OBJECTIVE:To provide reference for ADR evaluation in China.METHODS:The ADR signal evaluation method adopted by the pharmacovigilance center in Netherlands was analyzed by means of literature review,contrasting analysis and data reduction etc.RESULTS & CONCLUSION:We should draw experience from the pharmacovigilance center in Netherlands about the evaluation method on ADR signal and establish ADR evaluation databases of high quality;furthermore, we should attach great importance to the application of pharmacoepidemiology and statistics in ADR evaluation and gradually replace the qualitative evaluation with quantitative one for ADR signal.

During the last forty years, although cytotoxic chemotherapy for gastric cancer patients has improved to some extent, its therapeutic effect is limited. Simultaneously, great progression of oncobiology to increase our understanding of the molecular basis of gastric cancer has been made. Currently the cancer cell has been characterized by several genetic changes that lead to altered cellular functions. In addition, multiple cancer-cell environment factors affect the tumor cell via various receptors and subsequent signaling pathways. The increasing knowledge of cellular signaling offers the opportunity to develop novel substances that target specific pathway molecules.

OBJECTIVE: To analyze and evaluate the quantitative evaluation of ADR signals in FDA and to provide a reference for ADR evaluation in China. METHODS: By means of literature review,contrasting analysis and data reduction,ADR signal evaluation in FDA was investigated. RESULTS&CONCLUSION: In USA MGPS method is used for the quantitative evaluation of ADR signal, which can earlier obtain ADR signal and effectively promote the risk warning ability of ADR information. This is practical in our country and we should learn from them. Combined with various data analyzing methods, we can set up a high-quality evaluation database for ADR signals. The importance of pharmacoepidemiology and statistics in ADR evaluation should be highly recognized and the methods for ADR signals evaluation should be gradually shifted from qualitative to quantitative evaluation.

Objective To observe the effect of GPR30 agonist G1 on high glucose-induced endoplasmic reticulum stress ( ERS) in endothelial EA .hy926 cells.Methods EA.hy926 endothelial cells were divided into three groups:nor-mal control group (Con, 17.51 mmol /L glucose), high glucose (HG, 33.3 mmol /L), high glucose +G1 group (HG+G1, HG +1 μmol/L G1).The apoptosis rate of endothelial cells was measured by flow cytometry , the protein expres-sion changes of ERS related molecules Bip , IRE1, PERK and apoptotic molecules Bax , Bcl-2 were measured by Western blot, the mRNA expressions of Bip and CHOP were measured by RT-PCR assay.Results Compared with Con group , the apoptosis in HG group was significantly increased (P <0.01), Bip, IRE1, PERK and apoptotic molecule Bax were upreg-ulateded (P <0.05, P<0.01 or P <0.001), Bcl-2 downregulatted (P <0.01) and Bip mRNA, CHOP mRNA expres-sion were upregulated (P <0.001 and P<0.01).Compared with the HG group, apoptosis rate in HG +G1 group was significantly lower (P <0.05), BIP, IRE1, PERK and apoptotic molecules Ba.0 downregulated ( P <0.05 or P <0.01), Bcl-2 expressions was increased (P <0.05), Bip mRNA and CHOP mRNA expression were decreased (P<0.001 or P<0.01).Conclusion GPR30 agonist G-1 inhibits EA.hy926 ERS in endothelial cells.

Objective To evaluate the safety and effectiveness of immunosuppression regimens,postoperative complications,dead causes and risk factors of lung transplantation (LTx).Methods The immunosuppression regimens and clinical data of 100 patients with end-stage lung diseases receiving LTx in our hospital were retrospectively analyzed between Sept.2002 to Dec.2010.There were 72 patients subject to single LTx and 28 patients to bilateral LTx,amongst them 61 patients received LTx under circulation support,including 5 cases of cardopulmonary bypass (CPB) support and 56 cases of extracorporeal membrane oxygenation (ECMO) support.The immunosuppression regimens including Cyclosporin,mycophemolate Mofeil and corticosteroids were utilized in 53 recipients before the year of 2007,and Cyclosporin was switched to Tacrolimus in 47 patients after 2007.All the patients received Daclizumab or Basiliximab as immunosuppression induction regimens.Results The 1-,2-,3-and 5-year survival rate after LTx was 73.3％,61.6％,53.5％ and 40.7％ respectively.The mean survival time post-transplant in the patients who received Cyclosporin-based regimens and Tacrolimus-based regimens were (36.57 ± 3.44) months and (35.00 ± 2.33) months,repectively,with no significant differences (P＞0.05).The main causes of mortality included primary graft dysfunction (PGD),acute rejection (AR),bronchiolitis obliterans (BOS) and sepsis.The incidence of AR and BOS in Tacrolimus group was significantly lower than that in Cyclosporin grou (P ＜0.05),but the incidence of diabetes mellitus was significantly higher in Tacrolimus group.Analysis of Spearman rank correlation revealed that there was a direct correlation between the incidence of AR and BOS (r =0.340,P＜0.01).The use of circulation support,diagnosis of IPF,postoperative complications such as AR,BOS and infection were associated with decreased survival time postoperatively,in both univariate and multivariate proportional hazards regression models (P＜0.05).Conclusion Cyclosporin-and Tacrolimus-based regimens were both effective immunosuppression strategies postoperatively,Consummate follow-up surveillance and prompt treatment of complications were the key points in prolongation of survival time and improving quality of life after LTx.

Objective To investigate the effects of ω-3 fatty acids (FA) on inflammatory reaction and immunologic function of patients after hepatectomy. Methods Totally 82 patients were randomized into control group and ω-3 FA group. Both groups received parenteral nutrition (PN) with equal nitrogen and calories. Patients in the control group received medium and long-chain lipid emulsion, and those in the ω-3 FA group received ω-3 FA combined with medium and long-chain lipid emulsion. Liver function test (serum total protein, prealbumin, albumin ,aspartate aminotransferase, alanine aminotransferase) , blood coagulation function (international normalized ratio) , immune globubin (IgA, IgG, and IgM) , CD3 and CD4/CD8 were measured on the first, third, and seventh post-operative day. Results Serum total protein in the ω-3 FA group [(61. 40 ±5. 12) g/L] was significantly higher than in the control group [(58. 54 ± 5. 53 ) g/L] (P = 0. 018 ) . Aspartate aminotransferase in the ω-3 FA group [(32. 37 ± 11. 92) U/L] was significantly lower than in the control group [(42. 50 ± 29. 97) U/L] (P = 0. 048). IgA in the ω-3 FA group [(2. 67 ± 1. 01) g/L] was significantly higher than in the control group [(2. 15 ±0.77) g/L] (P=0.027). IL-1β in the ω-3 FA group [(7.88 ±6.45) pg/ml] was significantly lower than in the control group [(12. 98 ± 11. 07) pg/ml] (P = 0.034). IL-2 in the ω-3 FA group [(24.98±20.38) pg/ml] was significantly lower than the control group [(43. 09 ± 20. 74) pg/ml] (P = 0.002). The white blood cell counts and coagulation function were not significantly different between two groups. Conclusion Total PN containing ω-3 FA can effectively improve immunologic function and liver function of patients after hepatectomy.

ObjectiveTo investigate the treatment effects of comprehensive nursing intervention on patients with chronic obstructive pulmonary disease(COPD) treated by non-invasive mechanical ventilation with BiPAP mode.Methods96 patients with diagnosed COPD and using non-invasive mechanical ven- tilation with BiPAP mode were randomly divided into the control group(46 cases) which was treated with routine measures and the comprehensive nursing intervention group (50 cases) which adopted comprehen- sive nursing intervention according to experimental design. The frightening degree, incidence rate of com- plications and clinical treatment effect by ventilator were compared between the two groups.ResultsPa- tients compliance with treatment and clinical treatment effect by ventilator in the comprehensive nursing in- tervention group was better than that of the control group. The frightening degree and incidence rate ofcomplications were lower than those of the control group (P < 0.01 ).ConclusionsComprehensive nurs-ing intervention with non-invasive mechanical ventilation with BiPAP mode can improve the treatmentcompliance of COPD patients,reduce complications followed by non-invasive mechanical ventilation andreach the prospective treatment effect.

Objective To evaluate the therapeutic efficacy of gamma knife in treatment of primary trigeminal neuralgia Methods Retrospectively analysis of 120 cases with primary trigeminal neuralgia treated by gamma knife in our department From Jan. 2003 to Mar. 2008 were performed. All cases were treated with the 4 mm collimator and targeted at the proximal nerve at the root entry zone located by MRI. The target dose varied from 80 -90 Gy. Results After a follow-up of 20. 0 ±4. 5 months, complete relief of pain occurred in 69 patients (57. 5%), 50% -90% relief in 34 (28. 3%), relief less than 50% in 12(10.0%) but no relief in 5(4.2 %).The efficient rate was 95. 8% . The common complications include numbness, absence of corneal reflex. 83 patients (69. 2%) experienced temporal facial numbness and 14 patients (11. 7%) reported continuous numbness after treatment of the gamma knife. Conclusions Gamma knife radiosurgery is a minimally invasive technique for the treatment of primary trigeminal neuralgia with few complications.

Background and purpose:Although intermittent endocrine therapy is a treatment strategy for new patients with advanced prostate cancer, the use of hormonal therapy is still controversial. This study aimed to investigate the efficacy of intermittent hormonal therapy for the patients with advanced prostate cancer and determine the factors influencing efficacy of the treatment.Methods:From Jul. 2009 to May 2015, patients with advanced prostate cancer were treated with 6 months of hormonal therapy, and then efficacy was assessed. A hundred and twenty-eight hormone sensitive patients were randomly divided into intermittent and continuous treatment groups, and were observed with efficacy, side effects, quality of life scores and other indicators. The prognostic factors for intermittent group were analyzed.Results:A total of 128 patients with advanced prostate cancer were enrolled in the study. Prostate-specific antigen (PSA) levels were significantly decreased in 96 patients after endocrine therapy. Among those, 43 patients received intermittent endocrine therapy while 53 patients received continuous endocrine therapy. The score of KPS in the intermittent treatment group was 82.6±7.4, which was significantly higher than that of the continuous group (KPS score was 69.8±8.7). There was a sig-nificant difference between them (P<0.05). The incidence of treatment related side effects and the proportion of developing hormone independent tumor in the intermittent group were significantly lower than that in the continuous treatment group (P<0.05). The 5-year survival rate in intermittent group was 72.1%, higher than that in the continuous group (63%). How-ever, the difference was not statistically significant (P>0.5). PSA level in the early stage of endocrine therapy and G1eason score before treatment were important factors affecting the prognosis of patients. The patients in the intermittent group were followed up for 13-70 months, and received 1 to 4 cycles of treatment. The number of patients in the treatment was declined during the extension of the treatment, and the treatment interval was shorter.Conclusion:Intermittent endocrine therapy is an effective treatment for advanced prostate cancer. It is safe and reliable. It can improve the quality of life for patients and reduce the economic burden on them.