BACKGROUND: Reports of severe gastrointestinal side effects associated with sodium polystyrene sulfonate (SPS), particularly intestinal necrosis, have led some to recommend costlier alternative medications. No prior systematic review has included studies with controls reporting intestinal necrosis rates associated with SPS.

METHODS: A systematic literature search was conducted using Cochrane Library, Embase, Medline, Google Scholar, PubMed, Scopus, and Web of Science Core Collection from database inception through October 4, 2020. We included any clinical trial, cohort, or case-control study reporting an association between SPS and intestinal necrosis or severe gastrointestinal side effects.

RESULTS: Six studies including 26,716 patients treated with SPS with controls met inclusion criteria. The pooled odds ratio (OR) of intestinal necrosis was 1.43 (95% CI, 0.39-5.20). The pooled hazard ratio (HR) for intestinal necrosis from the two studies that performed survival analysis was 2.00 (95% CI, 0.45-8.78). The pooled HR for the composite outcome of severe gastrointestinal adverse events was 1.46 (95% CI, 1.01-2.11).

CONCLUSION: Based on our review of six studies, the risk of intestinal necrosis with SPS is not statistically greater than controls, although there was a statistically significantly increased risk for the composite outcome of severe gastrointestinal side effects based on two studies. Because of the risk of bias from potential confounding and selective reporting, the overall strength of evidence to support an association between SPS and intestinal necrosis or other severe gastrointestinal side effects is low. PROSPERO registration CRD42020213119.

背景：与聚苯乙烯磺酸钠 (SPS) 相关的严重胃肠道副作用的报告，特别是肠坏死，导致一些人推荐更昂贵的替代药物。之前没有系统评价纳入对照报告与 SPS 相关的肠坏死率的研究。

方法：使用 Cochrane Library、Embase、Medline、Google Scholar、PubMed、Scopus 和 Web of Science Core Collection 从数据库开始到 2020 年 10 月 4 日进行了系统的文献检索。我们纳入了任何临床试验、队列或病例对照研究报告了 SPS 与肠坏死或严重胃肠道副作用之间的关联。

结果：六项研究（包括 26,716 名接受 SPS 治疗的患者和对照组）符合纳入标准。肠坏死的汇总比值比 (OR) 为 1.43（95% CI，0.39-5.20）。来自进行生存分析的两项研究的肠坏死的汇总风险比 (HR) 为 2.00（95% CI，0.45-8.78）。严重胃肠道不良事件复合结果的汇总 HR 为 1.46（95% CI，1.01-2.11）。

结论：根据我们对六项研究的回顾，SPS 导致肠坏死的风险在统计学上并不高于对照组，尽管根据两项研究，严重胃肠道副作用的复合结果的风险在统计学上显着增加。由于潜在混杂和选择性报告存在偏倚风险，支持 SPS 与肠坏死或其他严重胃肠道副作用之间关联的证据的总体强度较低。PROSPERO 注册 CRD42020213119。