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美国克罗恩病伴和不伴肛周瘘患者的疾病负担观察性研究

Observational Burden of Illness Study in Patients With Crohn's Disease With and Without Perianal Fistulas in the United States.

作者信息

Jiang Jeanne, Cazzetta Susan E, Athavale Amod, Kuharic Maja, Fan Tao, Silber Abigail, Abilash Vijay, Hadker Nandini, Sharpe Emily, Nazarey Pradeep P

机构信息

Takeda Pharmaceuticals USA, Inc., Lexington, Massachusetts.

Trinity Life Sciences, Waltham, Massachusetts.

出版信息

Gastro Hep Adv. 2023 Aug 24;2(8):1066-1076. doi: 10.1016/j.gastha.2023.08.011. eCollection 2023.

Abstract

BACKGROUND AND AIMS

This study compared disease burden, experiences, and health-related quality of life (HRQoL) between patients with Crohn's perianal fistulas (CPFs) and those with Crohn's disease (CD) without perianal fistulas (PFs; non-PF CD).

METHODS

This cross-sectional, observational study was conducted in 3 cohorts of US patients aged 18-89 years with self-reported, physician-diagnosed CD: (1) non-PF CD; (2) CPF without PF-related surgery; and (3) CPF with PF-related surgery. Data on medical and surgical interventions, CD-specific symptoms, HRQoL (assessed using the Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaires), and fecal incontinence (assessed using Revised Faecal Incontinence Scale and Fecal Incontinence Quality of Life questionnaires) were collected via a web-enabled questionnaire.

RESULTS

In total, 403 patients with CD completed the questionnaire (non-PF CD, n = 300; CPF without surgery, n = 51; CPF with surgery, n = 52). A high symptom burden was seen across cohorts. More patients with CPF underwent ≥1 CD-related surgery and experienced ≥1 failure of CD-related surgery (79% and 20%) vs non-PF CD (53% and 9%; < .001). Overall HRQoL outcomes were worse for patients with CPF vs non-PF CD, with significantly worse Short Inflammatory Bowel Disease and 5-dimension EuroQol questionnaire scores for those without PF-related surgery ( < .01). Across all cohorts, 58% of patients reported experiencing fecal incontinence, which had a greater negative impact (higher Revised Faecal Incontinence Scale scores; lower Fecal Incontinence Quality of Life scores) in patients with CPF vs non-PF CD.

CONCLUSION

Patients with CPF experience substantial HRQoL burden, reflecting the impact of symptoms and medical/surgical interventions. These results may help to inform comprehensive care strategies to improve patient HRQoL.

摘要

背景与目的

本研究比较了克罗恩肛周瘘管(CPF)患者与无肛周瘘管(PF;非PF CD)的克罗恩病(CD)患者之间的疾病负担、经历及健康相关生活质量(HRQoL)。

方法

本横断面观察性研究在美国3组年龄18 - 89岁、自我报告且经医生诊断为CD的患者中进行:(1)非PF CD;(2)未进行与PF相关手术的CPF;(3)进行了与PF相关手术的CPF。通过网络问卷收集有关医疗和手术干预、CD特异性症状、HRQoL(使用简短炎症性肠病问卷和5维度欧洲生活质量问卷进行评估)以及大便失禁(使用修订的大便失禁量表和大便失禁生活质量问卷进行评估)的数据。

结果

共有403例CD患者完成问卷(非PF CD,n = 300;未手术的CPF,n = 51;手术的CPF,n = 52)。各队列均观察到较高的症状负担。与非PF CD相比,更多CPF患者接受了≥1次与CD相关的手术且经历了≥1次与CD相关手术失败(分别为79%和20%对比53%和9%;P <.001)。CPF患者的总体HRQoL结果比非PF CD患者更差,未进行与PF相关手术的患者的简短炎症性肠病问卷和5维度欧洲生活质量问卷得分明显更差(P <.01)。在所有队列中,58%的患者报告有大便失禁经历,与非PF CD患者相比,CPF患者的大便失禁产生的负面影响更大(修订的大便失禁量表得分更高;大便失禁生活质量得分更低)。

结论

CPF患者经历了相当大的HRQoL负担,反映了症状及医疗/手术干预的影响。这些结果可能有助于为改善患者HRQoL的综合护理策略提供信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a549/11307624/b0ac42dcad0b/gr1.jpg

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