Stomatitis-reducing effect of Azeptin (Azelastine hydrochloride) in concomitant chemo-radiotherapy

Stomatitis-reducing effect of Azelastine hydrochloride (Azeptin) was examined in patients with oral squamous cell carcinoma treated with concomitant chemo-radiotherapy. From the start of therapy to the disappearance of oral ulcer, a combination of vitamin C (500 mg/day), vitamin E (200 mg/day) and glutathione (200 mg/day) was applied to 26 patients (group A), and Azeptin (2 mg/day) with these drugs was administered to other 37 patients (group B). At the time of 14 Gy with cobalt 60 (60Co)-25 mg of peplomycin (PLM)-1,500 mg of 5-fluorouracil (5-FU), stomatitis of grade 2 (limited erosion with mild contact pain) was observed in about half patients of both groups. At the end of therapy (60Co: up to 28 Gy, PLM: up to 38 mg, 5-FU: up to 3,000 mg), stomatitis of grade 3 (wide erosion with strong irritability) and grade 4 (unbearable contact pains due to severe erosion with ulceration) was induced in 23% and 58% of patients in group A, however these grades of stomatitis were observed in only 16% and 27% in group B, respectively. Besides, the duration of grade 4 stomatitis was 19.0±5.8 days in group A and 14.9±4.8 days in group B. These results seem to indicate that the regimen including Azeptin reduces the severity of stomatitis. (author)