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英夫利昔单抗治疗溃疡性结肠炎:术前治疗对不列颠哥伦比亚省结肠切除术率和处方实践的影响,加拿大。

Infliximab in ulcerative colitis: the impact of preoperative treatment on rates of colectomy and prescribing practices in the province of British Columbia, Canada.

机构信息

1Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada 2School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada 3Centre for Health Services and Policy Research, University of British Columbia, Vancouver, British Columbia, Canada 4Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

Dis Colon Rectum. 2014 Jan;57(1):83-90. doi: 10.1097/DCR.0000000000000003.

DOI:10.1097/DCR.0000000000000003
PMID:24316950
Abstract

BACKGROUND

Approximately 20% of patients with ulcerative colitis will require surgical treatment. Recent data suggest that infliximab may reduce the need for surgery in patients with severe ulcerative colitis. However, it is unclear whether data from these small trials will translate to reduced colectomy rates in populations with ulcerative colitis.

OBJECTIVE

The purpose of this study was to determine the impact of infliximab on the rates of colectomy for ulcerative colitis and the prescribing practices for infliximab in British Columbia, Canada.

DESIGN

We retrospectively reviewed data from 4 province-wide population-based databases maintained by the British Columbia Ministry of Health, a central registry, a hospital separations file, a physician payment file, and a pharmaceutical file. Data were collected from April 1, 2001, to March 31, 2010.

SETTINGS

This investigation was conducted at the University of British Columbia.

PATIENTS

All patients aged 18 to 75 with ulcerative colitis were included and identified using a validated strategy with International Classification of Diseases 9/10 codes. Patients with severe ulcerative colitis were defined by treatment with a course of corticosteroids during the study period. Patients treated with infliximab were identified using the provincial pharmaceutical file.

MAIN OUTCOME MEASURES

The primary outcome was surgery determined by an International Classification of Diseases 9/10 code for partial or total colectomy.

RESULTS

Between 2001 and 2010, 7227 subjects were identified with ulcerative colitis. The number of subjects with severe ulcerative colitis was 2537. For general ulcerative colitis, rates of colectomy decreased from 9.97% to 8.88% in the preinfliximab era (2003-2004) and postinfliximab era (2008-2009; p = 0.03). For severe ulcerative colitis, there was no significant difference in colectomy rates (9.97% vs 11.14%; p = 0.18). The highest rate of infliximab prescription was found to be in the provincial health region that encompasses the tertiary academic centers of the province.

LIMITATIONS

Although the overall number of patients in this analysis is sizeable, the number of patients who were prescribed infliximab during the study period is relatively modest, which may have impacted trends.

CONCLUSIONS

In the severe ulcerative colitis population, there has been no change in the colectomy rate over time despite the introduction of infliximab.

摘要

背景

约 20%的溃疡性结肠炎患者需要手术治疗。最近的数据表明,英夫利昔单抗可降低重度溃疡性结肠炎患者的手术需求。然而,这些小型试验的数据是否会转化为溃疡性结肠炎人群中结肠切除术率的降低尚不清楚。

目的

本研究旨在确定英夫利昔单抗对溃疡性结肠炎结肠切除术率的影响,并确定在加拿大不列颠哥伦比亚省英夫利昔单抗的处方实践。

设计

我们回顾性地分析了不列颠哥伦比亚省卫生部维护的 4 个全省范围的基于人群的数据库、中央登记处、医院分离文件、医生支付文件和药品文件中的数据。数据收集时间为 2001 年 4 月 1 日至 2010 年 3 月 31 日。

地点

本研究在不列颠哥伦比亚大学进行。

患者

所有年龄在 18 至 75 岁之间的溃疡性结肠炎患者均符合标准,并使用国际疾病分类第 9/10 版的验证策略进行识别。重度溃疡性结肠炎患者定义为在研究期间接受皮质类固醇治疗。使用省级药品文件识别接受英夫利昔单抗治疗的患者。

主要观察指标

主要结局为国际疾病分类第 9/10 版部分或全结肠切除术的手术。

结果

2001 年至 2010 年间,共确定了 7227 例溃疡性结肠炎患者。重度溃疡性结肠炎患者为 2537 例。对于一般溃疡性结肠炎,在英夫利昔单抗治疗前(2003-2004 年)和英夫利昔单抗治疗后(2008-2009 年),结肠切除术率从 9.97%降至 8.88%(p=0.03)。对于重度溃疡性结肠炎,结肠切除术率无显著差异(9.97%比 11.14%;p=0.18)。英夫利昔单抗处方率最高的是省级卫生区,该卫生区涵盖了该省的三级学术中心。

局限性

尽管本分析中的患者总数相当大,但在研究期间接受英夫利昔单抗治疗的患者数量相对较少,这可能会影响趋势。

结论

尽管引入了英夫利昔单抗,但在重度溃疡性结肠炎患者中,随着时间的推移,结肠切除术率并未发生变化。

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