不良事件报告系统与患者问卷调查显示的炎性肠病患者使用皮质类固醇的不良事件负担差异。

Eman Al Sulais, Edouard Louis, Bernd Bokemeyer, Krisztina B Gecse, Gareth C Parkes, Miles Parkes, Christian Selinger, Melvin Munsaka, Meng Liu, James Crooks, Tricia Finney-Hayward, Tim Raine
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引用次数: 0

摘要

背景和目的:皮质类固醇被广泛用于治疗炎症性肠病(IBD)。虽然皮质类固醇的不良事件已得到广泛认可,但目前对 IBD 中皮质类固醇相关不良事件负担的了解仍不全面:从食品药品管理局不良事件报告系统(FAERS)和 VigiBase 数据库中提取了泼尼松/泼尼松龙和布地奈德的不良事件报告。将总的和经常报告的 AEs 列成表格,并采用比例报告率标准将特别关注的 AEs 与所有药物的报告进行比较。数据库报告与患者调查中报告的皮质类固醇暴露和AE回忆进行了比较:在 FAERS 和 VigiBase 中,IBD 患者分别报告了 344140 例和 42836 例 AE,其中分别有 10157 例 [3.0%] 和 11391 例 [26.6%] 与泼尼松/泼尼松龙或布地奈德有关。随着时间的推移,与 IBD 患者使用皮质类固醇相关的 AEs 有所增加。肾上腺功能不全、库欣氏并发症、骨坏死、骨质疏松症、糖尿病和胰腺炎与皮质类固醇的报道不成比例。在回复调查的 9229 名患者中,有 6434 人[69.7%]报告接触过皮质类固醇。泼尼松[61.9%]与布地奈德[27.4%; p = 0.0001]相比,接触过泼尼松的患者更常回忆起AEs。最常回忆起的不良反应与药物警戒数据库中报告的不良反应不同,包括体重增加、睡眠问题、情绪障碍和皮肤变化。年轻患者和有精神疾病的患者更有可能回忆起自杀念头/企图:结论:与IBD相关的皮质类固醇激素使用相关的不良反应很常见。患者报告了影响生活质量的不良反应,而临床医生则根据客观诊断标准报告了过多的不良反应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Differences in the Adverse Event Burden of Corticosteroid Use in Inflammatory Bowel Disease as Reported Between Adverse Event Reporting Systems and a Patient Questionnaire.

Background and aims: Corticosteroids are widely used in managing inflammatory bowel disease [IBD]. While adverse events [AEs] of corticosteroids are well recognised, current understanding of corticosteroid-related AE burden in IBD remains incomplete.

Methods: AE reports for prednisone/prednisolone and budesonide were extracted from the Food and Drug Administration Adverse Event Reporting System [FAERS] and VigiBase databases. Total and frequently reported AEs were tabulated, and AEs of special interest were compared with reports for all drugs using proportional reporting ratio criteria. Database reports were compared with AEs reported in a patient survey capturing corticosteroid exposure and AE recall.

Results: In FAERS and VigiBase, 344,140 and 42,836 AEs were reported, respectively, in patients with IBD; among these, 10,157 [3.0%] and 11,391 [26.6%], respectively, were related to prednisone/prednisolone or budesonide. AEs associated with corticosteroid use in IBD increased over time. Adrenal insufficiency, Cushingoid complications, osteonecrosis, osteoporosis, diabetes and pancreatitis were disproportionately reported for corticosteroids. Among 9229 patients who responded to the survey, 6434 [69.7%] reported corticosteroid exposure. AEs were more frequently recalled by patients exposed to prednisone [61.9%] vs budesonide [27.4%; p = 0.0001]. The most commonly recalled AEs differed from those reported in the pharmacovigilance databases and included weight gain, sleep problems, mood disturbance and skin changes. Younger patients and those with mental health disorders were more likely to recall suicidal thoughts/attempts.

Conclusions: AEs associated with IBD-related corticosteroid use were frequent. Patients reported AEs affecting quality of life, while clinicians disproportionately reported AEs based on objective diagnostic criteria.

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