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3M Cavilon无刺痛屏障膜或外用皮质类固醇(糠酸莫米松)预防放射性皮炎的临床试验

3M Cavilon No-Sting Barrier Film or topical corticosteroid (mometasone furoate) for protection against radiation dermatitis: A clinical trial.

作者信息

Shaw Su-Zun, Nien Hsin-Hua, Wu Ching-Jung, Lui Louis Tak, Su Jui-Fen, Lang Chin-Hsin

机构信息

Department of Radiation Oncology, Cathay General Hospital, Taiwan.

Department of Radiation Oncology, Cathay General Hospital, Taiwan.

出版信息

J Formos Med Assoc. 2015 May;114(5):407-14. doi: 10.1016/j.jfma.2013.04.003. Epub 2013 May 17.

DOI:10.1016/j.jfma.2013.04.003
PMID:23685085
Abstract

BACKGROUND/PURPOSE: Evidence on the prevention of radiation dermatitis is lacking. The aim of this study was to investigate the effect of 3M Cavilon No Sting Barrier Film and topical corticosteroids on irradiated skin.

METHODS

Thirty-nine postoperative breast cancer patients were randomized into three groups for intraindividual comparison (skin to be irradiated was divided into 2 parts): (1) 3M No Sting Barrier Film versus no treatment; (2) corticosteroid versus no treatment; and (3) corticosteroid versus 3M No Sting Barrier Film. The primary end points monitored were the time to first occurrence of grade 1 pruritus, pain score of 3 and grade 2 radiation dermatitis. The secondary end points studied were the incidence of grade 3 radiation dermatitis and total pain scores. Data analysis was done using the SPSS software version 10.

RESULTS

Skin given the 3M barrier film experienced a later occurrence of pruritus compared to both corticosteroids and untreated, although this was statistically insignificant. Corticosteroids delayed the time to occurrence of grade 2 dermatitis compared to both untreated skin and 3M barrier film, (mean day of onset = corticosteroid: 52 vs. untreated: 43, p = 0.092; corticosteroid: 53.4 vs. 3M barrier film: 44.5, p = 0.002, t test). Skin given corticosteroids had the lowest incidence of grade 3 dermatitis among all three conditions, although the differences were statistically insignificant. No statistically significant differences were noted in total pain scores.

CONCLUSION

The 3M barrier film may be helpful against dermatitis associated pruritus. Corticosteroids may delay the time of onset of severe skin reactions and also reduce the incidence of severe radiation dermatitis.

摘要

背景/目的:缺乏关于预防放射性皮炎的证据。本研究旨在探讨3M Cavilon无刺痛隔离膜和外用皮质类固醇对受辐射皮肤的影响。

方法

39例乳腺癌术后患者被随机分为三组进行个体内比较(待照射皮肤分为两部分):(1)3M无刺痛隔离膜组与未治疗组;(2)皮质类固醇组与未治疗组;(3)皮质类固醇组与3M无刺痛隔离膜组。监测的主要终点是首次出现1级瘙痒、疼痛评分3分和2级放射性皮炎的时间。研究的次要终点是3级放射性皮炎的发生率和总疼痛评分。使用SPSS 10版软件进行数据分析。

结果

与皮质类固醇组和未治疗组相比,使用3M隔离膜的皮肤瘙痒出现时间较晚,尽管这在统计学上无显著意义。与未治疗皮肤和3M隔离膜相比,皮质类固醇延迟了2级皮炎的发生时间(平均发病天数 = 皮质类固醇组:52天 vs未治疗组:43天,p = 0.092;皮质类固醇组:53.4天 vs 3M隔离膜组:44.5天,p = 0.002,t检验)。在所有三种情况中,使用皮质类固醇的皮肤3级皮炎发生率最低,尽管差异无统计学意义。总疼痛评分未发现统计学上的显著差异。

结论

3M隔离膜可能有助于对抗与皮炎相关的瘙痒。皮质类固醇可能会延迟严重皮肤反应的发生时间,并降低严重放射性皮炎的发生率。

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