Khan O A, Tselis A C, Kamholz J A, Garbern J Y, Lewis R A, Lisak R P
Department of Neurology, Wayne State University School of Medicine, Detroit, MI, USA.
Eur J Neurol. 2001 Mar;8(2):141-8. doi: 10.1046/j.1468-1331.2001.00189.x.
A prospective, non-randomized, open-label treatment trial was performed in patients with relapsing-remitting multiple sclerosis (RRMS), with follow up for 12 months. Our primary objective was to prospectively compare the effect of IFNbeta-1a (Avonex), IFNbeta-1b (Betaseron), and glatiramer acetate (GA, Copaxone) on the relapse rate in patients with RRMS. Between August 1996 and September 1999, 156 consecutive patients with clinically definite RRMS with a Kurtzke scale (EDSS) score of 4 or less were followed for 12 months, from the time of initiating therapy or electing to remain untreated. Prior 2-year relapse history and available chart information was carefully reviewed at the time of enrolment. Thirty-three of 156 elected no treatment (mean age 32.5 years; mean EDSS 2.64) at enrolment; 40 elected IFNbeta-1a (mean age 32.4 years; mean EDSS 2.69), 41 IFNbeta-1b (mean age 32.1 years; mean EDSS 2.56), and 42 chose GA (mean age 31.5 years; mean EDSS 2.57). Annual relapse rate based upon the 2 years prior to enrolment was 1.08 in the untreated group, 1.20 in the AV group, 1.21 in the BE group, and 1.10 in the GA group. There were no statistically significant differences among the four groups at enrolment. After 12 months of treatment, patients in the untreated groups had a relapse rate of 0.97, whereas patients in the IFNbeta-1a, IFNbeta-1b, and GA groups had relapse rate of 0.85, 0.61, and 0.62, respectively. Compared to the untreated group, reduction in the relapse rate was statistically significant only in the GA (P=0.003) and IFNbeta-1b (P=0.002) groups, in contrast to the IFNbeta-1a treated patients, who did not show a significant reduction (P=0.309). Compared to the untreated patients, mean EDSS was significantly reduced only in the GA (P=0.001) and IFNbeta-1b (P=0.01), in contrast to IFNbeta-1a treated patients (P=0.51). In this prospective, controlled, open-label, non-randomized 12-month study, treatment with only GA and IFNbeta-1b significantly reduced the relapse rate compared to untreated patients, supporting early treatment in RRMS. Our results are similar to the observations made after 12 months of therapy in phase III studies of IFNbeta-1a, IFNbeta-1b, and GA. Despite some limitations of the study design, the results provide helpful clinical information regarding the relative efficacy of each therapy in mildly affected treatment-naïve RRMS patients.
对复发缓解型多发性硬化症（RRMS）患者进行了一项前瞻性、非随机、开放标签的治疗试验，随访12个月。我们的主要目的是前瞻性比较干扰素β-1a（阿沃尼克）、干扰素β-1b（倍泰龙）和醋酸格拉替雷（GA，考帕松）对RRMS患者复发率的影响。1996年8月至1999年9月，对156例临床确诊的RRMS患者进行了随访，这些患者的库尔特克量表（EDSS）评分在4分及以下，随访时间从开始治疗或选择不治疗时起持续12个月。在入组时仔细回顾了患者之前2年的复发史和可用的病历信息。156例患者中，33例在入组时选择不治疗（平均年龄32.5岁；平均EDSS 2.64）；40例选择干扰素β-1a（平均年龄32.4岁；平均EDSS 2.69），41例选择干扰素β-1b（平均年龄32.1岁；平均EDSS 2.56），42例选择GA（平均年龄31.5岁；平均EDSS 2.57）。未治疗组基于入组前2年的年复发率为1.08，阿沃尼克组为1.20，倍泰龙组为1.21，GA组为1.10。四组在入组时无统计学显著差异。治疗12个月后，未治疗组患者的复发率为0.97，而干扰素β-1a组、干扰素β-1b组和GA组患者的复发率分别为0.85、0.61和0.62。与未治疗组相比，复发率降低仅在GA组（P=0.003）和干扰素β-1b组（P=0.002）有统计学显著性，而干扰素β-1a治疗的患者未显示出显著降低（P=0.309）。与未治疗患者相比，平均EDSS仅在GA组（P=0.001）和干扰素β-1b组（P=0.01）有显著降低，而干扰素β-1a治疗的患者无显著变化（P=0.51）。在这项前瞻性、对照、开放标签、非随机的12个月研究中，与未治疗患者相比，仅GA和干扰素β-1b治疗显著降低了复发率，支持RRMS的早期治疗。我们的结果与干扰素β-1a、干扰素β-1b和GA的III期研究治疗12个月后的观察结果相似。尽管研究设计存在一些局限性，但结果为每种疗法在轻度受累的初治RRMS患者中的相对疗效提供了有用的临床信息。
