• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Cancer prevention research. >A Randomized Double-Blind Placebo-Controlled Phase IIB Trial of Curcumin in Oral Leukoplakia
【24h】

A Randomized Double-Blind Placebo-Controlled Phase IIB Trial of Curcumin in Oral Leukoplakia

机译：姜黄素在口腔白斑中的随机双盲安慰剂对照IIB期临床试验

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Oral leukoplakia is a potentially malignant lesion of the oral cavity, for which no effective treatment is available. We investigated the effectiveness of curcumin, a potent inhibitor of NF-kappa B/COX-2, molecules perturbed in oral carcinogenesis, to treat leukoplakia. Subjects with oral leukoplakia (n = 223) were randomized (1:1 ratio) to receive orally, either 3.6 g/day of curcumin (n = 111) or placebo (n = 112), for 6 months. The primary endpoint was clinical response obtained by bi-dimensional measurement of leukoplakia size at recruitment and 6 months. Histologic response, combined clinical and histologic response, durability and effect of long-term therapy for an additional six months in partial responders, safety and compliance were the secondary endpoints. Clinical response was observed in 75 (67.5%) subjects [95% confidence interval (CI), 58.4-75.6] in the curcumin and 62 (55.3%; 95% CI, 46.1-64.2) in placebo arm (P = 0.03). This response was durable, with 16 of the 18 (88.9%; 95% CI, 67.2-96.9) subjects with complete response in curcumin and 7 of 8 subjects (87.5%) in placebo arm, demonstrating no relapse after 6 months followup. Difference in histologic response between curcumin and placebo was not significant (HR, 0.88, 95% CI, 0.45-1.71; P = 0.71). Combined clinical and histologic response assessment indicated a significantly better response with curcumin (HR, 0.50; 95% CI, 0.27-0.92; P = 0.02). Continued therapy, in subjects with partial response at 6 months, did not yield additional benefit. The treatment did not raise any safety concerns. Treatment of oral leukoplakia with curcumin (3.6 g for six months), thus was well tolerated and demonstrated significant and durable clinical response for 6 months. (C) 2016 AACR.
机译：口腔白斑是口腔潜在的恶性病变，目前尚无有效的治疗方法。我们研究了姜黄素（一种有效的NF-κB/ COX-2抑制剂）在口腔癌发生中受到干扰的分子治疗白斑的有效性。将口服白斑（n = 223）的受试者随机（1：1比例）口服3.6克/天姜黄素（n = 111）或安慰剂（n = 112），持续6个月。主要终点是募集时和六个月时通过二维测量白斑大小获得的临床反应。次要终点是组织学反应，临床和组织学综合反应，部分反应者的持久性和长期治疗效果（另外六个月），安全性和依从性。在姜黄素中有75名（67.5％）受试者[95％置信区间（CI），58.4-75.6]和安慰剂组中有62名（55.3％; 95％CI，46.1-64.2）（P = 0.03）观察到临床反应。这种反应是持久的，在姜黄素中有18名受试者中的16名（88.9％; 95％CI，67.2-96.9）受试者完全缓解，在安慰剂组中有8名受试者中的7名（87.5％）表现出无复发。姜黄素和安慰剂之间的组织学应答差异不明显（HR，0.88，95％CI，0.45-1.71; P = 0.71）。结合临床和组织学反应评估表明姜黄素的反应明显更好（HR，0.50; 95％CI，0.27-0.92; P = 0.02）。在6个月有部分反应的受试者中继续治疗并没有产生额外的益处。该治疗未引起任何安全隐患。因此，用姜黄素（3.6 g服用六个月）治疗口腔白斑的耐受性良好，并在6个月内表现出显着且持久的临床反应。 （C）2016 AACR。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号