A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue
A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue
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DOI：
10.1097/00002820-200212000-00007
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发表时间：
2002-12-01
期刊：
影响因子：
2.6
通讯作者：
Health, J
中科院分区：
文献类型：
--
作者：
Heggie, S;Bryant, GP;Health, J
该研究的目的是观察与水性乳膏相比，局部芦荟凝胶是否有利于减少放射治疗的已确定皮肤副作用，包括红斑、疼痛、瘙痒、干燥脱皮和潮湿脱皮。第二个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，如乳房大小、吸烟习惯和术后一次或多次淋巴囊肿引流对其他皮肤副作用的影响。一项III期研究涉及225名乳房肿瘤切除术或部分乳房切除术后的乳腺癌患者，这些患者需要使用切线野进行一个疗程的放射治疗。患者被随机分配到局部芦荟凝胶或局部水霜，每天3次，在整个放射治疗完成后持续2周。每周由护理人员进行皮肤评估。在减少与治疗相关的干燥脱屑和疼痛方面，水性乳膏明显优于芦荟凝胶。D杯或较大尺寸乳房的受试者出现了更多的红斑，无论治疗组如何。对于接受淋巴囊肿引流的受试者，芦荟组比水性乳膏组经历了更多的疼痛。在水性乳膏组中，吸烟者在治疗区域内比非吸烟者更容易出现瘙痒。在芦荟组中，手术后接受过一次或多次淋巴囊肿引流的受试者比没有引流的受试者更容易在治疗区域内出现红斑和瘙痒。在这项研究中，芦荟凝胶没有显著减少辐射引起的皮肤副作用。水性乳膏在减少与放射治疗相关的干燥脱屑和疼痛方面是有用的。
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, le, 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 desquamotion 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.