Mitoxantrone in progressive multiple sclerosis:: a placebo-controlled, double-blind, randomised, multicentre trial
Mitoxantrone in progressive multiple sclerosis:: a placebo-controlled, double-blind, randomised, multicentre trial
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DOI：
10.1016/s0140-6736(02)12023-x
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发表时间：
2002-12-21
期刊：
影响因子：
168.9
通讯作者：
Zwingers, T
中科院分区：
文献类型：
--
作者：
Hartung, HP;Gonsette, R;Zwingers, T
背景 继发性进行性多发性硬化症患者的治疗选择很少。开放标签研究中令人鼓舞的结果促使我们在此类患者中进行了米托蒽醌的随机试验。方法 194 名患有恶化的复发缓解型或继发进展性多发性硬化症的患者被分配安慰剂或米托蒽醌（mg/m(2) [探索组] 或 12 mg/m(2) 静脉注射），每 3 个月一次，持续 24 个月。在 24 个月内每 3 个月进行一次临床评估。主要终点是五项临床指标的多变量分析。米托蒽醌 12 mg/m(2) 与安慰剂的分析基于至少接受一剂剂量并返回至少一次疗效评估的患者。结果 在 194 名入组患者中，188 名能够在 24 个月时进行评估。没有与药物相关的严重不良事件或临床上显着的心功能障碍的证据。 24 个月时，与安慰剂组相比，米托蒽醌组在主要结局方面获益（差异 0.30 [95% Cl 0.17-0.44]；p
Background Treatment options for patients with secondary progressive multiple,sclerosis are few. Encouraging results in open-label studies prompted this randomised trial of mitoxantrone in such patients.Methods 194 patients with worsening relapsing-remitting or secondary progressive multiple sclerosis were assigned placebo or mitoxantrone (mg/m(2) [exploratory group] or 12 mg/m(2) intravenously) every 3 months for 24 months. Clinical assessments were made every 3 months for 24 months. The primary endpoint was a multivariate analysis of five clinical measures. Analyses of mitoxantrone 12 mg/m(2) versus placebo were based on patients who received at least one dose and returned for at least one assessment of efficacy.Findings Of 194 patients enrolled, 188 were able to be assessed at 24 months. There were no drug-related serious adverse events or evidence of clinically significant cardiac dysfunction. At 24 months, the mitoxantrone group experienced benefits compared with the placebo group for the primary outcome (difference 0.30 [95% Cl 0.17-0.44]; p