PATIENTS AND METHODS Study design.The study was an open-label, single-group trial of miltefosine at 12 outpatient centers in VL-endemic regions of Dhaka, Rajshahi, and Mymensingh, Bangladesh.Patients. Patients were 2-65 years of age. Both male and female patients participated, and patents were enrolled during October 2006-September 2007. Inclusion criteria were signs and symptoms compatible with VL (fever for at least two weeks, palpable splenomegaly, weight loss by history), positive serologic test result for leishmaniasis (rK39), 7 hemoglobin level ≥ 6 g/dL, no infection with HIV, not pregnant or lactating, not being currently treated with an antileishmanial compound, and no significant concomitant medical condition. Malaria and enteric fever were ruled out by blood smears and the Widal test, respectively. If present, malaria and enteric fever were treated. These patients could then be admitted into the study. If tuberculosis was suspected on clinical grounds, the patient was not eligible for this study.Study procedures. Enrolled patients were given sufficient drugs for treatment for one week. Patients returned to the outpatient clinic once a week for three successive weeks for assessment of compliance and adverse events (AEs) and to receive drug for the next week's treatment. At the end of 28 days of treatment, patients were assessed for initial cure and were given instructions for follow-up at two months and six months after the end of treatment.Drug treatment. Miltefosine was administered daily for 28 days after meals. For children (≤ 12 years of age), the daily dose was 2.5 mg/kg body weight using 10-mg capsules split into twice-a-day doses. For adults (> 12 years of age) weighing < 25 kg, the daily dose was 50 mg of miltefosine/day as one capsule (50 mg) in the evening. For adults (> 12 years) weighing ≥ 25 kg, the daily dose was 100 mg of miltefosine as one capsule (50 mg) in the morning and one capsule in the evening.Assessments. Efficacy parameters (temperature and weight, spleen size, and hemoglobin level) were evaluated at initial screening and on days 7, 14, 21 and 28 of treatment and 2 months
Objective: to investigate the changes and potential significance of Treg (regulatory T cell) and IL-35 in rat model of acute pancreatitis in the primary 48hrs of the early developmental phase of the disease process.Methods: 36 S-D rats were divided into two groups, control group (6 rats) and acute pancreatitis (30 rats). A rat model of pancreatitis was developed by common bile duct (CBD) ligation method. After successful development of pancreatitis model, investigations were carried out and the rats were executed by six in number each time in 2, 6, 12, 24 and 48 hours. The durations were calculated from the time of CBD ligation. CD4+ CD25+ T cells in peripheral blood were calculated by flow cytometry. Serum IL-35 was measured by ELISA method. The pathological grading of pancreatic necrosis was determined during all stages.Results: Significant reduction of Treg and IL-35 in the AP group in 2, 6, 12, 24 and 48 hours were found in compares with the control group. Pancreatic pathology score was increased with the progression of disease. Conclusion:According to our study regulatory T cells and IL-35 both showed a significant positive correlation with the AP group with a downward trend in their circulating level and negatively correlated with the pathological grading of the pancreas.
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