A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer
A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer
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DOI：
10.1056/nejmoa021633
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发表时间：
2003-03-06
影响因子：
158.5
通讯作者：
Schilsky, R
中科院分区：
文献类型：
--
作者：
Sandler, RS;Halabi, S;Schilsky, R
背景：动物实验研究和人类观察研究表明，定期服用阿司匹林可能会降低结直肠腺瘤的风险，而结直肠腺瘤是大多数结直肠癌的前兆。方法：我们进行了一项随机、双盲试验，以确定阿司匹林对结直肠腺瘤发病率的影响。我们随机分配635名既往结直肠癌患者，每天服用325毫克阿司匹林或安慰剂。我们确定了腺瘤患者的比例，复发腺瘤的数量，以及随机分组和后续结肠镜检查之间腺瘤发展的时间。相对风险根据年龄、性别、癌症分期、结肠镜检查次数和第一次结肠镜检查的时间进行调整。当一个独立的数据和安全监测委员会在计划的中期分析中报告了具有统计学意义的结果时，该研究被提前终止。结果：共有517名随机患者在随机分组后的中位时间12.8个月至少进行了一次结肠镜检查。17%的阿司匹林组患者和27%的安慰剂组患者发现了一个或多个腺瘤（P=0.004）。阿司匹林组腺瘤的平均（+/-SD）数低于安慰剂组（0.30+/-0.87比0.49+/-0.99，经Wilcoxon检验P=0.003）。与安慰剂组相比，阿司匹林组中任何复发性腺瘤的调整相对风险为0.65（95%置信区间，0.46至0.91）。阿斯匹林组发现第一个腺瘤的时间比安慰剂组长（发现新息肉的风险比为0.64；95%可信区间为0.43至0.94；P=0.022）。结论：既往结直肠癌患者每日服用阿司匹林可显著降低结直肠腺瘤的发生率。
Background: Experimental studies in animals and observational studies in humans suggest that regular aspirin use may decrease the risk of colorectal adenomas, the precursors to most colorectal cancers.Methods: We conducted a randomized, double-blind trial to determine the effect of aspirin on the incidence of colorectal adenomas. We randomly assigned 635 patients with previous colorectal cancer to receive either 325 mg of aspirin per day or placebo. We determined the proportion of patients with adenomas, the number of recurrent adenomas, and the time to the development of adenoma between randomization and subsequent colonoscopic examinations. Relative risks were adjusted for age, sex, cancer stage, the number of colonoscopic examinations, and the time to a first colonoscopy. The study was terminated early by an independent data and safety monitoring board when statistically significant results were reported during a planned interim analysis.Results: A total of 517 randomized patients had at least one colonoscopic examination a median of 12.8 months after randomization. One or more adenomas were found in 17 percent of patients in the aspirin group and 27 percent of patients in the placebo group (P=0.004). The mean (+/-SD) number of adenomas was lower in the aspirin group than the placebo group (0.30+/-0.87 vs. 0.49+/-0.99, P=0.003 by the Wilcoxon test). The adjusted relative risk of any recurrent adenoma in the aspirin group, as compared with the placebo group, was 0.65 (95 percent confidence interval, 0.46 to 0.91). The time to the detection of a first adenoma was longer in the aspirin group than in the placebo group (hazard ratio for the detection of a new polyp, 0.64; 95 percent confidence interval, 0.43 to 0.94; P=0.022).Conclusions: Daily use of aspirin is associated with a significant reduction in the incidence of colorectal adenomas in patients with previous colorectal cancer.