Ben-David Merav A, Elkayam Ruth, Gelernter Ilana, Pfeffer Raphael M
Isr Med Assoc J. 2016 Mar-Apr;18(3-4):188-92.
Radiation-induced dermatitis is commonly seen during radiotherapy for breast cancer. Melatonin-based creams have shown a protective effect against ultraviolet-induced erythema and a radioprotective effect in rats.
To evaluate the efficacy of melatonin-containing cream in minimizing acute radiation dermatitis.
In this phase II, prospective, randomized, placebo-controlled double-blind study, patients who underwent breast-conserving surgery for stage 0-2 breast cancer were randomly allocated to melatonin emulsion (26 women) or placebo (21 women) for twice daily use during radiation treatment and 2 weeks following the end of radiotherapy. All women received 50 Gy whole breast radiation therapy with 2 Gy/fx using computed tomography-based 3D planning. Patients were examined and completed a detailed questionnaire weekly and 2 weeks following the end of treatment.
The occurrence of grade 1/2 acute radiation dermatitis was significantly lower (59% vs. 90%, P = 0.038) in the melatonin group. Women older than 50 had significantly less dermatitis than younger patients (56% vs. 100%, P = 0.021). The maximal radiation dermatitis in the study group was grade 2 in 15% of the treated patients.
Patients treated with melatonin-containing emulsion experienced significantly reduced radiation dermatitis compared to patients receiving placebo.
放射性皮炎在乳腺癌放疗期间很常见。基于褪黑素的乳膏已显示出对紫外线引起的红斑有保护作用，并且在大鼠中具有辐射防护作用。
评估含褪黑素乳膏在减轻急性放射性皮炎方面的疗效。
在这项II期前瞻性随机安慰剂对照双盲研究中，接受0-2期乳腺癌保乳手术的患者被随机分配至褪黑素乳剂组（26名女性）或安慰剂组（21名女性），在放疗期间及放疗结束后2周每天使用两次。所有女性均采用基于计算机断层扫描的3D计划接受50 Gy全乳放疗，每次2 Gy。每周及治疗结束后2周对患者进行检查并完成一份详细问卷。
褪黑素组1/2级急性放射性皮炎的发生率显著更低（59% 对90%，P = 0.038）。50岁以上女性的皮炎明显少于年轻患者（56% 对100%，P = 0.021）。研究组中15% 的接受治疗患者的最大放射性皮炎为2级。
与接受安慰剂的患者相比，接受含褪黑素乳剂治疗的患者放射性皮炎明显减轻。
