Effects of an Indomethacin Oral Spray on Pain Due to Oral Mucositis in Cancer Patients Treated With Radiotherapy and Chemotherapy: A Double-Blind, Randomized, Placebo-Controlled Trial (JORTC-PAL04).
Effects of an Indomethacin Oral Spray on Pain Due to Oral Mucositis in Cancer Patients Treated With Radiotherapy and Chemotherapy: A Double-Blind, Randomized, Placebo-Controlled Trial (JORTC-PAL04).
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吲哚美辛口腔喷雾剂对接受放疗和化疗的癌症患者口腔粘膜炎疼痛的影响：双盲、随机、安慰剂对照试验 (JORTC-PAL04)。
DOI：
10.1016/j.jpainsymman.2021.01.123
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发表时间：
2021
期刊：
影响因子：
--
通讯作者：
Kizawa Y.
中科院分区：
文献类型：
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作者：
Nagaoka H;Momo K;Hamano J;Miyaji T;Oyamada S;Kawaguchi T;Homma M;Yamaguchi T;Morita T;Kizawa Y.
口腔粘膜炎(OM)由抗癌化疗和放射治疗引起的疼痛对患者的生活质量有非常负面的影响。目的：本研究采用随机、安慰剂对照、双盲的方法，评价吲哚美辛口腔喷雾剂对抗癌放化疗引起的OM疼痛的止痛效果。我们招募了因抗癌化疗或放疗引起的OM疼痛的成年癌症患者，并在简明疼痛清单(BPI)第5项上被评为4级或更高。患者被随机分配到1：1的比例接受IM口腔喷雾剂或安慰剂。主要终点是BPI第6项(当前疼痛)从治疗前到治疗后30分钟的评分变化。次要终点是治疗后15、60、120、180和240min时BPI第6项曲线下的区域；5项与欧洲癌症研究和治疗组织生活质量问卷头颈部模块35的饮食和交谈相关的项目；临床总体印象改善量表；以及不良事件。结果总共60名患者被分配接受IM口腔喷雾剂(n = 33)或安慰剂喷雾剂(n = 27)。从治疗前到治疗后30分钟，IM喷雾组和安慰剂组BPI第6项评分的平均变化分别为−1.85(95%可信区间：−2.37至−1.32)和−0.59(−1.02至−0.16)，差异有统计学意义(−1.26，−1.94至−0.57，P<；0.01)。疼痛改善持续180分钟。组间比较，饮酒能力、交谈舒适度、CGI-I均有显著差异(P=0.03，P=0.02，P<；0.01)。结论IM口腔喷雾剂可减轻抗癌放化疗所致的短期OM疼痛，并可减轻进食困难。
ContextOral mucositis (OM) pain due to anticancer chemo- and radiotherapy has a very negative impact on patient quality of life. However, no high-quality studies have been performed regarding the analgesic efficacy of indomethacin (IM) oral spray for OM pain.ObjectivesThis randomized, placebo-controlled, double-blind trial aimed to evaluate the analgesic efficacy of IM oral spray for OM pain due to anticancer chemo- and radiotherapy.MethodsFrom July 2015 to December 2016, we enrolled adult cancer patients with OM pain that was due to anticancer chemo- or radiotherapy and was rated 4 or higher on Brief Pain Inventory (BPI) Item 5. Patients were randomly assigned in a 1:1 ratio to receive either IM oral spray or placebo.The primary endpoint was the change in the BPI Item 6 (“current pain”) score from before to 30 minutes after treatment. Secondary endpoints were the areas under the curves of BPI Item 6 at 15, 60, 120, 180, and 240 minutes after treatment; five items related to meals and conversation from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Head and Neck Module 35; the Clinical Global Impressions-Improvement (CGI-I) scale; and adverse events.ResultsA total of 60 patients were assigned to receive IM oral spray (n = 33) or placebo spray (n = 27). The average change in the BPI item 6 score from before to 30 minutes after treatment was −1.85 (95% confidence interval: −2.37 to −1.32) in the IM spray group and −0.59 (−1.02 to −0.16) in the placebo group, indicating a significant difference (−1.26, −1.94 to −0.57,P <0.01). The pain improvement persisted for 180 minutes. The intergroup differences in ability to drink liquids, ease in conversing, and CGI-I were all significant (P =0.03,P =0.02, andP <0.01, respectively). No serious adverse events were reported.ConclusionIM oral spray alleviated short-term OM pain due to anticancer chemo- and radiotherapy, and may reduce the difficulty in eating meals.