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一项关于局部应用芦荟凝胶对放疗后乳腺组织疗效的III期研究。

A Phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue.

作者信息

Heggie Sue, Bryant Guy P, Tripcony Lee, Keller Jacqui, Rose Pauline, Glendenning Mary, Heath Jenny

机构信息

Queensland Radium Institute, Division of Oncology, Royal Brisbane Hospital, Australia.

出版信息

Cancer Nurs. 2002 Dec;25(6):442-51. doi: 10.1097/00002820-200212000-00007.

DOI:10.1097/00002820-200212000-00007
PMID:12464836
Abstract

The aim of the study was to see if topical aloe vera gel would be beneficial in reducing the identified skin side-effects of radiation therapy, including erythema, pain, itching, dry desquamation, and moist desquamation, when compared with aqueous cream. The secondary aim was to assess the effect of other factors known to predict severity of radiation skin reaction, ie, breast size, smoking habit, and one or more drainages of lymphocele after surgery, on other skin side effects. A Phase III study was conducted involving 225 patients with breast cancer after lumpectomy or partial mastectomy, who required a course of radiation therapy using tangential fields. Patients were randomized to either topical aloe vera gel or topical aqueous cream to be applied 3 times per day throughout and for 2 weeks after completion of radiation treatment. Weekly skin assessments were performed by nursing staff. Aqueous cream was significantly better than aloe vera gel in reducing dry desquamation and pain related to treatment. Subjects with D cup or larger size breasts experienced significantly more erythema, regardless of treatment arm. For subjects who had undergone lymphocele drainage, the aloe vera group experienced significantly more pain than the aqueous cream group. Within the aqueous cream arm, smokers were significantly more likely to experience itching within the treatment field than were nonsmokers. Within the aloe vera arm, subjects who had undergone one or more lymphocele drainages after surgery were significantly more likely to experience erythema and itching within the treatment field than those who did not have drainage. In this study, aloe vera gel did not significantly reduce radiation-induced skin side effects. Aqueous cream was useful in reducing dry desquamation and pain related to radiation therapy.

摘要

本研究的目的是观察与水性乳膏相比,局部使用芦荟凝胶是否有助于减轻放射治疗所确定的皮肤副作用,包括红斑、疼痛、瘙痒、干性脱屑和湿性脱屑。次要目的是评估其他已知可预测放射性皮肤反应严重程度的因素,即乳房大小、吸烟习惯以及术后淋巴囊肿的一次或多次引流,对其他皮肤副作用的影响。进行了一项III期研究,纳入225例接受肿块切除术或部分乳房切除术后需要进行切线野放射治疗疗程的乳腺癌患者。患者被随机分为局部使用芦荟凝胶组或局部使用水性乳膏组,在整个放射治疗期间及放疗结束后2周每天涂抹3次。护理人员每周进行一次皮肤评估。在减轻与治疗相关的干性脱屑和疼痛方面,水性乳膏明显优于芦荟凝胶。无论治疗组如何,乳房尺寸为D罩杯或更大的受试者出现的红斑明显更多。对于接受过淋巴囊肿引流的受试者,芦荟凝胶组比水性乳膏组经历的疼痛明显更多。在水性乳膏组中,吸烟者在治疗区域内出现瘙痒的可能性明显高于不吸烟者。在芦荟凝胶组中,术后接受过一次或多次淋巴囊肿引流的受试者在治疗区域内出现红斑和瘙痒的可能性明显高于未接受引流的受试者。在本研究中,芦荟凝胶并未显著减轻放射诱导的皮肤副作用。水性乳膏有助于减轻与放射治疗相关的干性脱屑和疼痛。

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