ASPIRIN PREVENTION OF LARGE BOWEL POLYPS

流行病学和实验数据表明，非类固醇抗炎药 炎症药物(非甾体类抗炎药)，包括阿司匹林，有抗肿瘤作用 大肠内的属性。由于卵巢的肿瘤性息肉(腺瘤) 大肠被认为是癌前病变，因此 预防干预措施测试的有效终点，我们 建议一项随机、双盲、安慰剂对照试验 阿司匹林预防喉部肿瘤性息肉复发的疗效观察 大肠。 这将是一项涉及8个临床中心和一个 协调中心。受试者将至少患有一种肿瘤 在注册前三个月内摘除息肉，未发现息肉。 残留在大肠内，没有使用阿司匹林的禁忌症。 经过两个月的磨合期，870名受试者将被随机分配到 每天服用安慰剂、80毫克或阿司匹林，或每天服用325毫克阿司匹林。 所有受试者将在6个月内接受依从性和毒性监测。 间隔时间，并将接受三次全面的结肠镜检查 在资格赛结束数年后。在所有的下胃肠道 内窥镜检查，肠内所有隆起的粘膜病变将被切除并 做了组织学检查。 主要的分析将是对以下疾病复发风险的比较 两个阿司匹林组与安慰剂组的肿瘤性息肉 在随机化和为期3年的考试之间。在……里面 二次分析，两种阿司匹林剂量之间的差异将是 以及阿司匹林的使用对血管大小和数量的影响。 将对肿瘤性息肉进行调查。这项研究将至少有90% 检测能力为40：降低息肉复发风险 在两个阿司匹林组和安慰剂组中，假设复发率为40% 安慰剂组的风险(正如我们之前的研究所建议的那样)。 阿司匹林越来越多地被用作预防心脏病的药物。 心血管疾病，这项研究将阐明这是否 干预还将预防结直肠肿瘤。这项研究还将 帮助阐明大肠癌变的生物学基础 前列腺素合成酶抑制剂对卵巢癌发生的影响 肿瘤性息肉。

Epidemiological and experimental data suggest that non-steroidal anti- inflammatory drugs (NSAIDs), including aspirin, have anti-neoplastic properties in the large bowel. Since neoplastic polyps (adenomas) of the large bowel are recognized as pre-malignant lesions and therefore are effective endpoints for the testing of preventive interventions, we propose a randomized, double-blind placebo controlled trial of the efficacy of aspirin in preventing recurrence of neoplastic polyps of the large bowel. This will be a collaborative study involving 8 clinical centers and a coordinating center. Subjects will have had at least one neoplastic polyp removed in the three months before enrollment, with no known polyps remaining in the large bowel, and no contraindications to aspirin use. After a run-in period of 2 months, 870 subjects will be randomized to receive either placebo, 80 mg or aspirin daily, or 325 mg aspirin daily. All subjects will be monitored for compliance and toxicity at six month intervals, and will receive a complete colonoscopic examination three years after the qualifying exam. At all lower gastrointestinal endoscopies, all raised mucosal lesions in the bowel will be removed and examined histologically. The primary analysis will be a comparison of the risk of recurrence of neoplastic polyps in the two aspirin groups versus the placebo group during the period between randomization and the 3-year exam. In secondary analyses, differences between the two aspirin doses will be investigated, and the effect of aspirin use on the size and number of neoplastic polyps will be investigated. The study will have at least 90% power to detect a 40: reduction in polyp recurrence risk between either of the 2 aspirin groups and the placebo group, assuming a 40% recurrence risk in the placebo group (as suggested by our previous studies). Aspirin is being increasingly used as a preventive agent against cardiovascular diseases, and this study will elucidate whether this intervention will also prevent colorectal neoplasms. The study will also help elucidate the biology of large bowel carcinogenesis by defining the impact of a prostaglandin synthetase inhibitor on the occurrence of neoplastic polyps.