Walladbegi Java, Henriksson Roger, Tavelin Björn, Svanberg Anncarin, Larfors Gunnar, Jädersten Martin, Schjesvold Fredrik, Mahdi Aram, Garming Legert Karin, Peterson Douglas E, Jontell Mats
Department of Oral Medicine and Pathology, Institute of Odontology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Department of Radiation Sciences-Oncology, Umea University, Umea, Sweden.
Bone Marrow Transplant. 2022 Feb;57(2):191-197. doi: 10.1038/s41409-021-01512-6. Epub 2021 Nov 3.
Cryoprevention (CP) using ice (IC) is an effective strategy to prevent chemotherapy-induced oral mucositis (OM). However, the use of IC may cause adverse reactions and requires water of safe quality to minimize risk of serious infections. This randomized, blinded, parallel group, phase 3 trial was conducted in five Scandinavian centers. Eligible patients were diagnosed with multiple myeloma or lymphoma, scheduled to receive conditioning with high-dose chemotherapy prior to autologous hematopoietic stem cell transplantation (ASCT). Patients were assigned to cooling with IC or a novel intraoral cooling device (ICD). The primary outcome was the highest OM score during the study period, expressed as peak value on the Oral Mucositis Assessment Scale (OMAS-total). When the entire study population (n = 172) was analyzed for peak OMAS-total, the two cooling methods were equally effective. However, when the lymphoma group was analyzed separately, the ICD significantly reduced the peak OMAS-total score to a greater extent compared to IC (x̄ ± SD; 1.77 ± 1.59 vs. 3.08 ± 1.50; p = 0.047). Combined with existing evidence, the results of the present trial confirm that CP is an effective method to prevent OM. ClinicalTrials.gov. NCT03203733.
使用冰块进行冷冻预防（CP）是预防化疗引起的口腔黏膜炎（OM）的有效策略。然而，使用冰块可能会引起不良反应，并且需要安全质量的水以将严重感染的风险降至最低。这项随机、双盲、平行组3期试验在五个斯堪的纳维亚中心进行。符合条件的患者被诊断患有多发性骨髓瘤或淋巴瘤，计划在自体造血干细胞移植（ASCT）前接受大剂量化疗预处理。患者被分配接受冰块冷却或新型口腔内冷却装置（ICD）冷却。主要结局是研究期间的最高OM评分，以口腔黏膜炎评估量表（OMAS-总分）的峰值表示。当对整个研究人群（n = 172）进行OMAS-总分峰值分析时，两种冷却方法同样有效。然而，当单独分析淋巴瘤组时，与冰块相比，ICD在更大程度上显著降低了OMAS-总分峰值（x̄ ± SD；1.77 ± 1.59 对比 3.08 ± 1.50；p = 0.047）。结合现有证据，本试验结果证实CP是预防OM的有效方法。ClinicalTrials.gov. NCT03203733。
