Validation of diagnostic magnetic resonance imaging criteria for multiple sclerosis and response to interferon β1a
Validation of diagnostic magnetic resonance imaging criteria for multiple sclerosis and response to interferon β1a
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DOI：
10.1002/ana.10551
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发表时间：
2003-06-01
影响因子：
11.2
通讯作者：
Filippi, M
中科院分区：
文献类型：
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作者：
Barkhof, F;Rocca, M;Filippi, M
在McDonald最近提出的多发性硬化（MS）诊断标准中，已纳入了改良的磁共振成像（MRI）Barkhof标准。我们在MS早期治疗研究中检验了这种实施的有效性，这是一项随机、双盲、安慰剂对照研究，在309例首次发作与脱髓鞘疾病（和异常MRI）一致的患者中每周一次皮下注射22 μ g干扰素β 1a。41%的患者在随访2年内转换为临床确诊的MS（CDMS），表现为新的临床发作（与治疗无关）有钆增强或9个或更多T2病变的患者与11%没有任何发现的患者（p = 0.017）;类似地，幕下病变的转化率为44%对31（p = 0.026），40%对35%的脑皮质病变（p = 0.413），41%对17%的三个或更多脑室周围病变（p = 0.034）。根据改良Barkhof标准的数量，两个或两个以下阳性标准的CDMS转换率为22%，四个阳性标准的转换率增加到47%。对于三个阳性标准的截止值，至CDMS时间的风险比为2.3（95%置信区间，1.17-4.55; p = 0.016）。随着阳性标准数量的增加，治疗效果似乎更明显，避免一例患者转为CDMS所需的患者数量从1例或2例阳性标准患者的50例减少到4例阳性标准患者的5.6例。然而，该研究不足以检测变量相互作用的统计学显著性治疗，这仍然是进一步研究的重要问题。
In the recently proposed diagnostic criteria for multiple sclerosis (MS) by McDonald, the modified magnetic resonance imaging (MRI) Barkhof criteria have been incorporated. We examined the validity of this implementation in the Early Treatment of MS study, a randomized, double-blind, placebo-controlled study of 22mug interferon beta1a given subcutaneously once weekly in 309 patients with a first episode consistent with demyelinating disease (and abnormal MRI). Conversion to clinically definite MS (CDMS) within 2 years of follow-up, as evidenced by a new clinical episode, occurred in 41% of patients (independent of treatment) with gadolinium enhancement or nine or more T2 lesions versus 11% of those without either finding (p = 0.017); similarly, proportions converting were 44% versus 31% for infratentorial lesions (p = 0.026), 40% versus 35% for juxtacortical lesions (p = 0.413), and 41% versus 17% for three or more periventricular lesions (p = 0.034). The rate of conversion to CDMS based on the number of modified Barkhof criteria was 22% for two or fewer positive criteria, increasing to 47% with four positive criteria. For a cutoff of three positive criteria, the hazard ratio for time to CDMS was 2.3 (95% confidence interval, 1.17-4.55; p = 0.016). Treatment effect seemed more evident as the number of positive criteria increased, and the number of patients needed to avoid one patient converting to CDMS decreased from 50 in patients with one or two positive criteria to 5.6 in patients with four positive criteria. However, the study was not powered to detect statistically significant treatment by variable interaction, and this remains an important issue for further study.