一项将芦荟凝胶作为放射性皮肤毒性预防剂的III期双盲评估。
Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity.
作者信息
Williams M S, Burk M, Loprinzi C L, Hill M, Schomberg P J, Nearhood K, O'Fallon J R, Laurie J A, Shanahan T G, Moore R L, Urias R E, Kuske R R, Engel R E, Eggleston W D
机构信息
Toledo Community Clinical Oncology Program, OH, USA.
出版信息
Int J Radiat Oncol Biol Phys. 1996 Sep 1;36(2):345-9. doi: 10.1016/s0360-3016(96)00320-3.
PURPOSE
Considerable pilot data and clinical experience suggested that an aloe vera gel might help to prevent radiation therapy-induced dermatitis.
METHODS AND MATERIALS
Two Phase III randomized trials were conducted. The first one was double blinded, utilized a placebo gel, and involved 194 women receiving breast or chest wall irradiation. The second trial randomized 108 such patients to aloe vera gel vs. no treatment. Skin dermatitis was scored weekly during both trials both by patients and by health care providers.
RESULTS
Skin dermatitis scores were virtually identical on both treatment arms during both of the trials. The only toxicity from the gel was rare contact dermatitis.
CONCLUSIONS
This dose and schedule of an aloe vera gel does not protect against radiation therapy-induced dermatitis.
目的
大量的初步数据和临床经验表明，芦荟凝胶可能有助于预防放射治疗引起的皮炎。
方法和材料
进行了两项III期随机试验。第一项试验是双盲的，使用了安慰剂凝胶，有194名接受乳房或胸壁照射的女性参与。第二项试验将108名此类患者随机分为芦荟凝胶组和不治疗组。在两项试验中，患者和医护人员每周都对皮肤炎进行评分。
结果
在两项试验中，两个治疗组的皮肤炎评分几乎相同。该凝胶唯一的毒性是罕见的接触性皮炎。
结论
这种剂量和使用方案的芦荟凝胶不能预防放射治疗引起的皮炎。
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