与历史对照相比，依达拉奉在意大利东北部肌萎缩侧索硬化症患者中的安全性和有效性。
Safety and efficacy of edaravone compared to historical controls in patients with amyotrophic lateral sclerosis from North-Eastern Italy.
机构信息
Neuromuscular Center, Department of Neurosciences, University of Padova, Italy.
Neuromuscular Center, Department of Neurosciences, University of Padova, Italy; Department of Neurosciences, University of Padova, Italy.
出版信息
J Neurol Sci. 2019 Sep 15;404:47-51. doi: 10.1016/j.jns.2019.06.006. Epub 2019 Jun 6.
OBJECTIVE
To test efficacy and tolerability of edaravone in patients with amyotrophic lateral sclerosis (ALS) originating from North-Eastern Italy.
METHODS
We compared 3-month and 6-month changes of ALSFRS-R score, FVC value, and MRC score of 31 consecutive patients with ALS who were treated with edaravone to those of 50 historical ALS patients who were not treated with edaravone.
RESULTS
No significant difference for any functional measures was found between the two groups at each time point as compared to baseline. In treated patients, we also observed creatinine values to significantly decrease at 3 and 6 months (p = 0.0078 and 0.030, respectively) and ALSAQ5 score to significantly increase (i.e. worse quality of life) at 3 and 6 months (p = 0.0005 and 0.0078, respectively). Yet, we observed an overall safety of the medication over the 6-month period of observation.
CONCLUSIONS
Our retrospective study suggests no benefit of edaravone on ALS in populations of Caucasian ancestry.
目的
测试依达拉奉治疗源自意大利东北部的肌萎缩侧索硬化症（ALS）患者的疗效和耐受性。
方法
我们比较了 31 例连续接受依达拉奉治疗的 ALS 患者与 50 例未接受依达拉奉治疗的历史 ALS 患者的 3 个月和 6 个月时 ALSFRS-R 评分、FVC 值和 MRC 评分的变化。
结果
与基线相比，两组在任何功能测量指标上均未在每个时间点显示出显著差异。在治疗组中，我们还观察到 3 个月和 6 个月时肌酐值显著下降（p=0.0078 和 0.030），并且 3 个月和 6 个月时 ALSAQ5 评分显著升高（即生活质量更差）（p=0.0005 和 0.0078）。然而，我们观察到在 6 个月的观察期内药物总体安全。
结论
我们的回顾性研究表明，依达拉奉对源自白种人群的 ALS 患者没有益处。
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