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多发性硬化症免疫调节药物的长期持续治疗:一项回顾性数据库研究。

Long-term persistence with the immunomodulatory drugs for multiple sclerosis: a retrospective database study.

机构信息

Faculty of Medicine Neurology, University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

Clin Ther. 2012 Feb;34(2):341-50. doi: 10.1016/j.clinthera.2012.01.006. Epub 2012 Jan 31.

DOI:10.1016/j.clinthera.2012.01.006
PMID:22296946
Abstract

BACKGROUND

Immunomodulatory drugs (IMDs) for multiple sclerosis (MS) have been available in Canada since 1995 and are currently the most commonly prescribed treatment for MS. However, relatively little is known about the long-term persistence to these drugs.

OBJECTIVE

The purpose of this study was to describe patterns of, and factors associated with, long-term persistence to the first-line IMDs in an MS population in British Columbia, Canada.

METHODS

Study data were collected from the British Columbia MS database. Adults from British Columbia with definite MS who were prescribed a first-line IMD (interferon beta-1b, interferon beta-1a [subcutaneous and intramuscular], and glatiramer acetate) from January 1, 1995, through December 31, 2008, were eligible for the study. Time to discontinuation of use of all first-line IMDs (ie, switching among IMD therapies was allowed) and the initially prescribed IMD was assessed using Kaplan-Meier survival analysis and multivariate Cox regression.

RESULTS

A total of 1896 patients were included. Mean (SD) age was 40.2 (9.5) years, and 75.1% were female. Median time to discontinuation of all first-line IMD therapies was 6.3 years (95% CI, 5.8-6.7 years). Patients with a longer disease duration and higher level of disability were at higher risk for discontinuing use of the IMDs. Age, sex, and the initial IMD were not associated with discontinuation. Persistence appeared to have decreased over time (P = 0.01 for trend). Median time to discontinued use of, or switching from, the initially prescribed IMD was 2.9 years (95% CI, 2.5-3.2 years).

CONCLUSIONS

Approximately half of the MS patients discontinued use of their IMD within 6 years. It is unknown whether this persistence is adequate because uncertainties remain regarding the optimal level of persistence to the IMDs. Further investigation is needed to examine why some individuals are more at risk for discontinuation of IMD therapy and why, in contrast to other chronic diseases, persistence to IMDs in patients with MS has not improved over time.

摘要

背景

自 1995 年以来,免疫调节药物(IMD)已在加拿大上市,目前是多发性硬化症(MS)最常用的治疗药物。然而,人们对这些药物的长期持续使用相对知之甚少。

目的

本研究旨在描述不列颠哥伦比亚省(加拿大)MS 人群中,一线 IMD 长期持续使用的模式,并确定与之相关的因素。

方法

本研究的数据来自不列颠哥伦比亚省 MS 数据库。1995 年 1 月 1 日至 2008 年 12 月 31 日期间,在不列颠哥伦比亚省被诊断为明确 MS 且使用一线 IMD(包括干扰素 beta-1b、干扰素 beta-1a [皮下和肌内] 和醋酸格拉替雷)的成年人有资格参与本研究。通过 Kaplan-Meier 生存分析和多变量 Cox 回归评估所有一线 IMD(即允许 IMD 治疗之间转换)的停药时间和最初处方的 IMD。

结果

共纳入 1896 名患者。平均(SD)年龄为 40.2(9.5)岁,75.1%为女性。所有一线 IMD 治疗的中位停药时间为 6.3 年(95%CI,5.8-6.7 年)。疾病持续时间较长和残疾程度较高的患者停止使用 IMD 的风险更高。年龄、性别和初始 IMD 与停药无关。随着时间的推移,这种持续存在的现象似乎有所减少(趋势 P = 0.01)。最初处方的 IMD 停药或转换的中位时间为 2.9 年(95%CI,2.5-3.2 年)。

结论

大约一半的 MS 患者在 6 年内停止使用 IMD。尚不清楚这种持续存在是否足够,因为 IMD 持续使用的最佳水平仍存在不确定性。需要进一步研究以探讨为什么有些个体更有可能停止 IMD 治疗,以及为什么与其他慢性疾病相比,MS 患者对 IMD 的持续存在并没有随着时间的推移而改善。

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