Milanese C, La Mantia L, Palumbo R, Martinelli V, Murialdo A, Zaffaroni M, Caputo D, Capra R, Bergamaschi R
Centro Regionale per la Cura della Sclerosi Multipla, Istituto Nazionale Neurologico C Besta, Milan, Italy.
J Neurol Neurosurg Psychiatry. 2003 Dec;74(12):1689-92. doi: 10.1136/jnnp.74.12.1689.
Interferon beta 1b (Betaferon) and 1a (Avonex) were licensed in Italy for treating relapsing-remitting multiple sclerosis in February 1996 and August 1997, respectively.
To evaluate the effectiveness of these agents on the basis of clinical experience in northern Italian multiple sclerosis centres.
Clinical data on patients with relapsing-remitting multiple sclerosis were collected on an appropriate form from 65 centres in northern Italy. Intention to treat analysis was not possible, so patients who discontinued treatment (drop-outs) and who continued treatment (treated) were analysed separately. The main outcome measures were annual relapse frequency, number of relapse-free patients, mean change in extended disability status scale score (EDSS), and number of patients who worsened.
1481 patients were included; 834 were treated with Betaferon and 647 with Avonex for mean periods of 21.4 and 12.0 months, respectively. Basal EDSS was 2.37 and 2.17, respectively, and relapse frequency was 1.62 and 1.45. The annual relapse rate decreased by more than 60% with Betaferon and 55% with Avonex. The proportions of relapse-free, improved, and worsened patients were similar in the two groups. More patients interrupted treatment with Betaferon (41.1%) than with Avonex (15.3%); such patients showed more active disease at baseline and during treatment. The incidence of side effects was higher in Betaferon treated patients.
The effectiveness of Betaferon and Avonex is confirmed. There was a more marked effect than expected from the experimental trial results. This might reflect differences in inclusion criteria, or, more likely, loss of drop-outs, favouring selective retention of responders.
干扰素β1b（倍泰龙）和1a（阿沃尼）分别于1996年2月和1997年8月在意大利获批用于治疗复发缓解型多发性硬化症。
根据意大利北部多发性硬化症中心的临床经验评估这些药物的有效性。
从意大利北部的65个中心以合适的表格收集复发缓解型多发性硬化症患者的临床数据。由于无法进行意向性治疗分析，因此对停止治疗的患者（退出者）和继续治疗的患者（治疗者）分别进行分析。主要结局指标为年复发频率、无复发患者数量、扩展残疾状态量表评分（EDSS）的平均变化以及病情恶化的患者数量。
纳入1481例患者；834例接受倍泰龙治疗，647例接受阿沃尼治疗，平均治疗时间分别为21.4个月和12.0个月。基础EDSS分别为2.37和2.17，复发频率分别为1.62和1.45。使用倍泰龙时年复发率降低超过60%，使用阿沃尼时降低55%。两组中无复发、病情改善和病情恶化的患者比例相似。中断倍泰龙治疗的患者（41.1%）多于阿沃尼治疗的患者（15.3%）；此类患者在基线和治疗期间疾病活动度更高。接受倍泰龙治疗的患者副作用发生率更高。
倍泰龙和阿沃尼的有效性得到证实。其效果比实验性试验结果预期的更为显著。这可能反映了纳入标准的差异，或者更有可能是退出者的流失，有利于选择性保留反应者。
