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.

AIM: To investigate the mRNA changes of L-type Ca~(2+) channel ?_(1C) subunit (CaL-?_(1C)) and Na~+-Ca~(2+) exchanger (NCX) in the atria of renovascular hypertensive rats. METHODS: Two-kidney one-clip Goldblatt hypertensive Sprague-Dawley rats were divided into three groups 1 week after operation, HD group was treated with 250 mg/d diltiazem, LD group was treated with 50 mg/d diltiazem, control group (C group) was treated with vehicle. After 4 weeks treatment, semiquantitative RT-PCR was used to estimate the mRNA changes of CaL-?_(1C) and NCX, and GAPDH was used as internal control. RESULTS: Systolic blood pressure in LD group was comparable with C group, and that in HD group was decreased to normal level after diltiazem treatment. In C group, CaL-?_(1C) mRNA level were 2.5, 2.4 and 2.1 times of S, HD and LD group, and NCX mRNA level were 1.9, 1.6 and 2.1 times of S, HD and LD group. There were no significant difference in the mRNA level of CaL-?_(1C) and NCX among S, HD and LD group. CONCLUSION: The mRNA levels of CaL-?_(1C) and NCX are upregulated in the atria of hypertensive rats. Ca~(2+) antagonist inhibits their upregulation independent of blood pressure.

Objce tive To investgate the morphological monoclonal combined with SEMA 3B for detection of the tumorigenic components in gastric cancer .Methods Clones derived from gastric cancer SGC -7901 cells were assessed by morphological observation ,the clone formation rate was calculated .The expression of SEMA3B was detected by Western blot ,and the tumorigenic ability of each group was determined .Results Clones derived from GC SGC-7901 cells had three types,the total clone formation rate was(10.20 ±1.07)%,the expression of SEMA3B was the strongest in the Holoclone colonies ,SGC-7901 cells of Holoclone clones possessed strong abil-ity of self-renewal and in vivo tumorigenicity in the nude mice .Conclusion This study provides the experimen-tal basis for exploring the effect of SEMA 3B in gastric carcinoma tumor formation and proliferation .

Objective To understand whether or not artesunate (Art. ) combined with naphtho-quine (Nap. ) can delay the resistance of Plasmodium falciparum to Art. Methods In Group A, P. falciparum was cultured in culture medium and was stimulated by Art/Nap disconnectedly, and in Group B, stimulated by Art disconnectedly. When P. falciparum recovered to normal growth level, the changes of sensitivity (ID50) to the drugs were compared between the two groups after P. falciparum touched on the drug. Results In Group A, the times P. falciparum recovered to normal growth level were 24, 37 d respectively when it contacted the drugs in the first and second times; P. falciparum didn't recover to normal growth level in 90 d when it contacted the drugs in the third time. In Group B, the times P. falciparum recovered to normal growth level were 16. 7 d (15-20) on average. ID50(s) of Art/Nap were 2.42/37.81, 1. 70/26.30 nmol/L before and 65 d after contacting the drugs in Group A; ID50(s) of Art were 9. 60, 30. 61, 85.12 nmol/L before and 68 and 129 d after contacting the drug in Group B. Conclusion Artesunate-resistant P. falciparum can be cultured by touching artesunate at intervals in vitro; Artesunate combined with naph-thoquine may delay the resistance of P. falciparum to artesunate in vitro.

Objective The research about the effect of different chemotherapeutic drugs on CD19?CAR?T cells with CCK8 test to provide the theoretical support about the development of chemotherapy for clinical support. Methods Extract T cells from a normal adult peripheral blood and synthesize CD19?CAR?T cell. CD19?CAR?T cells were treated with different doses of chemotherapeutic drugs for 24,48,72 h and(or)96 h,and inhibition rate was calculated. Results First,we observed that the inhibition rates of fludarabine and Mafosfamide for CD19?CAR?T cells were increasing with the time and concentration (P < 0.05). Secondly , Bus ulfan had no effect in CD19?CAR?T cells in vitro(P > 0.05). Finally ,Cyclophosphamide had no effect in CD19?CAR?T cells in vitro (P > 0.05). Conclusion Mafosfamide and Fludarabine can inhibit the CD19?CAR?T cells. Cyclophosphamide have no activity in vitro.

Objective This article aims to study the impact of cyclopamine,a Hedgehog signaling pathway inhibitor,on the proliferation and apoptosis of QBC939 cholangiocarcinoma cells.Methods The proliferation of QBC939 cells was detected with the MTT assay,and the apoptotic rate was analyzed with the flow cytometry assay.RT-PCR and Western blow were used to detect the expressions of tumor-related genes and proteins in QBC939 cells before and after cyclopamine treatment.Results Our results show that cyclopamine inhibited the growth of QBC939 cells in time and dose dependent manners.After a 5,10,or 20 μmol/L cyclopamine treatment for 48 hours,QBC939 cells showed increased apoptotic rates significantly higher than those in the control group (P＜0.01).Furthermore,cyclopamine down regulated the mRNA and protein levels of PTCH1,GLI1,and EGFR in QBC939 cells.Conclusion Therefore,blockage of the Hedgehog signaling pathway with cyclopamine could suppress the proliferation and promote the apoptosis of QBC939 cholangiocarcinoma cells.

Objective To discuss whether preoperative extracorporeal shock wave lithotripsy (ESWL) could improve the efficacy of percutaneous nephrolithotomy (PCNL) for complicated renal calculi. Methods 160 cases of complicated renal calculi patients were divided into observation group (80) and control group (80) at random. Take conventional PCNL treatment for control group, and ESWL treatment one day before conventional PCNL treatment for observation group. Record the operation time, intraoperative blood loss, postoperative calculi clearance rate, complications, treatment costs, hospital stays of two groups of patients, then compare the curative effects between the two groups. Results Results are very different in the two groups, and the therapeutic effect of observation group is much better than control group (P < 0.05). Conclusions For complicated renal calculi, compared with conventional PCNL, in reducing the residual stone rate shorting the operation time, reducing the operation number, complications, treatment costs and the length of hospital stay, PCNL preoperative ESWL have obvious advantages. It is a kind of both economic and safe and effective treatment method.

OBJECTIVE:To investigate the clinical efficacy of Bacterial lysates capsule in the treatment of acute attack of asthma in children,and its effects on inflammatory factors and respiratory mechanics indexes.METHODS:A total of 87 children with acute attack of asthma in our hospital were divided into observation group (44 cases) and control group (43 cases).Control group was given glucocorticoid Beclomethasone dipropionate aerosol 0.05 mg,tid;observation group was additionally given Bacterial lysates capsule 3.5 mg,qd,on the basis of control group.Both groups received 120 days of treatment.Peripheral Thl/Th2 cell factor levels (IFN-γ,IL-2,IL-4,IL-5,IL-10,IL-13),lung function indexes (FVC,FEV1,PEF),respiratory mechanics indexes (mean airway pressure,respiratory resistance,static compliance,measured plateau pressure) and clinical efficacies were observed in 2 groups.RESULTS:Before treatment,there was no statistical significance in Th1/Th2 cell factors,lung function indexes or respiratory mechanics indexes between 2 groups (P＞0.05);after treatment,the levels of IFN-γ,IL-2,IL-10,FVC,FEV1 and PEF were increased significantly,while the levels of IL-5 and IL-3 were decreased significantly;IL-4 level of control group was decreased significantly;the levels of IL-2,IL-4,IL-10,FVC,FEV1 and PEF in observation group were significantly better than control group,with statistical significance (P＜0.05).Mean airway pressure,respiratory resistance and measured plateau pressure of observation group were significantly lower than those of control group,while static compliance was significantly higher than control group,with statistical significance (P＜0.05).Response rate of clinical control in observation group was 77.27％,which was significantly higher than 55.81％ of control group,with statistical significance (P＜0.05).CONCLUSIONS:Bacterial lysates capsule shows significantly therapeutic efficacy for acute attack of asthma,relieves airway inflammation and improves the immunity level of the body so as to improve airway respiratory mechanics parameters.