Фармацевтика Аналитика Акта

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Oral Mucositis related to Radiotherapy for Head and Neck cancer: Evaluation of the Effectiveness of a New Anti-inflammatory Product Containing Verbascoside, Polyvinylpyrrolidone, Hyaluronic Acid (Mucosyte)

Rossella Di Franco, Matteo Muto, Vincenzo Ravo, Domenico Borrelli, Alfonsina Pepe, Sara Falivene, Angela Argenone, Giovanna Guida and Paolo Muto

Introduction: Mucositis is a greater complication of chemotherapy and radiotherapy in head and neck cancer, linked with risk of interruption of therapy. Toxicity is related to reactive oxygen species, which cause transcription ofNF-kB, iNOS, AP-1, pro-inflammatory cytokines. Objectives: We have conducted a retrospective study to evaluate the preventive effect of Verbascoside (Mucosyte®) in the onset of mucositis due to radiotherapy. Methods: We evaluated 172 patients treated with radiotherapy, divided in two arms: Control Group of 83 patients treated with 3DCRT or IMRT and with Verbascoside (Mucosyte®) prescribed at appearance of mucositis, and on the other hand Mucosyte Group of 89 patients treated with 3DCRT, IMRT, Tomotherapy who received Mucosyte® previously and until two weeks from the end of radiotherapy. Radiotherapy doses were between 30-71.3Gy delivered with multiple coplanar fields. We calculated the percentage of patients with mucositis grade 1, 2, 3 or 4 in the two groups of patients, absolute risk reduction (ARR), relative risk (RR), relative risk reduction (RRR) and odds ratio (OR). We evaluated acute toxicity and Mean Dose (Dmean) to parotid glands to determine techniques’ influence to onset of mucositis. Results:The percentage of high toxicity is lower in Mucosyte Group. We calculated: risk of adverse events in MG PM= 0.17; Odds = 0.20; risk of adverse events in CG Pc = 0.52; Odds = 1.08; Odds Ratio OR = 0.19; relative risk RR: 0.33; relative risk reduction RRR: 0.67; absolute risk reduction ARR: 0.35. All parameters showed the effectiveness of Verbascoside in management of patients with head and neck cancer. Conclusions: Using Mucosyte® previously and until two weeks from the end of radiotherapy the incidence of muscositis is lower but this result is influenced also by technique. Xerostomia, mycosis and pain are much lower in the patient that used Mucosyte® in prevention independently from technique used.