Oguchi M, Shikama N, Sasaki S, Gomi K, Katsuyama Y, Ohta S, Hori M, Takei K, Arakawa K, Sone S
Department of Radiology, Shinshu University, School of Medicine, Matsumoto, Nagano, Japan.
Int J Radiat Oncol Biol Phys. 1998 Mar 15;40(5):1033-7. doi: 10.1016/s0360-3016(97)00903-6.
To examine the usefulness and safety of a mucosa-adhesive water-soluble polymer film (AD film) containing anesthetics and antibiotics for the treatment of acute radiation-induced oral mucositis.
To prepare AD films, 600 mg of hydroxy-propyl-cellulose was dissolved in ethyl alcohol, and mixed with a solution containing tetracaine, ofloxacine, miconazole, guaiazulene, and triacetin. The gel obtained was dried to form 30 translucent round sheets (20 mg per sheet) of 7.5 cm in diameter and 0.2 mm in thickness. The AD film showed excellent adhesive and coating properties when placed on wet oral mucosa. From 1993 to 1994, we used the AD film in 25 patients with acute radiation-induced oral mucositis, in an attempt to alleviate their pain and prevent secondary oral infection. All patients had received definitive radiotherapy for oral carcinoma. Intensity and duration of oral pain from mucositis, relief rates at rest and while eating, and presence of bacterial and/or fungal infection were compared with those of 27 patients treated with topical anesthetics (viscous lidocaine, Xylocaine and/or general systemic analgesics from 1990 to 1992 (NonAD Group).
The intensity of oral pain was the same in the two groups. The mean duration of pain of the AD film Group (10 days) was significantly shortened compared with the NonAD Group (15 days). The rates of complete pain relief at rest and while eating of the AD film Group were statistically higher than those of the NonAD Group: 82% vs. 44%, and 68% vs. 22%, respectively. No secondary bacterial or fungal infections were observed in the AD film Group, whereas 4 cases of documented infections were found in the NonAD Group. No acute or chronic adverse effects of AD film were observed during the 3-year follow-up period. The rates for local control of oral carcinoma and overall survival, at the end of the follow-up period, were 96% and 87% for the AD film Group vs. 92% and 85% for the NonAD Group, respectively.
The AD film, containing topical anesthetics and antibiotics, proved useful to alleviate pain due to acute radiation-induced oral mucositis, maintain good peroral feeding, and prevent secondary oral infections, without inducing adverse reactions.
探讨含麻醉剂和抗生素的黏膜黏附性水溶性聚合物膜（AD膜）治疗急性放射性口腔黏膜炎的有效性和安全性。
制备AD膜时，将600mg羟丙基纤维素溶于乙醇中，并与含丁卡因、氧氟沙星、咪康唑、愈创蓝油烃和三醋精的溶液混合。所得凝胶干燥后形成30片直径7.5cm、厚度0.2mm的半透明圆形薄片（每片20mg）。AD膜置于湿润的口腔黏膜上时显示出优异的黏附性和覆盖性。1993年至1994年，我们对25例急性放射性口腔黏膜炎患者使用AD膜，试图减轻其疼痛并预防口腔继发感染。所有患者均接受了口腔癌的根治性放疗。将黏膜炎引起的口腔疼痛强度和持续时间、休息及进食时的疼痛缓解率以及细菌和/或真菌感染情况与1990年至1992年接受局部麻醉剂（黏性利多卡因、赛罗卡因）和/或全身镇痛剂治疗的27例患者（非AD组）进行比较。
两组口腔疼痛强度相同。AD膜组的平均疼痛持续时间（10天）与非AD组（15天）相比显著缩短。AD膜组休息及进食时完全疼痛缓解率在统计学上高于非AD组：分别为82%对44%和68%对22%。AD膜组未观察到继发细菌或真菌感染，而非AD组发现4例有记录的感染。在3年随访期内未观察到AD膜的急性或慢性不良反应。随访期末，AD膜组口腔癌局部控制率和总生存率分别为96%和87%，非AD组分别为92%和85%。
含局部麻醉剂和抗生素的AD膜被证明可有效减轻急性放射性口腔黏膜炎引起的疼痛，维持良好的经口进食，并预防口腔继发感染，且不引起不良反应。
