Low-dose aspirin in the primary prevention of cancer the women's health study: A randomized controlled trial
Low-dose aspirin in the primary prevention of cancer the women's health study: A randomized controlled trial
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DOI：
10.1001/jama.294.1.47
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发表时间：
2005-07-06
影响因子：
120.7
通讯作者：
Buring, JE
中科院分区：
文献类型：
--
作者：
Cook, NR;Lee, IM;Buring, JE
背景
基础研究、观察证据以及结肠息肉复发试验的结果都表明阿司匹林在癌症化学预防中具有一定作用。
目的
研究阿司匹林对健康女性患癌风险的影响。
设计、地点和参与者
在妇女健康研究中，这是一项于1992年9月至2004年3月间进行的阿司匹林和维生素E的2×2析因随机试验，39876名年龄至少45岁且最初无癌症、心血管疾病或其他主要慢性疾病病史的美国女性被随机分配接受阿司匹林或阿司匹林安慰剂，并平均随访10.1年。
干预措施
每隔一天给予100毫克阿司匹林（n = 19934）或阿司匹林安慰剂（n = 19942）。
主要观察指标
确诊任何部位的新发浸润性癌症（非黑色素瘤皮肤癌除外）。乳腺癌、结直肠癌和肺癌的发病率是次要终点。
结果
未观察到阿司匹林对总体癌症（n = 2865；相对风险[RR]，1.01；95%置信区间[CI]，0.94 - 1.08；P = 0.87）、乳腺癌（n = 1230；RR，0.98；95%CI，0.87 - 1.09；P = 0.68）、结直肠癌（n = 269；RR，0.97；95%CI，0.77 - 1.24；P = 0.83）或任何其他部位癌症有影响，但肺癌风险有降低趋势（n = 205；RR，0.78；95%CI，0.59 - 1.03；P = 0.08）。总体癌症死亡率（n = 583；RR，0.95；95%CI，0.81 - 1.11；P = 0.51）或按部位分的癌症死亡率也没有降低，但肺癌死亡率除外（n = 140；RR，0.70；95%CI，0.50 - 0.99；P = 0.04）。未发现阿司匹林因随访时间不同而有差异效应或与维生素E有相互作用的证据。
结论
这项大规模、长期试验的结果表明，平均治疗10年、每隔一天使用低剂量阿司匹林（100毫克）不会降低总体、乳腺癌、结直肠癌或其他部位特异性癌症的风险。不能排除阿司匹林对肺癌有保护作用或高剂量阿司匹林有益的可能性。
Context Basic research and observational evidence as well as results from trials of colon polyp recurrence suggest a role for aspirin in the chemoprevention of cancer.Objective To examine the effect of aspirin on the risk of cancer among healthy women.Design, Setting, and Participants In the Women's Health Study, a randomized 2 X 2 factorial trial of aspirin and vitamin E conducted between September 1992 and March 2004, 39 876 US women aged at least 45 years and initially without previous history of cancer, cardiovascular disease, or other major chronic illness were randomly assigned to receive either aspirin or aspirin placebo and followed up for an average of 10.1 years.Intervention A dose of 100 mg of aspirin (n=19 934) or aspirin placebo (n=19942) administered every other day.Main Outcome Measures Confirmed newly diagnosed invasive cancer at any site, except for nonmelanoma skin cancer. Incidence of breast, colorectal, and lung cancer were secondary end points.Results No effect of aspirin was observed on total cancer (n=2865; relative risk [RR], 1.01; 95% confidence interval [CI], 0.94-1.08; P=.87), breast cancer (n =1230; RR, 0.98;.95% Cl, 0.87-1.09; P=.68), colorectal cancer (n=269; RR, 0.97; 95% Cl, 0.77-1.24; P=.83), or cancer of any other site, with the exception of lung cancer for which there was a trend toward reduction in risk (n=205; RR, 0.78; 95% Cl,-0.59-1.03; P=.08). There was also no reduction in cancer mortality either overall (n=583; RR, 0.95; 95% Cl, 0.81-1.11; P=.51) or by site, except for lung cancer mortality (n=140; RR, 0.70; 95% Cl, 0.50-0.99; P=.04). No evidence of differential effects of aspirin by follow-up time or interaction with vitamin E was found.Conclusions Results from this large-scale, long-term trial suggest that alternate day use of low-dose aspirin (100 mg) for an average 10 years of treatment does not lower risk of total, breast, colorectal, or other site-specific cancers. A protective effect on lung cancer or a benefit of higher doses of aspirin cannot be ruled out.