The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis
The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis
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DOI：
10.1056/nejm200006293422603
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发表时间：
2000-06-29
影响因子：
158.5
通讯作者：
Kelloff, G
中科院分区：
文献类型：
--
作者：
Steinbach, G;Lynch, PM;Kelloff, G
背景：家族性腺瘤性息肉病患者患结直肠癌的风险接近100%。在这种疾病中，非甾体类抗炎药物的化学预防作用可能与其抑制环氧化酶-2有关。方法：研究选择性环氧化酶-2抑制剂塞来昔布对家族性腺瘤性息肉病患者结肠息肉的治疗作用。在一项双盲、安慰剂对照研究中，我们随机分配77名患者接受塞来昔布（100或400毫克，每日两次）或安慰剂治疗，疗程为6个月。在研究开始和结束时，患者接受了内窥镜检查。我们从照片和录像带中确定了息肉的数量和大小；对治疗的反应表示为与基线的平均百分比变化。结果：在基线上，15名安慰剂组患者的息肉病灶区息肉数平均值（+/-SD）为15.5+/-13.4个，32名每天两次100 mg塞来昔布组患者为11.5+/-8.5个，30名每天两次400 mg塞来昔布组患者为12.3+/-8.2个（组间比较P=0.66）。六个月后，每天两次接受400毫克塞来昔布的患者结肠直肠息肉的平均数量减少了28.0%（与安慰剂相比，P = 0.003），息肉负荷（息肉直径的总和）减少了30.7% (P = 0.001)，而安慰剂组分别减少了4.5%和4.9%。一组内窥镜专家回顾了录像，证实了每天服用两次400毫克的人群结肠息肉病程度的改善。每天两次服用100毫克塞来昔布的组分别减少了11.9%（与安慰剂相比P = 0.33）和14.6% （P = 0.09）。两组间不良事件发生率相似。结论：在家族性腺瘤性息肉病患者中，给予400 mg塞来昔布（一种环氧化酶-2抑制剂）治疗6个月，可显著减少结直肠息肉的数量。[J] .中华医学杂志，2000;32(2):446 - 452。(C)2000年，马萨诸塞州医学协会。
Background: Patients with familial adenomatous polyposis have a nearly 100 percent risk of colorectal cancer. In this disease, the chemopreventive effects of nonsteroidal antiinflammatory drugs may be related to their inhibition of cyclooxygenase-2.Methods: We studied the effect of celecoxib, a selective cyclooxygenase-2 inhibitor, on colorectal polyps in patients with familial adenomatous polyposis. In a double-blind, placebo-controlled study, we randomly assigned 77 patients to treatment with celecoxib (100 or 400 mg twice daily) or placebo for six months. Patients underwent endoscopy at the beginning and end of the study. We determined the number and size of polyps from photographs and videotapes; the response to treatment was expressed as the mean percent change from base line.Results: At base line, the mean (+/-SD) number of polyps in focal areas where polyps were counted was 15.5+/-13.4 in the 15 patients assigned to placebo, 11.5+/-8.5 in the 32 patients assigned to 100 mg of celecoxib twice a day, and 12.3+/-8.2 in the 30 patients assigned to 400 mg of celecoxib twice a day (P=0.66 for the comparison among groups). After six months, the patients receiving 400 mg of celecoxib twice a day had a 28.0 percent reduction in the mean number of colorectal polyps (P = 0.003 for the comparison with placebo) and a 30.7 percent reduction in the polyp burden (the sum of polyp diameters) (P = 0.001), as compared with reductions of 4.5 and 4.9 percent, respectively, in the placebo group. The improvement in the extent of colorectal polyposis in the group receiving 400 mg twice a day was confirmed by a panel of endoscopists who reviewed the videotapes. The reductions in the group receiving 100 mg of celecoxib twice a day were 11.9 percent (P = 0.33 for the comparison with placebo) and 14.6 percent (P = 0.09), respectively. The incidence of adverse events was similar among the groups.Conclusions: In patients with familial adenomatous polyposis, six months of twice-daily treatment with 400 mg of celecoxib, a cyclooxygenase-2 inhibitor, leads to a significant reduction in the number of colorectal polyps. (N Engl J Med 2000;342:1946-52.) (C)2000, Massachusetts Medical Society.