Bielefeldt Klaus
Division of Gastroenterology, University of Pittsburgh Medical Center, Pittsburgh, PA, 15213, USA.
Dig Dis Sci. 2016 Sep;61(9):2655-65. doi: 10.1007/s10620-016-4162-x. Epub 2016 Apr 12.
More than one decade ago, rising cases of ischemic colitis (IC) prompted the Federal Drug Administration to revoke alosetron's approval as treatment of irritable bowel syndrome (IBS). The aim of this study was to identify medical therapies associated with development of IC.
The Federal Adverse Event Reporting System was queried for the time between January 2004 and September 2015. We identified reports listing IC as treatment complication and extracted suspected causative and concomitantly administered drugs, indications for their use and outcomes.
After eliminating duplicates, we found 2811 cases of IC (68.4 % women; 59.4 ± 0.4 years). Patients with IBS accounted for 3.9 % of the cases, mostly attributed to tegaserod or alosetron. Chemotherapeutic and immunosuppressive drugs, sex hormones, and anticoagulants were the most commonly suspected causes. Bisphosphonates, nonsteroidal anti-inflammatory drugs, antipsychotics, triptans, interferon therapy, and laxative use prior to colonoscopy were among the more commonly listed treatments. In 8 %, the adverse event contributed to the patient's death with male sex and older age predicting fatal outcomes.
Beyond confirming known risks of IC, the results identified several potential culprits of ischemic colitis. This information may not only explain the development of this serious adverse event, but could also guide treatment decisions, cautioning healthcare providers when considering these agents in persons with known risk factors or other drugs that may increase their risk of IC.
十多年前，缺血性结肠炎（IC）病例不断增加，促使美国食品药品监督管理局撤销了阿洛司琼治疗肠易激综合征（IBS）的批准。本研究的目的是确定与IC发生相关的药物治疗。
查询2004年1月至2015年9月期间的联邦不良事件报告系统。我们确定了将IC列为治疗并发症的报告，并提取了可疑的致病药物和同时使用的药物、用药指征及结果。
在剔除重复报告后，我们发现了2811例IC病例（68.4%为女性；年龄59.4±0.4岁）。IBS患者占病例的3.9%，主要归因于替加色罗或阿洛司琼。化疗药物、免疫抑制药物、性激素和抗凝剂是最常被怀疑的病因。双膦酸盐、非甾体抗炎药、抗精神病药物、曲坦类药物、干扰素治疗以及结肠镜检查前使用泻药是较常列出的治疗方法。在8%的病例中，不良事件导致患者死亡，男性和老年患者预示着致命结局。
除了确认IC已知的风险外......（此处原文似乎不完整）该结果还确定了缺血性结肠炎的几个潜在罪魁祸首。这些信息不仅可以解释这一严重不良事件的发生，还可以指导治疗决策，提醒医疗保健人员在考虑为有已知风险因素的患者或可能增加其IC风险的其他药物使用这些药物时要谨慎。
