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局部应用1%阿托伐他汀预防乳腺癌放疗患者皮肤毒性:一项随机、双盲、安慰剂对照试验。

Topical atorvastatin 1% for prevention of skin toxicity in patients receiving radiation therapy for breast cancer: a randomized, double-blind, placebo-controlled trial.

作者信息

Ghasemi Arash, Ghashghai Zahra, Akbari Jafar, Yazdani-Charati Jamshid, Salehifar Ebrahim, Hosseinimehr Seyed Jalal

机构信息

Department of Radiology and Radiation Oncology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.

Department of Radiopharmacy, Faculty of Pharmacy, Pharmaceutical Sciences Research Center, Mazandaran University of Medical Sciences, Sari, Iran.

出版信息

Eur J Clin Pharmacol. 2019 Feb;75(2):171-178. doi: 10.1007/s00228-018-2570-x. Epub 2018 Oct 6.

Abstract

BACKGROUND AND PURPOSE

The purpose of this randomized, placebo-controlled, double-blind study was to investigate the preventive effect of topical administration of atorvastatin (ATV) on the acute radiation-induced skin toxicity in patients with breast cancer.

PATIENTS AND METHODS

Seventy breast cancer patients were randomly assigned to use topical ATV 1% or placebo gels during radiotherapy twice daily. Radiation-induced dermatitis was classified according to the radiation therapy oncology group (RTOG) criteria, as well as pain and itching were scored according to VAS (visual analogue scale) for 6 weeks of treatment.

RESULTS

Topical administration of ATV gel during radiotherapy reduced significantly radiation-induced breast swelling, itching, and pain in breast cancer patients by factors of 1.8, 1.7, and 1.5, respectively. ATV reduced the redness caused by radiotherapy in patients as compared with placebo; however, this difference was statistically not significant.

CONCLUSION

ATV was able to reduce significantly itching, breast edema, and pain in patients during radiotherapy.

摘要

背景与目的

本随机、安慰剂对照、双盲研究旨在探讨局部应用阿托伐他汀(ATV)对乳腺癌患者急性放射性皮肤毒性的预防作用。

患者与方法

70例乳腺癌患者在放疗期间随机分为两组,分别每日两次局部使用1%的ATV凝胶或安慰剂凝胶。根据放射治疗肿瘤学组(RTOG)标准对放射性皮炎进行分类,并在6周的治疗期间根据视觉模拟量表(VAS)对疼痛和瘙痒进行评分。

结果

放疗期间局部应用ATV凝胶可使乳腺癌患者放射性乳房肿胀、瘙痒和疼痛分别显著减轻1.8倍、1.7倍和1.5倍。与安慰剂相比,ATV减轻了放疗引起的患者皮肤发红;然而,这种差异在统计学上不显著。

结论

ATV能够显著减轻放疗期间患者的瘙痒、乳房水肿和疼痛。

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