Harley Randall J, Bowers Eve, Li Jinhong, Bisignani Mikayla, Nilsen Marci L, Johnson Jonas T
Department of Otorhinolaryngology-Head and Neck Surgery University of Pennsylvania Philadelphia Pennsylvania USA.
Department of Otolaryngology-Head and Neck Surgery University of Miami Miller School of Medicine Miami Florida USA.
OTO Open. 2025 Jan 3;9(1):e70038. doi: 10.1002/oto2.70038. eCollection 2025 Jan-Mar.
This study aims to compare the effectiveness of 2 artificial saliva substitutes (Biotène vs HydraSmile) in the symptomatic management of radiation-induced xerostomia.
Randomized double-blind cross-over study.
Single tertiary care academic institution.
Included adult patients 6 months postradiotherapy (50-70 gy) for squamous cell carcinoma of the oral cavity, oropharynx, or larynx. The primary endpoint was change in overall subjective xerostomia score from baseline, through use of HydraSmile versus Biotène. Scores were derived from a 100-point visual analog scale, with higher scores indicating better symptomatic control. Analysis of covariance model was used to regress the difference in after-treatment measurement between HydraSmile and Biotène, with respect to baseline differences.
A total of 91 participants were included (mean age 63.0 years [SD 9.7]; 85.7% male; 97.8% White). Change in overall xerostomia score with respect to baseline was not significantly different between HydraSmile and Biotène (mean difference 1.24, 95% confidence interval [CI] -2.35 to 4.81). Compared to water alone, both HydraSmile (mean difference 7.45, 95% CI 3.61-11.29) and Biotène (mean difference 7.24, 95% CI 3.06-11.43) significantly improved overall xerostomia score. Forty (44%) patients reported a preference for Biotène, 46 (50.5%) preferred HydraSmile, and 5 (5.5%) had no preference. Patients who preferred Biotène did not significantly benefit from HydraSmile, whereas those who preferred HydraSmile did not significantly benefit from Biotène.
Biotène and HydraSmile significantly improved oral dryness among patients with radiation-induced xerostomia. While neither product demonstrated treatment superiority, individual product preference was predictive of greatest treatment benefit.
本研究旨在比较两种人工唾液替代品（保丽净与HydraSmile）对放射性口干症进行症状管理的有效性。
随机双盲交叉研究。
单一的三级医疗学术机构。
纳入口腔、口咽或喉鳞状细胞癌放疗（50 - 70 gy）6个月后的成年患者。主要终点是通过使用HydraSmile与保丽净，总体主观口干评分相对于基线的变化。评分来自100分的视觉模拟量表，分数越高表明症状控制越好。采用协方差分析模型对HydraSmile和保丽净治疗后测量值的差异相对于基线差异进行回归分析。
共纳入91名参与者（平均年龄63.0岁[标准差9.7]；85.7%为男性；97.8%为白人）。HydraSmile和保丽净在总体口干评分相对于基线的变化方面无显著差异（平均差异1.24，95%置信区间[CI] -2.35至4.81）。与单独用水相比，HydraSmile（平均差异7.45，95% CI 3.61 - 11.29）和保丽净（平均差异7.24，95% CI 3.06 - 11.43）均显著改善了总体口干评分。40名（44%）患者表示更喜欢保丽净，46名（50.5%）更喜欢HydraSmile，5名（5.5%）无偏好。更喜欢保丽净的患者使用HydraSmile未显著获益，而更喜欢HydraSmile的患者使用保丽净也未显著获益。
保丽净和HydraSmile显著改善了放射性口干症患者的口腔干燥。虽然两种产品均未显示出治疗优势，但个体对产品的偏好可预测最大的治疗获益。
