Department of Pharmacy, Peking University First Hospital, 6 Dahongluochang Street, Xicheng District, Beijing, 100034, China.
Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Science, Peking University, Beijing, China.
Orphanet J Rare Dis. 2021 Feb 15;16(1):87. doi: 10.1186/s13023-021-01694-8.
Multiple sclerosis (MS) is a chronic illness involving the central nervous system (CNS) that is characterised by inflammation, demyelination, and degenerative changes. Dalfampridine is one of the available treatments for MS symptoms and comorbidities. This meta-analysis aimed to assess the safety and benefits of dalfampridine versus placebo in MS by summarising data deriving from previously published clinical randomised controlled studies (RCTs).
A total of 9 RCTs were included in this meta-analysis, involving 1691 participants. There were significant differences between dalfampridine and placebo in terms of decreased 12-item Multiple Sclerosis Walking Scale score (weighted mean difference [WMD] = - 3.68, 95% confidence interval [CI] [- 5.55, - 1.80], p = 0.0001), improved response to the timed 25-foot walk test (relative risk [RR] = 2.57, 95% CI [1.04, 6.33], p = 0.04), increased 6-min walk test (WMD = 18.40, 95% CI [1.30, 35.51], p = 0.03), increased 9-Hole Peg Test score (WMD = 1.33, 95% CI [0.60, 2.05], p = 0.0004), and increased Symbol Digit Modalities Test score (WMD = 4.47, 95% CI [3.91, 5.02], p < 0.00001). Significant differences in the incidence of side effects were also observed (RR = 1.12, 95% CI [1.04, 1.21], p = 0.002).
Dalfampridine exerts positive effects on walking ability, finger dexterity, and cognitive function. Treatment should be administered under the guidance of a physician or pharmacist given the higher incidence of adverse events.
多发性硬化症（MS）是一种累及中枢神经系统（CNS）的慢性疾病，其特征为炎症、脱髓鞘和退行性改变。地夫可特是治疗 MS 症状和合并症的一种方法。本荟萃分析旨在通过汇总先前发表的临床随机对照研究（RCT）的数据，评估地夫可特相对于安慰剂治疗 MS 的安全性和疗效。
本荟萃分析共纳入 9 项 RCT，涉及 1691 名参与者。地夫可特与安慰剂相比，12 项 MS 步行量表评分降低（加权均数差 [WMD] = -3.68，95%置信区间 [CI] [-5.55，-1.80]，p = 0.0001）、 timed 25-foot walk test 反应改善（相对风险 [RR] = 2.57，95%CI [1.04，6.33]，p = 0.04）、6 分钟步行测试增加（WMD = 18.40，95%CI [1.30，35.51]，p = 0.03）、9 孔钉测试评分增加（WMD = 1.33，95%CI [0.60，2.05]，p = 0.0004）和符号数字模态测试评分增加（WMD = 4.47，95%CI [3.91，5.02]，p < 0.00001）。也观察到不良反应发生率的显著差异（RR = 1.12，95%CI [1.04，1.21]，p = 0.002）。
地夫可特对步行能力、手指灵巧度和认知功能有积极影响。鉴于不良事件发生率较高，应在医生或药剂师的指导下进行治疗。
