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炎症性肠病患者全身类固醇使用和手术率的变化:日本真实世界数据库分析。

Change in systemic steroid use and surgery rate in patients with inflammatory bowel disease: a Japanese real-world database analysis.

机构信息

Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, S1 W17, Chuo-Ku, Sapporo-Shi, Hokkaido, 060-8556, Japan.

AbbVie GK, 3-1-21 Shibaura, Minato-Ku, Tokyo, 108-0023, Japan.

出版信息

J Gastroenterol. 2024 May;59(5):389-401. doi: 10.1007/s00535-024-02086-y. Epub 2024 Mar 16.


DOI:10.1007/s00535-024-02086-y
PMID:38492011
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11033244/
Abstract

BACKGROUND: Corticosteroids are recommended only for induction of remission in inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD). This study aimed to evaluate the change in pharmacologic treatment use, particularly systemic corticosteroids, over approximately 30 years, and the impact of biologics on IBD treatment since their appearance in the 2000s. METHODS: This retrospective study conducted in Japan used data from the Phoenix cohort database (January 1990 to March 2021). Patients with disease onset at age ≥ 10 years who received treatment for UC or CD between January 1990 and March 2021 were included. Outcome measures were change in IBD treatments used, total cumulative corticosteroid doses, initial corticosteroid dose, duration of corticosteroid treatment, and surgery rate. RESULTS: A total of 1066 and 579 patients with UC and CD, respectively, were included. In UC, the rate of corticosteroid use as initial treatment was relatively stable regardless of the year of disease onset; however, in CD, its rate decreased in patients who had disease onset after 2006 (before 2006: 14.3-27.8% vs. after 2006: 6.6-10.5%). Compared with patients with disease onset before biologics became available, cumulative corticosteroid doses in both UC and CD, and the surgery rate in CD only, were lower in those with disease onset after biologics became available. CONCLUSIONS: Since biologics became available, corticosteroid use appears to have decreased, with more appropriate use. Furthermore, use of biologics may reduce surgery rates, particularly in patients with CD. UMIN Clinical Trials Registry; UMIN000035384.

摘要

背景:皮质类固醇仅推荐用于炎症性肠病(IBD)的诱导缓解,包括溃疡性结肠炎(UC)和克罗恩病(CD)。本研究旨在评估大约 30 年来皮质类固醇等药物治疗的变化,以及自 21 世纪初出现以来生物制剂对 IBD 治疗的影响。

方法:本研究在日本进行,使用 Phoenix 队列数据库(1990 年 1 月至 2021 年 3 月)的数据。纳入年龄≥10 岁发病、1990 年 1 月至 2021 年 3 月接受 UC 或 CD 治疗的患者。观察指标为 IBD 治疗方法的变化、累积皮质类固醇总剂量、初始皮质类固醇剂量、皮质类固醇治疗持续时间和手术率。

结果:共纳入 1066 例 UC 和 579 例 CD 患者。在 UC 中,无论发病年份如何,皮质类固醇作为初始治疗的使用率相对稳定;而在 CD 中,发病后 2006 年(2006 年前:14.3%-27.8%;2006 年后:6.6%-10.5%)皮质类固醇的使用率降低。与生物制剂问世前发病的患者相比,UC 和 CD 的累积皮质类固醇剂量以及 CD 的手术率在生物制剂问世后发病的患者中均较低。

结论:自生物制剂问世以来,皮质类固醇的使用似乎有所减少,且使用更合理。此外,生物制剂的使用可能会降低手术率,尤其是在 CD 患者中。UMIN 临床研究注册;UMIN000035384。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3f6/11033244/5737f64aea99/535_2024_2086_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3f6/11033244/3fe27f6e12f4/535_2024_2086_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3f6/11033244/953a2485c968/535_2024_2086_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3f6/11033244/d97a0e882478/535_2024_2086_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3f6/11033244/54b4076cd3cc/535_2024_2086_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3f6/11033244/5737f64aea99/535_2024_2086_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3f6/11033244/3fe27f6e12f4/535_2024_2086_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3f6/11033244/953a2485c968/535_2024_2086_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3f6/11033244/d97a0e882478/535_2024_2086_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3f6/11033244/54b4076cd3cc/535_2024_2086_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3f6/11033244/5737f64aea99/535_2024_2086_Fig5_HTML.jpg

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引用本文的文献

[1]
Nationwide estimates of patient numbers and prevalence rates of ulcerative colitis and Crohn's disease in Japan in 2023.

J Gastroenterol. 2025-9-2

[2]
"Remodeling the intestinal immune microenvironment": immune regulation and tissue regeneration by mesenchymal stem/stromal cells in the repair microenvironment of inflammatory bowel disease.

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[3]
Impact of Concomitant Prescriptions and Lifestyle Factors on the Initial Course of Newly Diagnosed Inflammatory Bowel Disease.

Inflamm Intest Dis. 2024-10-14

本文引用的文献

[1]
Effectiveness and Factors Associated with Response to Golimumab in Japanese Patients with Ulcerative Colitis in Real Clinical Practice: The Phoenix Study.

Inflamm Intest Dis. 2023-8-31

[2]
Long-Term Clinical Effectiveness of Ustekinumab in Patients With Crohn's Disease: A Retrospective Cohort Study.

Crohns Colitis 360. 2020-7-28

[3]
Real-world utilization of top-down and step-up therapy and initial costs in Crohn disease.

J Manag Care Spec Pharm. 2022-8

[4]
ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment.

J Crohns Colitis. 2022-1-28

[5]
Changes in the Long-term Prognosis of Crohn's Disease between 1986 and 2015: The Population-Based Songpa-Kangdong Inflammatory Bowel Disease Cohort Study.

Gut Liver. 2022-3-15

[6]
Steroid use and misuse: a key performance indicator in the management of IBD.

Frontline Gastroenterol. 2020-4-2

[7]
Evidence-based clinical practice guidelines for inflammatory bowel disease 2020.

J Gastroenterol. 2021-6

[8]
Trends in Corticosteroid Use During the Era of Biologic Therapy: A Population-Based Analysis.

Am J Gastroenterol. 2021-6-1

[9]
Real-World Prescription Pattern and Healthcare Cost Among Patients with Ulcerative Colitis in Japan: A Retrospective Claims Data Analysis.

Adv Ther. 2021-5

[10]
Contemporary Risk of Surgery in Patients With Ulcerative Colitis and Crohn's Disease: A Meta-Analysis of Population-Based Cohorts.

Clin Gastroenterol Hepatol. 2021-10

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