海萝菲治疗头颈部肿瘤放化疗引起口腔黏膜炎餐时疼痛--随机双盲、安慰剂对照、多中心前瞻性临床研究

来源 :第七届全国鼻咽癌学术大会 | 被引量 : 0次 | 上传用户:ks00459
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  [目的]评价海萝菲(卡波姆凝胶液)治疗头颈部肿瘤患者因放疗或化疗引起口腔黏膜炎餐时疼痛的安全性及有效性.[方法]本研究为随机双盲、安慰剂对照、多中心前瞻性临床研究.主要入选标准:18~70岁,性别不限,鼻咽癌及头颈部恶性肿瘤接受放疗或化疗期间,发生口腔黏膜炎≥Ⅱ级(NCI-CTC V3.0),三家医院120例受试者知情同意并签署知情同意书.按1∶1随机、双盲法入组,分为:海萝菲试验组(A组)、生理盐水组(B组)各60例.用药前1d测量基线值:口腔黏膜炎餐时疼痛评分、口腔pH值、口腔黏膜炎程度、体重.
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