ABSTRACT
Objective:To evaluate the bioequivalence of two kinds of domestic nimesulide granules in healthy volunteers. Meth-ods:In self-control and two-way crossover design, 18 healthy male volunteers were divided into two groups randomly. Each subject was given 100 mg test or reference nimesulide granules with single dose. The concentration of nimesulide in plasma was determined by HPLC. The concentration of nimesulide in plasma was calculated and compared statistically to evaluate the bioequivalence between the two kinds of granules by DAS 2. 1 software. Results:The main pharmacokinetic parameters of test and reference preparations were as follows:Cmax was(9. 28 ± 2. 05) and(9. 41 ± 2. 31)μg·ml-1;Tmax was(3. 50 ± 1. 86)and(3. 56 ± 1. 65)h;T1/2 was (3. 43 ± 0. 85) and(3.38 ±0.68)h;AUC0-24 was(77.78 ±18.42)and(81.69 ±23.50)μg·ml·h-1;AUC(0-∞) was (79.07 ±19.21)and(82.92 ± 24. 11)μg·ml·h-1, respectively. The 90% confidential interval of ln(AUC0-24), ln(AUC0-∞) and ln(Cmax) of the test preparation was 90. 7%-107. 9%,90. 6%-111. 2% and 90. 7%-103. 0%, respectively. The relative bioavailability was (96. 7 ± 37. 6)%. Con-clusion:The two nimesulide granules are bioequivalent.
ABSTRACT
Objective To investigate the predictive value of class Ⅲ β-tubulin protein expression in tumor tissue for the efficacy of taxol combined chemotherapy in stage Ⅲ s/Ⅳ gastric carcinoma patients.Methods Tumor biopsy samples were obtained and class Ⅲ β-tubulin protein expression were examined by immunohistochemical staining before chemotherapy.According to different expression of class Ⅲ β-tubulin,the patients were divided into two groups,group A(low expression of class Ⅲ β-tubulin),group B(high expression of class Ⅲ β-tubulin).The patients were assigned to be received 4 to 6 cycles of Taxol and S-1 chemotherapy regimens and followed up until death or lost.Response rate(RR),overall survival(OS)and time to tumor progression(TTP)were assessed.Results There was no significant difference in clinical characteristics among patients with different expression rate.The RR was higher and TIP was longer in group A than in group B(53.3 ％ vs 36.7 ％,198 days vs 146 days,P ＜ 0.05 respectively),and no significant differences of OS in two groups(P ＞ 0.05).Conclusion The expression level of class Ⅲ β-tubulin in tumor tissue is probably a predictor for the efficacy of taxol in gastric cancer patients,taxol combined chemotherapy is more suitable for patients with lower expression of class Ⅲ β-tubulin.
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Objective To investigate the effect of donor lymphocyte infusion(DU) by intra-bone marrow(IBM)or intravenous(Ⅳ)on the incidence of graft-versus-host disease(GVHD)and graft-versus-leukemia(GVL)after allogeneic peripheral hematopoietic stem cen transplantation(allo-PBSCT).Methods Female C57BL/6 mice as recipients received total body irradiation (TSr) Oil day 0,followed by injection of peripheral hematopoietic stem cells from mobilized male BALB/e with the granulocyte-colony stimulating factor(rhG-CSF),and DLI Was performed via Ⅳ or IBM.The extents of GVHD and GVL were compared in recipients received IBM-DLI with those received IV-DLI.The percentages of donor-defived cells and CD_4~+ CD_(25)~+ regulatory T cells(Treg) were detected by flow cytometry.Results It Was found that the frequency of GVHD and GVL were reduced in IBM-DLI compared with that of IV-DLI(P
ABSTRACT
Objective:To investigate the effect of donor lymphocyte infusion (DLI) by intra-bone marrow (IBM) or intravenous (IV) on the incidence of graft-versus-host disease(GVHD) after allogeneic peripheral hematopoietic stem cell transplantation (allo-PBSCT).Methods:Female C57BL/6 mice as recipients received total body irradiation (TBI) on day 0,followed by injection of peripheral hematopoietic stem cells from mobilized male BALB/c with granulocyte-colony stimulating factor (rhG-CSF),and DLI was performed via IV or IBM.The extent of GVHD was compared in recipients received allogeneic IBM-DLI with those received IV-DLI.The percentage of donor-derived cells and CD4~+CD25~+ regulatory T cells (Tregs) was detected by flow cytometry.14 days after DLI,the levels of IL-4 and interferon (IFN)-γ were tested by ELISA.Results:It was found that the frequency and severity of GVHD were reduced in IBM-DLI compared with that of IV-DLI (P＜0.01).7 days after transplantation,the percentage of H-2~d-positive cells was over 95% in all surviving transplanted mice;and 14 days after transplantation,the percentage of Tregs detected as CD4~+CD25~+ was significantly higher in recipients treated with IBM-DLI than those treated with IV-DLI(P＜0.01).Compared with that of the recipients in IBM-DLI group,the level of IL-4 was significantly decreased,while the level of IFN-γ were elevated in group IV-DLI (P＜0.01).Conclusion:IBM-DLI could induce the proliferation of Tregs and the Th polarizing to Th2,resulting in decreasing the incidence and alleviating severity of GVHD after allo-PBSCT.