Cocco E, Marchi P, Sardu C, Russo P, Paolillo A, Mascia Mg, Solla M, Frau J, Lorefice L, Massole S, Floris G, Marrosu Mg
Centro Sclerosi Multipla, Dipartimento di. Scienze Cardiovascolari e Neurologiche, University of Cagliari, Italy.
Mult Scler. 2007 Sep;13(8):975-80. doi: 10.1177/1352458507077621. Epub 2007 Apr 27.
We investigated the clinical and MRI effects of mitoxantrone (MITOX) administered to 45 patients during the first five years of highly active relapsing-remitting multiple sclerosis. Differences occurring between the end of treatment and follow-up (clinical mean: 3.6 years; brain MR: 1.8 years) with respect to baseline variables (EDSS, annualized relapse rate, active T2 lesions, new T1 lesions and number of Gd-enhancing lesions) were analysed using parametric and non-parametric tests. One patient developed leukemia four months after the end of the treatment; no other serious adverse events occurred during treatment and the follow-up period. A clinically relevant reduction in the annualized relapse rate ( P < 0.0001 at end of treatment and P < 0.0001 at follow-up) and improvement in the EDSS (P < 0.0001 at end of treatment and P = 0.0005 at follow-up) was found. At the end of treatment, 53% of patients experienced no increase in active T2 lesions, while 73% showed no increase in the number of new T1 lesions. At follow-up, 41 out of 45 (91%) patients showed a stable MRI pattern and were active-scan free. Despite potential serious adverse events, MITOX may be considered an option in selected patients with very active early MS.
我们研究了在高度活动性复发缓解型多发性硬化症的前五年中，对45例患者使用米托蒽醌（MITOX）的临床和MRI效果。使用参数检验和非参数检验分析了治疗结束与随访（临床平均：3.6年；脑部MRI：1.8年）之间相对于基线变量（扩展残疾状态量表[EDSS]、年化复发率、活动性T2病灶、新的T1病灶和钆增强病灶数量）出现的差异。一名患者在治疗结束后四个月患上白血病；在治疗和随访期间未发生其他严重不良事件。发现年化复发率有临床相关降低（治疗结束时P<0.0001，随访时P<0.0001），且EDSS有所改善（治疗结束时P<0.0001，随访时P=0.0005）。治疗结束时，53%的患者活动性T2病灶未增加，而73%的患者新T1病灶数量未增加。随访时，45例患者中有41例（91%）显示MRI模式稳定且无活动性扫描。尽管存在潜在的严重不良事件，但对于部分早期活动性很强的多发性硬化症患者，米托蒽醌可被视为一种选择。
