Pozzilli Carlo, Prosperini Luca, Tommasin Silvia, Gasperini Claudio, Barbuti Elena, De Giglio Laura
Department of Human Neuroscience, Sapienza University, Viale dell'Università 30, Rome, 00185, Italy.
Department of Neuroscience San Camillo-Forlanini Hospital, Rome, Italy.
Ther Adv Neurol Disord. 2021 Apr 24;14:17562864211011286. doi: 10.1177/17562864211011286. eCollection 2021.
To evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between cognitive and motor response to dalfampridine (DA) treatment.
This is a post hoc analysis of a randomized, double-blind, placebo-controlled trial in patients with MS randomized to receive DA 10 mg or placebo twice daily for 12 consecutive weeks. Here, we include only data from 71 patients in the arm treated with DA. According to the median value of Symbol Digit Modalities Test (SDMT) response, patients were categorized as "full responders" (FR) or "partially responders" (PR).
There was higher possibility of being FR in the presence of a baseline lower Expanded Disability Status Scale [odds ratio (OR) 0.69; 95% confidence interval (CI) 0.5-0.97, = 0.034], a higher Multiple Sclerosis Functional Composite value (OR 1.37; 95%CI 1.05-1.8, = 0.022), a lower Timed 25-Foot Walk Test (OR 0.76; 95% CI 0.6-0.98, = 0.033), and a lower 9-Hole Peg Test with dominant hand (OR 0.92; 95% CI 0.86-0.99, = 0.029). FR group did not show any significant improvement of motor performance compared with PR group.
The current analysis shows that in MS patients with cognitive deficit, the greatest improvement in SDMT provided by DA was observed in patients with milder motor impairment; cognitive and motor responses to treatments are not related.
EU Clinical Trials Register; ID 2013-002558-64 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002558-64).
评估预测多发性硬化症(MS)患者信息处理速度改善的基线特征,以及认知和运动对达氟吡啶(DA)治疗反应之间的关系。
这是一项对MS患者进行的随机、双盲、安慰剂对照试验的事后分析,患者被随机分配,连续12周每日两次接受10毫克DA或安慰剂治疗。在此,我们仅纳入接受DA治疗组中71例患者的数据。根据符号数字模态测验(SDMT)反应的中位数,患者被分类为“完全反应者”(FR)或“部分反应者”(PR)。
基线时扩展残疾状态量表较低时成为FR的可能性更高[比值比(OR)0.69;95%置信区间(CI)0.5 - 0.97,P = 0.034],多发性硬化功能综合评分较高(OR 1.37;95%CI 1.05 - 1.8,P = 0.022),定时25英尺步行试验较低(OR 0.76;95%CI 0.6 - 0.98,P = 0.033),以及优势手9孔插钉试验较低(OR 0.92;95%CI 0.86 - 0.99,P = 0.029)。与PR组相比,FR组运动表现未显示出任何显著改善。
当前分析表明,在有认知缺陷的MS患者中,DA对SDMT的最大改善见于运动障碍较轻的患者;认知和运动对治疗的反应无关。
欧盟临床试验注册库;编号2013 - 002558 - 64(https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002558-64)