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Dentoxol用于放疗引起的口腔黏膜炎的临床相关性:一项II期临床试验。

Clinical relevance of the use of Dentoxol for oral mucositis induced by radiotherapy: A phase II clinical trial.

作者信息

Solé Sebastián, Becerra Sergio, Carvajal Claudia, Bettolli Piero, Letelier Hernán, Santini Alejandro, Vargas Lorena, Cifuentes Alexander, Larsen Francisco, Jara Natalia, Oyarzún Jorge, Bustamante Eva, Martínez Benjamín, Rosenberg David, Galván Tomas

机构信息

Department of Radiotherapy, Radiomedicine Institute, Américo Vespucio Norte 1314 Vitacura, 7630370, Santiago, Chile.

National Institute of Cancer, Santiago, Servicio de Salud Metropolitano Norte, Av Profesor Zañartu 1010, Independencia, 8380455, Santiago, Chile.

出版信息

World J Clin Oncol. 2022 Oct 24;13(10):813-821. doi: 10.5306/wjco.v13.i10.813.

Abstract

BACKGROUND

Severe oral mucositis associated with cancer therapy is a frequent complication that may affect a patient's systemic condition, resulting in interruption and/or prolongation of cancer therapy. Dentoxol is a medical solution in the form of a mouthwash that has been shown to result in statistically significant improvement in the prevention of severe oral mucositis. However, knowing the measures of the clinical significance of this therapy is important for accurate decision-making.

AIM

To describe the clinical impact of Dentoxol use in severe oral mucositis.

METHODS

Clinical significance was measured using the results obtained in a randomized controlled clinical trial previously conducted by the same group of researchers. The measures of clinical significance evaluated were the absolute risk or incidence, relative risk, absolute risk reduction, relative risk reduction, number needed to treat, and odds ratio.

RESULTS

The data obtained show that the impact of Dentoxol on reducing the severity of oral mucositis has important clinical relevance.

CONCLUSION

The results of this study justify the incorporation of Dentoxol mouth rinse into clinical protocols as a complement to cancer therapy to prevent and/or treat oral mucositis secondary to radiotherapy.

摘要

背景

与癌症治疗相关的严重口腔黏膜炎是一种常见并发症,可能影响患者的全身状况,导致癌症治疗中断和/或延长。Dentoxol是一种漱口水形式的药物溶液,已证明在预防严重口腔黏膜炎方面有统计学上的显著改善。然而,了解这种治疗的临床意义指标对于准确决策很重要。

目的

描述使用Dentoxol治疗严重口腔黏膜炎的临床影响。

方法

使用同一组研究人员先前进行的一项随机对照临床试验的结果来衡量临床意义。评估的临床意义指标包括绝对风险或发病率、相对风险、绝对风险降低、相对风险降低、治疗所需人数和比值比。

结果

获得的数据表明,Dentoxol对减轻口腔黏膜炎严重程度的影响具有重要的临床相关性。

结论

本研究结果证明将Dentoxol漱口水纳入临床方案作为癌症治疗的补充,以预防和/或治疗放疗引起的口腔黏膜炎是合理的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824b/9630999/a29736d4b127/WJCO-13-813-g001.jpg

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