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一项前瞻性交叉试点研究,以评估局部伤口凝胶在表皮生长因子受体抑制剂引起的皮肤毒性患者中的应用。

A prospective crossover pilot study to evaluate the use of a topical wound gel in patients with cutaneous toxicity caused by epidermal growth factor receptor inhibitors.

作者信息

Wong Siu-Fun, Lindgren Alexander, Mummaneni Madhavi, Byun Timothy, Vasko Catherine, Arenos Rachel, Alexson Edward, Osann Kathryn

机构信息

Loma Linda University, School of Pharmacy, Loma Linda, California 92350, USA.

出版信息

J Support Oncol. 2010 Sep-Oct;8(5):202-8. doi: 10.1016/j.suponc.2010.09.003.

Abstract

One of the dose-limiting toxicities of epidermal growth factor receptor inhibitors (EGFRIs) is a papulopustular rash that is often pruritic and painful. Secondary skin infection can occur from scratching to relieve the pruritus. Studies suggest that this rash might be a surrogate marker for efficacy; therefore, effective rash management is needed to allow patients to use EGFRIs without unnecessary dose modifications. In this single-center, prospective, crossover study, we evaluated the use of a topical gel (Regenecare Wound Gel) for relieving the pruritus and pain of EGFRI-induced rash among oncology patients. The secondary end points were patient satisfaction, adverse effects, and EGFRI dose modifications. At the occurrence of grade 2 skin rash, patients started applying the study gel to the right side of their face; after 1 week, they began applying it to both sides of their face for up to an additional 5 weeks. Each week, providers performed a facial evaluation and patients rated their symptoms and satisfaction on questionnaires. Of the 20 patients enrolled, 13 were evaluable. Reduction in itch at the end of week 1 was greater on the right (treated) side in 69% of patients greater on the left (untreated) side in 8%, and the same in 23% (P = 0.01). The pattern was similar for pain, but the differences were not significant. On average, patients rated the gel as being moderately to extremely effective for alleviating symptoms, improving rash appearance, and promoting healing and found it easy to apply. No adverse effects were documented. Four patients (31%) required EGFRI dose modifications because of rash. Taken together, these findings suggest that the topical wound gel is effective in relieving rash-associated itching in patients receiving EGFRIs and is associated with high patient satisfaction.

摘要

表皮生长因子受体抑制剂(EGFRIs)的剂量限制性毒性之一是丘疹脓疱性皮疹,通常伴有瘙痒和疼痛。搔抓以缓解瘙痒可能会导致继发性皮肤感染。研究表明,这种皮疹可能是疗效的替代标志物;因此,需要有效的皮疹管理,以使患者能够在不进行不必要剂量调整的情况下使用EGFRIs。在这项单中心、前瞻性、交叉研究中,我们评估了一种外用凝胶(Regenecare伤口凝胶)用于缓解肿瘤患者中EGFRIs诱导皮疹的瘙痒和疼痛的效果。次要终点为患者满意度、不良反应和EGFRIs剂量调整。在出现2级皮疹时,患者开始将研究凝胶涂抹于面部右侧;1周后,他们开始将其涂抹于面部两侧,持续额外5周。每周,医护人员进行面部评估,患者在问卷上对其症状和满意度进行评分。在纳入的20名患者中,13名可进行评估。在第1周结束时,69%的患者右侧(治疗侧)瘙痒减轻程度大于左侧(未治疗侧),8%的患者左侧减轻程度大于右侧,23%的患者两侧相同(P = 0.01)。疼痛情况类似,但差异不显著。平均而言,患者认为该凝胶在缓解症状、改善皮疹外观和促进愈合方面有中度至极度效果,且易于涂抹。未记录到不良反应。4名患者(31%)因皮疹需要调整EGFRIs剂量。综上所述,这些发现表明外用伤口凝胶可有效缓解接受EGFRIs治疗患者的皮疹相关瘙痒,且患者满意度高。

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