Mucosa-adhesive water-soluble polymer film for treatment of acute radiation-induced oral mucositis
Mucosa-adhesive water-soluble polymer film for treatment of acute radiation-induced oral mucositis
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DOI：
10.1016/s0360-3016(97)00903-6
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发表时间：
1998-03-15
影响因子：
7
通讯作者：
Sone, S
中科院分区：
文献类型：
--
作者：
Oguchi, M;Shikama, N;Sone, S
用途：研究含有麻醉剂和抗生素的粘膜粘附性水溶性聚合物膜（AD膜）用于治疗急性放射性口腔粘膜炎的有用性和安全性。材料和方法：为了制备AD膜，将600 mg羟丙基纤维素溶解于乙醇中，并与含有丁卡因、氧氟沙星、咪康唑、愈创木蓝和三醋精的溶液混合。将得到的凝胶干燥，形成30个直径为7.5cm、厚度为0.2mm的半透明圆片（每片20 mg）。AD膜在湿润的口腔粘膜上表现出优异的粘附性和涂层性能。自1993年至1993年，我们对25例急性放射性口腔粘膜炎患者使用AD膜，试图减轻其疼痛并预防继发性口腔感染。所有患者均接受过口腔癌的确定性放射治疗。将1990 ~ 1992年27例局部麻醉（粘性利多卡因、Xylocaine（TM））和/或全身镇痛药治疗的患者（非AD组）与由粘膜炎引起的口腔疼痛的强度和持续时间、休息时和进食时的缓解率以及细菌和/或真菌感染的存在进行比较。与非AD组（15天）相比，AD膜组（10天）的平均疼痛持续时间显著缩短。AD膜组在休息和进食时的疼痛完全缓解率在统计学上高于非AD组：分别为82%和34%，68%和22%。在AD膜组中未观察到继发性细菌或真菌感染，而在非AD组中发现4例记录的感染。在3年的随访期间，没有观察到AD膜的急性或慢性不良反应。在随访期结束时，口腔癌局部控制率和总生存率分别为96%和87%，而非AD组分别为92%和85%。含有局部麻醉剂和抗生素的AD膜被证明可用于减轻由于急性辐射诱导的口腔粘膜炎引起的疼痛，保持良好的经口进食，并防止继发性口腔感染，不会引起不良反应。(C)1998年爱思唯尔科学公司
Purpose: 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.Materials and Methods: 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 1993, 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 (TM)) and/or general systemic analgesics from 1990 to 1992 (NonAD Group).Results: 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. 34%, 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, mere 96% and 87% for the AD film Group vs. 92% and 85% for the NonAD Group, respectively.Conclusion: 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. (C) 1998 Elsevier Science Inc.