Disproportionality analysis.

Background
Ischemic colitis (IC) is a serious but underrecognized complication potentially associated with bowel preparation. While previous studies have reported sporadic cases, the true frequency and drug-specific associations remain unclear. This study evaluates the association between oral bowel cleansers and IC using real-world pharmacovigilance data.
Methods
We conducted a disproportionality analysis using 20 years of data (2004–2024) from the FDA Adverse Event Reporting System (FAERS). IC cases linked to bisacodyl, polyethylene glycol (PEG), and oral sulfate solution (OSS) were identified. Multivariate logistic regression was applied to explore factors associated with IC and serious clinical outcomes.
Results
Among 43,958 adverse event reports related to bowel cleansers, 75 cases of IC were identified. Bisacodyl showed the strongest disproportionality signal for IC (reporting odds ratio (ROR) = 237.25), with a reporting proportion of 7.9%, followed by PEG (ROR = 2.18) and OSS (ROR = 3.64). Older age (≥70 years) and cardiovascular comorbidities were associated with more severe outcomes, such as hospitalization and death. Notably, reports of IC associated with PEG included six fatal and three life-threatening events.
Conclusions
To our knowledge, this is one of the largest pharmacovigilance analyses exploring ischemic colitis associated with bowel preparation agents. The findings raise concerns about the presumed safety of PEG and reveal a strong disproportionality signal for bisacodyl. These results highlight the need for individualized bowel preparation strategies, especially in elderly patients with comorbidities.

背景
缺血性结肠炎（Ischemic colitis, IC）是一种严重却常被忽视的并发症，可能与肠道准备操作相关。尽管既往研究已有散发病例报道，但其真实发生频率及与特定药物的关联仍尚不明确。本研究利用真实世界药物警戒数据，探讨口服肠道清洁剂与缺血性结肠炎之间的关联。
方法
本研究采用美国食品药品监督管理局不良事件报告系统（FDA Adverse Event Reporting System, FAERS）2004-2024年共20年的数据开展不成比例分析。筛选出与比沙可啶、聚乙二醇（polyethylene glycol, PEG）及口服硫酸盐溶液（oral sulfate solution, OSS）相关的缺血性结肠炎病例，并采用多因素logistic回归分析，探究与缺血性结肠炎及严重临床结局相关的影响因素。
结果
在43958份与肠道清洁剂相关的不良事件报告中，共识别出75例缺血性结肠炎病例。比沙可啶与缺血性结肠炎的不成比例分析信号最强，报告比值比（reporting odds ratio, ROR）为237.25，报告占比为7.9%；其次为聚乙二醇（ROR=2.18）与口服硫酸盐溶液（ROR=3.64）。高龄（≥70岁）及合并心血管疾病与更严重的临床结局（如住院、死亡）显著相关。值得注意的是，与聚乙二醇相关的缺血性结肠炎报告中，包含6例致死性病例及3例危及生命的事件。
结论
据我们所知，本研究是探索肠道准备制剂相关缺血性结肠炎的规模最大的药物警戒分析之一。研究结果引发了对聚乙二醇预设安全性的担忧，同时揭示了比沙可啶与缺血性结肠炎间极强的不成比例分析信号。上述结果凸显了制定个体化肠道准备方案的必要性，尤其针对合并基础疾病的老年患者。