Study on Dalfampridine in the treatment of Multiple Sclerosis Mobility Disability: A meta-analysis

ObjectiveSystematic Review was used to evaluate the efficacy and safety of Dalfampridine (DAP) in the treatment of Mobility Disability (MS) in patients with Multiple Sclerosis.MethodsClinical randomized controlled studies about DAP and placebo in the treatment of Mobility Disability in patients with Multiple Sclerosis until March 2019 were explored by searching Embase, PubMed, Cochrane, Web of Knowledge, and ClinicalTrials.gov. Literature screening, data extraction, quality assessment, and statistical analysis were performed by using Stata 14.0.Results10 papers were included in the meta-analysis, and the number of patients was 2100. In conclusion, the application of DAP in clinical can significantly improve the Mobility Disability of patients [OR = 2.73, 95%CI (1.66, 4.50), P2 = 74.1%] and boost the mobility speed of patients in Timing 24 Minute Walk Test (T24FW) [SMD = 3,08, 95%CI(1,58, 4.58), P2 = 98.7%]. There are no significant differences of the incidence of adverse events [RR = 1.06, 95%CI (0.99, 1.14), P = 0.928, I2 = 0.0%] and urinary tract infection [RR = 1.21, 95%CI(0.91, 1.60), P = 0.145, I2 = 37.2%] between the DAP test group (Doses≤10 mg) and the placebo control group, and the incidence of adverse events [RR = 1.14, 95%CI(1.02, 1.28), P = 0.793, I2 = 0.0%] and urinary tract infection[RR = 3.05, 95%CI(1.04, 8.99), P = 0.680, I2 = 0.0%] for the DAP test group (Doses>10 mg) is a litter higher than the placebo control group.ConclusionDAP can effectively improve Mobility Disability in patients with Multiple Sclerosis, which is safe and reliable in specific DAP usage doses.

目的：本研究采用系统评价（Systematic Review）方法，评估达伐吡啶（Dalfampridine, DAP）治疗多发性硬化（Multiple Sclerosis, MS）患者运动功能障碍的有效性与安全性。方法：本研究检索了Embase、PubMed、Cochrane图书馆、Web of Knowledge及ClinicalTrials.gov数据库中截至2019年3月收录的、有关达伐吡啶与安慰剂治疗多发性硬化患者运动功能障碍的临床随机对照研究。由研究者采用Stata 14.0统计软件完成文献筛选、数据提取、质量评价及统计学分析。结果：本研究共纳入10项文献进行Meta分析，合计纳入患者2100例。结果显示，临床应用达伐吡啶可显著改善多发性硬化患者的运动功能障碍[优势比（OR）=2.73，95%置信区间（CI）(1.66, 4.50)，I²=74.1%]，并可提升患者24分钟步行试验（Timing 24 Minute Walk Test, T24FW）中的步行速度[标准化均数差（SMD）=3.08，95%CI(1.58, 4.58)，I²=98.7%]。在不良反应发生率方面，剂量≤10mg的达伐吡啶试验组与安慰剂对照组无显著差异[相对危险度（RR）=1.06，95%CI(0.99, 1.14)，P=0.928，I²=0.0%]；两组尿路感染发生率亦无显著差异[RR=1.21，95%CI(0.91, 1.60)，P=0.145，I²=37.2%]。而剂量>10mg的达伐吡啶试验组，其不良反应发生率[RR=1.14，95%CI(1.02, 1.28)，P=0.793，I²=0.0%]及尿路感染发生率[RR=3.05，95%CI(1.04, 8.99)，P=0.680，I²=0.0%]略高于安慰剂对照组。结论：达伐吡啶可有效改善多发性硬化患者的运动功能障碍，在限定的使用剂量下具有良好的安全性与可靠性。