一项关于阿司匹林预防既往患有结直肠癌患者发生结直肠腺瘤的随机试验。

A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer.

作者信息

Sandler Robert S, Halabi Susan, Baron John A, Budinger Susan, Paskett Electra, Keresztes Roger, Petrelli Nicholas, Pipas J Marc, Karp Daniel D, Loprinzi Charles L, Steinbach Gideon, Schilsky Richard

机构信息

Department of Medicine, University of North Carolina, Chapel Hill 27599-7555, USA.

出版信息

N Engl J Med. 2003 Mar 6;348(10):883-90. doi: 10.1056/NEJMoa021633.

DOI:10.1056/NEJMoa021633

PMID:12621132

Abstract

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.

摘要

背景

动物实验研究和人体观察性研究表明，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癌前病变。

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。我们将635例既往有结直肠癌的患者随机分为两组，分别每日服用325毫克阿司匹林或安慰剂。我们确定了腺瘤患者的比例、复发性腺瘤的数量以及随机分组至随后结肠镜检查期间腺瘤发生的时间。相对风险根据年龄、性别、癌症分期、结肠镜检查次数以及首次结肠镜检查的时间进行了调整。在计划的中期分析期间报告了具有统计学意义的结果时，独立的数据和安全监测委员会提前终止了该研究。

结果

共有517例随机分组的患者在随机分组后中位数为12.8个月时至少进行了一次结肠镜检查。阿司匹林组17%的患者和安慰剂组27%的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（±标准差）数量低于安慰剂组（0.30±0.87对0.49±0.99，Wilcoxon检验P = 0.003）。与安慰剂组相比，阿司匹林组任何复发性腺瘤的调整后相对风险为0.65（95%置信区间，0.46至0.91）。阿司匹林组检测到首个腺瘤的时间比安慰剂组长（检测到新息肉的风险比，0.64；95%置信区间，0.43至0.94；P = 0.022）。