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局部使用基于重组人表皮生长因子(EGF)的乳膏预防乳腺癌患者放射性皮炎:一项单盲随机初步研究。

Topical use of recombinant human epidermal growth factor (EGF)-based cream to prevent radiation dermatitis in breast cancer patients: a single-blind randomized preliminary study.

作者信息

Kong Moonkyoo, Hong Seong Eon

机构信息

Department of Radiation Oncology, Kyung Hee University Medical Center, Kyung Hee University School of Medicine, Seoul, Republic of Korea E-mail :

出版信息

Asian Pac J Cancer Prev. 2013;14(8):4859-64. doi: 10.7314/apjcp.2013.14.8.4859.

Abstract

BACKGROUND

The purpose of this study was to assess the effectiveness of a recombinant human epidermal growth factor (EGF)-based cream for the prevention of acute radiation dermatitis in breast cancer patients receiving radiotherapy (RT).

MATERIALS AND METHODS

Between December 2012 and April 2013, 40 breast cancer patients who received postoperative RT were prospectively enrolled in this study and randomly assigned to receive human recombinant EGF-based cream (intervention group) or general supportive skin care (control group). The grade of radiation dermatitis and pain score were examined at weekly intervals during RT and 6 weeks after RT completion.

RESULTS

All patients completed the planned RT and complied well with instructions for applying the study cream and general supportive skin care. In the intervention group, radiation dermatitis of maximum grade 3, 2, and 1 developed in 3 (15%), 11 (55%), and 6 patients (30%), respectively. In comparison, in the control group, radiation dermatitis of maximum grade 3, 2, and 1 developed in 8 (40%), 10 (50%), and 2 patients (10%), respectively. The intervention group showed lower incidence of grade 3 radiation dermatitis than the control group (p=0.068 in univariate analysis and p=0.035 in multivariate analysis). There was no statistically significant difference in the maximal pain score between the two groups (p=0.934).

CONCLUSIONS

This single-blind randomized preliminary study showed that recombinant human EGF-based cream can have a beneficial role in preventing or minimizing radiation dermatitis in breast cancer patients. To confirm the results of our study, additional studies with a large sample size are required.

摘要

背景

本研究旨在评估一种基于重组人表皮生长因子(EGF)的乳膏对接受放疗(RT)的乳腺癌患者预防急性放射性皮炎的有效性。

材料与方法

2012年12月至2013年4月期间,40例接受术后放疗的乳腺癌患者前瞻性纳入本研究,并随机分为两组,分别接受基于人重组EGF的乳膏(干预组)或一般支持性皮肤护理(对照组)。在放疗期间每周及放疗结束后6周检查放射性皮炎的分级和疼痛评分。

结果

所有患者均完成了计划的放疗,并很好地遵守了使用研究乳膏和一般支持性皮肤护理的指导。干预组中,分别有3例(15%)、11例(55%)和6例(30%)患者出现最大分级为3级、2级和1级的放射性皮炎。相比之下,对照组中分别有8例(40%)、10例(50%)和2例(10%)患者出现最大分级为3级、2级和1级的放射性皮炎。干预组3级放射性皮炎的发生率低于对照组(单因素分析p = 0.068,多因素分析p = 0.035)。两组间最大疼痛评分无统计学显著差异(p = 0.934)。

结论

这项单盲随机初步研究表明,基于重组人EGF的乳膏在预防或减轻乳腺癌患者的放射性皮炎方面可能具有有益作用。为证实我们的研究结果,需要进行更多大样本量的研究。

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