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长期使用聚戊烯硫酸钠与黄斑病变的关联性:来自美国队列的研究结果。

Association of macular disease with long-term use of pentosan polysulfate sodium: findings from a US cohort.

机构信息

Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia, USA

Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia, USA.

出版信息

Br J Ophthalmol. 2020 Aug;104(8):1093-1097. doi: 10.1136/bjophthalmol-2019-314765. Epub 2019 Nov 6.

Abstract

BACKGROUND/AIMS: A series at a single clinical centre recently demonstrated an association between the interstitial cystitis drug pentosan polysulfate sodium (PPS) and a vision-threatening pigmentary maculopathy. The aim of this study was to determine if an association exists between PPS use and macular disease in a large national cohort.

METHODS

A retrospective, matched cohort study using data from a large US medical claims database from 2002 to 2016 was performed. A total of 3012 and 1604 PPS users were compared with 15 060 and 8017 matched controls at 5 and 7 years, respectively. The primary outcome measures included (1) any new diagnosis of a hereditary or secondary pigmentary maculopathy (atypical maculopathy outcome), and (2) any new diagnosis of dry age-related macular degeneration (AMD) or drusen in addition to the aforementioned diagnoses (atypical maculopathy+AMD outcome).

RESULTS

At the 5-year and 7-year follow-up, 9 (0.3%) and 10 (0.6%) PPS patients progressed to the atypical maculopathy outcome compared with 32 (0.2%) and 25 (0.3%) control patients, respectively. 103 (3.4%) and 87 (5.4%) PPS patients developed the atypical maculopathy+AMD outcome compared with 440 (2.9%) and 328 (4.1%) control patients at 5 and 7 years, respectively. At 5 years, multivariate analysis showed no significant association (p>0.13). At 7 years, PPS users had significantly increased odds of having the atypical maculopathy+AMD outcome (OR=1.41, 95% CI 1.09 to 1.83, p=0.009).

CONCLUSIONS

PPS exposure was associated with a new diagnosis of macular disease at the 7-year follow-up in a large national cohort.

摘要

背景/目的:最近在一个单一临床中心的一系列研究表明,间质性膀胱炎药物聚戊烯糖硫酸钠(PPS)与一种威胁视力的色素性黄斑病变之间存在关联。本研究的目的是在一个大型全国队列中确定 PPS 使用与黄斑疾病之间是否存在关联。

方法

使用来自 2002 年至 2016 年的大型美国医疗索赔数据库进行回顾性、匹配队列研究。在 5 年和 7 年的随访中,分别将 3012 名和 1604 名 PPS 使用者与 15060 名和 8017 名匹配对照者进行比较。主要观察指标包括:(1)任何新诊断的遗传性或继发性色素性黄斑病变(非典型黄斑病变结果),以及(2)除上述诊断外,任何新诊断的干性年龄相关性黄斑变性(AMD)或玻璃膜疣(非典型黄斑病变+AMD 结果)。

结果

在 5 年和 7 年的随访中,9 名(0.3%)和 10 名(0.6%)PPS 患者进展为非典型黄斑病变结果,而 32 名(0.2%)和 25 名(0.3%)对照患者分别进展为非典型黄斑病变结果。103 名(3.4%)和 87 名(5.4%)PPS 患者在 5 年和 7 年时分别发展为非典型黄斑病变+AMD 结果,而 440 名(2.9%)和 328 名(4.1%)对照患者分别发展为非典型黄斑病变+AMD 结果。在 5 年时,多变量分析显示无显著相关性(p>0.13)。在 7 年时,PPS 使用者发生非典型黄斑病变+AMD 结果的可能性显著增加(OR=1.41,95%CI 1.09 至 1.83,p=0.009)。

结论

在一个大型全国队列中,PPS 暴露与 7 年随访时黄斑疾病的新诊断相关。

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