Comparing pain control and ability to eat and drink with standard therapy vs Gelclair: a preliminary, double centre, randomised controlled trial on patients with radiotherapy-induced oral mucositis
Comparing pain control and ability to eat and drink with standard therapy vs Gelclair: a preliminary, double centre, randomised controlled trial on patients with radiotherapy-induced oral mucositis
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DOI：
10.1007/s00520-006-0171-1
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发表时间：
2007-04-01
影响因子：
3.1
通讯作者：
Hewett, Julie
中科院分区：
文献类型：
--
作者：
Barber, Claire;Powell, Roy;Hewett, Julie
工作目标：口腔粘膜炎 (OM) 是头颈癌侵袭性治疗的一种功能破坏性并发症，通常会导致剧烈疼痛、无法进食和饮水以及继发性营养不良和脱水。 Gelclair 的屏障形成特性有望缓解此类症状。这项随机对照试验的目的是评估 Gelclair 与标准疗法相比的疗效，作为放射治疗引起的 OM 患者的短期症状控制手段。材料和方法：在德文郡的两个肿瘤中心发现 20 名患有放疗引起的 OM 的患者，他们被随机接受标准治疗（硫糖铝和 Mucaine）或 Gelclair，并接受超过 24 It 的评估。两种治疗均在 24 小时内（饭前 30 分钟）服用四次。主要结果：在一般疼痛方面，Gelclair 和标准治疗组之间没有发现显着差异（F = 1.512，df = 1, 17, ns）。使用 Gelclair 后最初似乎确实有疼痛改善的趋势，但这并没有持续整个 24 小时评估期。尽管标准疗法的效果似乎确实比 Gelclair 持续时间更长，但说话时的疼痛没有显着减轻（F = 0.261，df = 1, 17, ns），饮食能力也没有改善。结论：这项研究表明，Gelclair 在缓解放疗引起的 OM 相关疼痛方面并不比目前的标准做法更有效。尽管如此，这项初步研究的观察结果值得进一步调查，以期在国家层面上确定头颈癌实践的前进方向。
Goal of the work: Oral mucositis (OM) is a functionally destructive complication of aggressive head and neck cancer therapy, often resulting in intense pain, an inability to eat and drink and secondary malnutrition and dehydration. The barrier-forming properties of Gelclair have shown promise in relieving such symptoms. The aim of this randomised-controlled trial was to evaluate the efficacy of Gelclair, as compared to standard therapy, as a means of short-term symptom control for patients suffering from radiotherapy-induced OM. Materials and methods: Twenty patients, with radiotherapy-induced OM seen in two oncology centres in Devon, were randomised to either standard therapy (Sucralfate and Mucaine) or Gelclair and assessed over 24 It. Both treatments were taken four times during the 24-h period, 30 min before meals. Main results: No significant difference was found between the Gelclair and standard therapy arms in terms of general pain (F = 1.512, df = 1, 17, ns). There did appear to be a trend towards pain improvement initially after the use of Gelclair, but this did not last for the full 24-h assessment period. There was no significant reduction in pain on speaking (F = 0.261, df = 1, 17, ns) nor an improvement in capacity to eat and drink, although the effects of standard therapy did appear to last longer than the Gelclair. Conclusion: This study indicates that Gelclair is no more effective than current standard practice in relieving the pain associated with radiotherapy-induced OM. Nevertheless, observations from this preliminary study warrant further investigation, with a view to shaping the way forward for head and neck cancer practice on a national level.