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关于达拉非尼治疗多发性硬化症运动障碍的研究:一项荟萃分析。

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

机构信息

School of Science Nantong University, NanTong, P.R. China.

Affiliated Hospital of Nantong University, NanTong, P.R. China.

出版信息

PLoS One. 2019 Sep 12;14(9):e0222288. doi: 10.1371/journal.pone.0222288. eCollection 2019.

Abstract

OBJECTIVE

Systematic Review was used to evaluate the efficacy and safety of Dalfampridine (DAP) in the treatment of Mobility Disability (MS) in patients with Multiple Sclerosis.

METHODS

Clinical 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.

RESULTS

10 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), P<0.001, I2 = 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), P<0.001, I2 = 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.

CONCLUSION

DAP can effectively improve Mobility Disability in patients with Multiple Sclerosis, which is safe and reliable in specific DAP usage doses.

摘要

目的

系统评价旨在评估达拉非尼(DAP)治疗多发性硬化症患者运动障碍的疗效和安全性。

方法

通过检索 Embase、PubMed、Cochrane、Web of Knowledge 和 ClinicalTrials.gov,检索截至 2019 年 3 月关于 DAP 和安慰剂治疗多发性硬化症运动障碍的临床随机对照研究。使用 Stata 14.0 进行文献筛选、数据提取、质量评估和统计分析。

结果

纳入 10 项荟萃分析研究,共 2100 例患者。结论:DAP 的临床应用能显著改善患者的运动障碍[OR = 2.73,95%CI(1.66,4.50),P<0.001,I2 = 74.1%],提高患者 24 分钟定时步行试验(T24FW)的移动速度[SMD = 3.08,95%CI(1.58,4.58),P<0.001,I2 = 98.7%]。不良事件的发生率[RR = 1.06,95%CI(0.99,1.14),P = 0.928,I2 = 0.0%]和尿路感染[RR = 1.21,95%CI(0.91,1.60),P = 0.145,I2 = 37.2%]无显著差异DAP 试验组(剂量≤10mg)与安慰剂对照组之间,不良事件发生率[RR = 1.14,95%CI(1.02,1.28),P = 0.793,I2 = 0.0%]和尿路感染[RR = 3.05,95%CI(1.04,8.99),P = 0.680,I2 = 0.0%]DAP 试验组(剂量>10mg)略高于安慰剂对照组。

结论

DAP 可有效改善多发性硬化症患者的运动障碍,在特定的 DAP 使用剂量下安全可靠。

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