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每日服用可溶性阿司匹林预防结直肠腺瘤复发:APACC 随机试验的 4 年结果。

Prevention by daily soluble aspirin of colorectal adenoma recurrence: 4-year results of the APACC randomised trial.

机构信息

Department of Gastroenterology, AP-HP, Avicenne Hospital, Paris-13 University, Bobigny, France.

出版信息

Gut. 2012 Feb;61(2):255-61. doi: 10.1136/gutjnl-2011-300113. Epub 2011 Sep 2.

DOI:10.1136/gutjnl-2011-300113
PMID:21890814
Abstract

BACKGROUND

Aspirin inhibits colorectal carcinogenesis. In a randomised double-blind placebo-controlled trial, daily soluble aspirin significantly reduced recurrence of colorectal adenomas at 1-year follow-up. In this study the results of daily intake of low-dose aspirin on polyp recurrence at 4-year follow-up are presented.

METHODS

272 patients (naive for chronic aspirin use) with colorectal adenomas were randomly assigned to treatment with lysine acetylsalicylate 160 mg/day (n=73) or 300 mg/day (n=67) or placebo (n=132) for 4 years. The primary endpoints were adenoma recurrence and adenomatous polyp burden at year 4, comparing aspirin at either dose with placebo. The same endpoints were also assessed at year 1 or 4 (last colonoscopy performed for each patient).

RESULTS

At the final year 4 colonoscopy the analysis included 185 patients (55 receiving aspirin 160 mg/day, 47 aspirin 300 mg/day and 83 placebo). There was no difference in the proportion of patients with at least one recurrent adenoma between patients receiving aspirin at either dose and those treated with placebo (42/102 (41%) vs 33/83 (40%); NS) or in the adenomatous polyp burden (3.1 ± 5.8 mm vs 3.4 ± 6.2 mm; NS). Also, the proportion of patients with at least one advanced recurrent adenoma did not differ (10/102 [corrected] (10%) in the aspirin group vs 7/83 (8.4%) [corrected] in the placebo group; NS).

CONCLUSION

Daily low-dose aspirin decreased adenoma recurrence significantly at 1 year but not at year 4. This discrepancy might be explained by a differential effect of aspirin according to the natural history of the polyp.

TRIAL REGISTRATION NUMBER

NCT 00224679.

摘要

背景

阿司匹林抑制结直肠肿瘤的发生。在一项随机、双盲、安慰剂对照试验中,每日服用可溶性阿司匹林可显著降低结直肠腺瘤患者 1 年时的复发率。本研究旨在报告为期 4 年的每日低剂量阿司匹林对息肉复发的影响。

方法

272 例(无慢性阿司匹林使用史)结直肠腺瘤患者随机分为赖氨酸乙酰水杨酸 160mg/天组(n=73)、300mg/天组(n=67)或安慰剂组(n=132),治疗 4 年。主要终点为 4 年时腺瘤复发率和腺瘤性息肉负担,比较阿司匹林各剂量组与安慰剂组之间的差异。同样在第 1 年或第 4 年(每位患者最后一次结肠镜检查)评估这些终点。

结果

在第 4 年的最终结肠镜检查中,共纳入 185 例患者(55 例接受阿司匹林 160mg/天,47 例接受阿司匹林 300mg/天,83 例接受安慰剂)。与安慰剂组相比,接受阿司匹林治疗的两组患者中至少有 1 个腺瘤复发的患者比例无差异(42/102(41%)vs 33/83(40%);NS),或腺瘤性息肉负担(3.1±5.8mm vs 3.4±6.2mm;NS)。此外,至少有 1 个高级别复发腺瘤的患者比例也无差异(阿司匹林组 10/102(10%),安慰剂组 7/83(8.4%);NS)。

结论

每日低剂量阿司匹林可显著降低腺瘤复发率,在第 1 年时有效,但在第 4 年时无效。这种差异可能是由于阿司匹林根据息肉的自然史产生的不同作用。

临床试验注册号

NCT00224679。

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