radiodermatitis

放射性皮炎
  • 文章类型: Journal Article
    关于预防放射性皮炎的产品的证据有限。主要目的是与基于金盏花和巴氏芦荟的标准化保湿剂相比,分析喷雾皮肤保护剂“非燃烧屏障膜”在预防肛管和直肠癌患者潮湿脱皮的放射性皮炎和护理咨询中的有效性。单盲随机临床试验。这项研究是在里约热内卢的一家医院进行的,巴西,63例接受肛管和直肠癌治疗的患者,随机分为以下两组之一:实验组,使用喷雾皮肤保护剂和对照组,用的是保湿霜.使用初始和后续评估表收集数据,并使用描述性和推断性分析进行评估。与对照组相比,使用喷雾皮肤保护剂的参与者出现潮湿脱屑的放射性皮炎的机会较低,并且没有这种结果的时间更长。放射性皮炎的总发病率为100%,36.5%是严重的。此外,17.5%的参与者因放射性皮炎停止放疗。两组之间在放射性皮炎的严重程度和停止放疗的患者人数方面没有差异。皮肤保护剂可有效预防肛管和直肠癌患者的放射性皮炎和湿脱皮。
    The evidence on products for the prevention of radiodermatitis is limited. The primary objective was to analyse the effectiveness of the spray skin protectant \'non-burning barrier film\' in the prevention of radiodermatitis with moist desquamation in patients with the anal canal and rectal cancer followed in nursing consultations compared to a standardised moisturiser based on Calendula officinalis and Aloe barbadensis. Single-blind randomised clinical trial. The study was performed in a hospital in Rio de Janeiro, Brazil, with 63 patients undergoing anal canal and rectal cancer treatment, randomised into one of the following two groups: an experimental group, which used a spray skin protectant and a control group, which used a moisturiser. Data were collected using an initial and subsequent evaluation form and were assessed using descriptive and inferential analyses. Participants who used the spray skin protectant had a lower chance of presenting radiodermatitis with moist desquamation and a longer time without this outcome when compared to the control group. The overall incidence of radiodermatitis was 100%, with 36.5% being severe. Furthermore, 17.5% of participants discontinued radiotherapy due to radiodermatitis. There were no differences between the groups regarding the severity of radiodermatitis and the number of patients who discontinued radiotherapy. The skin protectant was effective in preventing radiodermatitis with moist desquamation amongst patients with anal canal and rectal cancer.
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  • 文章类型: Journal Article
    背景:辐射回忆反应(RRR)是在触发剂之后在先前照射的区域中发生的罕见炎症反应。在儿科患者中,人们对它知之甚少,研究不足。吉西他滨-多西他赛(G/D)在儿童癌症中主要用作肉瘤的挽救方案。我们旨在描述儿童G/D引发的RRR。
    方法:回顾性回顾了2010年至2022年在两家医院接受G/D同时放疗的21例患者。RRR被认为是在先前照射的区域中G/D给药后发生的任何毒性。描述了RRR特征。Fisher和Mann-Whitney检验用于分析涉及的危险因素。
    结果:16例(76.2%)患者发生16次RRR发作。RRR主要涉及皮肤深层(58%),主要发生在两个G/D周期后。放疗和化疗的平均时间为28.5天(0-1359天),和RRR的平均放射量391mL(157-1810mL)。RRR治疗主要是全身性类固醇,11例患者中有6例(58%)有部分反应。再次暴露于G/D与15人中有9人的高复发率(56.2%)相关,提示药物停药。G/D后RRR的主要危险因素包括,没有统计学意义,照射场的体积更大,化疗和放疗之间的间隔更短。
    结论:儿童人群G/D后RRR的发生率高于以前的报道。药物再次暴露后通常会复发。较高的照射量和较短的化疗开始时间可能与RRR的风险增加有关。
    BACKGROUND: Radiation recall reaction (RRR) is a rare inflammatory reaction developing in a previously irradiated field after a triggering agent. In pediatric patients, it is poorly understood and deficiently studied. Gemcitabine-docetaxel (G/D) in childhood cancer is mainly used as a salvage regimen for sarcomas. We aim to describe RRR triggered by G/D in children.
    METHODS: Retrospective review of 21 patients receiving G/D along with radiotherapy at two hospitals from 2010 until 2022. RRR was considered as any toxicity occurring after G/D administration in a previously irradiated field. RRR features were described. Fisher\'s and Mann-Whitney tests were utilized to analyze the risk factors involved.
    RESULTS: Sixteen episodes of RRR developed in 16 (76.2%) patients. RRR mainly involved deep layers of the skin (58%) and occurred predominantly after two G/D cycles. The mean time between radiotherapy and chemotherapy was 28.5 days (0-1359 days), and the mean radiation volume 391 mL (157-1810 mL) for RRR. RRR treatment was mainly systemic steroids, with partial responses in six of 11 (58%) patients. Re-exposure to G/D was associated with a high rate of recurrence in nine of 15 (56.2%), prompting drug discontinuation. The major risk factors for RRR after G/D include, without statistical significance, a larger volume of the irradiated field and a shorter interval between chemotherapy and radiotherapy.
    CONCLUSIONS: The incidence of RRR after G/D in the pediatric population is higher than previously reported. Drug re-exposure is usually followed by recurrence. Higher irradiated volumes and a shorter time to the start of chemotherapy could be related with an increased risk of RRR.
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  • 文章类型: Journal Article
    目的:头颈部肿瘤患者在放疗过程中经常发生放射性皮炎(RD)。我们比较了含和不含洋甘菊提取物的脂质体凝胶在头颈部癌症放疗患者中预防和管理RD的作用。
    方法:在一项双盲随机临床试验中招募了60名首次接受头颈部肿瘤放疗的参与者。主要结果是干脱屑的发生和第一次发生干脱屑时电离辐射的累积剂量。次要结果是红斑的发生,潮湿的脱屑,全局RD,和参与者自我报告的症状。
    结果:在洋甘菊脂质体凝胶组中76.9%(95%CI:57.9,89.0)的参与者和88.9%(95%CI:71.9,96.1)的参与者中发生了干脱屑。脂质体凝胶组(p=0.43)。发生干脱屑时,洋甘菊脂质体凝胶组为48.0Gy,脂质体凝胶组为40.0Gy。在洋甘菊脂质体凝胶组中报告的症状较少。
    结论:两组间结局无统计学差异,尽管洋甘菊脂质体凝胶组的RD等级低于脂质体凝胶组。此外,与其他主题干预措施管理RD的文献相比,我们的结果表明,洋甘菊脂质体凝胶有可能更好地管理和预防该人群的RD,这应该进一步测试。这项研究为设计未来的研究提供了重要信息。临床试验注册(REBEC):RBR-92cts3。
    Head and neck cancer patients frequently develop radiation dermatitis (RD) during radiotherapy. We compared liposomal gel with and without chamomile extract for the prevention and management of RD in head and neck cancer patients undergoing radiotherapy.
    Sixty participants undergoing radiotherapy for the first time for head and neck cancer were recruited in a double-blind randomized clinical trial. Primary outcomes were the occurrence of dry desquamation and the cumulative dose of ionizing radiation at the first occurrence of dry desquamation. Secondary outcomes were the occurrence of erythema, moist desquamation, global RD, and participant self-reported symptoms.
    Dry desquamation occurred in 76.9 % (95 % CI: 57.9, 89.0) of participants in the chamomile liposomal gel group and in 88.9 % (95 % CI: 71.9, 96.1) in the liposomal gel group (p = 0.43). The median cumulative dose of ionizing radiation when dry desquamation occurred was 48.0 Gy in the chamomile liposomal gel group and 40.0 Gy in the liposomal gel group. Fewer symptoms were reported in the chamomile liposomal gel group.
    No statistically significant differences in outcomes were found between the two groups, though the chamomile liposomal gel group presented with lower grades of RD than the liposomal gel group. In addition, when compared to the literature on other topical interventions to manage RD, our results show that chamomile liposomal gel has potential for better management and prevention of RD in this population, which should be further tested. This study provides crucial information to design future studies. Clinical Trials Registration (REBEC): RBR-92cts3.
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  • 文章类型: Journal Article
    背景:急性放射性皮炎(ARD)是最广泛报道的放疗引起的不良事件。目前,没有客观或可靠的方法来测量ARD。
    目的:我们的主要目的是使用光学相干断层扫描(OCT)皮肤扫描的计算模型来识别和量化放射治疗的效果。次要目标包括确定不同放射治疗方案和辅助局部治疗的ARD影响。
    方法:我们进行了前瞻性,在三级转诊中心对符合全乳放疗(WBRT)条件的乳腺癌患者进行单中心病例系列研究.
    结果:根据放疗方案(15、20和25分)共纳入和分配了39名妇女。设计计算模型以定量分析OCT结果。放疗后,OCT扫描更敏感地显示了84.6%的患者的血管形成变化(对比69.2%的临床检查ARD患者)。OCT量化了WBRT结束时血管形成的增加(P<.05)和3个月后的减少(P=.032)。OCT显示的红斑性皮肤变化在25分方案中更为明显。
    结论:OCT计算模型允许识别和量化辐照皮肤上的血管形成变化,即使在没有临床ARD的情况下。这可以允许设计超出所涉及的患者的肤色的ARD的标准化方案。
    BACKGROUND: Acute radiation dermatitis (ARD) is the most widely reported radiotherapy-induced adverse event. Currently, there is no objective or reliable method to measure ARD.
    OBJECTIVE: Our main objective was to identify and quantify the effects of radiotherapy with a computational model using optical coherence tomography (OCT) skin scanning. Secondary objectives included determining the ARD impact of different radiotherapeutic schemes and adjuvant topical therapies.
    METHODS: We conducted a prospective, single-center case series study in a tertiary referral center of patients with breast cancer who were eligible for whole breast radiotherapy (WBRT).
    RESULTS: A total of 39 women were included and distributed according to the radiotherapeutic schemes (15, 20, and 25 fractions). A computational model was designed to quantitatively analyze OCT findings. After radiotherapy, OCT scanning was more sensitive revealing vascularization changes in 84.6% of the patients (vs 69.2% of the patients with ARD by clinical examination). OCT quantified an increased vascularization at the end of WBRT (P<.05) and a decrease after 3 months (P=.032). Erythematous skin changes by OCT were more pronounced in the 25-fraction regime.
    CONCLUSIONS: An OCT computational model allowed for the identification and quantification of vascularization changes on irradiated skin, even in the absence of clinical ARD. This may allow the design of standardized protocols for ARD beyond the skin color of the patients involved.
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  • 文章类型: Journal Article
    目的:放射性皮炎是放疗最常见的反应,几乎所有乳腺癌患者都在门诊接受放疗.目前,没有关于放射性皮炎的经历和自我管理能力的研究。因此,我们旨在通过定性的方法来更深入地了解实际经验和自我管理能力,为进一步提高自我管理的有效性和优化症状管理策略提供参考。
    方法:采用目的性抽样进行描述性定性研究,选取17例接受放疗的乳腺癌患者。半结构化访谈于2023年9月至11月进行。使用Colaizzi七步分析方法将数据分类为汇总主题。
    结果:从访谈答复中确定了四个主题:(1)患有放射性皮炎的乳腺癌患者的多种自我报告的皮肤症状;(2)对患者生活质量的多维影响,尤其是瘙痒,溃疡;(3)自我管理放射性皮炎的能力:精神韧性强,积极响应,和自我怀疑;(4)面临的挑战:对放疗副作用和复发的担忧,放疗后有针对性的症状管理和延续性护理。
    结论:医疗专业人员在评估放射性皮炎时应考虑患者自我报告的症状。瘙痒和疼痛,我们可以加强精准症状管理,以提高患者的生活质量。通过利用信息技术工具,我们可以提高乳腺癌患者有效管理放射性皮炎的能力和信心,同时加强放疗期间的准确症状管理。
    OBJECTIVE: Radiation dermatitis is the most common reaction to radiotherapy, almost all breast cancer patients receive radiotherapy on an outpatient basis. Currently, there are no studies on the experience of radiation dermatitis and the ability to self-manage it. Therefore, we aimed to use qualitative approaches to gain a deeper understanding of the actual experiences and self-management ability in order to provide a reference for further improving the effectiveness of self-management and to optimize symptom management strategies.
    METHODS: A descriptive qualitative study was conducted using purposive sampling to select 17 breast cancer patients undergoing radiotherapy. Semi-structured interviews were conducted from September to November 2023. The Colaizzi seven-step analysis method was used to classify the data into summarized themes.
    RESULTS: Four themes were identified from the interview responses: (1) multiple self-reported skin symptoms in breast cancer patients with radiation dermatitis; (2) the multidimensional impact on patient\'s quality of life, especially pruritus, ulceration; (3) the ability to self-manage radiation dermatitis: strong mental toughness, positive response, and self-doubt; (4) challenges faced: concerns about radiotherapy side effects and recurrence, targeted symptom management and continuity of care after the radiotherapy.
    CONCLUSIONS: Healthcare professionals should consider patients\' self-reported symptoms when assessing radiation dermatitis. For pruritus and pain, we can enhance precision symptom management to improve patients\' quality of life. By utilizing information technology tools, we can increase breast cancer patients\' ability and confidence in managing radiation dermatitis effectively while enhancing accurate symptom management during radiotherapy.
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  • 文章类型: Journal Article
    背景:急性放射性皮炎(ARD)是最广泛报道的放疗引起的不良事件。目前,没有客观或可靠的方法来测量ARD。
    目的:我们的主要目的是使用光学相干断层扫描(OCT)皮肤扫描的计算模型来识别和量化放射治疗的效果。次要目标包括确定不同放射治疗方案和辅助局部治疗的ARD影响。
    方法:我们进行了前瞻性,在三级转诊中心对符合全乳放疗(WBRT)条件的乳腺癌患者进行单中心病例系列研究.
    结果:根据放疗方案(15、20和25分)共纳入和分配了39名妇女。设计计算模型以定量分析OCT结果。放疗后,OCT扫描更敏感地显示了84.6%的患者的血管形成变化(对比69.2%的临床检查ARD患者)。OCT量化了WBRT结束时血管形成的增加(P<.05)和3个月后的减少(P=.032)。OCT显示的红斑性皮肤变化在25分方案中更为明显。
    结论:OCT计算模型允许识别和量化辐照皮肤上的血管形成变化,即使在没有临床ARD的情况下。这可以允许设计超出所涉及的患者的肤色的ARD的标准化方案。
    BACKGROUND: Acute radiation dermatitis (ARD) is the most widely reported radiotherapy-induced adverse event. Currently, there is no objective or reliable method to measure ARD.
    OBJECTIVE: Our main objective was to identify and quantify the effects of radiotherapy with a computational model using optical coherence tomography (OCT) skin scanning. Secondary objectives included determining the ARD impact of different radiotherapeutic schemes and adjuvant topical therapies.
    METHODS: We conducted a prospective, single-center case series study in a tertiary referral center of patients with breast cancer who were eligible for whole breast radiotherapy (WBRT).
    RESULTS: A total of 39 women were included and distributed according to the radiotherapeutic schemes (15, 20, and 25 fractions). A computational model was designed to quantitatively analyze OCT findings. After radiotherapy, OCT scanning was more sensitive revealing vascularization changes in 84.6% of the patients (vs 69.2% of the patients with ARD by clinical examination). OCT quantified an increased vascularization at the end of WBRT (P<.05) and a decrease after 3 months (P=.032). Erythematous skin changes by OCT were more pronounced in the 25-fraction regime.
    CONCLUSIONS: An OCT computational model allowed for the identification and quantification of vascularization changes on irradiated skin, even in the absence of clinical ARD. This may allow the design of standardized protocols for ARD beyond the skin color of the patients involved.
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  • 文章类型: Clinical Trial
    目的:CSMed®伤口敷料,含有各种草药提取物的敷料,对乳腺癌和头颈部癌症患者的放射性皮炎的治疗效果进行了测试。
    方法:本研究包括20名乳腺癌患者和10名头颈癌患者。照射区域的一半用CSMed®覆盖,另一半在常规处理下。在整个治疗和随访期间,通过放射治疗肿瘤组(RTOG)分级评估放射性皮炎的严重程度。比较穿衣和脱衣区域之间的RTOG等级以说明CSMed®敷料的治疗效果。
    结果:结果显示,CSMed®修整区域在治疗期间的3-7周和最终记录时,RTOG评分显着降低,和1-3周随访期间比脱衣区。
    结论:这表明CSMed®可以延迟发病,降低严重性,增强放射性皮炎的愈合。CSMed®可用于预防和管理放射性皮炎。
    OBJECTIVE: CSMed® wound dressing, a dressing with various herb extracts, was tested for its therapeutic effect in radiation dermatitis of breast and head-and-neck cancer patients.
    METHODS: This study included 20 breast cancer patients and 10 head-and-neck cancer patients. Half of the irradiated area was covered with CSMed® and the other half was under routine treatment. The severity of radiation dermatitis was evaluated with radiation therapy oncology group (RTOG) grade throughout the treatment and the follow-up period. The RTOG grade between the dressed and undressed area were compared to illustrate the therapeutic effect of CSMed® dressing.
    RESULTS: The results showed that CSMed® dressed area had significant lower RTOG score at 3-7 weeks and final record during the treatment, and 1-3 weeks during follow-up than undressed area.
    CONCLUSIONS: This indicated that CSMed® can delay the onset, reduce the severity, and enhance healing of radiation dermatitis. CSMed® can be used for prophylaxis and management of radiation dermatitis.
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  • 文章类型: Randomized Controlled Trial
    背景:皮炎是由多种原因引起的皮肤病,包括放射治疗。药物治疗可以变得慢性,并且不能免除副作用。美国皮肤病学会的最新建议建立了使用自然,滋养,和保湿化妆品作为预防和治疗皮炎的第一步。Alantel®是一种为减少发红和刺激而开发的乳霜,促进局部免疫系统,对抗免疫衰老,促进表皮病变的愈合。目的是评估基于高浓度天然产物的乳膏(Alantel)对乳腺癌患者放射性皮炎的预防和治疗(早期)的作用。
    方法:我们的方案是实验性的,prospective,三盲,多中心,具有两个平行臂的对照临床试验。实验组将使用Alantel治疗,而对照组将接受另一种保湿霜。放疗肿瘤专业人员将招募88名乳腺癌患者(每个对照组44名),他们将接受放疗肿瘤治疗15天,他们将被随机分配到实验组或对照组。选定的患者将在完成放疗后由初级保健医生随访4次,为期1周。主要研究变量将是轻度放射后皮炎的发生率。将进行意向治疗分析,对独立的均值和比例进行比较测试。还将开发双变量和多变量分析来检查治疗效果,调整预测社会人口统计学和临床变量。
    结论:通过进行这项临床试验,预计可以验证Alantel霜,基于高浓度的天然产物,与保湿霜相比,在乳腺癌患者中预防和治疗RD方面具有优势。COVID-19大流行受到了推迟研究开始的影响。这项研究的主要限制之一是从计划样本中招募患者所需的时间,鉴于选择标准是限制性的,尽管这项研究是多中心的,招募将通过一项关于放射治疗肿瘤学的单一服务进行协调。
    背景:ClinicalTrials.govNCT04116151。2019年10月4日注册。
    BACKGROUND: Dermatitis is a skin condition caused by multiple causes, including radiotherapy treatment. Pharmacological treatments can become chronic and are not exempt from side effects. The latest recommendations of the American Academy of Dermatology establish the use of natural, nourishing, and moisturizing cosmetic products as prevention and the first therapeutic step for dermatitis. Alantel® is a cream developed to reduce redness and irritation, promote the local immune system, combat immunosenescence, and promote the healing of epidermal lesions. The objective was to evaluate the effect of a cream (Alantel) based on natural products at high concentrations for the preventive and curative treatment (at early stages) of radiation-induced dermatitis in patients with breast cancer.
    METHODS: Our protocol is an experimental, prospective, triple-blind, multicenter, controlled clinical trial with two parallel arms. The experimental group will be treated with Alantel, while the control group will receive another moisturizing cream. Radiotherapy oncology professionals will recruit a total of 88 patients (44 per comparison group) with breast cancer who will receive radiotherapy oncology treatment for 15 days, and they will be randomly allocated to the experimental or control group. Selected patients will be followed up for four visits by primary care physicians for up to 1 week after completion of radiotherapy. The main study variable will be the incidence rate of mild post-radiation dermatitis. An intention-to-treat analysis will be performed, applying a comparison test for independent means and proportions. A bivariate and multivariate analysis will also be developed to check the treatment effect, adjusting for predictive sociodemographic and clinical variables.
    CONCLUSIONS: By carrying out this clinical trial, it is expected to verify that Alantel cream, based on natural products at high concentrations, has advantages over a moisturizing cream for the preventive and curative treatment of RD in patients with breast cancer. The COVID-19 pandemic has been influenced by delaying the start of the study. One of the main limitations of this study will be the time required to recruit the patients from the planned sample, given that the selection criteria are restrictive and, although the study is multicenter, recruitment will be coordinated through a single service on radiotherapy oncology.
    BACKGROUND: ClinicalTrials.gov NCT04116151 . Registered on 4 October 2019.
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  • 文章类型: Randomized Controlled Trial
    目的:放射治疗(RT)是乳腺癌的常用治疗方法,尽管分段给药时间表取得了进展,产生不良的皮肤毒性。这项研究的目的是评估使用基于角蛋白的外用乳膏的可行性,KeraStat®奶油(KC;KeraNetics,Inc.,温斯顿·塞勒姆,NC,美国)管理接受RT的乳腺癌患者的放射性皮炎(RD)症状。材料与方法:本单中心共纳入24名受试者,随机化,开放标签研究。参与者被随机分配到KC或标准护理(SOC,患者选择各种现成的面霜或保湿剂)。要求患者每天两次将指定的治疗应用于受照射的区域,从RT的第1天开始,通过RT后30天。主要结果是使用依从性。次要结果包括KC的安全性和耐受性,以及使用放射治疗肿瘤组(RTOG)量表和患者报告的皮肤病生活质量指数(DLQI)评估RD严重程度。结果:KC组的所有受试者均被评估为合规且无不良事件。KC组(30.8%)的RTOG2级RD率低于SOC组(54.5%,P=.408)。在RT的最后一次访问中,KC组(1.0)的平均RTOGRD评分低于SOC组(1.4).同样,KC组(平均4.25,效果较小)与SOC组(平均6.18,中等效果,P=.412)。结论:KC是安全的,耐受性良好,无不良事件。虽然疗效措施不能得出明确的结论,趋势和临床评估表明,与接受RT治疗的乳腺癌患者相比,使用KC比SOC更有益处,并且有必要进行更大规模的疗效研究。试验注册:该临床试验注册为NCT03374995,标题为用于放射性皮炎的KeraStat(R)乳膏。
    Purpose: Radiotherapy (RT) is commonly used in the treatment of breast cancer and often, despite advances in fractionated dosing schedules, produces undesirable skin toxicity. The purpose of this study was to evaluate the feasibility of using a keratin-based topical cream, KeraStat® Cream (KC; KeraNetics, Inc., Winston Salem, NC, USA) to manage the symptoms of radiation dermatitis (RD) in breast cancer patients undergoing RT. Materials and Methods: A total of 24 subjects were enrolled on this single-center, randomized, open-label study. Participants were randomly assigned to KC or standard of care (SOC, patient\'s choice of a variety of readily available creams or moisturizers). Patients were asked to apply the assigned treatment to the irradiated area twice daily, beginning with day 1 of RT, through 30 days post-RT. The primary outcome was compliance of use. Secondary outcomes included safety and tolerability of KC, as well as RD severity assessed using the Radiation Therapy Oncology Group (RTOG) scale and the patient-reported Dermatology Life Quality Index (DLQI). Results: All subjects in the KC group were assessed as compliant with no adverse events. The rate of RTOG Grade 2 RD was lower in the KC group (30.8%) compared to the SOC group (54.5%, P = .408). At the final RT visit, the mean RTOG RD score was lower in the KC group (1.0) versus the SOC group (1.4). Similarly, patient-reported quality of life measured by the DLQI at the end of RT was improved in the KC group (mean 4.25, small effect) versus the SOC group (mean 6.18, moderate effect, P = .412). Conclusions: KC was safe and well tolerated with no adverse events. Though efficacy measures were not powered to draw definitive conclusions, trends and clinical assessments suggest that there is a benefit of using KC compared to SOC for breast cancer patients treated with RT, and a larger powered study for efficacy is warranted. Trial Registry: This clinical trial is registered as NCT03374995 titled KeraStat(R) Cream for Radiation Dermatitis.
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  • 文章类型: Randomized Controlled Trial
    Episil®是一种生物粘附屏障形成液体凝胶,可缓解放射治疗(RT)引起的粘膜炎并有效缓解疼痛。这项试验的目的是比较Episil®在改善乳腺癌患者急性放射性皮炎(ARD)方面的疗效和安全性。这项研究包括符合乳腺癌术后放疗标准的患者。主要终点是治疗期间放射性皮炎的等级。本研究共纳入102名患者。使用随机数字表法将患者按2:1的比例进行分组:67例患者接受了Episil®联合常规皮肤护理(Episil®组),其余35例患者作为对照组,仅接受常规皮肤护理(对照组)。根据放射治疗肿瘤组(RTOG)的分级标准,Episil®组的皮肤反应率和严重程度明显优于对照组(24.62%,72.31%,3.08,0,0vs.0,85.71%,14.29%,0,0,0)跨越0至4年级(P<0.05)。与对照组相比,Episil®组的瘙痒评分显着降低(P<0.05)。EORTCQLQ-C30结果显示,放疗后Episil®组的总体健康状况(z=-5.855,P<0.001)和总体生活质量(z=-6.583,P<0.001)均优于对照组。总的来说,在接受放疗的乳腺癌患者中,Episil®的局部应用可能会显著降低ARD的分级,缓解患者症状,提高整体生活质量。
    Episil is a bioadhesive barrier-forming liquid gel that can relieve mucositis caused by radiotherapy (RT) and effectively relieve pain. The purpose of this trial is to compare the efficacy and safety of Episil in improving acute radiation dermatitis (ARD) in patients with breast cancer. This study included patients who met the criteria for postoperative RT for breast cancer. The primary end point was the grade of RD during treatment. A total of 102 patients were included in this study. The patients were grouped in a 2:1 ratio using the randomized number table method: 67 patients received Episil combined with conventional skin care (the Episil group), whereas the remaining 35 patients served as the control group and received conventional skin care only (the control group). According to the grading criteria of the Radiation Therapy Oncology Group (RTOG), the skin reaction rate and severity were significantly better in the Episil group than the control group (24.62%, 72.31%, 3.08, 0, 0 vs. 0, 85.71%, 14.29%, 0, 0, 0) across grades 0 to 4 (P < 0.05). The itchiness score exhibited s significant reduction in the Episil group as compared with the control group (P < 0.05). The results of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) showed that the overall health (z = -5.855, P < 0.001) and overall quality of life (z = -6.583, P < 0.001) were better in the Episil group than the control group after RT. Overall, in patients with breast cancer receiving RT, the topical application of Episil may significantly reduce the grading of ARD, alleviate patient symptoms, and improve the patient\'s overall quality of life.
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