Cole J Alexander, Cook Suzanne F, Sands Bruce E, Ajene Anuli N, Miller David P, Walker Alexander M
Ingenix Epidemiology, Newton, Massachusetts 02466, USA.
Am J Gastroenterol. 2004 Mar;99(3):486-91. doi: 10.1111/j.1572-0241.2004.04097.x.
In November 2000, alosetron HCl (Lotronex), a treatment for irritable bowel syndrome (IBS), was removed from the U.S. market in part because of the occurrence of colon ischemia in treated patients. Since the relation between colon ischemia and IBS is poorly understood, we evaluated the incidence of colon ischemia among people with and without IBS.
Using medical claims data from a large health care organization in the United States, we identified 87,449 people with an IBS diagnosis between January 1995 and December 1999. We calculated age- and sex-specific incidence rates in the general population and in IBS patients.
There were 740 cases of colon ischemia during 8.5 million person-years of observation in 5.4 million persons. The crude incidence rate was 42.8 cases per 100,000 person-years for IBS patients. By comparison, the incidence rate was 7.2 per 100,000 person-years in the general population. After adjustment for age, sex, and calendar year, the incidence of colon ischemia in people with IBS was 3.4 times higher than in persons without (95% CI 2.6-4.5).
Rates of colon ischemia among patients carrying a diagnosis of IBS are substantially higher than in the general population. Colon ischemia, though unusual in IBS patients, may nonetheless constitute a distinct part of the IBS natural history. Alternatively, it may be a consequence of therapy, or a manifestation of other bowel pathology that is sometimes confused with IBS.
2000年11月,用于治疗肠易激综合征(IBS)的盐酸阿洛司琼(洛曲克)从美国市场撤市,部分原因是接受治疗的患者出现了结肠缺血。由于结肠缺血与IBS之间的关系尚不清楚,我们评估了患有和未患有IBS的人群中结肠缺血的发生率。
利用美国一家大型医疗保健机构的医疗理赔数据,我们确定了1995年1月至1999年12月期间87449例诊断为IBS的患者。我们计算了普通人群和IBS患者中按年龄和性别划分的发病率。
在540万人850万人年的观察期内,有740例结肠缺血病例。IBS患者的粗发病率为每10万人年42.8例。相比之下,普通人群的发病率为每10万人年7.2例。在对年龄、性别和日历年份进行调整后,患有IBS的人群中结肠缺血的发生率比未患IBS的人群高3.4倍(95%可信区间2.6 - 4.5)。
诊断为IBS的患者中结肠缺血的发生率显著高于普通人群。结肠缺血在IBS患者中虽不常见,但仍可能构成IBS自然病程的一个独特部分。或者,它可能是治疗的结果,或是有时与IBS混淆的其他肠道病变的表现。