A prospective, randomized, double-blind, placebo-controlled trial of retinol palmitate (vitamin A) for symptomatic chronic radiation proctopathy
A prospective, randomized, double-blind, placebo-controlled trial of retinol palmitate (vitamin A) for symptomatic chronic radiation proctopathy
复制标题
DOI：
10.1007/s10350-004-0821-7
复制
发表时间：
2005-01-01
影响因子：
3.9
通讯作者：
Hong, J
中科院分区：
文献类型：
--
作者：
Ehrenpreis, ED;Jani, A;Hong, J
目得：本研究旨在确定口服棕榈酸视黄醇酯（维生素A）是否可以减轻放射性直肠病的症状。方法：进行了一项随机、双盲试验，比较棕榈酸视黄醇酯（10，000 IU，口服90天）与安慰剂。符合条件的患者盆腔放疗后超过6个月，并有显着的症状与放射性直肠病系统评估量表测量。共有19名患者随机分组：10名患者接受棕榈酸视黄醇，9名患者接受安慰剂。测量放射性直肠病系统评估量表评分前和每30天，共90天。五名安慰剂无效者被交叉到棕榈酸视黄醇组再治疗90天。反应被定义为减少两个或两个以上的症状，至少有两个放射性直肠病系统评估量表points.RESULTS：七个10视黄醇棕榈酸酯患者作出反应，而两个9安慰剂（P = 0.057）。棕榈酸视黄醇组的放射性直肠病系统评估量表（A放射性直肠病系统评估量表）的平均治疗前后变化为11 +/- 5，而安慰剂组的A放射性直肠病系统评估量表为2.5 +/- 3.6（P = 0.013，Mann-Whitney U检验）。此外，所有五个安慰剂无应答者谁是交叉到视网膜棕榈酸酯治疗respondingtotreatment.CONCLUSIONS：在我们的试验中，棕榈酸视黄醇显着减少直肠症状的放射性直肠病，也许是因为伤口愈合的影响。目前的结果可以作为未来在多机构环境中检查棕榈酸视黄醇酯的试验的基础。
PURPOSE: This study was designed to determine whether oral retinol palmitate (vitamin A) can reduce the symptoms of radiation proctopathy.METHODS: A randomized, doubleblind trial comparing retinol palmitate (10,000 IU by tnouth for 90 days) to placebo was conducted. Eligible patients were more than six months postpelvic radiotherapy and had significant symptoms as measured with the Radiation Proctopathy System Assessments Scale. Nineteen patients were randomized in total: ten to retinol palmitate and nine to placebo. The Radiation Proctopathy System Assessments Scale scores before and every 30 days for 90 days were measured. Five placebo nonresponders were crossed over to the retinol palmitate for another 90 days. Response was defined as a reduction in two or more symptoms by at least two Radiation Proctopathy System Assessments Scale points.RESULTS: Seven of ten retinol palmitate patients responded, whereas two of nine responded to placebo (P = 0.057). Mean pre-post-treatment change in Radiation Proctopathy System Assessments Scale (A Radiation Proctopathy System Assessments Scale) in the retinol palmitate group was 11 +/- 5, whereas A Radiation Proctopathy System Assessments Scale in the placebo group was 2.5 +/- 3.6 (P = 0.013, Mann-Whitney U test). Additionally, all five placebo nonresponders who were crossed over to treatment with retinal palmitate responded to treatment.CONCLUSIONS: In our trial, retinol palmitate significantly reduced rectal symptoms of radiation proctopathy, perhaps because of wound-healing effects. The current results can serve as the foundation for future trials examining retinol palmitate in the multi-institutional setting.