Chen Dan, Li Fang-Fang, Zhu Hong-Mei, Wang Xiao, Zhang Xiao-Mei, Ma Ting, Zhang Hui, Ma Yan-Qiong, Wang Xin-Miao, Wang Yong-Hua, Yao Hao, Yi Hai
Department of Hematology, People's Liberation Army The General Hospital of Western Theater Command, Chengdu, China.
Department of Nursing, People's Liberation Army The General Hospital of Western Theater Command, Chengdu, China.
Medicine (Baltimore). 2025 Jul 4;104(27):e42867. doi: 10.1097/MD.0000000000042867.
Oral mucositis is a common complication in patients undergoing autologous hematopoietic stem cell transplantation (auto-HSCT), and currently, there is no universally effective treatment. This study aims to evaluate the preventive and delaying effects of oral cryotherapy using Kangfuxin (KFX) on oral mucositis in auto-HSCT patients. A total of 86 patients, treated between January 2020 and August 2023, were randomly assigned into 2 groups: the control group (40 cases) received cryotherapy using frozen physiological saline ice cubes, and the experimental group (46 cases) received KFX ice cubes. Both treatments started 30 minutes before melphalan infusion, and continued until the end of the infusion. The primary outcome was the incidence and severity of oral mucositis, with secondary outcomes including pain levels and patient-reported general condition. The experimental group demonstrated a significantly higher proportion of patients with grade 0 oral mucositis compared to the control group. Furthermore, the incidence of grade III-IV oral mucositis in the control group was 32.5%, compared to 10.8% in the experimental group, showing a statistically significant difference (P < .05). The experimental group had fewer days of using lidocaine mouthwash and lower pain scores, showing statistically significant differences (P < .05). In conclusion, our findings suggest that KFX oral cryotherapy can be an effective approach for preventing and reducing the severity of oral mucositis in patients undergoing auto-HSCT. It may help alleviates the symptoms such as pain and discomfort, thereby improving patient well-being during treatment.
口腔黏膜炎是接受自体造血干细胞移植（auto-HSCT）患者的常见并发症，目前尚无普遍有效的治疗方法。本研究旨在评估康复新（KFX）口腔冷冻疗法对auto-HSCT患者口腔黏膜炎的预防和延缓作用。共有86例在2020年1月至2023年8月期间接受治疗的患者被随机分为两组：对照组（40例）使用冷冻生理盐水冰块进行冷冻疗法，实验组（46例）使用KFX冰块。两种治疗均在美法仑输注前30分钟开始，并持续至输注结束。主要结局是口腔黏膜炎的发生率和严重程度，次要结局包括疼痛程度和患者报告的总体状况。与对照组相比，实验组0级口腔黏膜炎患者比例显著更高。此外，对照组III-IV级口腔黏膜炎的发生率为32.5%，而实验组为10.8%，差异有统计学意义（P<0.05）。实验组使用利多卡因漱口水的天数更少，疼痛评分更低，差异有统计学意义（P<0.05）。总之，我们的研究结果表明，KFX口腔冷冻疗法可能是预防和减轻auto-HSCT患者口腔黏膜炎严重程度的有效方法。它可能有助于缓解疼痛和不适等症状，从而改善治疗期间患者的健康状况。
