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 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.

AIM:To investigate COX-2 and iNOS protein contents and their interaction in vascular endothelium injury of rats with deficiency of vital energy or qi stagnation,and the prevetion and treatment of Tongxinluo.METHODS:The model of vascular endothelium injury of rats with deficiency of vital energy or qi stagnation was established by using high L-Methionine,with load-carrying swimming or being fastened respectively.Western blotting was used to analyze protein contents of COX-2 and iNOS,co-immunoprecipitation and laser confocal microscopy were used to analyze the interaction between COX-2 and iNOS.Optical microscope and electronic microscope were used to evaluate pathological changes in vascular endothelium.RESULTS:The protein contents of COX-2 and iNOS,and their interaction increased significantly in deficiency of vital energy group and qi stagnation group,in accord with injury of vascular endothelium.Compared with deficiency of vital energy group and qi stagnation group respectively,their protein contents decreased and their interaction was weakened in Tongxinluo groups.CONCLUSION:When protein contents of COX-2 and iNOS increase and their interaction enhance after vascular endothelium injury of rats with deficiency of vital energy or qi stagnation,initiate exacerbations,Tongxinluo could attenuate the alterations and protect vascular endothelium from injury.

The changes in excitability and autorhthmicity of bladder detrusor in experimental non-insulin dependent diabetes mellitus (NIDDM) rats were observed. Sixty-nine NIDDM rats as NIDDM group and 69 normal rats as control group were enrolled into this experimental study. At 6th, 10th, 14th, 18th, 22nd and 26th week after the rats were injected last time, the changes in the excitability and autorhthmicity of detrusor strips in vitro were observed. The results showed that the threshold of the tension which made the detrusor strips contract was significantly higher in NIDDM group (0.716 +/- 0.325 g) than in control group (0.323 +/- 0.177 g) (F = 59.63, P < 0.001). At different stages, the threshold of the tension resulting the contract of the detrusor strips in NIDDM group was also higher than in control group. At 18th week after STZ injection, the frequency of spontaneous contract of the detrusor strips in NIDDM was significantly higher than in control group (P < 0.05), whereas at 22nd week, that in NIDDM group was significantly lower than in control group (P < 0.05). It was concluded that the decreased excitability of the bladder detrusor was the earliest and most obvious changes in bladder function in diabetes rats and the autorhthmicity had also changed at the early stage of diabetic bladder.
Diabetes Mellitus, Experimental/*physiopathology ; Diabetes Mellitus, Type 2/physiopathology ; Muscle Contraction/physiology ; Muscle Relaxation/physiology ; Rats, Wistar ; Urinary Bladder/*physiopathology ; Urinary Bladder Diseases/etiology ; Urinary Bladder Diseases/*physiopathology

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.

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.