Functional Outcomes of Patients Treated with Intensive Medications for Bowel and Pain Control for Low-Lying Rectal Cancer Who Received Preoperative Chemoradiotherapy.

PURPOSE: The aim of this study was to assess the functional outcomes of patients treated with intensive medications for bowel and pain control for low-lying rectal cancer who received preoperative chemoradiotherapy (CRT). METHODS: The inclusion criterion was sphincter-preserving surgery following CRT for T3 middle and low rectal cancer. Postoperative defecation control was conducted using calcium polycarbophil and loperamide, and anal pain control was conducted using oxycodone hydrochloride hydrate. The functional outcomes were determined by an annual questionnaire after stoma closure. RESULTS: Of 64 patients evaluated, 33 were reconstructed using the double stapling technique (DST) and 31 were reconstructed using the intersphincteric resection (ISR) technique. The median Visual Analogue Scale at ISR was improved from 7 to 1.5 at 1 year after surgery. The median Wexner scores were 6.0, 6.0, 5.0 and 5.0 for DST and 14.5, 12.0, 10.0 and 8.0 for ISR for the first 4 years, respectively. The only independent predictor of a poor bowel function (Wexner score >10) according to a multivariate analyses was pelvic infection (OR 3.994, 95% CI 1.235-13.52, p = 0.021), while ISR was not a predictor. CONCLUSIONS: Anal pain following ISR can be controlled with oxycodone hydrochloride hydrate therapy. ISR is feasible following CRT for low-lying rectal cancer.

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

<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.

Examination of a New Base for the Polaprezinc Oral Rinse / 医薬品情報学

<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.

[Efficacy and safety of polaprezinc as a preventive drug for radiation-induced stomatitis].

BACKGROUND: Radiation-induced stomatitis is one of the adverse effects of total body irradiation(TBI). We examined the usefulness of oral polaprezinc as a preventive drug for stomatitis. PATIENTS AND METHODS: The present study was conducted with 19 patients who were diagnosed with hematologic malignancy and who underwent TBI as pretreatment for bone marrow transplantation, peripheral blood stem transplantation, or cord blood stem cell transplantation. Eleven patients ingested the suspension of polaprezinc and 2% carmellose sodium (carboxymethylcellulose sodium: CMC) beginning the day before TBI(P-CMC group), while the other eight patients did not ingest P-CMC(control group). The severity of stomatitis was assessed in each group during a four-weeks period. RESULTS: Stomatitis (Grade: > or = 3) developed in one of 11 patients in the polaprezinc group and in 4 of 8 patients in the control group(P = 0.046). The times at which stomatitis development ranged between weeks 1 and 2 after the onset of TBI in the two groups. No adverse reaction owing to the ingestion of P-CMC was observed. CONCLUSIONS: These results suggested the efficacy and safety of polaprezinc as a preventive drug for radiation-induced stomatitis.