Abstract：
OBJECTIVE: Oral mucositis (OM) is a common complication in haematopoietic stem cell transplantation (HSCT). Polaprezinc, an anti-ulcer drug, has been shown to be effective to prevent OM in several studies when administered topically and systemically. This study aimed to evaluate the effectiveness of topical polaprezinc in patients undergoing HSCT.
METHODS: This was an open-label randomised clinical trial comparing polaprezinc and sodium bicarbonate mouthwashes for the prevention of severe OM in HSCT patients. Adult patients who received conditioning regimens at moderate to high risk of developing OM were included. The primary endpoint was the incidence of severe (WHO grades 3-4) OM. The secondary endpoints included duration of grades 3-4 OM, incidence and duration of grades 2-4 OM, patient-reported pain and functional limitations.
RESULTS: In total, 108 patients (55 test arm and 53 control arm) were randomised. There was no difference in the incidence of grades 3 to 4 OM (35% test arm versus 36% control arm). The secondary endpoints were not significantly different. In both arms, patients reported more throat pain compared to mouth pain.
CONCLUSIONS: Topical polaprezinc had no effect in the prevention of OM in HSCT patients. Further research is required to evaluate the effects of systemic polaprezinc. The OM assessment tool needs to be reviewed as throat mucositis was a main issue in this study.
BACKGROUND: ACTRN12320001188921 (Date Registered: 10th November 2020).
METHODS: This was an open-label randomised clinical trial comparing polaprezinc and sodium bicarbonate mouthwashes for the prevention of severe OM in HSCT patients. Adult patients who received conditioning regimens at moderate to high risk of developing OM were included. The primary endpoint was the incidence of severe (WHO grades 3-4) OM. The secondary endpoints included duration of grades 3-4 OM, incidence and duration of grades 2-4 OM, patient-reported pain and functional limitations.
RESULTS: In total, 108 patients (55 test arm and 53 control arm) were randomised. There was no difference in the incidence of grades 3 to 4 OM (35% test arm versus 36% control arm). The secondary endpoints were not significantly different. In both arms, patients reported more throat pain compared to mouth pain.
CONCLUSIONS: Topical polaprezinc had no effect in the prevention of OM in HSCT patients. Further research is required to evaluate the effects of systemic polaprezinc. The OM assessment tool needs to be reviewed as throat mucositis was a main issue in this study.
BACKGROUND: ACTRN12320001188921 (Date Registered: 10th November 2020).
摘要：
目的：口腔黏膜炎（OM）是造血干细胞移植（HSCT）的常见并发症。Polaprezinc,一种抗溃疡药,在一些研究中，当局部和全身给药时，已被证明可有效预防OM。本研究旨在评估接受HSCT的患者外用polaprezinin的有效性。
方法：这是一项开放标签的随机临床试验，比较了Polaprezinc和碳酸氢钠漱口水预防HSCT患者重度OM的作用。包括在中度至高度发生OM的风险下接受预处理方案的成年患者。主要终点是严重（WHO3-4级）OM的发生率。次要终点包括3-4级OM的持续时间，2-4级OM的发生率和持续时间，患者报告的疼痛和功能限制。
结果：总计，108名患者（55名测试臂和53名对照臂）被随机分配。3至4级OM的发生率没有差异（35％测试臂与36％控制臂）。次要终点没有显著差异。在双臂中，与口腔疼痛相比，患者报告的咽喉疼痛更多。
结论：外用polaprezinin对HSCT患者OM的预防没有作用。需要进一步的研究来评估全身polaprezinc的效果。由于咽喉粘膜炎是本研究的主要问题，因此需要对OM评估工具进行审查。
背景：ACTRN12320001188921（注册日期：2020年11月10日）。
方法：这是一项开放标签的随机临床试验，比较了Polaprezinc和碳酸氢钠漱口水预防HSCT患者重度OM的作用。包括在中度至高度发生OM的风险下接受预处理方案的成年患者。主要终点是严重（WHO3-4级）OM的发生率。次要终点包括3-4级OM的持续时间，2-4级OM的发生率和持续时间，患者报告的疼痛和功能限制。
结果：总计，108名患者（55名测试臂和53名对照臂）被随机分配。3至4级OM的发生率没有差异（35％测试臂与36％控制臂）。次要终点没有显著差异。在双臂中，与口腔疼痛相比，患者报告的咽喉疼痛更多。
结论：外用polaprezinin对HSCT患者OM的预防没有作用。需要进一步的研究来评估全身polaprezinc的效果。由于咽喉粘膜炎是本研究的主要问题，因此需要对OM评估工具进行审查。
背景：ACTRN12320001188921（注册日期：2020年11月10日）。
