Shariati Laleh, Amouheidari Alireza, Naji Esfahani Hajar, Abed Alireza, Haghjooy Javanmard Shaghayegh, Laher Ismail, Ghasemi Ahmad, Vaseghi Golnaz
Applied Physiology Research Center, Cardiovascular Research Institute, Department of Physiology, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Biomaterials, Nanotechnology and Tissue Engineering, School of Advanced Technologies in Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Br J Clin Pharmacol. 2020 Sep;86(9):1875-1881. doi: 10.1111/bcp.14238. Epub 2020 Feb 25.
Breast cancer is the most frequently occurring cancer in women. Lumpectomy followed by radiotherapy is suggested to be as effective as a total mastectomy. Radiation-induced dermatitis often occurs as a result of breast radiotherapy. Recent studies suggest that doxepin has promising anti-inflammatory properties. This study was undertaken to evaluate the effects of doxepin therapy on radiation dermatitis.
A double-blind randomized clinical trial was launched from 2016 to 2017, with a total of 48 patients who had undergone breast-conserving surgery and received postoperative radiation therapy. Radiotherapy was applied 5 days per week for 5 weeks. Adverse dermatological effects were evaluated by a physician at the beginning of the fifth week of radiotherapy and the patients were then randomly assigned (1:1 ratio) to receive either doxepin (5%) or placebo cream for 7 days.
There were no significant differences in the dermatitis grade between doxepin and placebo groups at baseline (P > .5). The occurrence of acute dermatitis (grade 2 or higher) was significantly lower with the use of doxepin than with placebo (P ≤ .0001, Z = 1.96 at 95% confidence interval).
Doxepin cream prevents dermatitis grade 2 or higher during post-operative breast irradiation. Doxepin cream is easy to use, affordable and prevents pain and irritation.
乳腺癌是女性中最常见的癌症。保乳手术加放疗被认为与全乳切除术效果相同。放射性皮炎常因乳腺癌放疗而发生。最近的研究表明多塞平具有良好的抗炎特性。本研究旨在评估多塞平治疗对放射性皮炎的影响。
2016年至2017年开展了一项双盲随机临床试验，共有48例接受保乳手术并接受术后放疗的患者。放疗每周进行5天，共5周。在放疗第五周开始时由医生评估皮肤不良反应，然后将患者随机分配（1:1比例）接受多塞平（5%）或安慰剂乳膏治疗7天。
多塞平组和安慰剂组在基线时的皮炎分级无显著差异（P>.5）。使用多塞平治疗时急性皮炎（2级或更高）的发生率显著低于安慰剂（P≤.0001，95%置信区间时Z=1.96）。
多塞平乳膏可预防术后乳房放疗期间2级或更高等级的皮炎。多塞平乳膏使用方便、价格低廉，可预防疼痛和刺激。
