Prescrire Int. 2007 Dec;16(92):252-7.
(1) Multiple sclerosis is a neurological disorder characterised by disseminated inflammatory lesions of the myelin sheath, the white fatty layer that covers the neurons in the brain and spinal column. The clinical repercussions are highly variable, ranging from minor deficits to severe disability and even death. Some patients have exacerbations separated by remissions of varying length, while others experience fairly steady progression of disability. This review article, based on Prescrire's standard in-house methodology, examines treatments proposed to slow the progression of multiple sclerosis. (2) For exacerbations (4 trials, a total of 140 patients), an improvement was noted in 64% of patients treated with intravenous methylprednisolone for 5 days, versus 40% of patients on placebo. (3) Interferon beta is the best-assessed of the disease-modifying drugs. Various marketed interferon beta products have been compared with one another in trials involving more than 1000 patients in total. There are no major differences in effectiveness or adverse effects. The latter are frequent, especially a flu-like syndrome and depression. (4) After a first episode suggestive of multiple sclerosis (3 trials, a total of 1160 patients), 35% of patients treated with interferon beta subsequently developed the disease, versus 50% of patients in the placebo groups. This advantage seemed to persist for at least 8 years. (5) In relapsing-remitting multiple sclerosis (4 trials, a total of 1426 patients), interferon beta prevented about one exacerbation every 2.5 to 3 years but had no clear preventive impact on progression of disability. (6) In secondary progressive multiple sclerosis (5 trials, a total of 3082 patients), interferon beta's effectiveness, if present, was limited to patients who continued to have exacerbations. (7) Natalizumab does not appear to be more effective than interferon beta. It is associated with serious adverse effects, about which only limited information is available. (8) Glatiramer has not been shown to prevent exacerbations or progression of disability. Intravenous immunoglobulin is still being tested in multiple sclerosis. In initially aggressive forms of multiple sclerosis, mitoxantrone has a negative risk-benefit balance (2 trials, 236 patients); it prevents less than one exacerbation during two years of treatment but causes heart failure in 1% to 2% of patients after 10 months of treatment. (9) Patients' anxiety as their disability worsens must not overshadow the fact that there are no treatments available with strong clinical effectiveness, and that all existing treatments carry a risk of serious adverse effects. Pending the arrival of something better, only interferon beta has a favourable risk-benefit balance, and only in selected patients.
（1）多发性硬化症是一种神经系统疾病，其特征是髓鞘出现弥漫性炎性病变，髓鞘是覆盖大脑和脊柱中神经元的白色脂肪层。临床影响差异很大，从轻微缺陷到严重残疾甚至死亡。一些患者病情有发作期，期间伴有长短不一的缓解期，而另一些患者则经历残疾程度相当稳定的进展。这篇综述文章基于Prescrire的标准内部方法，研究了为减缓多发性硬化症进展而提出的治疗方法。（2）对于发作期（4项试验，共140名患者），接受静脉注射甲基泼尼松龙治疗5天的患者中有64%病情有所改善，而接受安慰剂治疗患者的改善率为40%。（3）β-干扰素是评估最充分的疾病修正药物。在总共涉及1000多名患者的试验中，已将各种上市的β-干扰素产品相互比较。在有效性或不良反应方面没有重大差异。不良反应很常见，尤其是类流感综合征和抑郁。（4）在首次出现疑似多发性硬化症症状后（3项试验，共1160名患者），接受β-干扰素治疗的患者中有35%随后患上该疾病，而安慰剂组患者的这一比例为50%。这一优势似乎至少持续了8年。（5）在复发缓解型多发性硬化症中（4项试验，共1426名患者），β-干扰素大约每2.5至3年预防一次发作，但对残疾进展没有明显的预防作用。（6）在继发进展型多发性硬化症中（5项试验，共3082名患者），β-干扰素的有效性（如果存在的话）仅限于仍有发作的患者。（7）那他珠单抗似乎并不比β-干扰素更有效。它与严重不良反应相关，关于这方面的信息有限。（8）醋酸格拉替雷尚未被证明能预防发作或残疾进展。静脉注射免疫球蛋白仍在多发性硬化症中进行试验。在最初病情进展迅速的多发性硬化症中，米托蒽醌的风险效益比为负（2项试验，236名患者）；在两年的治疗期间，它预防发作的次数不到一次，但在治疗10个月后，1%至2%的患者会出现心力衰竭。（9）随着残疾程度加重，患者的焦虑情绪不应掩盖这样一个事实，即目前没有具有强大临床疗效的治疗方法，而且所有现有治疗方法都有产生严重不良反应的风险。在更好的治疗方法出现之前，只有β-干扰素具有良好的风险效益比，而且仅适用于特定患者。
