芦荟、洋甘菊和百里香美容膏对预防和治疗乳腺癌患者因放疗引起的轻度皮炎的疗效(Alantel 研究)

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
E. Villegas-Becerril , C. Jimenez-Garcia , L.A. Perula-de Torres , M. Espinosa-Calvo , C.M. Bueno-Serrano , F. Romero-Ruperto , F. Gines-Santiago , M.C. Moreno-Manzanaro , J.J. Muñoz-Gavilan , G. Montes-Redondo , M.A. Quesada-Roman , M.C. Linares-Ramirez , J.M. Parras-Rejano , N. Muñoz-Alcaraz , M.D. Maestre-Serrano , E.M. Romero-Rodriguez
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引用次数: 0

摘要

放疗引起的皮炎(RD)是放疗(RT)患者最常见的毒性反应之一。皮质类固醇、免疫抑制剂和天然产物(NPs)已被用于治疗。我们进行了一项对照、随机、双盲临床试验。研究地点西班牙索菲亚王后医院放射肿瘤科以及科尔多瓦和瓜达尔基维尔河卫生区的 5 个初级保健中心。干预措施实验组(GTA)患者接受阿仑特尔治疗,对照组(GTE)患者接受保湿润肤霜治疗。结果研究共纳入了 70 名患者,其中 GTA 和 GTE 各占 35 人。随访 4 周后,GTA 的 RD 发生率(71.4%)低于 GTE(91.4%)(RR = 0.78;NNT = 5;p < 0.031)。Skindex-29 问卷调查显示,在以下语句中存在差异:"结论事实证明,与对照药膏相比,Alantel® 能更有效地降低乳腺癌妇女的 RD 发病率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients (the Alantel study)

Objectives

Radiation-induced dermatitis (RD) is one of the most common toxicities in radiation therapy (RT) patients. Corticosteroids, immunosuppressants, and natural products (NPs) have been used as treatment. The objective was to evaluate the efficacy of a NPs-based cream (Alantel®) to reduce the incidence of RD in women with breast cancer undergoing RT treatment.

Design

We conducted a controlled, randomized, double-blind clinical trial.

Setting

Radiation Oncology Unit of the Reina Sofía Hospital and 5 Primary Care centers of the Cordoba and Guadalquivir Health District (Spain).

Interventions

Patients assigned to the experimental group (GTA) were treated with Alantel, while those in the control group (GTE) were treated with a moisturizer and emollient cream.

Main outcome measures

The primary outcome variable was the incidence of RD. RD-free time, duration of RD, quality of life, and product safety were also assessed.

Results

Seventy patients were included in the study, 35 in the GTA and 35 in the GTE. The incidence of RD was lower in the GTA (71.4%) than in the GTE (91.4%) after 4 weeks of follow-up (RR = 0.78; NNT = 5; p < 0.031). The Skindex-29 questionnaire showed differences in the statement: “My skin condition makes it hard to work or do hobbies” (17.1% in the GTE vs. 2.9% in GTA; p = 0.024).

Conclusions

The higher efficacy of Alantel® compared to the control cream in reducing the incidence of RD in women with breast cancer has been demonstrated.

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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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