含或不含阿昔洛韦的复方漱口水在癌症患者化疗所致口腔黏膜炎管理中的作用：一项随机对照试验

The role of compounded mouthwash with or without acyclovir in managing chemotherapy-induced oral mucositis in cancer patients: a randomized controlled trial.

作者信息

Abdelnasser Amira, El-Ashwah Shaimaa, Elashwah Salma, Mabed Mohamed

机构信息

PharmD, Clinical Pharmacy, Oncology Center, Mansoura University, Mansoura, Egypt.

Clinical Haematology, Internal Medicine, Oncology Center, Mansoura University, Mansoura, Egypt.

出版信息

BMC Oral Health. 2025 Jun 21;25(1):953. doi: 10.1186/s12903-025-06324-4.

DOI:10.1186/s12903-025-06324-4

PMID:40544276

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12182692/

Abstract

BACKGROUND

Chemotherapy-induced oral mucositis (CIOM) is a prevalent and debilitating condition observed in cancer patients, especially in those suffering from hematologic malignancies. The present study assessed the efficacy of a compounded mouthwash, both with and without the addition of acyclovir, in the management of CIOM. Although various treatment options exist for this condition, their effectiveness remains limited, underscoring the necessity for innovative approaches to the formulation of compounded mouthwashes for improved management of CIOM.

METHODS

A prospective, double-blind, randomized controlled study design with 110 patients with newly diagnosed acute leukemia or who underwent hematopoietic stem cell transplantation. Participants were allocated randomly to either the acyclovir-containing mouthwash group (Arm A) or the control group without acyclovir (Arm B). The incidence, duration, and severity of mucositis were assessed via standardized scale, the World Health Organization (WHO) scale for oral mucositis.

RESULTS

The incidence of mucositis was significantly lower in Arm A (25.5%) compared to Arm B (45.5%), with a p-value of 0.028. Furthermore, the duration of mucositis was significantly shorter in Arm A, exhibiting a median duration of 4.5 days, in contrast to a median of 7.5 days observed in Arm B (p = 0.01). Grade 3 mucositis was absent in the acyclovir group, whereas there were five cases reported in Arm B (p = 0.045). Logistic regression analysis corroborated the protective effect of the acyclovir-containing mouthwash against the development of mucositis, yielding an odds ratio (OR) of 2.444 with a p-value of 0.03.

CONCLUSIONS

The incorporation of acyclovir into compounded mouthwash significantly reduced the incidence, severity, and duration of oral mucositis in patients undergoing chemotherapy, indicating its potential for expanded clinical application. Further large-scale studies are warranted to validate these findings and to standardize mouthwash formulations for institutional utilization.

TRIAL REGISTRATION

This trial was approved by the Institutional Research Board (IRB) under the code R.23.05. 2176.R1. Date: 20 May 2023.

摘要

背景

化疗引起的口腔黏膜炎（CIOM）是癌症患者中普遍存在且使人衰弱的病症，尤其是血液系统恶性肿瘤患者。本研究评估了一种复方漱口水在添加和不添加阿昔洛韦的情况下对CIOM的治疗效果。尽管针对这种病症存在多种治疗选择，但其有效性仍然有限，这凸显了创新复方漱口水配方以改善CIOM管理的必要性。

方法

一项前瞻性、双盲、随机对照研究设计，纳入110例新诊断的急性白血病患者或接受造血干细胞移植的患者。参与者被随机分配到含阿昔洛韦漱口水组（A组）或不含阿昔洛韦的对照组（B组）。通过标准化量表，即世界卫生组织（WHO）口腔黏膜炎量表，评估黏膜炎的发生率、持续时间和严重程度。

结果

A组黏膜炎的发生率（25.5%）显著低于B组（45.5%），p值为0.028。此外，A组黏膜炎的持续时间明显更短，中位持续时间为4.5天，而B组观察到的中位持续时间为7.5天（p = 0.01）。阿昔洛韦组无3级黏膜炎病例，而B组报告有5例（p = 0.045）。逻辑回归分析证实了含阿昔洛韦漱口水对黏膜炎发生的保护作用，优势比（OR）为2.444，p值为0.03。