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【NEJM】阿司匹林或抗性淀粉对林奇综合征易感者
ABSTRACT
Background Observational and epidemiologic data indicate that the use of aspirin reduces the risk of colorectal neoplasia; however, the effects of aspirin in the Lynch syndrome (hereditary nonpolyposis colon cancer) are not known. Resistant starch has been associated with an antineoplastic effect on the colon.
Methods In a randomized, placebo-controlled trial, we used a two-by-two design to investigate the effects of aspirin, at a dose of 600 mg per day, and resistant starch (Novelose), at a dose of 30 g per day, in reducing the risk of adenoma and carcinoma among persons with the Lynch syndrome.
Results Among 1071 persons in 43 centers, 62 were ineligible to participate in the study, 72 did not enter the study, and 191 withdrew from the study. These three categories were equally distributed across the study groups. Over a mean period of 29 months (range, 7 to 74), colonic adenoma or carcinoma developed in 141 participants. Of 693 participants randomly assigned to receive aspirin or placebo, neoplasia developed in 66 participants receiving aspirin (18.9%), as compared with 65 receiving placebo (19.0%) (relative risk, 1.0; 95% confidence interval [CI], 0.7 to 1.4). There were no significant differences between the two groups with respect to the development of advanced neoplasia (7.4% and 9.9%, respectively; P=0.33). Among the 727 participants receiving resistant starch or placebo, neoplasia developed in 67 participants receiving starch (18.7%), as compared with 68 receiving placebo (18.4%) (relative risk, 1.0; 95% CI, 0.7 to 1.4). Advanced adenomas and colorectal cancers were evenly distributed in the two groups. The prevalence of serious adverse events was low, and the events were evenly distributed.
Conclusions The use of aspirin, resistant starch, or both for up to 4 years has no effect on the incidence of colorectal adenoma or carcinoma among carriers of the Lynch syndrome. (Current Controlled Trials number, ISRCTN59521990 [controlled-trials.com] .)
http://intl-content.nejm.org/cgi/content/abstract/359/24/2567 本人已认领该文翻译，48小时后若未提交译文，请其他战友自由认领 Effect of Aspirin or Resistant Starch on Colorectal Neoplasia in the Lynch Syndrome
阿司匹林或抗性淀粉对Lynch综合症患者发生结肠癌的影响
ABSTRACT
Background Observational and epidemiologic data indicate that the use of aspirin reduces the risk of colorectal neoplasia; however, the effects of aspirin in the Lynch syndrome (hereditary nonpolyposis colon cancer) are not known. Resistant starch has been associated with an antineoplastic effect on the colon.
背景：观察研究和流行病学数据表明阿司匹林可以降低结肠癌发生的风险；但是阿司匹林对Lynch综合症（遗传性非息肉性结肠癌）的影响却不清楚。抗性淀粉对于抗结肠肿瘤形成的作用已经是明确的。
Methods In a randomized, placebo-controlled trial, we used a two-by-two design to investigate the effects of aspirin, at a dose of 600 mg per day, and resistant starch (Novelose), at a dose of 30 g per day, in reducing the risk of adenoma and carcinoma among persons with the Lynch syndrome.
方法：在一个随机的、设安慰剂对照的研究中，我们设计了一个two-by-two的实验来检测阿司匹林对于降低Lynch综合症患者发生腺癌或上皮癌风险的作用，阿司匹林的剂量为600 mg每天，抗性淀粉剂量为30 g每天。
Results Among 1071 persons in 43 centers, 62 were ineligible to participate in the study, 72 did not enter the study, and 191 withdrew from the study. These three categories were equally distributed across the study groups. Over a mean period of 29 months (range, 7 to 74), colonic adenoma or carcinoma developed in 141 participants. Of 693 participants randomly assigned to receive aspirin or placebo, neoplasia developed in 66 participants receiving aspirin (18.9%), as compared with 65 receiving placebo (19.0%) (relative risk, 1.0; 95% confidence interval [CI], 0.7 to 1.4). There were no significant differences between the two groups with respect to the development of advanced neoplasia (7.4% and 9.9%, respectively; P=0.33). Among the 727 participants receiving resistant starch or placebo, neoplasia developed in 67 participants receiving starch (18.7%), as compared with 68 receiving placebo (18.4%) (relative risk, 1.0; 95% CI, 0.7 to 1.4). Advanced adenomas and colorectal cancers were evenly distributed in the two groups. The prevalence of serious adverse events was low, and the events were evenly distributed.
结果：选取了43个中心的1071例患者，其中62例不符合研究条件，72例没有参加研究，还有191例中途退出研究。这3类病例都是相等的分布在各研究组中。平均随访时间为29个月（7－74个月），有141例患者发生结肠腺癌或上皮癌。693例随机接受阿司匹林或安慰剂治疗的患者中，66例(18.9%)服用阿司匹林患者产生肿瘤，相对于安慰剂组的65例(19.0%)（相对危险度1.0；95％置信区间：0.7－1.4）。两组进展期肿瘤发生率（分别为7.4% 和9.9%，P=0.33）没有明显差别。727例随机服用抗性淀粉或安慰剂的患者中，67例服用抗性淀粉的患者罹患癌症，相对于安慰剂组的68例(19.0%)（相对危险度1.0；95％置信区间：0.7－1.4）。进展期腺癌和结肠癌发生率在两组中分布大致相同。严重危害事件发生率很低，在各组之间分布相同。
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作者:admin@医学,生命科学 2011-03-09 17:11
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