multicenter were randomly devided into trial group and control group. Each group had 45 patients. Chemotherapy with CAP regimen was given for the patients in the trial group. Meanwhile, nrhTNF injection of 4×10⁶U/m ² was also given from the 1st to 7th days, the 11th to 17th days on the chemotherapy course. Twenty-one days were as a cycle, 2 cycles were given each patients. Chemotherapy alone with CAP regimen was given in the control group. The chemothepeutic effects and toxicity were observed and compared between the two groups after the therapy.

RESULTSOf the 90 patients, 3 cases in each group were out of the trial because of economy. The other 84 cases (each group had 42 patients) could be used to analyze and evaluate the clinical effects and toxicity. The response rate of chemotherapy was 47.62% (20/42) in the trial group and 19.05% (8/42) in the control group (P=0.002) respectively. The KPS was 85.02±10.74 in the trial group, and 81.35±9.63 in the control group (P=0.038). No significant difference of degree III+IV toxicity was observed between the trial group and control group (P > 0.05). The side effects related to nrhTNF included slight fever, cold like symptoms, pain, and red and swelling in injection site. All of them were mild and didn't need any treatment and disappeared after the therapy.

CONCLUSIONSThe results demonstrate that the effects of domestic nrhTNF combined with chemotherapy can remarkably higher than that of chemotherapy alone in the treatment of NSCLC. It is able to increase the sensitivity to chemotherapy and improve the quality of life of the patients. The toxicity is also slight and is worth to expand clinical use, so as to further evaluate its effect and toxicity.

OBJECTIVESTo increase the number and quality of adverse events reported in medical devices, dealing with adverse events that have occurred in time, preventing the occurrence of adverse events, and ensuring the safety of device use.

METHODSBased on risk management methods, through a comprehensive analysis of risk of adverse events, scientifically assessing the risk level and completing the classification of adverse events. Administrative supervision departments take corresponding supervision measures according to the classification results.

RESULTSBuilding a classification monitoring model of medical device adverse events based on risk management.

CONCLUSIONSThe classification of adverse events will help the administrative supervision department to focus on the work, reduce the workload, and improve the efficiency of supervision.

OBJECTIVES: To solve the problem that medical device adverse event monitoring entities perform their duties inadequately, to provide reference for perfecting the post-market surveillance system. METHODS: Through theoretical and empirical research, the paper explored the ways to improve the performance of monitoring the adverse events of medical devices. RESULTS: The survey found that the number of adverse event monitoring reports was few and the quality of report was poor. The root causes included lack of motivation of monitoring entities, the imperfect monitoring system, and the monitoring capability failure, etc. CONCLUSIONS The methods such as strengthening the main body responsibility consciousness, establishing evaluation system and accountability system, building social work network, are beneficial to the adverse events monitoring.
Equipment Safety ; Equipment and Supplies ; adverse effects ; Product Surveillance, Postmarketing ; Surveys and Questionnaires

OBJECTIVE: To improve the monitoring mode of diagnostic medical devices adverse events. METHODS: By discussing the objective laws of the characteristics, performances and causes of diagnostic medical devices adverse events, the key points of monitoring work were clarified. RESULTS: The whole-process cloud monitoring mode for adverse events of diagnostic medical devices was constructed based on risk management, and the working procedures for the four core links i.e. collection and report, investigation, analysis and evaluation, and controlling were formulated. CONCLUSIONS The whole-process cloud monitoring mode contributes to improve the monitoring level and efficiency of diagnostic medical devices adverse events in China, so as to strengthen risk control capability and ensure the public can use medical devices safely.
China ; Equipment and Supplies ; Reagent Kits, Diagnostic ; Risk Management

BACKGROUNDTo evaluate and compare the effects and toxicity of the domestic product of recombinant mutant human tumor necrosis factor (rmhTNF) combined with chemotherapy and chemotherapy alone in the treatment of patients with non-small cell lung cancer (NSCLC).

METHODSTwo hundred patients with NSCLC in multicenter were randomly devided into trial group (150 cases) and control group (50 cases). Chemotherapy with CAP regimen was given to the patients. Meanwhile, rmhTNF injection of 4×10⁶U/m² was also given from the 1st to 7th days, the 11th to 17th days on the chemotherapy cycle in the trial group. The control patients received chemotherapy alone. Twenty-one days were as a cycle, 2 cycles were given to each patient. The chemotherapeutic effects and toxicity were observed and compared between the two groups after the therapy.

RESULTSof the 200 patients, 5 cases in the trial group and 3 cases in the control group were out of the trial because of economy. The other 192 cases (145 cases in the trial group and 47 cases in the control group) could be analyzed and evaluated the clinical effects and toxicity. The response rate of chemotherapy was 46.90% (68/145) in the trial group and 17.02% (8/47) in the control group respectively ( P =0.001). The KPS scores was 86.02±9.74 in the trial group, and 80.14±9.10 in the control group ( P =0.025). No significant difference of degree III+IV toxicity was observed between the two groups ( P > 0.05). The side effects related to rmhTNF included slight fever, cold-like symptoms, pain and red and swelling in the injection site. All of them were mild and didn't need any treatment and disappeared after the therapy. There were no severe abnormality of liver and kidney function and ECG in both groups.

CONCLUSIONSThe results demonstrate that the effects of domestic rmhTNF combined with chemotherapy are remarkably higher than that of chemotherapy alone in the treatment of NSCLC. rmhTNF can increase the sensitivity to chemotherapy and improve the quality of life of the patients with slight toxicity. Hence rmhTNF is worth expanding clinical use.

The oral microbiota is associated with oral diseases and digestive systemic diseases. Nevertheless, the causal relationship between them has not been completely elucidated, and colonisation of the gut by oral bacteria is not clear due to the limitations of existing research models. The aim of this study was to develop a human oral microbiota-associated (HOMA) mouse model and to investigate the ecological invasion into the gut. By transplanting human saliva into germ-free (GF) mice, a HOMA mouse model was first constructed. 16S rRNA gene sequencing was used to reveal the biogeography of oral bacteria along the cephalocaudal axis of the digestive tract. In the HOMA mice, 84.78% of the detected genus-level taxa were specific to the donor. Principal component analysis (PCA) revealed that the donor oral microbiota clustered with those of the HOMA mice and were distinct from those of specific pathogen-free (SPF) mice. In HOMA mice, OTU counts decreased from the stomach and small intestine to the distal gut. The distal gut was dominated by Streptococcus, Veillonella, Haemophilus, Fusobacterium, Trichococcus and Actinomyces. HOMA mice and human microbiota-associated (HMA) mice along with the GF mice were then cohoused. Microbial communities of cohoused mice clustered together and were significantly separated from those of HOMA mice and HMA mice. The Source Tracker analysis and network analysis revealed more significant ecological invasion from oral bacteria in the small intestines, compared to the distal gut, of cohoused mice. In conclusion, a HOMA mouse model was successfully established. By overcoming the physical and microbial barrier, oral bacteria colonised the gut and profiled the gut microbiota, especially in the small intestine.
Animals ; Bacteria ; Gastrointestinal Microbiome ; Germ-Free Life ; Humans ; Mice ; Microbiota ; RNA, Ribosomal, 16S