Anahuac University, Naucalpan de Juárez, Mexico.
Massachusetts General Hospital, Boston, MA.
Urology. 2021 Jan;147:109-118. doi: 10.1016/j.urology.2020.08.072. Epub 2020 Oct 10.
To conduct a review of current literature to assess whether an association exists between Pentosan Polysulfate Sodium and the development of macular disease, as it is the only oral medication approved by the Food and Drug Administration for the management of interstitial cystitis.
A systematic review was conducted by the authors separately, with review methods established prior to the conduct of the review. Databases searched included PubMed, Ovid, Medline, EBSCO, and Google Scholar. A search was conducted for the terms "Pentosan Polysulfate Maculopathy," "Pentosan Polysulfate Retinopathy," and "Interstitial Cystitis Maculopathy." All papers reporting on primary data were included. There were no study sponsors.
A total of 14 papers reporting on primary data were identified. Most papers reported on the development of macular disease in the setting of chronic pentosan polysulfate sodium exposure. No randomized controlled trials have been performed to date and data was insufficient to perform a meta-analysis. Nevertheless, patients with interstitial cystitis were more likely to receive a diagnosis of maculopathy after several years of the medication use.
Although the nature of the published studies renders them prone to confounders, currently available data suggest an increased risk for developing maculopathy after years of pentosan polysulfate sodium use. In light of this, and the marginal effectiveness of the medication for the average individual, we suggest that education be provided as to the possible association and that regular ophthalmic evaluation be recommended for patients who are continued on chronic Pentosan Polysulfate Sodium.
对当前文献进行综述,以评估戊聚糖多硫酸钠与黄斑病变发展之间是否存在关联,因为它是食品和药物管理局唯一批准用于治疗间质性膀胱炎的口服药物。
作者分别进行了系统评价,在进行评价之前制定了评价方法。搜索的数据库包括 PubMed、Ovid、Medline、EBSCO 和 Google Scholar。搜索了“戊聚糖多硫酸钠黄斑病变”、“戊聚糖多硫酸钠视网膜病变”和“间质性膀胱炎黄斑病变”等术语。纳入了所有报告原始数据的论文。没有研究赞助商。
共确定了 14 篇报告原始数据的论文。大多数论文报告了在慢性戊聚糖多硫酸钠暴露的情况下黄斑病变的发展。迄今为止,尚未进行随机对照试验,且数据不足以进行荟萃分析。然而,接受间质性膀胱炎治疗的患者在使用药物数年后更有可能被诊断为黄斑病变。
尽管已发表的研究具有易受混杂因素影响的性质,但目前可用的数据表明,在使用戊聚糖多硫酸钠多年后,发生黄斑病变的风险增加。鉴于此,以及该药物对普通个体的边际疗效,我们建议对可能的关联进行教育,并建议继续使用慢性戊聚糖多硫酸钠的患者定期进行眼科评估。