ABSTRACT
<b>Objective: </b>Oral mucositis is one of the serious and frequent acute side effects due to chemoradiotherapy (CRT) for head and neck cancer. In this study, we prepared an oral rinse as a hospital preparation for the treatment of oral mucositis, which was a suspension of polaprezinc (PZ), a zinc-containing therapeutic agent for gastric ulcer, in carboxyvinyl polymer (CP), a water-soluble large molecule.<br><b>Methods: </b>We carried out stability tests of the PZ-CP oral rinse, and investigated its effects on the radiation-induced oral mucositis in patients who received CRT for head and neck cancer.<br><b>Results: </b>In the stability test, the pH, viscosity, adhesion and PZ content in the preparations did not change throughout 28 days after preparation. In the clinical evaluation on the basis of the distribution of the Grade of oral mucositis, the Grade of oral mucositis in the PZ group was significantly lower than in the control group at 6 and 7 weeks (<i>p</i>=0.016, <i>p</i>=0.018). The incidence of severe oral mucositis of Grade 3 was 15.0% (3 cases) in the PZ group and 41.7% (10 cases) in the control group at 6 weeks, and was 15.0% (3 cases) in the PZ group and 33.3% (8 cases) in the control group at 7 weeks.<br><b>Conclusion: </b>These results suggest that PZ-CP oral rinse inhibits the aggravation of oral mucositis induced by CRT or promotes its healing.
ABSTRACT
<b>Objective: </b>In The Hospital of Hyogo College of Medicine, a oral rinse containing polaprezinc (PZ), a zinc-containing drug for gastric ulcers, was used as a hospital preparation to treat radiotherapy-related oral mucositis, and its efficacy was reported. However, the dispersibility of PZ for carboxymethylcellulose sodium (CMC), which was used as the base of the oral rinse, was unfavorable, raising an issue. In this study, we newly prepared a PZ oral rinse containing carboxyvinyl polymer (CP) as a base, and examined its usefulness.<br><b>Methods: </b>A questionnaire survey regarding the usefulness involving 10 healthy volunteers and a pharmaceutical test were conducted.<br><b>Results: </b>The results of the questionnaire survey showed that the optimal concentration of CP was 0.5%. There were no serial changes in the pH, adhesiveness, or PZ content for 7 days after preparation. Furthermore, there were no differences between CMC and CP. The dispersibility of PZ in the oral rinse containing CP as a base was more favorable than that in the oral rinse containing CMC.<br><b>Conclusion: </b>The results of this study suggest that the PZ oral rinse containing 0.5% CP as a base is useful, and that its stability is similar to that of the oral rinse containing CMC as a base.