Novel Submicronized Rebamipide Liquid with Moderate Viscosity: Significant Effects on Oral Mucositis in Animal Models

Nakashima, Takako; Sako, Nobutomo; Matsuda, Takakuni; Uematsu, Naoya; Sakurai, Kazumasa; Ishida, Tatsuhiro

doi:10.1248/bpb.b13-01006

Cited by 8 publications

(2 citation statements)

References 8 publications

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“…Numerous research studies involving ROU animal models have been conducted around the world; however, one major limitation of most animal models of ROU is that they do not reproduce the chronic or relapsing-remitting pattern characteristic of ROU that is observed in humans. The establishment of an ROU animal model is generally performed by introducing trauma such as the acetic acid method [ 20 ] or the No. 15 scalpel blade method [ 21 ].…”

Section: Discussionmentioning

confidence: 99%

The effects of freeze-dried Ganoderma lucidum mycelia on a recurrent oral ulceration rat model

Xie

Zhong

Liu

et al. 2017

BMC Complement Altern Med

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BackgroundConventional scientific studies had supported the use of polysaccharides and β-glucans from a number of fungi, including Ganoderma lucidum for the treatment of recurrent oral ulceration (ROU). Our aim of the present study was to evaluate whether freeze-dried powder from G. lucidum mycelia (FDPGLM) prevents ROU in rats.MethodsA Sprague-Dawley (SD) rat model with ROU was established by autoantigen injection. The ROU rats were treated with three different dosages of FDPGLM and prednisone acetate (PA), and their effects were evaluated according to the clinical therapeutic evaluation indices of ROU.ResultsHigh-dose FDPGLM induced significantly prolonged total intervals and a reduction in the number of ulcers and ulcer areas, thereby indicating that the treatment was effective in preventing ROU. Enzyme-linked immunosorbent assay (ELISA) showed that high-dose FDPGLM significantly enhanced the serum transforming growth factor-β1 (TGF-β1) levels, whereas reduced those of interleukin-6 (IL-6) and interleukin-17 (IL-17). Flow cytometry (FCM) showed that the proportion of CD4+ CD25+ Foxp3+ (forkhead box P3) regulatory T cells (Tregs) significantly increased by 1.5-fold in the high-dose FDPGLM group compared to that in the rat model group (P < 0.01). The application of middle- and high-dose FDPGLM also resulted in the upregulation of Foxp3 and downregulation of retinoid-related orphan receptor gamma t(RORγt) mRNA.ConclusionHigh-dose FDPGLM possibly plays a role in ROU by promoting CD4+ CD25+ Foxp3+ Treg and inhibiting T helper cell 17 differentiation. This study also shows that FDPGLM may be potentially used as a complementary and alternative medicine treatment scheme for ROU.Electronic supplementary materialThe online version of this article (10.1186/s12906-017-2021-8) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

The effects of freeze-dried Ganoderma lucidum mycelia on a recurrent oral ulceration rat model

Xie

Zhong

Liu

et al. 2017

BMC Complement Altern Med

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“…Additionally, rebamipide liquid administered at doses of 1%, 2%, and 4%, resulted in a dose-dependent reduction of total injury extension and tongue ulcerations in a rat model of irradiation-induced oral mucositis [15]. …”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study

et al. 2017

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BackgroundRecent preclinical and phase I studies have reported that rebamipide decreased the severity of chemoradiotherapy-induced oral mucositis in patients with oral cancer. This placebo-controlled randomized phase II study assessed the clinical benefit of rebamipide in reducing the incidence of severe chemoradiotherapy-induced oral mucositis in patients with head and neck cancer (HNC).MethodsPatients aged 20–75 years with HNC who were scheduled to receive chemoradiotherapy were enrolled. Patients were randomized to receive rebamipide 2% liquid, rebamipide 4% liquid, or placebo. The primary endpoint was the incidence of grade ≥ 3 oral mucositis determined by clinical examination and assessed by central review according to the Common Terminology Criteria of Adverse Events version 3.0. Secondary endpoints were the time to onset of grade ≥ 3 oral mucositis and the incidence of functional impairment (grade ≥ 3) based on the evaluation by the Oral Mucositis Evaluation Committee.ResultsFrom April 2014 to August 2015, 97 patients with HNC were enrolled, of whom 94 received treatment. The incidence of grade ≥ 3 oral mucositis was 29% and 25% in the rebamipide 2% and 4% groups, respectively, compared with 39% in the placebo group. The proportion of patients who did not develop grade ≥ 3 oral mucositis by day 50 of treatment was 57.9% in the placebo group, whereas the proportion was 68.0% in the rebamipide 2% group and 71.3% in the rebamipide 4% group. The incidences of adverse events potentially related to the study drug were 16%, 26%, and 13% in the placebo, rebamipide 2%, and rebamipide 4% groups, respectively. There was no significant difference in treatment compliance among the groups.ConclusionsThe present phase II study suggests that mouth washing with rebamipide may be effective and safe for patients with HNC receiving chemoradiotherapy, and 4% liquid is the optimal dose of rebamipide.Trial registrationClinicalTrials.gov under the identifier NCT02085460 (the date of trial registration: March 11, 2014).Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-017-3295-4) contains supplementary material, which is available to authorized users.

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Intra-oral administration of rebamipide liquid prevents tongue injuries induced by X-ray irradiation in rats

Nakashima

Uematsu

Sakurai

2017

Support Care Cancer

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Novel Submicronized Rebamipide Liquid with Moderate Viscosity: Significant Effects on Oral Mucositis in Animal Models

Cited by 8 publications

References 8 publications

The effects of freeze-dried Ganoderma lucidum mycelia on a recurrent oral ulceration rat model

The effects of freeze-dried Ganoderma lucidum mycelia on a recurrent oral ulceration rat model

Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study

Intra-oral administration of rebamipide liquid prevents tongue injuries induced by X-ray irradiation in rats

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