一种用于预防和治疗接受化疗的血液系统恶性肿瘤患者口腔黏膜炎的新型口服装置的耐受性和安全性。

Tolerability and safety of a new oral device for prevention and treatment of oral mucositis in patients with hematologic malignancies undergoing chemotherapy.

作者信息

Oganesyan Artem, Harutyunyan Lusine, Vanoyan Araksya, Martirosyan Nare, Badikyan Maria, Gregory Mark, Oganesyan Tigran, Ghahramanyan Nerses, Ehrenpreis Eli D, Hakobyan Yervand

机构信息

Department of Hematology and Transfusion Medicine, National Institute of Health, 0051, Yerevan, Armenia.

Internal Medicine Department, Jefferson Abington Hospital, Abington, PA, 19001, USA.

出版信息

Support Care Cancer. 2025 Jul 31;33(8):733. doi: 10.1007/s00520-025-09722-0.

DOI:10.1007/s00520-025-09722-0

PMID:40742572

Abstract

PURPOSE

Around 40% of patients undergoing systemic chemotherapy develop oral mucositis (OM), a major cause of morbidity in cancer patients. There are only a few options for preventing and treating OM. This study examines the tolerability of a novel oral device (Bocaliner™), designed to enhance the effects of oral topical therapies, in patients with hematologic malignancies receiving chemotherapy.

METHODS

Data from phase 1/phase 2 randomized controlled trial SPOM (Study for the Prevention of Oral Mucositis) was analyzed. Patients from the Yeolyan Hematology and Oncology Center (Yerevan, Armenia) were randomized into two groups: benzydamine or saline mouthwash. Half of the patients in each study group were randomly assigned to Bocaliner™. Tolerability and safety questionnaires on days 1 and 14 of chemotherapy were completed.

RESULTS

Twenty-eight patients (mean age of 49 years; 50% female) received oral devices and completed the study. On the tryout of the device, 22 (78.6%) patients reported tolerating it well, and six (21.4%) reported some discomfort. After 14 days, 15 patients (35.7%) reported benefit from the use, with six (21.4%) of patients stating the device helped to reduce pain, four (14.3%) indicating that it helped them to eat, and five (17.8%) claiming both. Adverse events included discomfort (n = 2, 7.1%), pain around the cheekbone (n = 3, 10.7%), nausea (n = 2, 7.1%), and increased salivation (n = 1, 3.6%); none of these led to discontinuation of the use. Eighteen (64%) participants said they would use the device again. OM developed in five patients (17.8%).

CONCLUSIONS

The use of a new medical device designed to enhance oral topical medications in combination with oral topical therapy is well tolerated among patients with hematologic malignancies on chemotherapy.

CLINICALTRIALS

gov registry ID: NCT05338398 (Date of registry: April 15, 2022).

摘要

目的

约40%接受全身化疗的患者会发生口腔黏膜炎（OM），这是癌症患者发病的主要原因。预防和治疗OM的选择有限。本研究考察了一种新型口腔装置（Bocaliner™）在接受化疗的血液系统恶性肿瘤患者中的耐受性，该装置旨在增强口腔局部治疗的效果。

方法

分析了1/2期随机对照试验SPOM（口腔黏膜炎预防研究）的数据。来自叶利扬血液学和肿瘤学中心（亚美尼亚埃里温）的患者被随机分为两组：使用苄达明或生理盐水漱口。每个研究组中一半的患者被随机分配使用Bocaliner™。完成了化疗第1天和第14天的耐受性和安全性问卷调查。

结果

28名患者（平均年龄49岁；50%为女性）接受了口腔装置并完成了研究。在试用该装置时，22名（78.6%）患者报告耐受性良好，6名（21.4%）患者报告有一些不适。14天后，15名患者（35.7%）报告使用该装置有益，其中6名（21.4%）患者表示该装置有助于减轻疼痛，4名（14.3%）患者表示有助于进食，5名（17.8%）患者表示两者都有帮助。不良事件包括不适（n = 2，7.1%）、颧骨周围疼痛（n = 3，10.7%）、恶心（n = 2，7.1%）和唾液分泌增加（n = 1，3.6%）；这些均未导致停止使用。18名（64%）参与者表示会再次使用该装置。5名患者（17.8%）发生了OM。