Shillingburg Alexandra, Kanate Abraham S, Hamadani Mehdi, Wen Sijin, Craig Michael, Cumpston Aaron
Department of Pharmacy, West Virginia University Medicine, P.O. Box 8045, Medical Center Drive, Morgantown, WV, 26506, USA.
Osborn Hematopoietic Malignancy and Transplantation Program, West Virginia University Cancer Institute, Morgantown, WV, USA.
Support Care Cancer. 2017 Jul;25(7):2215-2219. doi: 10.1007/s00520-017-3627-6. Epub 2017 Feb 11.
Mucositis is a significant complication of intensive chemotherapy or hematopoietic cell transplantation (HCT), with few treatment options. Ketamine mouthwashes have been used for pain relief, but supporting evidence is limited. The primary objective of this study was to assess the reduction in pain intensity of stomatodynia and odynophagia compared to baseline assessment.
This open-label, prospective, phase II interventional study (NCT01566448) was conducted from February 2012 through July 2015. Patients with grade 3 or 4 oral mucositis according to the World Health Organization (WHO) scale as a result of chemotherapy were treated with ketamine mouthwash 20 mg/5 mL four times daily and every 4 h as needed.
Thirty patients were enrolled and a total of 136 assessments were conducted. A statistically significant reduction in pain scores of 2 and 3 points was achieved after 1 h and 3 days, respectively (p < 0.0001, p = 0.0003). Pain scores were significantly improved while swallowing, reduced 1 and 4 points at 1-h and 3-day assessment, respectively (p = 0.0006, p = 0.0001). No patients developed adverse effects related to ketamine administration.
Ketamine mouthwashes resulted in clinically meaningful and statistically significant reduction in pain scores, have an acceptable safety profile, and can be a useful adjunctive treatment in the multi-modal management of severe mucositis.
口腔黏膜炎是强化化疗或造血细胞移植（HCT）的一种严重并发症，治疗选择有限。氯胺酮漱口水已用于缓解疼痛，但支持证据有限。本研究的主要目的是评估与基线评估相比，口腔疼痛和吞咽痛的疼痛强度降低情况。
本开放标签、前瞻性、II期干预性研究（NCT01566448）于2012年2月至2015年7月进行。因化疗导致世界卫生组织（WHO）量表3级或4级口腔黏膜炎的患者，使用20mg/5mL氯胺酮漱口水，每日4次，必要时每4小时1次。
共纳入30例患者，进行了136次评估。分别在1小时和3天后，疼痛评分在统计学上显著降低了2分和3分（p<0.0001，p=0.0003）。吞咽时疼痛评分显著改善，在1小时和3天评估时分别降低了1分和4分（p=0.0006，p=0.0001）。没有患者出现与氯胺酮给药相关的不良反应。
氯胺酮漱口水可使疼痛评分在临床上有意义且在统计学上显著降低，具有可接受的安全性，可作为严重黏膜炎多模式管理中的一种有用辅助治疗方法。
