The Lancet:他汀类药物或可治疗多发性硬化症
新华网 · 2014/03/21
多发性硬化症是造成瘫痪的一大病因,最近英国医学杂志《柳叶刀》网站19日刊登一项新成果说,主要用于降血脂的他汀类药物可能对多发性硬化症患者有益,帮助他们减缓脑萎缩,缓解相关病情。


英国医学杂志《柳叶刀》网站19日刊登一项新成果说,主要用于降血脂的他汀类药物可能对多发性硬化症患者有益,帮助他们减缓脑萎缩,缓解相关病情。

多发性硬化症是造成瘫痪的一大病因,患者大脑和脊髓中的神经受损,导致运动能力、平衡能力和视力下降。据介绍,约有一半患者在患病约10年后,进入症状更为严重的后期阶段,目前尚没有专用药物能有效缓解这一阶段的病情。

英国伦敦大学学院等机构的研究人员报告说,他们共征集了140名多发性硬化症患者参与第二期临床实验,这些患者均已进入较严重的患病后期。研究人员将他们随机分为两组,在为期两年的实验中,一组患者每天服用80毫克辛伐他汀,另一组则只服用安慰剂。

定期脑部扫描发现,与对照组相比,服用辛伐他汀的患者脑萎缩速度平均减缓约43%。包括辛伐他汀之内的他汀类药物目前广泛用于降血脂,减少心血管疾病风险。研究人员推测,此类药物可帮助抵抗炎症、保护神经系统,这也许是其有助于缓解多发性硬化症的原因。

不过研究人员强调,这项研究成果只是对他汀类药物这一作用的初步验证,不应夸大其效果。下一步他们将征集更多参与者,开展更大规模的临床实验。

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  • Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial


    Background

    Secondary progressive multiple sclerosis, for which no satisfactory treatment presently exists, accounts for most of the disability in patients with multiple sclerosis. Simvastatin, which is widely used for treatment of vascular disease, with its excellent safety profile, has immunomodulatory and neuroprotective properties that could make it an appealing candidate drug for patients with secondary progressive multiple sclerosis.

    Methods

    We undertook a double-blind, controlled trial between Jan 28, 2008, and Nov 4, 2011, at three neuroscience centres in the UK. Patients aged 18—65 years with secondary progressive multiple sclerosis were randomly assigned (1:1), by a centralised web-based service with a block size of eight, to receive either 80 mg of simvastatin or placebo. Patients, treating physicians, and outcome assessors were masked to treatment allocation. The primary outcome was the annualised rate of whole-brain atrophy measured from serial volumetric MRI. Analyses were by intention to treat and per protocol. This trial is registered with ClinicalTrials.gov, number NCT00647348.

    Findings

    140 participants were randomly assigned to receive either simvastatin (n=70) or placebo (n=70). The mean annualised atrophy rate was significantly lower in patients in the simvastatin group (0·288% per year [SD 0·521]) than in those in the placebo group (0·584% per year [0·498]). The adjusted difference in atrophy rate between groups was −0·254% per year (95% CI −0·422 to −0·087; p=0·003); a 43% reduction in annualised rate. Simvastatin was well tolerated, with no differences between the placebo and simvastatin groups in proportions of participants who had serious adverse events (14 [20%] vs nine [13%]).

    Interpretation

    High-dose simvastatin reduced the annualised rate of whole-brain atrophy compared with placebo, and was well tolerated and safe. These results support the advancement of this treatment to phase 3 testing.

    Funding

    The Moulton Foundation [charity number 1109891], Berkeley Foundation [268369], the Multiple Sclerosis Trials Collaboration [1113598], the Rosetrees Trust [298582] and a personal contribution from A Pidgley, UK National Institute of Health Research (NIHR) University College London Hospitals/UCL Biomedical Research Centres funding scheme.

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