A twenty eight-day repeated dose toxicity study of black soybean extract in Sprague-Dawley rats

Hagiwara, Akeo; Imai, Norio; Numano, Takamasa; Nakashima, Hironao; Tamano, Seiko; Sakaue, Kazushi; Tanaka, Kiyofumi; Yasuhara, Kazuo; Hayashi, Shim-mo

doi:10.2131/jts.35.87

Cited by 6 publications

(5 citation statements)

References 20 publications

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“…Two study groups also showed that BS could assist in the myeloproliferation of irradiated rats (8,16). Administering BS in rats with or without condition medium can assist in reticulocyte count proliferation (1,17). BS was also found to promote myelopoiesis in mouse splenocytes and bone marrow cells in a previous study.…”

Section: Discussionmentioning

confidence: 84%

A phase II double-blinded study to evaluate the efficacy of EW02 in reducing chemotherapy-induced neutropenia in breast cancer

Liu

Huang

et al. 2015

Oncology Letters

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Abstract. EW02, a polysaccharide-enriched crude extract from black soybean, has been shown to assist hematopoiesis in chemotherapy-treated animals. The present study aimed to clarify the safety, quality of life (QOL) and efficacy for myelopoiesis of EW02 administration in early breast cancer (EBC) patients receiving adjuvant chemotherapy. A total of 60 eligible EBC patients were enrolled in a randomized, double-blinded trial, 40 of whom were prescribed 700 mg oral EW02 three times daily for 15 days in chemotherapy cycle (C)2. The remainder were prescribed a placebo. All subjects took EW02 in C3 for 15 days. Blood samples were collected at different time-points for determining the blood cell count, and the serum level of granulocyte colony-stimulating factor (G-CSF) and interleukin (IL)-6. All patients tolerated EW02 well without severe side-effects. QOL evaluation showed that only the score of one questionnaire section (QLQ-C30) was significantly increased at C1 day (D)8 to C2D8 when the EW02 and placebo groups were compared (P=0.045). No significant myelopoiesis recovery, and no incremental change in IL-6 and G-CSF levels were found in C2. Subgroup analysis showed a slightly lower decrease in absolute neutrophil count (ANC) in the EW02 patients who underwent Adriamycin + cyclophosphamide treatment compared with the placebo group. Although EW02 failed to show efficacy for myelopoiesis in the present study, EW02 was still well tolerated in EBC patients who underwent adjuvant chemotherapy.

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Section: Discussionmentioning

confidence: 84%

A phase II double-blinded study to evaluate the efficacy of EW02 in reducing chemotherapy-induced neutropenia in breast cancer

Liu

Huang

et al. 2015

Oncology Letters

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“…An example is given in Table 6, where a significant difference is not shown by ANOVA, but shown by Dunnett's test. In Japan, data obtained from several toxicity studies were not analysed by using ANOVA [32], [33], [34], [35], and [36]. …”

Section: Notes On Few Statistical Techniques Commonly Used In Analysimentioning

confidence: 99%

Transition of Japan’s statistical tools by decision tree for quantitative data obtained from the general repeated dose administration toxicity studies in rodents

Kobayashi¹,

Pillai²,

Michael³

et al. 2014

IJBAS

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Statistical significance is one of important criteria on judgment of regulatory toxicological testing. The decision tree for analysing quantitative data obtained from repeated dose administration studies in rodents has been in use in Japan around 1981. Since then, several authors proposed improved versions of the decision tree incorporating all possible situations of statistical analysis normally encountered in such studies. Recently, a decision tree, which traces a simple route, unlike the previously proposed ones which trace complex routes has been proposed by a few researchers in Japan. While tracing to the most appropriate statistical tool using a decision tree, we propose to consider following points which also play a significant role in selecting the most appropriate statistical tool: (1) statistical tools that fails to detect a significant difference in the low dose group, (2) use of the one-sided test with high power to detect a significant difference compared with two-sided, (3) as far as possible avoid carrying out statistical analysis on the transformed data, since the analytical result of such data is difficult to interpret, (4) it is important to mention what statistical tools of the decision tree are used for the analysis, (5) examine the data for both normality and homogeneity and (6) for testing homogeneity, use Levene's test. Selection of widely accepted statistical tools is usually preferred to less popular and complex statistical analysis. It has been observed that in recent years the preferred statistical tools for analyzing quantitative data obtained from toxicity studied are of simple in nature but with high power to detect a significant difference.

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“…This strategy provides a quick, inexpensive, quantitative and relatively noninvasive approach to monitoring and screening the drugs toxicity. [11][12][13] However, with increasing safety standards from worldwide regulatory agencies, an increased requirement for better safety biomarkers has been emphasized. 14 However, the sensitivity and specialty of the clinical chemistry analysis are quite varied and sometimes is considered sub-optimal, with changes generally occurring only after significant tissue injury occurred.…”

Section: Introductionmentioning

confidence: 99%

Ingenuity pathways analysis of urine metabonomics phenotypes toxicity of gentamicin in multiple organs

Liu

Zhang

et al. 2010

Mol. BioSyst.

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We introduce the use of Ingenuity Pathway Analysis to analyzing global metabonomics in order to characterize phenotypically biochemical perturbations and the potential mechanisms of the gentamicin-induced toxicity in multiple organs. A single dose of gentamicin was administered to Sprague Dawley rats (200 mg/kg, n = 6) and urine samples were collected at -24-0 h pre-dosage, 0-24, 24-48, 48-72 and 72-96 h post-dosage of gentamicin. The urine metabonomics analysis was performed by UPLC/MS, and the mass spectra signals of the detected metabolites were systematically deconvoluted and analyzed by pattern recognition analyses (Heatmap, PCA and PLS-DA), revealing a time-dependency of the biochemical perturbations induced by gentamicin toxicity. As result, the holistic metabolome change induced by gentamicin toxicity in the animal's organisms was characterized. Several metabolites involved in amino acid metabolism were identified in urine, and it was confirmed that gentamicin biochemical perturbations can be foreseen from these biomarkers. Notoriously, it was found that gentamicin induced toxicity in multiple organs system in the laboratory rats. The proof-of-knowledge based Ingenuity Pathway Analysis revealed gentamicin induced liver and heart toxicity, along with the previously known toxicity in kidney. The metabolites creatine, nicotinic acid, prostaglandin E2, and cholic acid were identified and validated as phenotypic biomarkers of gentamicin induced toxicity. Altogether, the significance of the use of metabonomics analyses in the assessment of drug toxicity is highlighted once more; furthermore, this work demonstrated the powerful predictive potential of the Ingenuity Pathway Analysis to study of drug toxicity and its valuable complementation for metabonomics based assessment of the drug toxicity.

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A twenty eight-day repeated dose toxicity study of black soybean extract in Sprague-Dawley rats

Cited by 6 publications

References 20 publications

A phase II double-blinded study to evaluate the efficacy of EW02 in reducing chemotherapy-induced neutropenia in breast cancer

A phase II double-blinded study to evaluate the efficacy of EW02 in reducing chemotherapy-induced neutropenia in breast cancer

Transition of Japan’s statistical tools by decision tree for quantitative data obtained from the general repeated dose administration toxicity studies in rodents

Ingenuity pathways analysis of urine metabonomics phenotypes toxicity of gentamicin in multiple organs

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