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三臂随机III期试验:优质芦荟与安慰剂乳膏及粉末在乳腺癌放射治疗期间作为皮肤治疗的对比研究

Three-Arm Randomized Phase III Trial: Quality Aloe and Placebo Cream Versus Powder as Skin Treatment During Breast Cancer Radiation Therapy.

作者信息

Hoopfer Donna, Holloway Caroline, Gabos Zsolt, Alidrisi Maha, Chafe Susan, Krause Barbara, Lees Alan, Mehta Nirmal, Tankel Keith, Strickland Faith, Hanson John, King Charlotte, Ghosh Sunita, Severin Diane

机构信息

KADA Consulting, Edmonton, AB, Canada.

BC Cancer Agency Vancouver Island Centre, Victoria, BC, Canada.

出版信息

Clin Breast Cancer. 2015 Jun;15(3):181-90.e1-4. doi: 10.1016/j.clbc.2014.12.006. Epub 2014 Dec 24.

DOI:10.1016/j.clbc.2014.12.006
PMID:25619686
Abstract

BACKGROUND

The efficacy of aloe extract in reducing radiation-induced skin injury is controversial. The purpose of the present 3-arm randomized trial was to test the efficacy of quality-tested aloe extract in reducing the severity of radiation-induced skin injury and, secondarily, to examine the effect of a moist cream versus a dry powder skin care regimen.

MATERIALS AND METHODS

A total of 248 patients with breast cancer were randomized to powder, aloe cream, or placebo cream. Acute skin toxicity was scored weekly and after treatment at weeks 1, 2, and 4 using a modified 10-point Catterall scale. The patients scored their symptom severity using a 6-point Likert scale and kept an acute phase diary.

RESULTS

The aloe formulation did not reduce acute skin toxicity or symptom severity. Patients with a greater body mass index were more likely to develop acute skin toxicity. A similar pattern of increased skin reaction toxicity occurred with both study creams compared with the dry powder regimen.

CONCLUSION

No evidence was found to support prophylactic application of quality aloe extract or cream to improve the symptoms or reduce the skin reaction severity. Our results support a dry skin care regimen of powder during radiation therapy.

摘要

背景

芦荟提取物在减轻辐射所致皮肤损伤方面的疗效存在争议。本三项分组随机试验的目的是检验经质量检测的芦荟提取物在减轻辐射所致皮肤损伤严重程度方面的疗效,其次是研究保湿乳膏与干粉皮肤护理方案的效果。

材料与方法

总共248例乳腺癌患者被随机分为干粉组、芦荟乳膏组或安慰剂乳膏组。每周以及在第1、2和4周治疗后使用改良的10分卡特拉尔量表对急性皮肤毒性进行评分。患者使用6分量表对症状严重程度进行评分,并记录急性期日记。

结果

芦荟制剂并未减轻急性皮肤毒性或症状严重程度。体重指数较高的患者更易发生急性皮肤毒性。与干粉方案相比,两种研究乳膏的皮肤反应毒性增加模式相似。

结论

未发现有证据支持预防性应用经质量检测的芦荟提取物或乳膏来改善症状或减轻皮肤反应严重程度。我们的结果支持放疗期间使用干粉的干性皮肤护理方案。

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