富马酸二甲酯治疗进展型多发性硬化症的有效性和安全性。
Effectiveness and safety of dimethyl fumarate in progressive multiple sclerosis.
作者信息
Moreira Ferreira Vanessa F, Liu Yanqing, Healy Brian C, Stankiewicz James M
机构信息
Department of Neurology, Brigham and Women's Hospital, Brigham MS Center, Harvard Medical School, Boston, MA, USA.
出版信息
Mult Scler J Exp Transl Clin. 2021 Apr 29;7(2):20552173211010832. doi: 10.1177/20552173211010832. eCollection 2021 Apr-Jun.
BACKGROUND
There is limited data analyzing the safety and effectiveness of dimethyl fumarate (DMF) in the progressive multiple sclerosis (PMS) population.
OBJECTIVE
To analyze the safety and effectiveness of DMF in patients with PMS.
METHODS
We used Cox proportional hazards models to compare the time to confirmed worsening and improvement on the Expanded Disability Status Scale (EDSS) and timed 25-foot walk (T25FW) between patients treated with DMF and glatiramer acetate (GA) for at least one year.
RESULTS
We included 46 patients treated with DMF and 42 patients treated with GA. The safety and tolerability of GA and DMF were consistent with established profiles. There was no difference in confirmed EDSS progression. A trend towards reduced T25FW was seen in the DMF compared to GA after adjustment (HR = 0.86; 95% CI:0.37, 1.98; p = 0.72 and HR = 0.60; 95% CI:0.27, 1.34; p = 0.21, respectively).
CONCLUSION
Dimethyl fumarate showed a trend towards reduction in T25FW but no evidence of clinically significant impact on EDSS. The small sample precluded definitive determination.
背景
分析富马酸二甲酯（DMF）在进展型多发性硬化症（PMS）患者中的安全性和有效性的数据有限。
目的
分析DMF在PMS患者中的安全性和有效性。
方法
我们使用Cox比例风险模型比较了接受DMF和醋酸格拉替雷（GA）治疗至少一年的患者在扩展残疾状态量表（EDSS）和25英尺步行时间（T25FW）上确认病情恶化和改善的时间。
结果
我们纳入了46例接受DMF治疗的患者和42例接受GA治疗的患者。GA和DMF的安全性和耐受性与既定情况一致。在确认的EDSS进展方面没有差异。调整后，与GA相比，DMF组的T25FW有下降趋势（HR = 0.86；95% CI：0.37，1.98；p = 0.72和HR = 0.60；95% CI：0.27，1.34；p = 0.21）。
结论
富马酸二甲酯显示出T25FW有下降趋势，但没有证据表明对EDSS有临床显著影响。样本量小妨碍了确定性的判定。
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