betadex and Stomatitis--Aphthous

Patients often experience difficulties in applying topical steroids in orabase to the oral mucosa, particularly when large areas need to be covered. An aqueous hydrocortisone mouthwash solution has been developed, one that was anticipated to be more acceptable to patients. The solution contains hydrocortisone (0.3% w/v) in a 4.5% (w/v) 2-hydroxypropyl-beta-cyclodextrin solution. Hydroxypropylmethylcellulose (0.5% w/v) was used to increase the viscosity of the solution and to promote the hydrocortisonecyclodextrin complex. One hundred and two patients with aphthous ulceration, lichen planus, and other mucosal conditions used the mouthwash in an open clinical efficacy study. Most patients reported some or considerable improvement following a 2-week course of treatment with the mouthwash: 26 of 33 (78.8%) patients with aphthous ulceration were 'much better', as were 26 of 54 (48.1%) patients with lichen planus and 5 of 16 (31.3%) patients with other mucosal lesions. No serious side effects were reported. Aqueous mouthwash solutions offer a potential vehicle for topical steroid therapy of oral mucosal lesions.

Topics: 2-Hydroxypropyl-beta-cyclodextrin; Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; beta-Cyclodextrins; Chelating Agents; Chemistry, Pharmaceutical; Child; Cyclodextrins; Excipients; Female; Humans; Hydrocortisone; Hypromellose Derivatives; Lichen Planus, Oral; Male; Methylcellulose; Middle Aged; Mouth Diseases; Mouth Mucosa; Mouthwashes; Pharmaceutic Aids; Pharmaceutical Vehicles; Remission Induction; Stomatitis, Aphthous; Treatment Outcome; Viscosity

We evaluated the usefulness of PGE2 on chemotherapy-associated oral mucosal lesions of the patients with hematological malignancies and compared the efficacy of the troche with that of the tablet. One hundred and fifty three patients were given 0.5 mg of these PGE2 topically three times daily. One hundred and fourty five cases were evaluable (Tablet; 85, Troche; 60). 1) Symptoms and signs were improved in 102/144 (70.8%) and 102/145 (70.3%), respectively. The overall response rate was 70.3%. 2) The improvement rates were 77.5% (55/71), 85.7% (6/7) and 62.7% (32/51) in leukocyte count-increased, -unchanged and -decreased patients, respectively. 3) No background factor of the patients except performance status affected the improvement rate. 4) Higher improvement rate was noted in the PGE2 early starting group (within 5 days after the appearance of oral lesions) than the late group (6 days and thereafter) (76.5% v.s. 55.8%: U-test p less than 0.1, chi2-test p less than 0.05). 5) There was no difference in the efficacy rate between the tablet and the troche. 6) Mild side effects were seen in 10 cases. These results suggest that topical administration of PGE2 is safe and useful for improving chemotherapy-associated oral mucosal lesions of patients with hematological malignancies.

Topics: Administration, Oral; Adult; Aged; beta-Cyclodextrins; Cyclodextrins; Dinoprostone; Drug Evaluation; Female; Humans; Leukemia; Male; Middle Aged; Mouth Mucosa; Myelodysplastic Syndromes; Stomatitis, Aphthous; Tablets