Randomised clinical trial: a comparative study of 10-day sequential therapy with 7-day standard triple therapy for Helicobacter pylori infection in naïve patients.

BACKGROUND: The eradication rates following standard triple therapy for Helicobacter pylori infection are declining worldwide. Recent studies have shown that sequential therapy for H. pylori infection yields high cure rates. AIM: To compare the efficacy and tolerability of a sequential regimen as first-line treatment of H. pylori infection with a standard triple regimen. METHODS: A total of 348 naïve H. pylori-infected patients from six hospitals in Korea were assigned randomly to standard triple or sequential therapy groups. Standard triple therapy consisted of 20 mg of rabeprazole, 1 g of amoxicillin and 500 mg of clarithromycin, twice daily for 7 days. Sequential therapy consisted of a 5-day dual therapy (20 mg of rabeprazole and 1 g of amoxicillin, twice daily) followed by a 5-day triple therapy (20 mg of rabeprazole, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily). RESULTS: The intention-to-treat (ITT) and per-protocol (PP) eradication rates were 62.2% (95% CI 54.8-69.6%) and 76.0% (95% CI 68.5-83.5%) in the standard triple group, and 77.8% (95% CI 71.4-84.2%) and 87.9% (95% CI 82.3-93.5%) in the sequential group, respectively. The eradication rate was significantly higher in the sequential group compared with the standard triple group in both the ITT and PP populations (P = 0.002 and P = 0.013 respectively), whereas the incidence of adverse events was similar. CONCLUSIONS: Ten-day sequential therapy is more effective and equally tolerated for eradication of H. pylori infection compared with standard triple therapy. Sequential therapy may have a role as first-line treatment for H. pylori infection.

UV/TiO2 and UV/TiO2/chemical oxidant processes for the removal of humic acid, Cr and Cu in aqueous TiO2 suspensions.

The objective of this study was to investigate the treatment efficiency of UV/TiO2 and UV/TiO2/chemical oxidant processes for the removal of humic acid and hazardous heavy metals in aqueous TiO2 suspensions. The reaction rate (k) of humic acid and hazardous heavy metals by UV/TiO2 was higher than that of UV illumination alone or TiO2 alone. The removal efficiency for humic acid and Cr(VI) at acid or neutral pH values was higher than that at basic pH values. However, the removal efficiency for Cu(II) at acid pH values was smaller compared with that at neutral or basic pH values. The reaction rate (k) of humic acid and hazardous heavy metals in the TiO2 concentration range of 0.1-0.3 g l(-1) increased with increasing TiO2 dosage. However, amounts higher than a TiO2 dosage of 0.3 g l(-1) reduced the removal efficiency for humic acid and hazardous heavy metals because of the shielding effect on the UV light penetration in the aqueous solution caused by the presence of excessive amounts of TiO2. The addition of oxidants to the UV/TiO2 system showed an increase in degradation efficiency for the treatment of humic acid and hazardous heavy metals. The optimal concentration of oxidants was: H2O2 50 mg l(-1), O3 20 g m(-3) and K2S2O8 50 mg l(-1), respectively. The degradation efficiency of UV/TiO2/oxidant systems for the removal of humic acid and hazardous heavy metals was much greater when H2O2 was used as the oxidant.

GM-CSF-based mobilization effect in normal healthy donors for allogeneic peripheral blood stem cell transplantation.

It is important to optimize methods to mobilize hematopoietic stem cells into peripheral blood (PB) for successful allogeneic peripheral blood stem cell (PBSC) transplantation. Our primary intent was to investigate the role of GM-CSF for mobilization in normal healthy donors and to compare its efficacy in mobilizing stem cells alone, in concurrent combination and in sequential combination with G-CSF in this study. We analyzed the results of the PBSC harvest through large volume leukapheresis from 48 normal healthy donors mobilized by three different regimens including GM-CSF. Donors were assigned sequentially to one of the following regimens for mobilization: GM-CSF 10 microg/kg/day alone (group 1, n = 9); concurrent combination (group 2, n = 20) of G-CSF 5 microg/kg/day and GM-CSF 5 microg/kg/day; sequential combination (group 3, n = 19) of GM-CSF alone 10 microg/kg/day for 3 days followed by G-CSF alone 10 microg/kg/day for 2-3 days. The harvested CD34(+) cell count (P < 0.05) was statistically higher in group 3 than in group 1 or 2. Pre-collection WBC count in donors (P < 0.05), harvested MNC (P < 0.05) and CD3(+) cell count (P < 0.05) of group 2 or 3 were significantly higher than those of group 1. Recipients who received stem cells mobilized with combination regimens showed an earlier recovery of WBC and platelets count than those with GM-CSF alone. The incidence of acute graft-versus-host disease was not statistically different among three recipient groups. GM-CSF-based mobilization was well tolerated in normal healthy donors. The sequential combination regimen appears to be an excellent mobilization strategy and might be preferred as the optimal method in some clinical situations that need a higher number of stem cells.

Human intravenous immunoglobulin preparation and virus inactivation by pasteurization and solvent detergent treatment.

Human intravenous immunoglobulin (IVIG) solutions were prepared by two different methods and compared to each other. The crude immunoglobulin fraction obtained from Cohn-Oncley fractionation of plasma was further purified and subjected to virus inactivation, either by polyethylene glycol precipitation and pasteurization at 60 degrees C for 10 hours, or by ion exchange chromatography and solvent/detergent treatment. The final preparations, formulated in 5% immunoglobulin solutions were characterized by in vitro analyses of biochemical and biological properties and compared with the samples of other manufacturer's IVIG solution products. The critical properties evaluated in this study were purity, molecular intactness, and the biological functions such as Fc function and anticomplementary activity. Virus inactivation and removal by processing steps and by deliberate virucidal steps, as described above, were tested on various human pathogenic viruses, such as human immunodeficiency and experimental model viruses. The tested viruses were successfully inactivated and removed. We conclude that the intravenous immunoglobulins prepared by two different methods, as described above, provide an equivalent viral safety and quality.

Successful allogeneic stem-cell transplantation with prophylactic stepwise G-CSF primed-DLIs for relapse after autologous transplantation in mantle cell lymphoma: a case report and literature review on the evidence of GVL effects in MCL.

Mantle cell lymphoma (MCL) is a distinctive clinicopathologic entity and represents 2-8% of all non-Hodgkin's lymphomas. The median survival of patients with MCL is only 3 years, and none of the available conventional chemotherapy regimens appears curative. Encouraging results have been reported with high-dose chemotherapy with autologous stem-cell transplantation (autoSCT). However, a plateau in disease-free survival was not observed in relapsed MCL on the autoSCT trials. Promisingly, alloSCT appears to induce durable remissions via a graft-versus-lymphoma (GVL) effect. Donor lymphocyte infusions (DLIs), by virtue of a GVL effect, have been shown to induce durable remissions in a few cases with refractory MCL that recur after alloSCT. In this article, we review the literature on the evidence of the GVL effects in MCL and describe a patient with relapsed MCL shortly after high-dose chemotherapy with autoSCT. The patient was then successfully treated with Bu/Cy/VP-16 for an alloSCT followed by DLIs in a stepwise fashion. MNCs > 10 x 10(8)/kg were collected by two large-volume leukaphereses from the donor. Harvested stem cells from the 2(nd) day were cryopreserved for the future use as prophylactic DLIs to be given in a stepwise fashion. Cyclosporin and methotrexate were used for GVHD prophylaxis. He had achieved only a partial response by D+64 post transplant. G-CSF-primed cryopreserved DLIs were then infused on D+64 and D+92 to enhance the GVL effect. Grade 3 intestinal GVHD developed 20 days after the 2(nd) DLI and was partially controlled with the combination of cyclosporin, prednisone, and mycophenolate mofetil. Clinical complete remission was observed at D+112, and maintained until the last follow-up day (D+615). Our findings suggest that alloSCT followed by prophylactic DLIs may offer a curative approach to refractory MCL.

Hepatosplenic T-cell lymphoma: prolymphocytic transformation 18 months after splenectomy.

We report a young woman with pancytopenia and huge splenomegaly who was also found to have peripheral T-cell lymphoma with massive infiltration of T-cell evident in the liver and spleen. A liver biopsy showed predominant sinusoidal infiltration of pan-T cell antibody-stained T-lymphoid cells. Histologic examination of the spleen revealed numerous tumor cells predominantly infiltrated in the cords and sinuses of the red pulp, which were identical to those described in the liver. Several clusters of small round abnormal cells were observed in marrow cytology. Although the patient felt well during 18 months after the splenectomy was done, the patient eventually manifested a huge hepatomegaly, showed increasing white blood cell count to 42 x 10(9)/l, and numerous prolymphocytes (66.9%) in the bone marrow. This change represented a prolymphocytic transformation of the patient's original hepatosplenic T-cell lymphoma.