The Effect of Celecoxib, a Cyclooxygenase-2 Inhibitor, in Familial Adenomatous Polyposis

作者：Gideon Steinbach, Patrick M. Lynch, Robin K. S. Phillips, Marina Helen Wallace, Ernest T. Hawk, Gary Gordon, Naoki Wakabayashi, Brian P. Saunders, Yu Shen, Takashi Fujimura, Li-Kuo Su, Bernard S. Levin, LOUIS B. GODIO, Sherri L. Patterson, Miguel A. Rodrı́guez-Bigas, Susan L. Jester, Karen L. King, Marta Schumacher, James L. Abbruzzese, Raymond N. DuBois, Walter N. Hittelman, Stuart O. Zimmerman, Jeffrey W. Sherman, Gary J. Kelloff · 发表于：New England Journal of Medicine · 年份：2000 · DOI：10.1056/nejm200006293422603 · 被引用次数：2538 · 研究领域：Inflammatory mediators and NSAID effects、Genetic factors in colorectal cancer、Cancer, Stress, Anesthesia, and Immune Response

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 gro...