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Neurology:卡介苗有助预防多发性硬化症

来源:生物谷 2013-12-07 09:34

2013年12月7日讯 /生物谷BIOON/--发表在2013年12月4日Neurology杂志上的一项研究中,科学家们证实一种在世界其他地区用于预防肺结核的疫苗可能有助于预防多发性硬化症(MS)。

这项研究共涉及73人参与,这些人表现有MS发病迹象,如麻木,视力问题或平衡问题,同时核磁共振检查表明存在MS发病迹象。这下携带临床孤立综合症的人大约有一半人,最终会在两年之内发展成明确的MS,但有10%的人不会出现更多的MS相关疾病问题。

在这项研究中,参与者中的33人接收注射活疫苗卡介苗,卡介苗是用来在其他国家预防结核病的,但不能在美国使用。其他参与者接受安慰剂,所有的参与者进行脑部扫描每月一次,持续六个月。

然后,他们服用MS药物干扰素beta-1a一年。之后,他们服用自己神经科医生推荐的MS药物。研究开始五年后对MS的最终发生情况进行评价。首六个月后,接受疫苗的人有较少的脑病变,MS迹象比那些接受安慰剂的人少。

本研究结束时,接种的人中有58%的人没有罹患MS,而那些接受安慰剂的人中只有30%的人没有发展罹患MS。在研究期间,没有出现大的副作用,接受疫苗和那些没有接受疫苗的人之间发生的副作用没什么区别。研究作者Giovanni Ristori博士认为:这些结果是令人鼓舞的,但更多的研究需要做,以便更多地了解这个疫苗的安全性和长期影响,现在医生还不应该开始使用这种疫苗来治疗MS或临床孤立综合症。(生物谷Bioon.com)

 

Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS

G. Ristori, S. Romano, S. Cannoni, A. Visconti, E. Tinelli, L. Mendozzi, P. Cecconi, R. Lanzillo, M. Quarantelli, C. Buttinelli, C. Gasperini, M. Frontoni, G. Coarelli, D. Caputo, V. Bresciamorra, N. Vanacore, C. Pozzilli, M. Salvetti.

Objective: To evaluate Bacille Calmette-Guérin (BCG) effects after clinically isolated syndromes (CIS).

Methods: In a double-blind, placebo-controlled trial, participants were randomly assigned to receive BCG or placebo and monitored monthly with brain MRI (6 scans). Both groups then entered a preplanned phase with IM interferon-β-1a for 12 months. From month 18 onward, the patients took the disease-modifying therapies (DMTs) that their neurologist considered indicated in an open-label extension phase lasting up to 60 months.

Results: Of 82 randomized subjects, 73 completed the study (33 vaccinated and 40 placebo). During the initial 6 months, the number of cumulative lesions was significantly lower in vaccinated people. The relative risks were 0.541 (95% confidence interval [CI] 0.308–0.956; p = 0.03) for gadolinium-enhancing lesions (the primary endpoint), 0.364 (95% CI 0.207–0.639; p = 0.001) for new and enlarging T2-hyperintense lesions, and 0.149 (95% CI 0.046–0.416; p = 0.001) for new T1-hypointense lesions. The number of total T1-hypointense lesions was lower in the BCG group at months 6, 12, and 18: mean changes from baseline were 0.09 ± 0.72 vs 0.75 ± 1.81 (p = 0.01), 0.0 ± 0.83 vs 0.88 ± 2.21 (p = 0.08), and 0.21 ± 1.03 vs 1.00 ± 2.49 (p = 0.02). After 60 months, the cumulative probability of clinically definite multiple sclerosis was lower in the BCG + DMT arm (hazard ratio = 0.52, 95% CI 0.27–0.99; p < 0.05), and more vaccinated people remained DMT-free (odds ratio = 0.20, 95% CI 0.04–0.93; p = 0.04).

Conclusions: Early BCG may benefit CIS and affect its long-term course.

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