Ghezzi A
Centro Studi Sclerosi Multipla, Ospedale S. Antonio Abate, Via Pastori 4, I-21013, Gallarate, Italy.
Neurol Sci. 2005 Dec;26 Suppl 4:S183-6. doi: 10.1007/s10072-005-0512-8.
The ITEM study group was organised in Italy to evaluate the effectiveness and safety of interferon-beta (IFNbeta) and glatiramer acetate (GA) in multiple sclerosis (MS) patients treated before 16 years of age. Eighty-six patients (58 females) were included in our database: as subjects with pre- and treatment duration <3 months were excluded, the data of 81 subjects were analysed: 51 were treated with IFNbeta-1a 6 million once weekly (Avonex), 19 with IFNbeta three times weekly (16 with Rebif, 3 with Betaferon) and 11 with GA (Copaxone). The mean age at onset was 12.4 (SD 2.4) years and the mean pre-treatment duration was 19.7 (SD 25.5) months. After a treatment duration of 36.1 (SD 24.2) months, the mean annualised relapse rate decreased from 2.8 (SD 2.6) to 0.5 (SD 0.7). The EDSS score remained unchanged (basal=1.4, final=1,4). Clinical side effects were recorded in 46 subjects of the IFNB group, transient in 35 (flu-like syndrome in 24, headache in 12, myalgia in 10, injection reaction in 5, fever in 3) and persistent in 11 (headache in 5, fever in 4, flu-like syndrome in 3, myalgia in 3, injection reaction in 1). In the GA-treated group, side effects were recorded in 3 cases: injection reaction in 2 and transient chest pain in 1. Abnormal laboratory findings (mainly reduction of WBC) were observed in 24 subjects (transient in 22). Nine subjects treated with Avonex discontinued the treatment: 7 shifted to Rebif, 2 stopped the therapy. Four subjects treated with INFbeta three times weekly shifted to other medications and 2 increased the dose. Four subjects treated with GA discontinued the treatment: 3 shifted to other medications and 1 stopped GA because of injection reaction. On the whole, 3 cases stopped the treatment definitively. To conclude 81, clinically definite MS subjects were treated during childhood or adolescence with immunomodulatory drugs. The treatment was generally well tolerated. It reduced the relapse rate and the progression of the disease in most cases.
ITEM研究小组在意大利成立，旨在评估β-干扰素（IFNβ）和醋酸格拉替雷（GA）对16岁之前接受治疗的多发性硬化症（MS）患者的有效性和安全性。我们的数据库纳入了86名患者（58名女性）：由于排除了病程小于3个月的患者，因此对81名患者的数据进行了分析：51名患者接受每周一次600万单位的IFNβ-1a（阿沃尼克斯）治疗，19名患者接受每周三次的IFNβ治疗（16名使用利比，3名使用β-干扰素），11名患者接受GA（考帕松）治疗。发病时的平均年龄为12.4（标准差2.4）岁，治疗前的平均病程为19.7（标准差25.5）个月。经过36.1（标准差24.2）个月的治疗，年化复发率从2.8（标准差2.6）降至0.5（标准差0.7）。扩展残疾状态量表（EDSS）评分保持不变（基线=1.4，最终=1.4）。IFNβ组有46名患者记录到临床副作用，35名是短暂性的（24名出现流感样综合征，12名头痛，10名肌痛，5名注射反应，3名发热），11名是持续性的（5名头痛，4名发热，3名流感样综合征，3名肌痛，1名注射反应）。在GA治疗组中，有3例记录到副作用：2例注射反应，1例短暂性胸痛。24名患者观察到实验室检查异常（主要是白细胞减少）（22名是短暂性的）。9名接受阿沃尼克斯治疗的患者停止了治疗：7名转用利比，2名停止治疗。4名每周接受三次IFNβ治疗的患者改用其他药物，2名增加了剂量。4名接受GA治疗的患者停止了治疗：3名转用其他药物，1名因注射反应停止使用GA。总体而言，3例患者最终停止了治疗。总之，81名临床确诊的MS患者在儿童期或青少年期接受了免疫调节药物治疗。该治疗总体耐受性良好。在大多数情况下，它降低了复发率和疾病进展。
