Bacterial Decolonization With Mupirocin Ointment for Acute Radiation Oral Mucositis Prevention: A Phase 3 Randomized Clinical Trial.

Reduction of severe (grade ≥3) AROM by bacterial decolonization (BD) could improve treatment tolerance and quality of life.

通过细菌去定植（BD）减少严重（3级或以上）AROM，可以改善治疗耐受性和生活质量。

Background

To evaluate the efficacy of BD with mupirocin nasal ointment in alleviating severe AROM compared with standard of care (SoC) by reducing Staphylococcus aureus colonization in nasal and oral mucosal during radiotherapy for nasopharyngeal cancer.

评估BD联合莫匹罗星鼻膏在减轻鼻咽癌放疗期间严重急性放射性口炎（AROM）中的疗效，通过减少鼻腔和口腔黏膜的金黄色葡萄球菌定植，与标准治疗（SoC）进行比较。

DESIGN, SETTING, AND PARTICIPANTS: This was a single-center, open-label, phase 3 randomized clinical trial in China that enrolled patients with nasopharyngeal carcinoma (NPC) undergoing definitive chemoradiotherapy between July 2023 and February 2024.

设计、地点和参与者：这是一项在中国进行的单中心、开放标签的III期随机临床试验，招募了2023年7月至2024年2月期间接受确定性化疗和放疗的鼻咽癌（NPC）患者。

Data were analyzed from June 2024 to September 2024.

数据分析时间为2024年6月至2024年9月。

Methods

The BD group received mupirocin nasal ointment twice daily for 3 days before radiotherapy for 5 consecutive days followed by a 1-week break, which was repeated throughout radiotherapy.

BD组在放疗前3天每天两次使用莫匹罗星鼻膏，连续5天后休息1周，此过程在放疗期间重复进行。

Patients in the SoC group received routine nasal and oral care.

标准治疗组的患者接受了常规的鼻腔和口腔护理。

main_outcomes_and_measures

The primary outcome was the incidenceof severe (grade ≥3) AROM.

主要结果是严重（3级或以上）AROM的发生率。

Oral mucositis assessments were performed by independent evaluators who were blinded to group assignments.

口腔粘膜炎的评估由独立评估者进行，这些评估者对分组情况不知情。

Secondary end points included quality of life assessed using the Quality-of-Life Questionnaire-Head and Neck 43 [QLQ-H&N43]), and the colonization levels of S aureus in nasal and oral mucosa.

次要终点包括使用头颈部生活质量问卷-43（QLQ-H&N43）评估的生活质量，以及鼻腔和口腔粘膜中金黄色葡萄球菌的定植水平。

Results

A total of 176 patients (mean [SD] age, 52.1 [10.1] years; 42 female [23.9%] individuals) were randomly assigned to the BD intervention group (n = 88) or the SoC control group (n = 88).

共有176名患者（平均年龄[标准差]为52.1[10.1]岁；42名女性[23.9%]）被随机分配到BD干预组（n = 88）或SoC对照组（n = 88）。

In the BD group, severe AROM occurred in 20 of 88 patients (22.7%) compared with 42 (47.7%) in the SoC group (relative risk, 0.48; 95% CI, 0.31-0.74; P < .001).

在BD组中，88名患者中有20名（22.7%）出现了严重的AROM，而在SoC组中，88名患者中有42名（47.7%）出现了严重的AROM（相对风险，0.48；95%置信区间，0.31-0.74；P < .001）。

Multivariable logistic analysis confirmed the effect of BD (odds ratio, 0.27, 95% CI, 0.13-0.54; P < .001) on severe AROM risk reduction.

多变量逻辑回归分析证实了BD对降低严重AROM风险的效果（比值比为0.27，95%置信区间为0.13-0.54；P < .001）。

The QLQ-H&N43 assessment showed BD significantly reduced symptom severity compared to SoC during radiotherapy, with lower median (IQR) pain scores (25.0 [25.0-50.0] vs 50.0 [25.0-50.0]) and fewer swallowing difficulties (8.3 [8.3-33.3] vs 33.3 [8.3-33.3]).

QLQ-H&N43评估显示，在放疗期间，BD显著降低了症状严重程度，与标准治疗相比，疼痛评分的中位数（四分位数间距）较低（25.0 [25.0-50.0] vs 50.0 [25.0-50.0]），并且吞咽困难较少（8.3 [8.3-33.3] vs 33.3 [8.3-33.3]）。

Colonization rates of S aureus at the end of radiotherapy were lower in the BD than in the SoC group: nasal, 9.4% (8 of 85) vs 22.9 % (19 of 83) and oral, 5.9% (5 of 85) vs 20.5% (17 of 83).

在放疗结束时，BD组的金黄色葡萄球菌定植率低于SoC组：鼻部为9.4%（85人中有8人）对比22.9%（83人中有19人），口腔为5.9%（85人中有5人）对比20.5%（83人中有17人）。

conclusions_and_relevance

This phase 3 randomized clinical trial demonstrated that BD with mupirocin nasal ointment effectively reduced severe AROM, improved quality of life by alleviating oral pain and swallowing difficulties, and significantly reduced both nasal and oral S aureus colonization during radiotherapy.

这项III期随机临床试验表明，使用莫匹罗星鼻膏的BD治疗能有效降低严重的急性放射性口炎（AROM）发生率，通过缓解口腔疼痛和吞咽困难改善生活质量，并显著降低放疗期间鼻部和口腔的金黄色葡萄球菌定植率。

This approach offers a cost-effective strategy for AROM management, and although further studies are required to validate the findings, these results highlight the potential of microbial management to reduce radiation-related complications in patients with nasopharyngeal carcinoma.

该方法为鼻咽癌患者的AROM管理提供了一种成本效益高的策略，尽管需要进一步的研究来验证这些发现，但这些结果突显了微生物管理在减少与放射治疗相关的并发症方面的潜力。

trial_registration

ClinicalTrials.gov Identifier: NCT05893810.

ClinicalTrials.gov注册号：NCT05893810。