PURPOSE:Phytochemicals in plants may have cancer preventive benefits through antioxidation and via gene-nutrient interactions. We sought to determine the effects of pomegranate juice (a major source of antioxidants) consumption on prostate-specific antigen (PSA) progression in men with a rising PSA following primary therapy. EXPERIMENTAL DESIGN:A phase II, Simon two-stage clinical trial for men with rising PSA after surgery or radiotherapy was conducted. Eligible patients had a detectable PSA > 0.2 and < 5 ng/mL and Gleason score < or = 7. Patients were treated with 8 ounces of pomegranate juice daily (Wonderful variety, 570 mg total polyphenol gallic acid equivalents) until disease progression. Clinical end points included safety and effect on serum PSA, serum-induced proliferation and apoptosis of LNCaP cells, serum lipid peroxidation, and serum nitric oxide levels. RESULTS:The study was fully accrued after efficacy criteria were met. There were no serious adverse events reported and the treatment was well tolerated. Mean PSA doubling time significantly increased with treatment from a mean of 15 months at baseline to 54 months posttreatment (P < 0.001). In vitro assays comparing pretreatment and posttreatment patient serum on the growth of LNCaP showed a 12% decrease in cell proliferation and a 17% increase in apoptosis (P = 0.0048 and 0.0004, respectively), a 23% increase in serum nitric oxide (P = 0.0085), and significant (P < 0.02) reductions in oxidative state and sensitivity to oxidation of serum lipids after versus before pomegranate juice consumption. CONCLUSIONS:We report the first clinical trial of pomegranate juice in patients with prostate cancer. The statistically significant prolongation of PSA doubling time, coupled with corresponding laboratory effects on prostate cancer in vitro cell proliferation and apoptosis as well as oxidative stress, warrant further testing in a placebo-controlled study.

译文

目的:植物中的植物化学物质可能通过抗氧化和基因-营养相互作用而具有预防癌症的作用。我们试图确定石榴汁(抗氧化剂的主要来源)的摄入量对主要治疗后PSA升高的男性前列腺特异性抗原(PSA)进程的影响。
实验设计:一项针对手术或放疗后PSA升高的男性进行的II期,Simon两阶段临床试验的第二阶段。符合条件的患者可检测PSA> 0.2且<5 ng / mL,格里森评分<或=7。患者每天接受8盎司石榴汁治疗(奇妙品种,总多酚570毫克没食子酸当量),直至疾病进展。临床终点包括对血清PSA的安全性和影响,血清诱导的LNCaP细胞的增殖和凋亡,血清脂质过氧化和血清一氧化氮水平。
结果:在达到疗效标准后,该研究已全部完成。没有严重不良反应的报道,治疗耐受性良好。平均PSA倍增时间随治疗时间的增加而从基线的平均15个月增加到治疗后的54个月(P <0.001)。体外分析比较了治疗前后患者血清LNCaP的生长情况,发现细胞增殖减少12%,凋亡增加17%(分别为P = 0.0048和0.0004),血清一氧化氮增加23%(P =食用石榴汁之前和之后的氧化状态和对血清脂质氧化敏感性的显着降低(P <0.02)(P <0.02)。
结论:我们报道了石榴汁在前列腺癌患者中的第一项临床试验。 PSA倍增时间的统计学显着延长,再加上相应的实验室作用对前列腺癌的体外细胞增殖和凋亡以及氧化应激反应,有必要在安慰剂对照研究中进行进一步测试。

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