Stability of Polaprezinc-Containing Oral Rinse and Its Clinical Effectiveness against Radiotherapy-Induced Oral Mucositis / 医薬品情報学

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.