Ursodeoxycholic acid as a chemopreventive agent in patients with ulcerative colitis and primary sclerosing cholangitis
Ursodeoxycholic acid as a chemopreventive agent in patients with ulcerative colitis and primary sclerosing cholangitis
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DOI：
10.1053/gast.2003.50156
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发表时间：
2003-04-01
期刊：
影响因子：
29.4
通讯作者：
Lindor, KD
中科院分区：
文献类型：
--
作者：
Pardi, DS;Loftus, EV;Lindor, KD
背景与目的：熊去氧胆酸（UDCA）作为结肠癌化学预防剂在临床前研究中显示出有效性。此外，最近的一份报告表明，它也可能降低溃疡性结肠炎（UC）和原发性硬化性胆管炎（PSC）患者发生结直肠发育不良的风险。我们试图在一项随机、安慰剂对照试验中评估UDCA对一组UC和PSC患者结直肠肿瘤的影响。研究方法：根据我们中心先前在PSC中进行的UDCA治疗的随机、安慰剂对照试验，我们对合并UC的患者进行了随访，以评估UDCA与安慰剂相比对结直肠异型增生和癌症发展的影响。结果：52例受试者接受了总计355人年的随访。最初分配接受UDCA的患者发生结直肠异型增生或癌症的相对风险为0.26（95%置信区间，0.06-0.92; P = 0.034）。许多最初分配到安慰剂组的患者最终接受了开放标签UDCA。将这些患者从开始积极治疗时纳入UDCA组并没有改变保护作用的程度（相对风险，0.26; 95%置信区间，0.07-0.99; P = 0.049）。结论：UDCA可显著降低UC和PSC患者发生结直肠异型增生或癌症的风险。
Background & Aims: Ursodeoxycholic acid (UDCA) has shown effectiveness as a colon cancer chemopreventive agent in preclinical studies. In addition, a recent report suggests that it also may decrease the risk for developing colorectal dysplasia in patients with ulcerative colitis (UC) and primary sclerosing cholangitis (PSC). We sought to evaluate the effect of UDCA on colorectal neoplasia in a group of patients with UC and PSC enrolled in a randomized, placebo-controlled trial. Methods: From a prior, randomized, placebo-controlled trial of UDCA therapy in PSC at our center, we followed-up patients with concomitant UC to assess the effect of UDCA on the development of colorectal dysplasia and cancer as compared with placebo. Results: Fifty-two subjects were followed-up for a total of 355 person-years. Those originally assigned to receive UDCA had a relative risk of 0.26 for developing colorectal dysplasia or cancer (95% confidence interval, 0.06-0.92; P = 0.034). Many of the patients originally assigned to the placebo group eventually received open-label UDCA. Assigning these patients to the UDCA group from the time they began active therapy did not change the magnitude of the protective effect (relative risk, 0.26; 95% confidence interval, 0.07-0.99; P = 0.049). Conclusions: UDCA significantly decreases the risk for developing colorectal dysplasia or cancer in patients with UC and PSC.