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Selected AbstractsEfficacy and safety of a new clobetasol propionate 0.05% foam in alopecia areata: a randomized, double-blind placebo-controlled trialJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 10 2006Antonella Tosti Abstract Background, Clinical efficacy of topical corticosteroids in alopecia areata (AA) is still controversial. Positive clinical results have been obtained using ointments with occlusive dressing but this approach has a low patient compliance. Recently, a new topical formulation (thermophobic foam: Versafoam®) of clobetasol propionate 0.05% has been introduced on the market (Olux®, Mipharm, Milan, Italy) (CF). This formulation is easy to apply. After application to the skin the foam quickly evaporates without residues and it has a good patient compliance. In vitro studies have also shown that this formulation enhances the delivery of the active compound through the skin. Aim, To evaluate the efficacy, safety and tolerability of CF in the treatment of moderate to severe AA. Subjects and methods, Thirty-four patients with moderate to severe AA (eight men, mean age 40 ± 13 years) were enrolled in a randomized, double-blind, right-to-left, placebo-controlled, 24-week trial. Alopecia grading score (AGS) was calculated at baseline and after 12 and 24 weeks of treatment using a 0,5 score (0 = no alopecia; 5 = alopecia totalis). Clobetasol foam and the corresponding placebo foam (PF) were applied twice a day for 5 days/week for 12 weeks (phase 1) using an intrapatient design (right vs. left). From weeks 13 to 24 each enrolled patient continued only with the treatment (both on the right and left site) that was judged to have a greater efficacy than that on the contralateral side (phase 2). The primary outcome of the trial, evaluated on an intention-to-treat basis, was the hair regrowth rate, which was evaluated using a semiquantitative score (RGS) (from 0: no regrowth, to 4: regrowth of 75%). Results, At baseline the AGS was 4.1 (range: 2,5). Nine (26%) patients prematurely concluded the trial. At the end of phase 1, a greater hair regrowth was observed in 89% of the head sites treated with CF vs. 11% in the sites treated with PF. The RGS was 1.2 ± 1.6 in the CF-treated sites and 0.4 ± 0.8 in the PF-treated sites (P = 0.001). A RGS of 2 (hair regrowth of more than 25%) was observed in 42% CF-treated sites and in 13% of PF-treated sites (P = 0.027). In seven subjects (20%) a RGS of 3 to 4 (hair regrowth of 50%) was observed in CF-treated sites. In three subjects (9%) a RGS of 4 (hair regrowth of 75%) was observed in CF-treated sites. In one patient only, in a PF-treated region, a RGS of 3 was observed. The AS was reduced to 3.8 by CF treatment at the end of phase 1 and to 3.3 at the end of phase 2 (P = 0.01). From weeks 12 to 24 the treatment with CF induced a further increase in the RGS (from 1.2 to 1.5 ± 1.4). Forty-seven per cent of CF-treated patients had a RGS of 2 at the end of the trial. A total of eight patients (25%) at the end of the treatment with CF showed a RGS of 3. Folliculitis occurred in two patients. No significant modifications in cortisol and ACTH blood levels were observed during the trial. Conclusion, This new formulation of clobetasol propionate foam is an effective, safe and well-tolerated topical treatment for AA. This formulation has a good cosmetic acceptance and patient compliance profile. [source] Effect of Point-of-care Influenza Testing on Management of Febrile ChildrenACADEMIC EMERGENCY MEDICINE, Issue 12 2006Srikant B. Iyer MD Abstract Objectives To determine the effect of point-of-care testing (POCT) for influenza on the physician management of febrile children who are at risk for serious bacterial illness (SBI) on the basis of age and temperature and who are presenting to a pediatric emergency department (ED) during an influenza outbreak. Methods Patients 2,3 months of age with temperature of ,38°C and patients 3,24 months of age with temperature of ,39°C who were presenting to a pediatric ED during an influenza outbreak were enrolled into a prospective, quasi-randomized, controlled trial. Influenza testing was performed on enrolled patients by either the POCT or the standard-testing (ST) methods. The two groups were compared in terms of laboratory testing, chest radiography, antibiotic use, visit-associated costs, pediatric ED lengths of stay, inpatient admission, and return visits to the pediatric ED. Similar analyses also were performed on the resulting subgroups of patients on the basis of method of testing (POCT or ST) and test result (positive or negative). Results Of 767 eligible patients, 700 (91%) completed the study. No significant differences were demonstrated between the POCT and ST groups with respect to laboratory tests ordered, chest radiographs obtained, antibiotic administration, inpatient admission, return visits to the pediatric ED, lengths of stay, or visit-associated costs. In the subgroup analysis, the adjusted odds ratios (ORs) for blood culture in influenza test,positive to ,negative patients were 0.59 and 0.71 in the POCT and ST groups, respectively (p = 0.088). The adjusted ORs for urine culture in influenza test,positive to ,negative patients were 0.46 and 0.67 in the POCT and ST groups, respectively (p = 0.005). Conclusions When using a strategy of performing influenza testing on all patients at risk for SBI who presented to a pediatric ED during an influenza outbreak, the method of testing (POCT or ST) did not appear to significantly alter physician management, cost, or length of stay in the pediatric ED. However, if the interaction of the method of testing and the test result (positive or negative) were considered, a positive POCT for influenza was associated with a significant reduction in orders for urinalyses and urine cultures. [source] Comparison of Impedance Cardiography to Direct Fick and Thermodilution Cardiac Output Determination in Pulmonary Arterial HypertensionCONGESTIVE HEART FAILURE, Issue 2004Gordon L. Yung MD Cardiac output (CO) is an important diagnostic and prognostic tool for patients with ventricular dysfunction. Pulmonary hypertension patients undergo invasive right heart catheterization to determine pulmonary vascular and cardiac hemodynamics. Thermodilution (TD) and direct Fick method are the most common methods of CO determination but are costly and may be associated with complications. The latest generation of impedance cardiography (ICG) provides noninvasive estimation of CO and is now validated. The purpose of this study was to compare ICG measurement of CO to TD and direct Fick in pulmonary hypertension patients. Thirty-nine enrolled patients were analyzed: 44% were male and average age was 50.8±17.4 years. Results for bias and precision of cardiac index were as follows: ICG vs. Fick (,0.13 L/min/m2 and 0.46 L/min/m2), TD vs. Fick (0.10 L/min/m2 and 0.41 L/min/m2), ICG vs. TD (respectively, with a 95% level of agreement between ,0.72 and 0.92 L/min/m2; CO correlation of ICG vs. Fick, TD vs. Fick, and ICG vs. TD was 0.84, 0.89, and 0.80, respectively). ICG provides an accurate, useful, and cost-effective method for determining CO in pulmonary hypertension patients, and is a potential tool for following responses to therapeutic interventions. [source] Utilization of the Ottawa Ankle Rules by Nurses in a Pediatric Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 2 2002Anna Karpas MD Objectives: To determine the ability of pediatric emergency department (ED) nurses to accurately apply the Ottawa Ankle Rules (OAR) and to evaluate whether the rate of negative ankle radiographs can be reduced by incorporating the OAR into an existing collaborative practice protocol (CPP). Methods: The authors' ED currently uses a CPP in which patients with ankle pain, swelling, deformity, or decreased range of motion on primary nursing assessment undergo radiography prior to physician evaluation. A cross-sectional study was conducted between June and November 2000. Patients aged 5-19 years with an ankle injury who met at least one of the CPP criteria were eligible for enrollment. The OAR were applied by the primary nurse after initial assessment. Ankle radiographs were ordered for all enrolled patients. The interobserver variability between nurses was evaluated on a random sample. Results: One hundred ninety subjects were enrolled in the study. The OAR were correctly interpreted by nurses in 98.4% of subjects. Agreement on the interobserver reliability sample was 100%. Of the 185 subjects, 31 (16.8%) had positive radiographs. Positive OAR results were noted in 30 of 31 subjects with positive radiographs. The sensitivity of the OAR was 97% (95% CI = 0.82 to 0.99) with a specificity of 25% (95% CI = 0.18 to 032). Use of the OAR would have reduced the radiography rate by 21%. Conclusions: Trained nurses can accurately apply and interpret the OAR. The incorporation of the OAR into the nursing assessment of children with acute ankle injuries may reduce the number of radiographs ordered. [source] Phase II study of arsenic trioxide and ascorbic acid for relapsed or refractory lymphoid malignancies: a Wisconsin Oncology Network study,HEMATOLOGICAL ONCOLOGY, Issue 1 2009JE Chang Abstract Arsenic trioxide (As2O3) has established clinical activity in acute promyelocytic leukaemia and has pre-clinical data suggesting activity in lymphoid malignancies. Cell death from As2O3 may be the result of oxidative stress. Agents which deplete intracellular glutathione, such as ascorbic acid (AA), may potentiate arsenic-mediated apoptosis. This multi-institution phase II study investigated a novel dosing schedule of As2O3 and AA in patients with relapsed or refractory lymphoid malignancies. Patients received As2O3 0.25,mg/kg IV and AA 1000,mg IV for five consecutive days during the first week of each cycle followed by twice weekly infusions during weeks 2,6. Cycles were repeated every 8 weeks. The primary end point was objective response. In a subset of patients, sequential levels of intracellular glutathione and measures of Bcl-2 and Bax gene expression were evaluated in peripheral blood mononuclear cells during treatment. Seventeen patients were enrolled between March 2002 and February 2004. The median age was 71, and the majority of enrolled patients had non-Hodgkin's lymphoma (12/17). Sixteen patients were evaluable, and one patient with mantle cell lymphoma achieved an unconfirmed complete response after five cycles of therapy for an overall response rate of 6%. The trial, which had been designed as a two-stage study, was closed after the first stage analysis due to lack of activity. Haematologic toxicities were the most commonly reported events in this heavily pre-treated population, and comprised the majority of grade 3 and 4 toxicities. Intracellular depletion of glutathione was not consistently observed during treatment. As2O3 and AA in this novel dosing strategy was generally well tolerated but had limited activity in patients with relapsed and refractory lymphoid malignancies. Copyright © 2008 John Wiley & Sons, Ltd. [source] The International Quotidian Dialysis Registry: Annual report 2008HEMODIALYSIS INTERNATIONAL, Issue 3 2008Gihad E. NESRALLAH Abstract Alternative hemodialysis (HD) schedules, including short-daily and nocturnal HD, continue to proliferate, with the hope of offering improved patient outcomes. Three nights per week and every other night, nocturnal HD are now being provided to more patients worldwide, both at home and in-center. However, alternative HD schedules are still experimental in most centers, and studies establishing the efficacy of these therapies with respect to major clinical outcomes are needed. Endorsed by the National Institutes of Health, the International Quotidian Dialysis Registry is an international collaboration that was established in 2002 to prospectively study large numbers of patients treated with alternate HD schedules. The Registry will ultimately allow alternate HD modalities to be compared to conventional thrice-weekly HD with respect to clinical endpoints, including mortality, using a prospective cohort study. To date, the Registry has enrolled 182, 1193, and 740 subjects from Canada, the United States, and Australia, respectively. This report is the fourth annual update and describes recruitment progress, baseline characteristics of enrolled patients, and worldwide prescription patterns. [source] The Clinical Noncompliance of Oral Sotalol/Magnesium for Prophylactic Treatment of Atrial Fibrillation After Coronary Artery Bypass GraftingJOURNAL OF CARDIAC SURGERY, Issue 4 2007Giovanni Mariscalco M.D. The present aim was to study the clinical compliance of a suggested prophylactic treatment, oral sotalol, and magnesium. Methods: Coronary-bypass patients without clinical contraindications to receive oral sotalol (80 mg twice daily) and magnesium supplementation were enrolled (n = 49) with an intention-to-treat strategy and being compared with a matched control group (n = 844). A protocol listed exclusion criteria of clinical compliance that was postoperatively evaluated prior to and during treatment. Results: Twenty-seven of the 49 enrolled patients (55%) were compliant to sustain the treatment according to the protocol. The remaining patients were postoperatively excluded, mainly because of hemodynamic reasons, of whom 14 were noncompliant to initiate any treatment. The AF occurrence in the compliant group was 7% versus 36% in noncompliant patients (p = 0.035), and 24% in the control group (p = 0.076). However, with an intention-to-treat policy the overall AF incidence became 18%. The subgroups of enrolled patients demonstrated skewing phenomena. The noncompliant group had higher requirement for inotropic support (p = 0.029) and longer aortic cross-clamp time (p = 0.048) compared to compliant patients. Further, the body weight of noncompliant patients was markedly lower than in the compliant counterpart (p = 0.015). Conclusions: The tested treatment protocol showed limited compliance among routine cardiac-surgery patients, and further, introduced a biased selection of patients that skewed the results and may have partly explained the treatment effect. [source] Photodynamic therapy: update 2006 Part 2: Clinical resultsJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 4 2007PG Calzavara-Pinton Abstract In several randomized, controlled studies, the application of a standard preparation containing methyl-aminolevulinate (MAL; Metvix®, Galderma, F), followed by red light irradiation proved effective and well tolerated in the treatment of actinic keratosis and basal cell carcinoma, and has now been approved for clinical use in European countries. A brand name aminolevulinic acid (ALA) solution (Levulan Kerastick®, Dusa Pharmaceuticals Inc., Wilmington, MA) plus blue light exposure has been approved for the treatment of actinic keratosis in the USA. Randomized and controlled studies have shown that MAL as well as ALA are also effective in the treatment of Bowen's disease. In addition, a large and growing number of open studies or case reports have evaluated its use in the treatment of a broad range of other neoplastic, inflammatory and infectious skin diseases. However, efficacy and definite advantages over standard therapies remain to be clarified because the experimental design of these studies was often poor, the number of enrolled patients was generally low, and the follow-up was shorter than 12 months. However, these studies have suggested a few possible clinical applications worthy of further investigation. A growing number of laboratory and clinical findings suggest that several new synthetic sensitizers, besides ALA and MAL, may be helpful in the treatment of non-melanoma skin cancers, melanoma metastasis, and selected inflammatory and infective skin diseases. These compounds are deliverable intravenously, have short half-lives both in the blood and skin, and are highly efficient. However, they are as of yet not approved for clinical use. [source] What You See (Sonographically) Is What You Get: Vein and Patient Characteristics Associated With Successful Ultrasound-guided Peripheral Intravenous Placement in Patients With Difficult AccessACADEMIC EMERGENCY MEDICINE, Issue 12 2009Nova L. Panebianco MD Abstract Objectives:, Ultrasound (US) has been shown to facilitate peripheral intravenous (IV) placement in emergency department (ED) patients with difficult IV access (DIVA). This study sought to define patient and vein characteristics that affect successful US-guided peripheral IV placement. Methods:, This was a prospective observational study of US-guided IV placement in a convenience sample of DIVA patients in an urban, tertiary care ED. DIVA patients were defined as having any of the following: at least two failed IV attempts or a history of difficult access plus the inability to visualize or palpate any veins on physical exam. Patient characteristics (demographic information, vital signs, and medical history) were collected on enrolled patients. The relationships between patient characteristics, vein depth and diameter, US probe orientation, and successful IV placement were analyzed. Results:, A total of 169 patients were enrolled, with 236 attempts at access. Increasing vessel diameter was associated with a higher likelihood of success (odds ratio [OR] = 1.79 per 0.1-cm increase in vessel diameter, 95% confidence interval [CI] = 1.37 to 2.34). Increasing vessel depth did not affect success rates (OR = 0.96 per 0.1-cm increase of depth, 95% CI = 0.89 to 1.04) until a threshold depth of 1.6 cm, beyond which no vessels were successfully cannulated. Probe orientation and patient characteristics were unrelated to success. Conclusions:, Success was solely related to vessel characteristics detected with US and not influenced by patient characteristics or probe orientation. Successful DIVA was primarily associated with larger vessel, while vessel depth up to >1.6 cm and patient characteristics were unrelated to success. Clinically, if two vessels are identified at a depth of <1.6 cm, the larger diameter vessel, even if comparatively deeper, should yield the greatest likelihood of success. [source] A randomized, multicentre, open-label, parallel-group trial to compare the efficacy and safety profile of daming capsule in patients with hypercholesterolemiaPHYTOTHERAPY RESEARCH, Issue 7 2009Ai Jing Abstract To study the efficacy and tolerability of Daming capsule (DMC) in Chinese patients with hyperlipidemia, a randomized, multi-centre, open-label, parallel-group trial was conducted. Sixty enrolled patients with hyperlipidemia allocated to six medical centers were randomly divided into two groups of 30 individuals each. One group received DMC 2 g b.i.d. for 6 weeks, and the other received pravastatin 10 mg o.d. for 6 weeks. For efficacy assessment, serum total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C) and high density lipoprotein cholesterol (HDL-C) were measured before and after drug treatment. Serum TC and LDL-C levels in the DMC-treatment group were significantly decreased compared with those before treatment (p < 0.05), while TG and HDL-C levels did not change much. Tolerability was assessed by heart rate (HR), blood pressure (BP), body mass index (BMI), alanine aminotransferase (ALT) and creatinine (Cr), which were not changed in either the DMC or pravastatin groups at 3 and 6 weeks (p > 0.05). Besides, eight patients experienced diarrhea during DMC treatment and two experienced myalgia and epigastric discomfort during pravastatin treatment. Based on the above results, it was concluded that DMC may be a good candidate for the treatment of hyperlipidemia and further clinical trials are warranted. Copyright © 2009 John Wiley & Sons, Ltd. [source] Impact of QT Variables on Clinical Outcome of Genotyped Hypertrophic CardiomyopathyANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 1 2009Katsuharu Uchiyama M.D. Background: Although QT variables such as its interval and/or dispersion can be clinical markers of ventricular tachyarrhythmia, few data exist regarding the role of QT variables in genotyped hypertrophic cardiomyopathy (HCM). Therefore, we analyzed QT variables in genotyped subjects with or without left ventricular hypertrophy (LVH). Methods: QT variables were analyzed in 111 mutation and 43 non-mutation carriers who were divided into three groups: A, those without ECG abnormalities and echocardiographically determined LVH (wall thickness ,13 mm); B, those with ECG abnormalities but LVH; and C, those with ECG abnormalities and LVH. We also examined clinical outcome of enrolled patients. Results: Maximal LV wall thickness in group C (19.0 ± 4.3 mm, mean ±SD) was significantly greater than that in group A (9.2 ± 1.8) and group B (10.4 ± 1.8). Under these conditions, maximum QTc interval and QT dispersion were significantly longer in group C than those in group A (438 ± 38 ms vs 406 ± 30 and 64 ± 31 vs 44 ± 18, respectively; P < 0.05). QTc interval and QT dispersion in group B (436 ± 50 and 64 ± 22 ms) were also significantly greater than those in group A. During follow-up periods, four sudden cardiac deaths and one ventricular fibrillation were observed in group C, and two nonlethal ventricular tachyarrhythmias were observed in group B. Conclusions: Patients with HCM-related gene mutation accompanying any ECG abnormalities frequently exhibited impaired QT variables even without LVH. We suggest that careful observation should be considered for those genotyped subjects. [source] Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registryARTHRITIS & RHEUMATISM, Issue 9 2010J.-E. Gottenberg Objective The risk of severe infection is a crucial factor in the assessment of the short-term risk:benefit ratio of biologic drugs in rheumatoid arthritis (RA). There is no increase in severe infections in RA patients treated with rituximab (RTX) in controlled trials, but this has not yet been assessed in daily practice. We undertook this study to investigate the occurrence of and risk factors for severe infections in off-trial patients using data from the AutoImmunity and Rituximab (AIR) registry. Methods The AIR registry was set up by the French Society of Rheumatology. The charts of patients with severe infections were reviewed. Results Of the enrolled patients, 1,303 had at least 1 followup visit at 3 months or later, with a mean ± SD followup period of 1.2 ± 0.8 years (1,629 patient-years). Eighty-two severe infections occurred in 78 patients (5.0 severe infections per 100 patient-years), half of them in the 3 months following the last RTX infusion. Multivariate analysis showed that chronic lung disease and/or cardiac insufficiency (odds ratio 3.0 [95% confidence interval 1.3,7.3], P = 0.01), extraarticular involvement (odds ratio 2.9 [95% confidence interval 1.3,6.7], P = 0.009), and low IgG level (<6 gm/liter) before initiation of RTX treatment (odds ratio 4.9 [95% confidence interval 1.6,15.2], P = 0.005) were significantly associated with increased risk of a severe infection. Conclusion The rate of severe infections in current practice is similar to that reported in clinical trials. The risk factors for severe infections include chronic lung and/or cardiac disease, extraarticular involvement, and low IgG before RTX treatment. This suggests that serum IgG should be checked and the risk:benefit ratio of RTX discussed for patients found to have low levels of IgG. [source] Design and implementation of a randomized trial evaluating systematic care for bipolar disorderBIPOLAR DISORDERS, Issue 4 2002Gregory E Simon Objectives: Everyday care of bipolar disorder typically falls short of evidence-based practice. This report describes the design and implementation of a randomized trial evaluating a systematic program to improve quality and continuity of care for bipolar disorder. Methods: Computerized records of a large health plan were used to identify all patients treated for bipolar disorder. Following a baseline diagnostic assessment, eligible and consenting patients were randomly assigned to either continued usual care or a multifaceted intervention program including: development of a collaborative treatment plan, monthly telephone monitoring by a dedicated nurse care manager, feedback of monitoring results and algorithm-based medication recommendations to treating mental health providers, as-needed outreach and care coordination, and a structured psychoeducational group program (the Life Goals Program by Bauer and McBride) delivered by the nurse care manager. Blinded assessments of clinical outcomes, functional outcomes, and treatment process were conducted every 3 months for 24 months. Results: A total of 441 patients (64% of those eligible) consented to participate and 43% of enrolled patients met criteria for current major depressive episode, manic episode, or hypomanic episode. An additional 39% reported significant subthreshold symptoms, and 18% reported minimal or no current mood symptoms. Of patients assigned to the intervention program, 94% participated in telephone monitoring and 70% attended at least one group session. Conclusions: In a population-based sample of patients treated for bipolar disorder, approximately two-thirds agreed to participate in a randomized trial comparing alternative treatment strategies. Nearly all patients accepted regular telephone monitoring and over two-thirds joined a structured group program. Future reports will describe clinical effectiveness and cost-effectiveness of the intervention program compared with usual care. [source] Oral or intravenous proton pump inhibitor in patients with peptic ulcer bleeding after successful endoscopic epinephrine injectionBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 3 2009Jai-Jen Tsai WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT? , Endoscopic therapy significantly reduces recurrent bleeding, surgery and mortality in patients with bleeding peptic ulcers. , Intravenous (i.v.) proton pump inhibitors (PPIs) have been found to be effective as adjuvant pharmacotherapy in preventing rebleeding in these patients. , It remains undetermined whether oral and i.v. regular-dose PPIs are equally effective. WHAT THIS STUDY ADDS? , Oral rabeprazole and i.v. regular-dose omeprazole are comparable in preventing rebleeding in patients with high-risk bleeding peptic ulcers after successful endoscopic injection with epinephrine. AIMS We aimed to assess the clinical effectiveness of oral vs. intravenous (i.v.) regular-dose proton pump inhibitor (PPI) after endoscopic injection of epinephrine in patients with peptic ulcer bleeding. METHODS Peptic ulcer patients with active bleeding, nonbleeding visible vessels, or adherent clots were enrolled after successful endoscopic haemostasis achieved by epinephrine injection. They were randomized to receive either oral rabeprazole (RAB group, 20 mg twice daily for 3 days) or i.v. omeprazole (OME group, 40 mg i.v. infusion every 12 h for 3 days). Subsequently, the enrolled patients receive oral PPI for 2 months (rabeprazole 20 mg or esomeprazole 40 mg once daily). The primary end-point was recurrent bleeding up to 14 days. The hospital stay, blood transfusion, surgery and mortality within 14 days were compared as well. RESULTS A total of 156 patients were enrolled, with 78 patients randomly allocated in each group. The two groups were well matched for factors affecting the clinical outcomes. Primary end-points (recurrent bleeding up to 14 days) were reached in 12 patients (15.4%) in the OME group and 13 patients (16.7%) in the RAB group [95% confidence interval (CI) of difference ,12.82, 10.22]. All the rebleeding events occurred within 3 days of enrolment. The two groups were not different in hospital stay, volume of blood transfusion, surgery or mortality rate (1.3% of the OME group and 2.6% of the RAB group died, 95% CI of difference ,5.6, 3.0). CONCLUSIONS Oral rabeprazole and i.v. regular-dose omeprazole are equally effective in preventing rebleeding in patients with high-risk bleeding peptic ulcers after successful endoscopic injection with epinephrine. [source] Phase I study of dexamethasone, methotrexate, ifosfamide, l -asparaginase, and etoposide (SMILE) chemotherapy for advanced-stage, relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma and leukemiaCANCER SCIENCE, Issue 5 2008Motoko Yamaguchi Extranodal natural killer (NK)/T-cell lymphoma, nasal type, and aggressive NK-cell leukemia are rare, and their standard therapy has not been established. They are Epstein,Barr virus-associated lymphoid malignancies, and tumor cells express P-glycoprotein leading to multidrug resistance of the disease. Patients with stage IV, relapsed or refractory diseases have a dismal prognosis, with survival measured in months only. To develop an efficacious chemotherapeutic regimen, we conducted a dose-escalation feasibility study of a new chemotherapeutic regimen, SMILE, comprising the steroid dexamethasone, methotrexate, ifosfamide, l -asparaginase, and etoposide. The components of SMILE are multidrug resistance-unrelated agents and etoposide. Etoposide shows both in vitro and in vivo efficacy for Epstein,Barr virus-associated lymphoproliferative disorders. Eligible patients had newly diagnosed stage IV, relapsed or refractory diseases after first-line chemotherapy, were 15,69 years of age, and had satisfactory performance scores (0,2). Four dose levels of methotrexate and etoposide were originally planned to be evaluated. At level 1, six patients with extranodal NK/T-cell lymphoma, nasal type, were enrolled. Their disease status was newly diagnosed stage IV (n = 3), first relapse (n = 2), and primary refractory (n = 1). All of the first three patients developed dose-limiting toxicities, and one of them died of sepsis with grade 4 neutropenia. A protocol revision stipulating early granulocyte colony-stimulating factor administration was made. Two out of three additional patients developed dose-limiting toxicities that were all manageable and transient. For the six enrolled patients, the overall response rate was 67% and the complete response rate was 50%. Although its safety and efficacy require further evaluation, we recommend a SMILE chemotherapy dose level of 1 for further clinical studies. (Cancer Sci 2008; 99: 1016,1020) [source] | |||||||||||||||||||