|
标题 钙和维生素D补充剂预防结直肠腺瘤的效果 背景 流行病学和基础研究均提示，增加维生素D和钙的摄入有助降低结直肠腺瘤的风险。为明确这些化学药物预防方法的实际效果，我们进行了这项随机、双盲、安慰剂对照临床试验，旨在探究维生素D和钙对结直肠腺瘤的作用。 方法 所有入组患者均为新确诊的结直肠腺瘤患者，已接受完整的结直肠镜检查且无结直肠息肉残留。最终纳入2259名患者，被随机分为四组：维生素D3组（1000 IU）、碳酸钙组（1200 mg）、联合补充组、安慰剂组。女性受试者在补充碳酸钙的基础上可选择随机增加维生素D或安慰剂。所有受试者在入组3~5年内根据内镜医生的建议，接受内镜随访。主要研究终点为试验期间确诊的腺瘤复发。 结果 维生素D3组较安慰剂组受试者体内的血清25-羟维生素D平均水平出现7.83 ng/ml的净增长。总体而言，随访期间有43%的受试者出现一个或以上的腺瘤复发。维生素D3组、碳酸钙组、联合补充组与安慰剂组比较的校正后腺瘤复发危险比分别为0.99、0.95、0.93。严重不良事件罕见。 结论 本研究提示，腺瘤切除术后每日补充维生素D3组或碳酸钙组并未显著降低术后3~5年间的腺瘤复发风险。（本研究由美国国立癌症研究所资助） 参考文献 Baron, J.A., et al., A Trial of Calcium and Vitamin D for the Prevention of Colorectal Adenomas. New England Journal of Medicine, 2015. 373(16): p. 1519-1530. A Trial of Calcium and Vitamin D for the Prevention of Colorectal Adenomas BACKGROUND Epidemiologic and preclinical data suggest that higher intake and serum levels of vitamin D and higher intake of calcium reduce the risk of colorectal neoplasia. To further study the chemopreventive potential of these nutrients, we conducted a randomized, double-blind, placebo-controlled trial of supplementation with vitamin D, calcium, or both for the prevention of colorectal adenomas. METHODS We recruited patients with recently diagnosed adenomas and no known colorectal polyps remaining after complete colonoscopy. We randomly assigned 2259 participants to receive daily vitamin D3 (1000 IU), calcium as carbonate (1200 mg), both, or neither in a partial 2×2 factorial design. Women could elect to receive calcium plus random assignment to vitamin D or placebo. Follow-up colonoscopy was anticipated to be performed 3 or 5 years after the baseline examinations, according to the endoscopist’s recommendation. The primary end point was adenomas diagnosed in the interval from randomization through the anticipated surveillance colonoscopy. RESULTS Participants who were randomly assigned to receive vitamin D had a mean net increase in serum 25-hydroxyvitamin D levels of 7.83 ng per milliliter, relative to participants given placebo. Overall, 43% of participants had one or more adenomas diagnosed during follow-up. The adjusted risk ratios for recurrent adenomas were 0.99 (95% confidence interval [CI], 0.89 to 1.09) with vitamin D versus no vitamin D, 0.95 (95% CI, 0.85 to 1.06) with calcium versus no calcium, and 0.93 (95% CI, 0.80 to 1.08) with both agents versus neither agent. The findings for advanced adenomas were similar. There were few serious adverse events. CONCLUSIONS Daily supplementation with vitamin D3 (1000 IU), calcium (1200 mg), or both after removal of colorectal adenomas did not significantly reduce the risk of recurrent colorectal adenomas over a period of 3 to 5 years. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00153816.) |
|
|
