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炎症性肠病中英夫利昔单抗剂量的稳定性:来自美国多中心图表回顾的结果。

Stability of infliximab dosing in inflammatory bowel disease: results from a multicenter US chart review.

机构信息

Centocor Ortho Biotech Services, LLC , Horsham, PA, USA.

出版信息

J Med Econ. 2011;14(4):397-402. doi: 10.3111/13696998.2011.583152. Epub 2011 May 19.

DOI:10.3111/13696998.2011.583152
PMID:21595522
Abstract

OBJECTIVE

Infliximab dosing for inflammatory bowel disease (IBD) is based on patient weight and treatment response. Understanding dosing patterns may provide insight into treatment response and predictability of treatment cost. The purpose of this medical record review was to assess dose and dose frequency of infliximab maintenance treatment in patients with IBD using patient chart data.

METHODS

A retrospective chart review was conducted at 14 community gastroenterology clinics (GI clinics). Patients were aged ≥18 years, diagnosed with Crohn's disease (CD) or ulcerative colitis (UC), and had a first infliximab administration (index date) between January 1, 2005 and September 30, 2007. At least 24 months of continuous data availability were required with dosing data collected for 12 months after initiation of infliximab therapy. Patients with biologic use and/or participation in an IBD clinical trial within 12 months before the index date were excluded.

RESULTS

Charts from 182 CD patients and 86 UC patients were analyzed. About half of the patients were female. Over 90% of patients initiated treatment with infliximab 5 mg/kg. Among CD patients and UC patients, respectively, 79% and 61% continued receiving this dose for maintenance therapy at stable intervals.

LIMITATIONS

This retrospective descriptive study is limited by the type and quantity of information available in patient charts from 14 GI clinics during the first year of infliximab treatment. Further, non-anti-tumor necrosis factor medication data were intermittently collected in some charts and, therefore, did not allow for analysis.

CONCLUSIONS

Weight-based dosing and, presumably, patient response enabled providers to find the effective infliximab dose for IBD patients. The maintenance dose and administration frequency remained stable during the initial year.

摘要

目的

炎症性肠病(IBD)的英夫利昔单抗剂量基于患者体重和治疗反应。了解给药模式可能有助于了解治疗反应和预测治疗成本。本病历回顾的目的是使用患者图表数据评估 IBD 患者英夫利昔单抗维持治疗的剂量和剂量频率。

方法

在 14 家社区胃肠病学诊所(GI 诊所)进行了回顾性图表审查。患者年龄≥18 岁,诊断为克罗恩病(CD)或溃疡性结肠炎(UC),并且在 2005 年 1 月 1 日至 2007 年 9 月 30 日之间首次接受英夫利昔单抗治疗(索引日期)。在开始英夫利昔单抗治疗后 12 个月内需要至少有 24 个月的连续数据可用性,并收集了生物制剂使用和/或在索引日期前 12 个月内参与 IBD 临床试验的数据。

结果

分析了 182 例 CD 患者和 86 例 UC 患者的图表。超过一半的患者为女性。超过 90%的患者以英夫利昔单抗 5mg/kg 开始治疗。分别在 CD 患者和 UC 患者中,79%和 61%的患者继续以稳定的间隔接受此剂量进行维持治疗。

局限性

本回顾性描述性研究受 14 家 GI 诊所英夫利昔单抗治疗第一年患者图表中可用信息的类型和数量限制。此外,在一些图表中,间歇性地收集了非抗肿瘤坏死因子药物数据,因此无法进行分析。

结论

基于体重的给药和可能的患者反应使提供者能够为 IBD 患者找到有效的英夫利昔单抗剂量。在最初的一年中,维持剂量和给药频率保持稳定。

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