Jaszewski Richard, Misra Sabeena, Tobi Martin, Ullah Nadeem, Naumoff Jo Ann, Kucuk Omer, Levi Edi, Axelrod Bradley N, Patel Bhaumik B, Majumdar Adhip P N
John D Dingell VA Medical Center, Detroit, MI 48201, USA.
World J Gastroenterol. 2008 Jul 28;14(28):4492-8. doi: 10.3748/wjg.14.4492.
To determine whether folic acid supplementation will reduce the recurrence of colorectal adenomas, the precursors of colorectal cancer, we performed a double-blind placebo-controlled trial in patients with adenomatous polyps.
In the current double-blind, placebo-controlled trial at this VA Medical Center, patients with colorectal adenomas were randomly assigned to receive either a daily 5 mg dose of folic acid or a matched identical placebo for 3 years. All polyps were removed at baseline colonoscopy and each patient had a follow up colonoscopy at 3 years. The primary endpoint was a reduction in the number of recurrent adenomas at 3 years.
Of 137 subjects, who were eligible after confirmation of polyp histology and run-in period to conform compliance, 94 completed the study; 49 in folic acid group and 45 in placebo group. Recurrence of adenomas at 3-year was compared between the two groups. The mean number of recurrent polyps at 3-year was 0.36 (SD, 0.69) for folic acid treated patients compared to 0.82 (SD, 1.17) for placebo treated subjects, resulting in a 3-fold increase in polyp recurrence in the placebo group. Patients below 70 years of age and those with left-sided colonic adenomas or advanced adenomas responded better to folic acid supplementation.
High dose folic acid supplementation is associated with a significant reduction in the recurrence of colonic adenomas suggesting that folic acid may be an effective chemopreventive agent for colorectal neoplasia.
为了确定补充叶酸是否会降低结直肠癌的癌前病变——结肠腺瘤的复发率,我们对患有腺瘤性息肉的患者进行了一项双盲安慰剂对照试验。
在这家退伍军人事务医疗中心进行的当前双盲、安慰剂对照试验中,患有结肠腺瘤的患者被随机分配,接受每日5毫克剂量的叶酸或匹配的相同安慰剂,为期3年。在基线结肠镜检查时切除所有息肉,每位患者在3年后进行随访结肠镜检查。主要终点是3年后复发性腺瘤数量的减少。
在137名经息肉组织学确认且经过导入期以确保依从性后符合条件的受试者中,94名完成了研究;叶酸组49名,安慰剂组45名。比较了两组3年时腺瘤的复发情况。叶酸治疗患者3年时复发性息肉的平均数量为0.36(标准差,0.69),而安慰剂治疗受试者为0.82(标准差,1.17),导致安慰剂组息肉复发增加了3倍。70岁以下的患者以及患有左侧结肠腺瘤或高级别腺瘤的患者对补充叶酸的反应更好。
高剂量补充叶酸与结肠腺瘤复发的显著减少相关,表明叶酸可能是一种有效的结直肠癌化学预防剂。