Doxepin Rinse Versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Head and Neck Radiotherapy With or Without Chemotherapy: A Phase III, Randomized, Double-Blind Trial (NCCTG-N09C6 [Alliance])
Doxepin Rinse Versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Head and Neck Radiotherapy With or Without Chemotherapy: A Phase III, Randomized, Double-Blind Trial (NCCTG-N09C6 [Alliance])
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DOI：
10.1200/jco.2013.53.2630
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发表时间：
2014-05-20
影响因子：
45.3
通讯作者：
Loprinzi, Charles L.
中科院分区：
文献类型：
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作者：
Leenstra, James L.;Miller, Robert C.;Loprinzi, Charles L.
目的疼痛性口腔黏膜炎（OM）是头颈部肿瘤放射治疗的重要毒副反应。这项随机、双盲、安慰剂对照试验的目的是测试盐酸多虑平在减少放疗引起的OM疼痛方面的疗效。患者和方法155例患者被随机分配到多塞平口腔冲洗液或安慰剂组，用于治疗放疗相关的OM疼痛。患者在第一天接受单剂量的多虑平或安慰剂，然后在第二天接受相反的药物。疼痛问卷分别在基线和5、15、30、60、120和240分钟时进行。然后，患者可以选择继续使用多虑平。主要终点是疼痛减轻，通过疼痛量表的曲线下面积（AUC）测量，使用第1天的数据。结果主要终点分析显示，多塞平减轻口腔和咽喉疼痛的AUC（-9.1）大于安慰剂（-4.7,P < 0.001）。完成这两个阶段的患者的交叉分析证实，患者使用多塞平后口腔和咽喉疼痛减轻更大（多塞平-安慰剂组患者的患者内变化为4.1，安慰剂-多塞平组患者的患者内变化为-2.8,P < 0.001）。与安慰剂漱口剂相比，多虑平与更多的刺痛或灼烧、不愉快的味道和更大的嗜睡有关。在研究的每个随机阶段结束后，接受多肽治疗的患者比接受安慰剂治疗的患者更愿意继续治疗。结论多塞平冲洗液可减轻OM疼痛。需要进一步研究以确定其在OM管理中的作用。(C) 2014年由美国临床肿瘤学会出版
PurposePainful oral mucositis (OM) is a significant toxicity during radiotherapy for head and neck cancers. The aim of this randomized, double-blind, placebo-controlled trial was to test the efficacy of doxepin hydrochloride in the reduction of radiotherapy-induced OM pain.Patients and MethodsIn all, 155 patients were randomly allocated to a doxepin oral rinse or a placebo for the treatment of radiotherapy-related OM pain. Patients received a single dose of doxepin or placebo on day 1 and then crossed over to receive the opposite agent on a subsequent day. Pain questionnaires were administered at baseline and at 5, 15, 30, 60, 120, and 240 minutes. Patients were then given the option to continue doxepin. The primary end point was pain reduction as measured by the area under the curve (AUC) of the pain scale using data from day 1.ResultsPrimary end point analysis revealed that the AUC for mouth and throat pain reduction was greater for doxepin (-9.1) than for placebo (-4.7; P < .001). Crossover analysis of patients completing both phases confirmed that patients experienced greater mouth and throat pain reduction with doxepin (intrapatient changes of 4.1 for doxepin-placebo arm and -2.8 for placebo-doxepin arm; P < .001). Doxepin was associated with more stinging or burning, unpleasant taste, and greater drowsiness than the placebo rinse. More patients receiving doxepin expressed a desire to continue treatment than did patients with placebo after completion of each of the randomized phases of the study.ConclusionA doxepin rinse diminishes OM pain. Further studies are warranted to determine its role in the management of OM. (C) 2014 by American Society of Clinical Oncology