A 90-day dietary study with fibrillated cellulose in Sprague-Dawley rats.

Novel forms of fibrillated cellulose offer improved attributes for use in foods. Conventional cellulose and many of its derivatives are already widely used as food additives and are authorized as safe for use in foods in many countries. However, novel forms have not yet been thoroughly investigated using standardized testing methods. This study assesses the 90-day dietary toxicity of fibrillated cellulose, as compared to a conventional cellulose, Solka Floc. Sprague Dawley rats were fed 2 %, 3 %, or 4 % fibrillated cellulose for 90 consecutive days, and parallel Solka Floc groups were used as controls. Survival, clinical observations, body weight, food consumption, ophthalmologic evaluations, hematology, serum chemistry, urinalysis, post-mortem anatomic pathology, and histopathology were monitored and performed. No adverse observations were noted in relation to the administration of fibrillated cellulose. Under the conditions of this study and based on the toxicological endpoints evaluated, the no-observed-adverse-effect level (NOAEL) for fibrillated cellulose was 2194.2 mg/kg/day (males) and 2666.6 mg/kg/day (females), corresponding to the highest dose tested (4 %) for male and female Sprague Dawley rats. These results demonstrate that fibrillated cellulose behaves similarly to conventional cellulose and raises no safety concerns when used as a food ingredient at these concentrations.

Large Unstained Cell, Blast Suspect and Delta Neutrophil Index ll Analyzed with Automated Hematology Analyzer as Parameters for the Prediction of Acute Leukemia Relapse

BACKGROUND: Here we investigated the clinical utilities of blast suspect, large unstained cell (LUC), delta neutrophil index ll (DN ll), and delta neutrophil index l (DN l), analyzed in peripheral blood samples with automated hematology analyzers to predict the relapse of acute leukemia. METHODS: We retrospectively reviewed the medical records of 112 patients, including 56 patients with acute leukemia relapse and 56 controls. Blast suspect, LUC, DN ll, and DN l were compared between the control and leukemia relapse groups. RESULTS: Significant differences in blast suspect (P<0.001), LUC (P<0.001), DN ll (P<0.001), and DN l (P=0.002) were observed between the leukemia relapse and control groups. The areas under the curve (AUC) value was 0.927 for blast suspect (95% confidence interval [CI]: 0.8750.978, P<0.001), 0.868 for LUC (95% CI: 0.794–0.941, P<0.001), and 0.900 for DN ll (95% CI: 0.841–0.960, P<0.001). Logistic regression analysis for the prediction of leukemia relapse revealed odds ratio values of 1.52 (95% CI: 1.26–1.96, P=0.0002) for blast suspect, 1.66 (95% CI: 1.27–2.42, P=0.0019) for LUC, 1.16 (95% CI: 1.08–1.29, P=0.0014) for DN ll, and 1.05 (95% CI: 1.01–1.13, P=0.0845) for DN l. CONCLUSIONS: Multiple parameters provided by automated blood cell analyzers may serve as powerful ancillary tools for the prediction and diagnosis of leukemia relapse.

Application of bone marrow samples for discrimination of acute promyelocytic leukemia from other types of acute leukemia using the routine automated hematology analyzer.

INTRODUCTION: Unreported parameters produced by automated blood cell counter, particularly large unstained cells (LUC) and delta neutrophil index (DNI), indicated the presence of immature and possibly abnormal cell populations in white blood cell population. The purpose of this study was to investigate the laboratory performance for discrimination of acute promyelocytic leukemia (APL) cells from other types of leukemia cells and clinical value of LUC and DNI parameters in bone marrow (BM) samples of patients with acute leukemia. METHODS: A total of 73 BM samples of patients with various type of acute leukemia were analyzed. LUC and DNI parameters were determined by an automated hematology analyzer (ADVIA 120; Siemens Healthcare Diagnostics, New York, NY, USA). Statistical analysis was performed using Kruskal-Wallis and Mann-Whitney U methods. Receiver operating characteristic curve (ROC) analysis, survival analysis, and Cox proportional hazard model were used to evaluate the clinical implication. RESULTS: There were significant differences (P < 0.05) between APL group and other group in the DNI and LUC values except for DNI between APL group and non-APL myeloid leukemia group. The area under curve of LUC was larger than that of DNI from the ROC analysis for discrimination between APL group and other group. High LUC value was associated with the increased risk of adverse outcomes and the worse overall survival in patients with acute leukemia. CONCLUSION: Delta neutrophil index and LUC in BM showed discriminating power of APL cells from other leukemia cells.