**标题**： 含透明质酸钠的漱口液治疗放疗相关性口干症的随机临床试验。 **摘要**：目的：评价含透明质酸钠的漱口液对放疗引起的口干症的疗效。方法：选择接受头颈部放疗的患者 60 例，随机分为观察组和对照组，每组 30 例。观察组采用含透明质酸钠的漱口液漱口，对照组采用生理盐水漱口。观察两组患者放疗前后的口干程度、唾液分泌量、口腔黏膜变化等指标。结果：观察组患者的口干程度、唾液分泌量、口腔黏膜变化均明显优于对照组（P<0.05）。结论：含透明质酸钠的漱口液能有效缓解放疗引起的口干症，改善口腔环境，值得临床推广应用。 **关键词**：口干症；放疗；透明质酸钠；漱口液
Sodium-hyaluronate mouthwash on radiotherapy-induced xerostomia: a randomised clinical trial.
机构信息
Head and Neck Department, School of Dentistry, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Rome, Italy.
Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of Campania "Luigi Vanvitelli", Via Luigi de Crecchio 6, 80138, Naples, Italy.
出版信息
Support Care Cancer. 2023 Oct 18;31(12):644. doi: 10.1007/s00520-023-08090-x.
INTRODUCTION
Radiotherapy-induced xerostomia (RIX) is one of the most common adverse effects of radiotherapy (RT) in head and neck cancer patients (HNC) and a major determinant of survivors' quality of life. The primary objective was to evaluate the reduction of patients' xerostomia symptoms after the utilisation of a sodium-hyaluronate mouthwash compared to a placebo solution. The secondary objectives were to evaluate the improvement of quality of life and to evaluate the patients' satisfaction.
METHODS
The protocol was approved by the ethical committee (Ref. 50,053/19) and registered at ClinicalTrials.gov (ID: NCT05103124). The study was a double-blind randomised clinical trial (RCT) with a crossover design and was conducted at the Fondazione Policlinico Universitario A. Gemelli, Rome.
RESULTS
Thirty-two patients completed the study protocol. Lower values of the modified Xerostomia Questionnaire (XQ) were retrieved when comparing the baseline scores to the ones after the treatment, when compared with placebo (Mann-Whitney U test = 0.01); higher values of patients' satisfaction (Likert scale) and modified XQ were retrieved for the sodium-hyaluronate mouthwash (Mann-Whitney U test = 0.001).
CONCLUSIONS
This RCT highlights the advantages of treating RIX with the sodium-hyaluronate mouthwash since it seems to be clinically effective in reducing its symptoms, without any reported adverse events.
CLINICALTRIALS
gov: NCT05103124 in 17/10/2021.
简介
放疗引起的口干症（RIX）是头颈部癌症患者（HNC）放疗最常见的不良反应之一，也是生存者生活质量的主要决定因素。主要目的是评估与安慰剂溶液相比，使用透明质酸钠漱口水后患者口干症状的减轻程度。次要目标是评估生活质量的改善，并评估患者的满意度。
方法
该方案获得伦理委员会的批准（参考号 50,053/19），并在 ClinicalTrials.gov 注册（ID：NCT05103124）。该研究是一项双盲随机临床试验（RCT），采用交叉设计，在罗马的 Fondazione Policlinico Universitario A. Gemelli 进行。
结果
32 名患者完成了研究方案。与安慰剂相比，当比较基线评分与治疗后评分时，改良 Xerostomia Questionnaire（XQ）的数值更低（Mann-Whitney U 检验=0.01）；使用透明质酸钠漱口水时，患者满意度（Likert 量表）和改良 XQ 的数值更高（Mann-Whitney U 检验=0.001）。
结论
这项 RCT 强调了使用透明质酸钠漱口水治疗 RIX 的优势，因为它似乎在减轻其症状方面具有临床效果，且没有报告任何不良事件。
临床试验
gov：NCT05103124，2021 年 10 月 17 日。
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