[A multicenter clinical study of oral topical administration of G-512 on chemotherapy-associated intraoral mucosal lesions of patients with hematological malignancies. G-512 Therapeutic Study Group for Intraoral Mucosal Lesions].
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.
Takaku
F
F
Faculty of Medicine, University of Tokyo.
Kitani
T
T
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D003505:Cyclodextrins / Q000008:administration & dosage; D015232:Dinoprostone / Q000008:administration & dosage*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007938:Leukemia / Q000188:drug therapy / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000473:pathology*; D009190:Myelodysplastic Syndromes / Q000188:drug therapy / Q000473:pathology; D013281:Stomatitis, Aphthous / Q000188:drug therapy* / Q000473:pathology; D013607:Tablets; D047392:beta-Cyclodextrins
D003505:Cyclodextrins; D013607:Tablets; D047392:beta-Cyclodextrins; C031215:betadex; D015232:Dinoprostone